Thursday, September 15, 2016

levothyroxine



lee-voe-thye-ROX-een


Oral route(Tablet)

Thyroid hormones, including levothyroxine, should not be used either alone or with other therapeutic agents for the treatment of obesity or weight loss. In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction. Larger doses may produce serious or even life-threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects .



Commonly used brand name(s)

In the U.S.


  • Levothroid

  • Levoxyl

  • Synthroid

  • Tirosint

  • Unithroid

Available Dosage Forms:


  • Tablet

  • Capsule, Liquid Filled

Therapeutic Class: Thyroid Supplement


Uses For levothyroxine


Levothyroxine is used to treat hypothyroidism, a condition where the thyroid gland does not produce enough thyroid hormone. Levothyroxine is also used to help decrease the size of enlarged thyroid glands (also called a goiter) and to treat thyroid cancer.


levothyroxine is available only with your doctor's prescription.


Importance of Diet


Certain foods may affect how levothyroxine works in the body. Dose adjustments may be needed if you or your child routinely consume any of the following:


  • Cotton seed meal.

  • Dietary fiber.

  • Soybean flour (infant formula).

  • Walnuts.

Before Using levothyroxine


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For levothyroxine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to levothyroxine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of levothyroxine in children.


Geriatric


Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of levothyroxine in the elderly. However, elderly patients are more likely to have age-related heart problems, which may require caution and an adjustment in the dose for patients receiving levothyroxine.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersAAdequate studies in pregnant women have not shown an increased risk of fetal abnormalities.

Breast Feeding


Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking levothyroxine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using levothyroxine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Acenocoumarol

  • Aluminum Carbonate, Basic

  • Aluminum Hydroxide

  • Aluminum Phosphate

  • Anisindione

  • Calcium Acetate

  • Calcium Carbonate

  • Calcium Citrate

  • Cholestyramine

  • Chromium

  • Colesevelam

  • Conjugated Estrogens

  • Dicumarol

  • Dihydroxyaluminum Aminoacetate

  • Dihydroxyaluminum Sodium Carbonate

  • Eltrombopag

  • Esterified Estrogens

  • Estradiol

  • Estriol

  • Estrone

  • Estropipate

  • Imatinib

  • Iron

  • Kelp

  • Lanthanum Carbonate

  • Lopinavir

  • Magaldrate

  • Magnesium Carbonate

  • Magnesium Hydroxide

  • Magnesium Oxide

  • Magnesium Trisilicate

  • Phenindione

  • Phenprocoumon

  • Phenytoin

  • Rifampin

  • Rifapentine

  • Ritonavir

  • Sevelamer

  • Simvastatin

  • Sodium Polystyrene Sulfonate

  • Soybean

  • Warfarin

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using levothyroxine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use levothyroxine, or give you special instructions about the use of food, alcohol, or tobacco.


  • Enteral Nutrition

Other Medical Problems


The presence of other medical problems may affect the use of levothyroxine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Abnormal heart rhythms (arrhythmias), history of or

  • Angina, history of or

  • Blood vessel disease, history of or

  • Heart disease, history of or

  • Osteoporosis, history of—Use with caution. May make these conditions worse.

  • Adrenal gland insufficiency (underactive adrenal gland), untreated or

  • Heart attack, recent or

  • Thyrotoxicosis (overactive thyroid), untreated—Should not use in patients with these conditions.

Proper Use of levothyroxine


levothyroxine will need to be taken for the rest of your life or your child's life. Do not stop taking levothyroxine or change your dose without first checking with your doctor. It may take several weeks before you start to notice that your symptoms are better.


It is best to take levothyroxine on an empty stomach. Take it with a full glass of water at least 30 minutes to 1 hour before eating breakfast.


levothyroxine should be taken at least 4 hours before or 4 hours after these medicines: antacids (Maalox®, Mylanta®, or Tums®), calcium supplements, cholestyramine (Prevalite®, Questran®), colestipol (Colestid®), iron supplements, orlistat (Alli®, Xenical®), simethicone (Gas-X®, Mylicon®), and sucralfate (Carafate®).


For infants and children who cannot swallow the tablet form, the tablet can be crushed and mixed with a small amount of water (5 to 10 milliliters [mL] or 1 to 2 teaspoonfuls). You may use a spoon or dropper to give the mixture. Use the mixture right away and do not store it to use later.


Dosing


The dose of levothyroxine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of levothyroxine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For oral dosage form (tablet):
    • For hypothyroidism:
      • Older adults—The dose is based on body weight and must be determined by your doctor. The usual dose is less than 1 microgram (mcg) per kilogram (kg) per day.

      • Adults and teenagers—The dose is based on body weight and must be determined by your doctor. The usual dose is 1.7 micrograms (mcg) per kilogram (kg) per day.

      • Children older than 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 2 to 3 mcg per kg per day.

      • Children 6 to 12 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 4 to 5 mcg per kg per day.

      • Children 1 to 5 years of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 5 to 6 mcg per kg per day.

      • Children 6 to 12 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 6 to 8 mcg per kg per day.

      • Children 3 to 6 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 8 to 10 mcg per kg per day.

      • Children 0 to 3 months of age—The dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 15 mcg per kg per day.



Missed Dose


If you miss a dose of levothyroxine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Precautions While Using levothyroxine


It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood and urine tests will be needed to check for unwanted effects.


Levothyroxine should not be used for the treatment of obesity or for the purpose of losing weight. levothyroxine is not effective for weight reduction. If taken in large amounts, levothyroxine may cause serious unwanted effects.


Hypothyroidism can sometimes cause infertility in men and women. Levothyroxine should not be used for the treatment of infertility unless it is caused by hypothyroidism.


For patients with diabetes, it is very important that you keep track of your blood or urine sugar levels as instructed by your doctor. Check with your doctor right away if you notice any changes in your sugar levels.


If you think you have become pregnant while using levothyroxine, tell your doctor right away. You may need a larger dose of levothyroxine while you are pregnant.


Women who use levothyroxine for a long time may have some bone loss, which could lead to osteoporosis. Talk with your doctor if you have questions or concerns about this.


Call your doctor right away if you or your child start to have rapid or irregular heartbeats, chest pain, shortness of breath, leg cramps, headaches, nervousness, irritability, sleeplessness, tremors, a change in appetite, weight gain or loss, vomiting, diarrhea, excessive sweating, heat intolerance, a fever, changes in menstrual periods, hives, or a skin rash. These could be symptoms of too much medicine in your body.


Make sure any doctor or dentist who treats you knows that you or your child are using levothyroxine. You may need to stop using levothyroxine several days before having surgery or medical tests.


A temporary loss of hair may occur during the first few months of levothyroxine therapy. Ask your doctor about this if you have any concerns.


levothyroxine Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor immediately if any of the following side effects occur:


Less common
  • Chest pain or discomfort

  • decreased urine output

  • difficult or labored breathing

  • difficulty with swallowing

  • dilated neck veins

  • extreme fatigue

  • fainting

  • fast, slow, irregular, pounding, or racing heartbeat or pulse

  • fever

  • heat intolerance

  • hives or welts

  • increased blood pressure

  • increased pulse

  • irregular breathing

  • irritability

  • menstrual changes

  • nausea

  • pain or discomfort in the arms, jaw, back, or neck

  • shortness of breath

  • skin itching, rash, or redness

  • sweating

  • swelling of the eyes, face, lips, throat, or tongue

  • tightness in the chest

  • tremors

  • troubled breathing

  • wheezing

Rare
  • Blurred or double vision

  • dizziness

  • eye pain

  • lack or slowing of normal growth in children

  • limp or walk favoring one leg

  • pain in the hip or knee

  • seizures

  • severe headache

Get emergency help immediately if any of the following symptoms of overdose occur:


Symptoms of Overdose
  • Change in consciousness

  • cold clammy skin

  • confusion

  • disorientation

  • fast or weak pulse

  • lightheadedness

  • loss of consciousness

  • sudden headache

  • sudden loss of coordination

  • sudden slurring of speech

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


Less common
  • Abdominal cramps

  • change in appetite

  • crying

  • diarrhea

  • false or unusual sense of well-being

  • fear

  • feeling not well or unhappy

  • feeling of discomfort

  • feeling of warmth

  • feeling things are not real

  • feelings of suspicion and distrust

  • hair loss

  • headache

  • increased appetite

  • mental depression

  • muscle weakness

  • nervousness

  • quick to react or overreact emotionally

  • rapidly changing moods

  • redness of the face, neck, arms, and occasionally, upper chest

  • restlessness

  • sleeplessness

  • trouble getting pregnant

  • trouble sitting still

  • trouble sleeping

  • unable to sleep

  • unusual tiredness or weakness

  • vomiting

  • weight gain

  • weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: levothyroxine side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More levothyroxine resources


  • Levothyroxine Side Effects (in more detail)
  • Levothyroxine Use in Pregnancy & Breastfeeding
  • Drug Images
  • Levothyroxine Drug Interactions
  • Levothyroxine Support Group
  • 128 Reviews for Levothyroxine - Add your own review/rating


  • Levothyroxine MedFacts Consumer Leaflet (Wolters Kluwer)

  • Levothyroxine Prescribing Information (FDA)

  • Levothroid Prescribing Information (FDA)

  • Levothyroxine Sodium Monograph (AHFS DI)

  • Levoxyl Prescribing Information (FDA)

  • Levoxyl Consumer Overview

  • Synthroid Prescribing Information (FDA)

  • Synthroid Consumer Overview

  • Tirosint Prescribing Information (FDA)

  • Tirosint MedFacts Consumer Leaflet (Wolters Kluwer)



Compare levothyroxine with other medications


  • Hashimoto's disease
  • Hypothyroidism, After Thyroid Removal
  • Myxedema Coma
  • Thyroid Suppression Test
  • TSH Suppression
  • Underactive Thyroid

Lotrimin Topical


Generic Name: clotrimazole (Topical route)

kloe-TRIM-a-zole

Commonly used brand name(s)

In the U.S.


  • Clotrim Antifungal

  • Cruex Prescription Strength

  • Lotrimin

  • Lotrimin AF

  • Mycelex

In Canada


  • Canesten

  • Clotrimaderm

  • Desenex

  • Myclo-Derm

  • Neo-Zol

Available Dosage Forms:


  • Lotion

  • Solution

  • Cream

Therapeutic Class: Antifungal


Chemical Class: Imidazole


Uses For Lotrimin


Clotrimazole topical preparations are used to treat fungus infections on the skin.


This medicine is available both over-the-counter (OTC) and with your doctor's prescription.


Before Using Lotrimin


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical clotrimazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Fentanyl

  • Tacrolimus

  • Trimetrexate

Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Proper Use of clotrimazole

This section provides information on the proper use of a number of products that contain clotrimazole. It may not be specific to Lotrimin. Please read with care.


Apply enough clotrimazole to cover the affected and surrounding skin areas, and rub in gently.


Keep this medicine away from the eyes.


When clotrimazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.


To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses .


Dosing


The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For topical dosage forms (cream, lotion, and solution):
    • Fungal infections (treatment):
      • Adults and children—Use two times a day, morning and evening.



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Lotrimin


If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your doctor.


Lotrimin Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


  • Skin rash, hives, blistering, burning, itching, peeling, redness, stinging, swelling, or other sign of skin irritation not present before use of this medicine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Lotrimin Topical side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More Lotrimin Topical resources


  • Lotrimin Topical Side Effects (in more detail)
  • Lotrimin Topical Use in Pregnancy & Breastfeeding
  • Lotrimin Topical Support Group
  • 0 Reviews for Lotrimin Topical - Add your own review/rating


Compare Lotrimin Topical with other medications


  • Tinea Corporis
  • Tinea Pedis

Lactobacillus Acidophilus


Class: Antidiarrhea Agents
ATC Class: G01AX14
Brands: Bacid, Bulgaricum IB, DDS-Acidophilus, FLORAjen, Intestinex, Kyo-Dophilus, Lactinex, Probiata, ProBiotic Restore, Superdophilus, Super Vegi-dophilus, Trenev Trio

Introduction

A bacterium that creates an environment unfavorable to the overgrowth of potentially pathogenic fungi and bacteria; used as an antidiarrheal agent.a


Uses for Lactobacillus Acidophilus


Diarrhea


Preparations containing Lactobacillus acidophilus with or without L. bulgaricus are used for treatment of uncomplicated diarrhea, particularly that caused by modification of the intestinal flora by antibiotics.a


Lactobacillus preparations may assist in reestablishing the normal physiologic and bacterial flora of the intestinal tract.a


Also has been used for treatment of infectious diarrhea, ulcerative colitis, irritable colon, diverticulitis, colostomies with either diarrhea or constipation, functional constipation, mucous or spastic diarrhea, and diarrhea following amebiasis.a


Because of a lack of substantial evidence from well-designed, controlled studies to support claims of efficacy, manufacturers can no longer claim usefulness in the treatment of diarrhea.a Lactobacillus preparations may remain on the market in the US as foods or food (nutritional) supplements.a


Lactobacillus acidophilus, in combination with Bifidobacterium bifidum, may be effective in the prevention of traveler's diarrhea.c


Bacterial Vaginosis


Lactobacillus preparations have been used intravaginally for the treatment of bacterial vaginosis.b Results of some studies indicate that intravaginal administration of Lactobacillus acidophilus for 6–12 days or oral administration of Lactobacillus acidophilus for 2 months is more effective than placebo, acetic acid, or no treatment.b However, other clinical trials found no substantial difference in cure rate of bacterial vaginosis and in the number of vaginal lactobacilli after intravaginal administration of lactobacilli when compared with placebo and estrogens.b


Other Uses


May provide relief to patients with hives, fever blisters, canker sores, and adolescent acne; however, results in these largely self-limiting conditions have been equivocal.a


Lactobacillus Acidophilus Dosage and Administration


Administration


Oral Administration


Administer orally, preferably with milk, fruit juice, or water.a


Conventional capsules, tablets, and granules may be chewed or swallowed whole.a


Granules or contents of Intestinex capsules may be added to or taken with cereal, food, milk, fruit juice, or water.a


Enteric-coated capsules should be swallowed whole.a


Dosage


Pediatric Patients


Diarrhea

Children <3 years of age

Oral

Some manufacturers recommend that Lactobacillus preparations not be used in infants and children <3 years of age unless under the direction and supervision of a physician.a e f g


Children ≥3 years of age

Oral

Lactobacillus acidophilus preparations (containing sodium carboxymethylcellulose): 2 capsules 2–4 times daily.a


Lactobacillus acidophilus preparations containing L. bulgaricus: 2 capsules, 4 tablets, or 1 packet of granules 3 or 4 times daily.a


Enteric-coated capsules containing Lactobacillus acidophilus and L. casei: 1 capsule daily for the first 2 weeks of therapy; dosage may then be increased up to a maximum of 3 capsules daily if necessary.a


When used for self-medication of diarrhea or in the presence of a high fever, do not use Lactobacillus acidophilus preparations for >2 days, unless otherwise directed by a physician.a


Adults


Diarrhea

Oral

Lactobacillus acidophilus preparations (containing sodium carboxymethylcellulose): 2 capsules 2–4 times daily.a


Lactobacillus acidophilus preparations containing L. bulgaricus: 2 capsules, 4 tablets, or 1 packet of granules 3 or 4 times daily.a


Enteric-coated capsules containing Lactobacillus acidophilus and L. casei: 1 capsule daily for the first 2 weeks of therapy; dosage may then be increased up to a maximum of 3 capsules daily if necessary.a


When used for self-medication of diarrhea or in the presence of a high fever, do not use Lactobacillus acidophilus preparations for >2 days, unless otherwise directed by a physician.a


Cautions for Lactobacillus Acidophilus


Contraindications



  • Hypersensitivity to milk or lactose products.a j



Warnings/Precautions


General Precautions


Intestinal Damage, Infection, or Flatus

Do not use in patients with intestinal damage or infection. h


May produce an increase in intestinal flatus at the beginning of therapy; usually subsides with continued therapy.a


Weakened Immune System

Do not use in patients with weakened immune system. h


Self-medication in Presence of High Fever

Do not use Lactobacillus acidophilus preparations for >2 days, unless otherwise directed by a physician.a


Specific Populations


Pregnancy

No adequate and well-controlled studies have been conducted in pregnant women; pregnant women should only use Lactobacillus acidophilus under medical supervision.i


Pediatric Use

Some manufacturers recommend that Lactobacillus preparations not be used in infants and children <3 years of age unless under the direction and supervision of a physician.a


Common Adverse Effects


Flatulence.a


Stability


Storage


Oral


Capsules, Tablets, and Powder

2–8°C.a


ActionsActions



  • Through the production of lactic acid, creates an environment unfavorable to the overgrowth of potentially pathogenic fungi and bacteria (including putrefactive bacteria) and favors establishment of an aciduric flora.a




  • Some commercially available preparations containing Lactobacillus acidophilus also contain standardized viable culture of Lactobacillus bulgaricus, which provides transient beneficial flora and enhances the growth of desirable bacteria by forming lactic acid on fermentation of carbohydrates.a



Advice to Patients



  • Advise patient of possible increased production of intestinal flatus at the beginning of therapy, which usually subsides with continued therapy.a




  • Importance of informing clinicians of existing or contemplated therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses.j




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.j




  • Importance of informing patients of other important precautionary information.j (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.





























































































Lactobacillus Acidophilus

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



DDS-Acidophilus (dairy-free)



UAS Laboratories



FLORAjen Acidophilus Extra Strength (dairy-free)



American Lifeline



Intestinex (with Lactobacillus bulgaricus)



Marin



Kyo-Dophilus (with Bifidobacterium bifidum and Bifidobacterium longum)



Wakunaga



ProBiotic Restore (with Bifidobacterium bifidum)



AdvoCare



Superdophilus (dairy-free)



Natren



Trenev Trio (with Bifidobacterium bifidum and Lactobacillus bulgaricus; dairy-free)



Natren



Powder



Bulgaricum IB (with Lactobacillus bulgaricus)



Natren



DDS-Acidophilus (dairy-free)



UAS Laboratories



Lactinex Granules (with Lactobacillus bulgaricus)



Becton Dickinson Microbiology



Superdophilus (dairy-free)



Natren



Super Vegi-dophilus (dairy-free)



Natren



Tablets



Bacid Caplets ( with Bifidobacterium bifidum, Lactobacillus bulgaricus, and Thermophilus spp.)



Insight



DDS-Acidophilus (dairy-free)



UAS Laboratories



Kyo-Dophilus



Wakunaga



Lactinex (with Lactobacillus bulgaricus)



Becton Dickinson Microbiology



Probiata



Wakunaga



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



a. AHFS drug information 2007. McEvoy GK, ed. Lactobacillus Acidiphilus. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2915-6.



b. Falagas ME, Betsi GI, Athanasiou S et al. Probiotics or the treatment of women with bacterial vaginosis. Clin Microbiol Infec. 2007; 13:657-64.



c. McFarland LV. Meta-analysis of probiotics for the prevention of traveler's diarrhea. Travel Med Infect Dis. 2007; 5:97-105 [PubMed 17298915]



e. Superdophilus. Drug Digest website. Available at: . Accessed 2007 July 27.



f. Drugs and treatment-Probiotica Oral. Webmd website. Available at: . Accessed 2007 July 29.



g. Bd microbio.sys. Lactinex. Accessed from Processrx website (). Accessed 2007 July 22.



h. Lactobacillus acidophilus. Natural standard website. Available at http://www.naturalstandard.com. Accessed 2007 Aug 8.



i. Lactobacillus acidophilus. Mayo clinic website. Available at: . Accessed 2007 Aug 8.



j. Marin Pharm. Intestinex. Accessed from Vastrx website (). Accessed 2007 Sept 26.



More Lactobacillus Acidophilus resources


  • Lactobacillus Acidophilus Side Effects (in more detail)
  • Lactobacillus Acidophilus Support Group
  • 6 Reviews for Lactobacillus Acidophilus - Add your own review/rating


  • Acidophilus Natural MedFacts for Professionals (Wolters Kluwer)

  • Acidophilus Natural MedFacts for Consumers (Wolters Kluwer)

  • Acidophilus Consumer Overview



Compare Lactobacillus Acidophilus with other medications


  • Clostridial Infection
  • Diarrhea
  • Irritable Bowel Syndrome
  • Oral Thrush
  • Traveler's Diarrhea
  • Urinary Tract Infection
  • Vaginal Yeast Infection

levetiracetam



Generic Name: levetiracetam (LEE ve tye RA se tam)

Brand Names: Keppra, Keppra XR


What is levetiracetam?

Levetiracetam is an anti-epileptic drug.


Levetiracetam is used to treat partial onset seizures in adults and children who are at least 4 years old.


Levetiracetam is also used to treat tonic-clonic seizures in adults and children who are at least 6 years old, and myoclonic seizures in adults and children who are at least 12 years old.


Levetiracetam may also be used for other purposes not listed in this medication guide.


What is the most important information I should know about levetiracetam?


Do not stop taking levetiracetam without first talking to your doctor, even if you feel better. If you stop taking levetiracetam suddenly, you may have increased seizures. Tell your doctor if you have new or worsening seizures.

You may have thoughts about suicide while taking this medication. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.


Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself. Carry an ID card or wear a medical alert bracelet stating that you are taking levetiracetam, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking levetiracetam. Levetiracetam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

What should I discuss with my healthcare provider before taking levetiracetam?


You should not use this medication if you are allergic to levetiracetam.

Before using this medication, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests during treatment.


You may have thoughts about suicide while taking this medication. Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months of treatment, or whenever your dose is changed.


Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits. Do not miss any scheduled appointments.


FDA pregnancy category C. It is not known whether levetiracetam is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Levetiracetam can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child without the advice of a doctor.

How should I take levetiracetam?


Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the instructions on your prescription label.


Your doctor may occasionally change your dose to make sure you get the best results from this medication.


Take the medication with a full glass of water. You may take levetiracetam with or without food.

Measure the liquid form of levetiracetam with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.


Do not crush, chew, or break a levetiracetam tablet. Swallow the pill whole.

Levetiracetam can be taken with or without food.


It is important to use levetiracetam regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.


Do not stop taking levetiracetam without first talking to your doctor, even if you feel better. If you stop taking levetiracetam suddenly, you may have increased seizures. Tell your doctor if you have new or worsening seizures.

Seizures are often treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.


Carry an ID card or wear a medical alert bracelet stating that you are taking levetiracetam, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking levetiracetam.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.


Store levetiracetam at room temperature away from moisture, heat, and light.

See also: Levetiracetam dosage (in more detail)

What happens if I miss a dose?


If you have missed your dose by only a few hours, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical treatment if you think you have used too much of this medicine.

Overdose symptoms may include drowsiness, agitation, aggression, shallow breathing, weakness, or fainting.


What should I avoid while taking levetiracetam?


Avoid drinking alcohol. It can increase some of the side effects of levetiracetam and may also increase the risk of seizures. Levetiracetam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Levetiracetam side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.


Call your doctor at once if you have any of these serious side effects:

  • hallucinations;




  • fever, chills, body aches, flu symptoms;




  • weakness, lack of coordination;




  • increasing or worsening seizures; or




  • nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • dizziness, spinning sensation;




  • drowsiness;




  • feeling irritable;




  • headache;




  • runny nose, sore throat; or




  • neck pain.



This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.


Levetiracetam Dosing Information


Usual Adult Dose for Seizures:

16 years of age and older:

Initial Dose: 1000 mg daily by either immediate release oral or intravenous administration, given as 500 mg twice daily. Additional dosing increments may be given (1000 mg/day additional every 2 weeks) to a maximum recommended daily dose of 3000 mg. There is no evidence that doses greater than 3000 mg/day confer additional benefit.

Extended release:
Initial dose: 1000 mg orally once daily
This dose may be increased every 2 weeks by 1000 mg/day to a maximum of 3000 mg once daily.

Usual Pediatric Dose for Seizures:

Myoclonic seizures:
Oral:
Children 12 years and older: Immediate release: Initial: 500 mg twice daily; may increase every 2 weeks by 500 mg/dose to the recommended dose of 1500 mg twice daily. Efficacy of doses greater than 3000 mg/day has not been established.

Partial onset seizures:
Oral:
Children 1 month to less than 6 months old: Immediate release: 7 mg/kg/dose given twice daily (14 mg/kg/day); may increase every 2 weeks by increments of 14 mg/kg to the recommended daily dose of 42 mg/kg.
Children 6 months to less than 4 years old: Immediate release: 10 mg/kg given twice daily (20 mg/kg/day); may increase in 2 weeks by an increment of 20 mg/kg to the recommended daily dose of 50 mg/kg (25 mg/kg twice daily). The daily dose of 50 mg/kg may be reduced in patients who cannot tolerate this dose.
Children 4 to less than 16 years: Immediate release: 10 mg/kg/dose given twice daily; may increase every 2 weeks by 10 mg/kg/dose to the recommended dose of 30 mg/kg/dose twice daily (60 mg/kg/daily). The daily dose of 60 mg/kg may be reduced in patients who cannot tolerate this dose.
Children 16 years and older: Refer to adult dosing.
Maximum dose: 3000 mg/day

Tonic-clonic seizures:
Oral:
Children 6 to less than 16 years: Immediate release: Initial: 10 mg/kg dose given twice daily; may increase every 2 weeks by 10 mg/kg/dose to the recommended dose of 30 mg/kg twice daily. Efficacy of doses greater than 60 mg/kg/day has not been established.
Children 16 years and older: Refer to adult dosing.
Maximum dose: 3000 mg/day


What other drugs will affect levetiracetam?


There may be other drugs that can interact with levetiracetam. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.



More levetiracetam resources


  • Levetiracetam Side Effects (in more detail)
  • Levetiracetam Dosage
  • Levetiracetam Use in Pregnancy & Breastfeeding
  • Drug Images
  • Levetiracetam Drug Interactions
  • Levetiracetam Support Group
  • 101 Reviews for Levetiracetam - Add your own review/rating


  • levetiracetam Advanced Consumer (Micromedex) - Includes Dosage Information

  • Keppra Consumer Overview

  • Keppra Prescribing Information (FDA)

  • Keppra XR Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Levetiracetam Prescribing Information (FDA)

  • Levetiracetam Monograph (AHFS DI)

  • Levetiracetam MedFacts Consumer Leaflet (Wolters Kluwer)

  • Levetiracetam Professional Patient Advice (Wolters Kluwer)



Compare levetiracetam with other medications


  • Bipolar Disorder
  • Epilepsy
  • Hyperekplexia
  • Neuralgia
  • New Daily Persistent Headache
  • Seizures


Where can I get more information?


  • Your pharmacist can provide more information about levetiracetam.

See also: levetiracetam side effects (in more detail)


Wednesday, September 14, 2016

Lantus Solostar Pens


Pronunciation: IN-su-lin GLAR-jeen
Generic Name: Insulin Glargine
Brand Name: Lantus Solostar


Lantus Solostar Pens are used for:

Treating diabetes mellitus.


Lantus Solostar Pens are a long-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.


Do NOT use Lantus Solostar Pens if:


  • you are allergic to any ingredient in Lantus Solostar Pens

Contact your doctor or health care provider right away if any of these apply to you.



Before using Lantus Solostar Pens:


Some medical conditions may interact with Lantus Solostar Pens. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you drink alcoholic beverages

  • if you have liver or kidney problems, diabetic ketoacidosis, or nerve problems

  • if you have high blood sodium levels or are on a low salt diet

Some MEDICINES MAY INTERACT with Lantus Solostar Pens. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased

  • Atypical antipsychotics (eg, olanzapine), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), protease inhibitors (eg, ritonavir), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Lantus Solostar Pens's effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lantus Solostar Pens may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Lantus Solostar Pens:


Use Lantus Solostar Pens as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • A Lantus Solostar Instruction Leaflet and an extra patient leaflet are available with Lantus Solostar Pens. Talk to your pharmacist if you have questions about this information.

  • Use Lantus Solostar Pens at the same time each day, as directed by your doctor.

  • Before the first use of a new pen, remove the pen from the refrigerator 1 to 2 hours before use. Do NOT store used pens in the refrigerator.

  • A health care provider will teach you how to use Lantus Solostar Pens. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

  • Wash your hands before you use Lantus Solostar Pens. Always attach a new needle and perform the safety test as directed before each use.

  • Check the dose window before each use to be sure you have dialed the correct dose of insulin. Using too much or too little insulin may result in serious side effects.

  • Lantus Solostar Pens should be clear and colorless. Do not use Lantus Solostar Pens if it contains particles or is discolored, or if the container is cracked or damaged.

  • Do NOT dilute Lantus Solostar Pens or mix it with other insulin.

  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.

  • Injection sites within an injection area (abdomen, thigh, or upper arm) must be rotated from one injection to the next.

  • After you have injected your dose, slowly count to 10 before you take the needle out of your skin. This will help make sure that you receive the full dose.

  • Protect the insulin pen from dust and dirt. You may clean the pen by wiping it with a damp cloth. Do NOT soak, wash, or lubricate the pen.

  • Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.

  • The effect of Lantus Solostar Pens lasts for up to 24 hours.

  • Lantus Solostar Pens begins lowering blood sugar about 1 to 2 hours after an injection. There is no peak effect. The effect lasts for up to 24 hours.

  • Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Lantus Solostar Pens.



Important safety information:


  • Lantus Solostar Pens may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Lantus Solostar Pens with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.

  • Do not exceed the recommended dose, use Lantus Solostar Pens more often than prescribed, or change the type or dose of insulin you are taking without checking with your doctor.

  • Proper diet, regular exercise, and regular testing of blood sugar are important for best results when using Lantus Solostar Pens. Follow your doctor's instructions carefully. If your blood sugar level is often higher or lower than it should be and you are taking Lantus Solostar Pens according to directions, check with your doctor.

  • Illness, especially with nausea and vomiting, emotional problems, stress, or changes in diet or activity level, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.

  • If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.

  • An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

  • Developing a fever or infection, eating significantly more than usual, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. If not treated, loss of consciousness, coma, or death may occur.

  • Carry an ID card at all times that says you have diabetes.

  • Lab tests, including fasting blood glucose levels or glycosylated hemoglobin levels, may be performed while you use Lantus Solostar Pens. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Lantus Solostar Pens with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar.

  • Lantus Solostar Pens should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lantus Solostar Pens while you are pregnant. Lantus Solostar Pens are found in breast milk. If you are or will be breast-feeding while you use Lantus Solostar Pens, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Lantus Solostar Pens:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Redness, swelling, itching, or mild pain at the injection site.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Lantus Solostar side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.


Proper storage of Lantus Solostar Pens:

Store new (unopened) pens in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Lantus Solostar Pens. Store used (open) pens at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) pens in the refrigerator. Store away from heat and light. If Lantus Solostar Pens has been frozen or overheated, throw it away. Throw away unrefrigerated or used pens after 28 days, even if they still contain medicine.


Do not leave Lantus Solostar Pens in a car on a warm or sunny day. Do not use Lantus Solostar Pens after the expiration date stamped on the label. Keep Lantus Solostar Pens, as well as syringes and needles, out of the reach of children and away from pets.


General information:


  • If you have any questions about Lantus Solostar Pens, please talk with your doctor, pharmacist, or other health care provider.

  • Lantus Solostar Pens are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lantus Solostar Pens. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Lantus Solostar resources


  • Lantus Solostar Side Effects (in more detail)
  • Lantus Solostar Use in Pregnancy & Breastfeeding
  • Lantus Solostar Drug Interactions
  • Lantus Solostar Support Group
  • 5 Reviews for Lantus Solostar - Add your own review/rating


Compare Lantus Solostar with other medications


  • Diabetes, Type 1
  • Diabetes, Type 2

Lantus Cartridge Systems



Pronunciation: IN-su-lin GLAR-jeen
Generic Name: Insulin Glargine
Brand Name: Examples include Lantus and Lantus Solostar


Lantus Cartridge Systems are used for:

Treating diabetes mellitus.


Lantus Cartridge Systems are a long-acting form of the hormone insulin. It works by helping your body to use sugar properly. This lowers the amount of glucose in the blood, which helps to treat diabetes.


Do NOT use Lantus Cartridge Systems if:


  • you are allergic to any ingredient in Lantus Cartridge Systems

Contact your doctor or health care provider right away if any of these apply to you.



Before using Lantus Cartridge Systems:


Some medical conditions may interact with Lantus Cartridge Systems. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you drink alcoholic beverages

  • if you have liver or kidney problems, diabetic ketoacidosis, or nerve problems

  • if you have high blood sodium levels or are on a low salt diet

Some MEDICINES MAY INTERACT with Lantus Cartridge Systems. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), clonidine, guanethidine, lithium, or reserpine because they may increase the risk of high or low blood sugar or may hide the signs and symptoms of low blood sugar, if it occurs

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), disopyramide, fenfluramine, fibrates (eg, clofibrate, gemfibrozil), fluoxetine, monoamine oxidase inhibitors (MAOIs) (eg, phenelzine), oral medicine for diabetes (eg, glipizide, metformin, nateglinide), pentamidine, propoxyphene, salicylates (eg, aspirin), somatostatin analogs (eg, octreotide), or sulfonamide antibiotics (eg, sulfamethoxazole) because the risk of low blood sugar may be increased

  • Atypical antipsychotics (eg, olanzapine), corticosteroids (eg, prednisone), danazol, diuretics (eg, furosemide, hydrochlorothiazide), estrogen, hormonal contraceptives (eg, birth control pills), isoniazid, phenothiazines (eg, chlorpromazine), progesterones (eg, medroxyprogesterone), protease inhibitors (eg, ritonavir), somatropin, sympathomimetics (eg, albuterol, epinephrine, terbutaline), or thyroid hormones (eg, levothyroxine) because they may decrease Lantus Cartridge Systems's effectiveness, resulting in high blood sugar

This may not be a complete list of all interactions that may occur. Ask your health care provider if Lantus Cartridge Systems may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Lantus Cartridge Systems:


Use Lantus Cartridge Systems as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Extra patient leaflets are available with Lantus Cartridge Systems. Talk to your pharmacist if you have questions about this information.

  • Use Lantus Cartridge Systems at the same time each day, as directed by your doctor.

  • A health care provider will teach you how to use Lantus Cartridge Systems. Be sure you understand how to use it. Follow the procedures you are taught when you use a dose. Contact your health care provider if you have any questions.

  • Wash your hands before you use Lantus Cartridge Systems.

  • Always check before each use to be sure you are injecting the correct dose of insulin. Using too much or too little insulin may result in serious side effects.

  • Lantus Cartridge Systems should be clear and colorless. Do not use Lantus Cartridge Systems if it contains particles or is discolored, or if the container is cracked or damaged.

  • Do NOT dilute Lantus Cartridge Systems or mix it with other insulin. Do NOT use it in an insulin pump.

  • Use the proper technique taught to you by your doctor. Inject deep under the skin, NOT into a vein or muscle.

  • Injection sites within an injection area (abdomen, thigh, or upper arm) must be rotated from one injection to the next.

  • Be sure you have purchased the correct insulin. Insulin comes in a variety of containers, including vials, cartridges, and pens. Make sure that you understand how to properly measure and prepare your dose. If you have any questions about measuring and preparing your dose, contact your doctor or pharmacist for information.

  • The effect of Lantus Cartridge Systems lasts for up to 24 hours.

  • Lantus Cartridge Systems begins lowering blood sugar about 1 to 2 hours after an injection. There is no peak effect. The effect lasts for up to 24 hours.

  • Do not mix this insulin together with any other type of insulin or any other medicine in the same syringe.

  • Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

  • It is very important to follow your insulin regimen exactly. Do NOT miss any doses. Ask your doctor for specific instructions to follow in case you ever miss a dose of insulin.

Ask your health care provider any questions you may have about how to use Lantus Cartridge Systems.



Important safety information:


  • Lantus Cartridge Systems may cause drowsiness, dizziness, blurred vision, or lightheadedness. These effects may be worse if you take it with alcohol or certain medicines. Use Lantus Cartridge Systems with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol without discussing it with your doctor. Drinking alcohol may increase your risk of developing high or low blood sugar.

  • Do not exceed the recommended dose, use Lantus Cartridge Systems more often than prescribed, or change the type or dose of insulin you are taking without checking with your doctor.

  • Proper diet, regular exercise, and regular testing of the blood sugar are important for best results when using Lantus Cartridge Systems.

  • Illness, especially with nausea and vomiting, emotional problems, stress, or changes in diet or activity level, may cause your insulin requirements to change. Even if you are not eating, you still require insulin. You and your doctor should establish a sick day plan to use in case of illness. When you are sick, test your blood/urine frequently and call your doctor as instructed.

  • If you will be traveling across time zones, consult your doctor concerning adjustments in your insulin schedule.

  • An insulin reaction resulting from low blood sugar levels (hypoglycemia) may occur if you take too much insulin, skip a meal, or exercise too much. Low blood sugar may make you anxious, sweaty, weak, dizzy, drowsy, or faint. It may also make your heart beat faster; make your vision change; give you a headache, chills, or tremors; or make you more hungry. It is a good idea to carry a reliable source of glucose (eg, tablets or gel) to treat low blood sugar. If this is not available, you should eat or drink a quick source of sugar like table sugar, honey, candy, orange juice, or non-diet soda. This will raise your blood sugar level quickly. Tell your doctor right away if this happens. To prevent low blood sugar, eat meals at the same time each day and do not skip meals.

  • Developing a fever or infection, eating significantly more than usual, or missing your dose of insulin may cause high blood sugar (hyperglycemia). High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away. If not treated, loss of consciousness, coma, or death may occur.

  • Carry an ID card at all times that says you have diabetes.

  • Lab tests, including fasting blood glucose levels or glycosylated hemoglobin levels, may be performed while you use Lantus Cartridge Systems. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Lantus Cartridge Systems with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sugar.

  • Lantus Cartridge Systems should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Lantus Cartridge Systems while you are pregnant. Lantus Cartridge Systems are found in breast milk. If you are or will be breast-feeding while you use Lantus Cartridge Systems, check with your doctor. Discuss any possible risks to your baby.


Possible side effects of Lantus Cartridge Systems:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Redness, swelling, itching, or mild pain at the injection site.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); changes in vision; chills; confusion; dizziness; drowsiness; fainting; fast heartbeat; fast, shallow breathing; headache; hoarseness; increased hunger, thirst, or urination; loss of consciousness; nervousness; seizures; slurred speech; stomach pain; sweating; sweet or fruity breath odor; swelling of the arms or legs; tremor; weakness.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Lantus side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center or emergency room immediately. Symptoms may include chills; dizziness; drowsiness; fainting; headache; increased heartbeat; increased hunger; loss of consciousness; nervousness; seizures; shakiness; sweating; tremor; vision changes; weakness.


Proper storage of Lantus Cartridge Systems:

VIALS: Store new (unopened) vials in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Lantus Cartridge Systems. Store used (open) vials either in the refrigerator, between 36 and 46 degrees F (2 and 8 degrees C), or at room temperature, below 86 degrees F (30 degrees C). Store away from heat and light. If Lantus Cartridge Systems has been frozen or overheated, throw it away. Throw away unrefrigerated or used vials after 28 days, even if they still contain medicine.


CARTRIDGE SYSTEMS and PENS: Store new (unopened) cartridge systems and pens in a refrigerator, between 36 and 46 degrees F (2 and 8 degrees C). Do not freeze Lantus Cartridge Systems. Store used (open) cartridge systems and pens at room temperature, below 86 degrees F (30 degrees C). Do NOT store used (open) cartridges and pens in the refrigerator. Store away from heat and light. If Lantus Cartridge Systems has been frozen or overheated, throw it away. Throw away unrefrigerated or used cartridge systems pens after 28 days, even if they still contain medicine.


Do not leave Lantus Cartridge Systems in a car on a warm or sunny day. Do not use Lantus Cartridge Systems after the expiration date stamped on the label. Keep Lantus Cartridge Systems, as well as syringes and needles, out of the reach of children and away from pets.


General information:


  • If you have any questions about Lantus Cartridge Systems, please talk with your doctor, pharmacist, or other health care provider.

  • Lantus Cartridge Systems are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Lantus Cartridge Systems. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Lantus resources


  • Lantus Side Effects (in more detail)
  • Lantus Use in Pregnancy & Breastfeeding
  • Lantus Drug Interactions
  • Lantus Support Group
  • 7 Reviews for Lantus - Add your own review/rating


Compare Lantus with other medications


  • Diabetes, Type 1
  • Diabetes, Type 2

Lexapro



Generic Name: Escitalopram Oxalate
Class: Selective Serotonin-reuptake Inhibitors
VA Class: CN609
Chemical Name: 1-[3-(Dimethylamino)propyl]-1-(4-fluorophenyl)-1,3-dihydro-S-(+)-5-isobenzofurancarbonitrile oxalate
Molecular Formula: C20H21FN2O•C2H2O4
CAS Number: 219861-08-2


  • Suicidality


  • Antidepressants may increase risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (18–24 years of age) with major depressive disorder and other psychiatric disorders; balance this risk with clinical need.1 e f Escitalopram is not approved for use in pediatric patients.1 (See Pediatric Use under Cautions.)




  • In pooled data analyses, risk of suicidality was not increased in adults >24 years of age and apparently was reduced in adults ≥65 years of age with antidepressant therapy compared with placebo.e f




  • Depression and certain other psychiatric disorders are themselves associated with an increased risk of suicide.e f g




  • Appropriately monitor and closely observe all patients who are started on escitalopram therapy for clinical worsening, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.1 e f g (See Worsening of Depression and Suicidality Risk under Cautions.)




Introduction

Antidepressant; selective serotonin-reuptake inhibitor (SSRI) and S-enantiomer of citalopram.1


Uses for Lexapro


Major Depressive Disorder


Management of major depressive disorder.1


Efficacy in hospital settings not established.1 8


Generalized Anxiety Disorder


Management of generalized anxiety disorder.1


Lexapro Dosage and Administration


General



  • Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of escitalopram, and vice versa.1




  • Monitor for possible worsening of depression, suicidality, or unusual changes in behavior, especially at the beginning of therapy or during periods of dosage adjustments.1 e f g (See Worsening of Depression and Suicidality Risk under Cautions.)




  • Sustained therapy may be required; monitor periodically for need for continued therapy.1




  • Avoid abrupt discontinuance of therapy.1 To avoid withdrawal reactions, taper dosage gradually.1 5 6 7 (See Worsening of Depression and Suicidality Risk and also see Withdrawal of Therapy under Cautions.)




  • Consider cautiously tapering dosage during third trimester of pregnancy prior to delivery.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)



Administration


Oral Administration


Administer orally once daily (morning or evening) without regard to meals.1


Dosage


Available as escitalopram oxalate; dosage is expressed in terms of escitalopram.1


Escitalopram dosages of 10 mg daily appear to be comparable to racemic citalopram dosages of 40 mg daily.2


Adults


Major Depressive Disorder

Oral

Initially, 10 mg daily.1 May be increased to 20 mg daily after ≥1 week; no additional therapeutic benefit with higher dosages.1


Optimum duration not established; may require several months of therapy or longer.1 5


Generalized Anxiety Disorder

Oral

Initially, 10 mg daily.1 Dosage may be increased to 20 mg daily after ≥1 week.1


Not studied >8 weeks of therapy; periodically reevaluate need for therapy.1


Special Populations


Hepatic Impairment


10 mg daily.1


Renal Impairment


No dosage adjustment required in patients with mild to moderate renal impairment; not studied in patients with severe renal impairment (Clcr <20 mL/minute).1


Geriatric Patients


10 mg daily.1


Cautions for Lexapro


Contraindications



  • Concurrent or recent (i.e., within 2 weeks) therapy with an MAO inhibitor.1 (See MAO Inhibitors under Warnings and see Specific Drugs under Interactions.)




  • Concurrent pimozide therapy.1 (See Specific Drugs under Interactions.)




  • Known hypersensitivity to escitalopram, citalopram, or any ingredient in the formulation.1



Warnings/Precautions


Warnings


MAO Inhibitors

Concomitant use with MAO inhibitors associated with serious, sometimes fatal reactions, including manifestations resembling serotonin syndrome (e.g., hyperthermia, rigidity, myoclonus, autonomic instability, mental status changes) or neuroleptic malignant syndrome (NMS).1 (See Serotonin Syndrome under Cautions and also see Specific Drugs under Interactions.)


Serotonin Syndrome

Potentially life-threatening serotonin syndrome reported during concurrent therapy with SSRIs or selective serotonin- and norepinephrine-reuptake inhibitors (SNRIs) and other serotonergic drugs (e.g., 5-HT1 receptor agonists [“triptans”] or drugs that impair serotonin metabolism (e.g., MAO inhibitors).1 18 Symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile BP, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination), and/or GI symptoms (e.g., nausea, vomiting, diarrhea).1 18 (See Specific Drugs under Interactions.)


Worsening of Depression and Suicidality Risk

Possible worsening of depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior in both adult and pediatric patients with major depressive disorder, whether or not they are taking antidepressants; may persist until clinically important remission occurs.1 e f g h However, suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.e f g


Appropriately monitor and closely observe patients receiving escitalopram for any reason, particularly during initiation of therapy (i.e., the first few months) and during periods of dosage adjustments.1 e f g (See Boxed Warning and also see Pediatric Use under Cautions.)


Anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and/or mania may be precursors to emerging suicidality.f g Consider changing or discontinuing therapy in patients whose depression is persistently worse or in those with emerging suicidality or symptoms that might be precursors to worsening depression or suicidality, particularly if severe, abrupt in onset, or not part of patient’s presenting symptoms.1 e f g If decision is made to discontinue therapy, taper escitalopram dosage as rapidly as is feasible but consider risks of abrupt discontinuance.1 f (See Withdrawal of Therapy under Cautions.)


Prescribe in smallest quantity consistent with good patient management to reduce risk of overdosage.1 f


Observe these precautions for patients with psychiatric (e.g., major depressive disorder, obsessive-compulsive disorder) or nonpsychiatric disorders.1 f


Bipolar Disorder

May unmask bipolar disorder.1 f (See Activation of Mania or Hypomania under Cautions.) Escitalopram is not approved for use in treating bipolar depression.1


Screen for risk of bipolar disorder by obtaining detailed psychiatric history (e.g., family history of suicide, bipolar disorder, depression) prior to initiating therapy.1 f


Fetal/Neonatal Morbidity and Mortality

Possible complications, sometimes severe and requiring prolonged hospitalization, respiratory support, enteral nutrition, and other forms of supportive care, reported in neonates exposed to escitalopram, other SSRIs, or SNRIs late in the third trimester; may arise immediately upon delivery.1


Increased risk of persistent pulmonary hypertension of the newborn (PPHN) in infants exposed to SSRIs during late pregnancy; PPHN is associated with substantial morbidity and mortality.1 25 27


Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.1 25 26


Sensitivity Reactions


Hypersensitivity Reactions

Possible anaphylaxis, allergic reactions, and angioedema.1


General Precautions


Withdrawal of Therapy

Possibly severe withdrawal reactions (e.g., dysphoric mood, irritability, agitation, dizziness, sensory disturbances, anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania); avoid abrupt discontinuance of therapy.1 Taper dosage gradually (e.g., over a period of several weeks).1 5 6 7


Abnormal Bleeding

Possible increased risk of bleeding, including upper GI bleeding; use with caution.1


Concomitant use of an NSAIA (e.g., aspirin) or warfarin may potentiate such risk.1 (See Interactions.)


SIADH or Hyponatremia

Possible SIADH secretion or hyponatremia requiring medical intervention and/or escitalopram discontinuance.1


Activation of Mania or Hypomania

Possible activation of mania and hypomania in major depressive disorder; use with caution in patients with a history of mania.1 (See Bipolar Disorder under Cautions.)


Seizures

Risk of seizures not systematically evaluated; use with caution in patients with a history of seizures.1


Cognitive/Physical Impairment

Risk of impaired mental alertness or physical coordination required for performing hazardous tasks (e.g., driving, operating machinery).1


Concomitant Disease

Limited experience; use with caution in patients with altered metabolism or hemodynamics.1


Electroconvulsive Therapy (ECT)

Effects of concomitant use with ECT not studied.1


Specific Populations


Pregnancy

Category C.1 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)


Increased risk of depression relapse observed in women who discontinued antidepressant therapy during pregnancy compared with those who remained on antidepressant therapy.1 25 26


Lactation

Distributed into milk;23 24 possible serious adverse reactions (e.g., excessive somnolence, decreased feeding, weight loss) in nursing infants.1 Discontinue nursing or the drug.1


Pediatric Use

Safety and efficacy not established in children <18 years of age.1 8 The manufacturer states that escitalopram was not demonstrated to be effective in a placebo-controlled trial in children and adolescents with major depressive disorder.1


FDA warns that a greater risk of suicidal thinking or behavior (suicidality) occurred during first few months of antidepressant treatment (4%) compared with placebo (2%) in children and adolescents with major depressive disorder, obsessive-compulsive disorder (OCD), or other psychiatric disorders based on pooled analyses of 24 short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others).1 f However, a more recent meta-analysis of 27 placebo-controlled trials of 9 antidepressants (SSRIs and others) in patients <19 years of age with major depressive disorder, OCD, or non-OCD anxiety disorders suggests that the benefits of antidepressant therapy in treating these conditions may outweigh the risks of suicidal behavior or suicidal ideation.h No suicides occurred in these pediatric trials.1 f h


Carefully consider these findings when assessing potential benefits and risks of escitalopram in a child or adolescent for any clinical use.1 e f g h (See Worsening of Depression and Suicidality Risk under Cautions.)


Geriatric Use

No substantial differences in safety and efficacy relative to younger adults, but increased sensitivity cannot be ruled out.1


Titrate dosage carefully.1 (See Geriatric Patients under Dosage and Administration.)


In pooled data analyses, a reduced risk of suicidality was observed in adults ≥65 years of age with antidepressant therapy compared with placebo.e f (See Boxed Warning and also see Worsening of Depression and Suicidality Risk under Cautions.)


Hepatic Impairment

Systemic exposure to escitalopram may be increased.1 (See Elimination: Special Populations, under Pharmacokinetics.) Use with caution.1


Renal Impairment

Use with caution in patients with severe renal impairment (Clcr <20 mL/minute).1 (See Elimination: Special Populations, under Pharmacokinetics.)


Common Adverse Effects


Insomnia,1 nausea,1 increased sweating,1 sexual dysfunction (ejaculation disorder [primarily ejaculatory delay], decreased libido, anorgasmia),1 fatigue,1 and somnolence.1


Interactions for Lexapro


Extensively metabolized in the liver, principally by CYP2C19 and 3A4.1 Does not inhibit CYP1A2, 2C9, 2C19, 2E1, or 3A4 in vitro and exhibits only modest inhibition against CYP2D6.1


Drugs Affecting Hepatic Microsomal Enzymes


Inhibitors of CYP2C19 and 3A4: clinically important pharmacokinetic interaction unlikely since escitalopram is metabolized by multiple enzyme systems.1


Drugs Metabolized by Hepatic Microsomal Enzymes


Substrates of CYP2D6: potential pharmacokinetic (increased peak plasma concentrations and AUC of the substrate) interactions.1 Use with caution.1


Drugs Affecting Hemostasis


Potential pharmacologic interaction (increased risk of bleeding) with drugs that affect coagulation; use with caution.1 11


Drugs Associated with Serotonin Syndrome


Potential pharmacologic interaction (serotonin syndrome) with serotonergic agents.1 18 Avoid such use, or use with caution.1 18 (See Serotonin Syndrome under Cautions.)


Specific Drugs








































































Drug



Interaction



Comment



Alcohol



Does not potentiate the cognitive and motor effects of alcohol1



Concomitant use not recommended1



Antidepressants, tricyclics (TCAs) (e.g., desipramine, imipramine)



Possible increased plasma TCA concentrations with TCAs that are substrates of CYP2D61 c



Use with caution1



Carbamazepine



Possible increased escitalopram clearance1



Cimetidine



Increased racemic citalopram AUC and peak plasma concentrations1 7



Citalopram



Therapeutic duplication; escitalopram is the more active isomer of racemic citalopram1



Concomitant use not recommended1



CNS drugs



Potentially additive CNS effects1



Use with caution1



Digoxin



Pharmacokinetic interaction unlikely1



5-HT1 receptor agonists (“triptans”)



Potentially life-threatening serotonin syndrome1 18



Observe carefully if used concomitantly, particularly during treatment initiation, dosage increases, or when another serotonergic agent is initiated1 18



Isoniazid



Possible serotonin syndromed



Ketoconazole



Decreased peak plasma concentrations and AUC of ketoconazole1



Linezolid



Possible serotonin syndrome1 19 20 21 22



Use with caution1



Lithium



Enhanced serotonergic effects of escitalopram1


Pharmacokinetic interaction unlikely1



Use with caution1



MAO inhibitors



Possible serotonin syndrome or NMS1



Concomitant use contraindicated1


Allow at least 2 weeks to elapse between discontinuance of an MAO inhibitor and initiation of escitalopram, or vice versa1



Metoprolol



Increased plasma metoprolol concentrations possibly resulting in decreased cardioselectivity1



NSAIAs (e.g., aspirin)



Increased risk of bleeding1



Use with caution1



Pimozide



Possible increased risk of QTc interval prolongation with racemic citalopram1


Pharmacokinetic interactions unlikely with racemic citalopram1



Concomitant use contraindicated1



Ritonavir



Pharmacokinetic interactions unlikely1



Sibutramine



Possible serotonin syndrome18



Use with caution18



Theophylline



No effects evident on theophylline pharmacokinetics1



Triazolam



Pharmacokinetic interactions unlikely1



Tryptophan and other serotonin precursors



Possible serotonin syndrome1



Concomitant use not recommended1



Warfarin



Possible increased PT and risk of bleeding1 11


Pharmacokinetic interactions unlikely with racemic citalopram1 11



Use with caution1


Lexapro Pharmacokinetics


Absorption


Bioavailability


Well absorbed following oral administration, with peak plasma concentration usually attained within 5 hours.1


Commercially available tablets and oral solution are bioequivalent.1


Onset


Antidepressant effect usually occurs within 1–4 weeks.1


Food


Food does not affect absorption.1


Special Populations


In geriatric patients, AUC is increased approximately 50%.1


Distribution


Extent


Crosses the placenta.1


Distributed into breast milk.23 24


Plasma Protein Binding


Approximately 56%.1


Elimination


Metabolism


Extensively metabolized in the liver to less pharmacologically active metabolites by multiple enzyme systems, including CYP3A4 and CYP2C19.1


Elimination Route


Eliminated principally in urine.1


Half-life


27–32 hours.1


Special Populations


In geriatric patients, half-life is increased by 50%.1


Hepatic impairment decreases racemic citalopram oral clearance by 37% and doubles its half-life.1


Mild to moderate renal impairment decreases racemic citalopram oral clearance by 17%.1 Pharmacokinetics not studied in patients with severe renal impairment (Clcr <20 mL/minute).1


Stability


Storage


Oral


Solution and Tablets

25°C; excursions permitted to 15–30°C.1


ActionsActions



  • S-enantiomer of citalopram,1 an SSRI that occurs as a 50:50 racemic mixture of the R- and S-enantiomers.1 4




  • At least 100-fold more potent as an inhibitor of serotonin (5-hydroxytryptamine [5-HT]) reuptake at presynaptic membranes and 5-HT neuronal firing rate than R-enantiomer and is twice as potent as racemic mixture.1 2 9 b




  • Mechanism of action as an antidepressant is presumed to be linked to potentiation of serotonergic activity in the CNS resulting from its inhibition of CNS neuronal reuptake of serotonin (5-HT).1




  • Highly selective; minimal effects on norepinephrine (NE) and dopamine (DA) neuronal reuptake and little or no affinity for α- or β-adrenergic, dopamine D1–5, histamine H1–3, GABA-benzodiazepine, muscarinic M1–5, or 5-HT1–7 receptors or various ion channels (e.g., calcium, chloride, potassium, sodium channels).1



Advice to Patients



  • Risk of suicidality; importance of patients, families, and caregivers being alert to and immediately reporting emergence of suicidality, worsening depression, or unusual changes in behavior, especially during the first few months of therapy or during periods of dosage adjustment.1 e f g FDA recommends providing written patient information (medication guide) explaining risks of suicidality each time the drug is dispensed.1 e f g




  • Risk of psychomotor impairment; importance of exercising caution while operating hazardous machinery, including automobile driving, until they gain experience with the drug’s effects.1




  • Risks associated with concomitant use of escitalopram with alcohol or racemic citalopram.1




  • Importance of continuing escitalopram therapy even if a response is not evident within 1–4 weeks, unless directed otherwise.1




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses (e.g., bipolar disorder) or personal or family history of suicidality or bipolar disorder.1 15




  • Importance of informing patients of risk of serotonin syndrome with concurrent use of escitalopram and 5-HT1 receptor agonists (“triptans”) or other serotonergic agents.1 18 Importance of seeking immediate medical attention if symptoms of serotonin syndrome develop.1 18




  • Importance of informing patients of other important precautionary information.1 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.




























Escitalopram Oxalate

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Solution



5 mg (of escitalopram) per 5 mL



Lexapro (with parabens and propylene glycol)



Forest



Tablets, film-coated



5 mg (of escitalopram)



Lexapro



Forest



10 mg (of escitalopram)



Lexapro (scored)



Forest



20 mg (of escitalopram)



Lexapro (scored)



Forest


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Lexapro 10MG Tablets (FOREST): 30/$109.99 or 90/$289.97


Lexapro 20MG Tablets (FOREST): 30/$109.99 or 90/$309.97


Lexapro 5MG/5ML Solution (FOREST): 240/$169.99 or 720/$485.95


Lexapro 5MG Tablets (FOREST): 30/$99.99 or 90/$279.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.




References



1. Forest Pharmaceuticals, Inc. Lexapro (escitalopram oxalate) tablets/oral solution prescribing information. St. Louis, MO; 2006 Sep.



2. Burke WJ, Gergel I, Bose A. fixed-dose trial of the single isomer SSRI escitalopram in depressed outpatients. J Clin Psychiatry. 2002; 63:331-6. [IDIS 479908] [PubMed 12000207]



3. Anon. Forest Lexapro approval includes label claim of greater potency than celexa. FDC Rep. Aug 19, 2002:3.



4. Forest Pharmaceuticals, Inc. Celexa (citalopram hydrobromide) prescribing information. (dated 2000 Dec). In: Physicians’ desk reference. 56th ed. Montvale, NJ: Medical Economics Company Inc; 2002:1365-9.



5. American Psychiatric Association. Practice guideline for the treatment of patients with major depressive disorder (revision). Am J Psychiatry. 2000; 150(Suppl 4):1-45.



6. The European Agency for the Evaluation of Medicinal Products (EMEA). Committee for proprietary medicinal products (CPMP) position paper on selective serotonin uptake inhibitors (SSRIs) and dependency/withdrawal reactions. London, UK; 2000 Apr 12. From EMEA web site.



7. Lazowick AL, Levin GM. Potential withdrawal syndrome associated with SSRI discontinuation. Ann Pharmacother. 1995; 29:1284-5.



8. Forest Pharmaceuticals, Inc., St. Louis, MO: Personal communication.



9. Anon. Escitalopram (Lexapro) for depression. Med Lett Drugs Ther. 2002; 44:83-4. [PubMed 12360121]



10. Reviewers’ comments (personal observations).



11. Priskorn M, Sidhu JS, Larsen F et al. Investigation of multiple dose citalopram on the pharmacokinetics and pharmacodynamics of racemic warfarin. Br J Clin Pharmacol. 1997; 44:199-202.



12. Anon. FDA issues public health advisory entitled: Reports of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder (MDD). FDA Talk Paper. Rockville, MD: Food and Drug Administration; 2003 Oct 27. From the FDA website.



13. Anon. Reports of suicidality in pediatric patients being treated with antidepressant medications for major depressive disorder (MDD). FDA Public Health Advisory. Rockville, MD: Food and Drug Administration; 2003 Oct 27. From the FDA website.



14. Food and Drug Administration. Class suicidality labeling language for antidepressants. From the FDA website.



15. Food and Drug Administration. Medication guide: about using antidepressants in children or teenagers. Rockville, MD; 2005 Jan 16. From the FDA web site.



16. Lepola UM, Loft H, Reines EH. Escitalopram (10-20 mg/day) is effective and well tolerated in a placebo-controlled study in depression in primary care. Int Clin Psychopharmacol. 2003; 18:211-7. [PubMed 12817155]



17. Food and Drug Administration (FDA). FDA Public Health Advisory regarding worsening depression and suicidality in patients being treated with antidepressant medications. From FDA website. 2003 Mar 22.



18. Food and Drug Administration. Public health advisory: combined use of 5-hydroxytryptamine receptor agonists (triptans), selective serotonin reuptake inhibitors (SSRIs) or selective serotonin/norepinephirne reuptake inhibitors (SNRIs) may result in life-threatening serotonin syndrome. Rockville, MD; 2006 Jul 19. From the FDA website.



19. Clark DB, Andrus MR, Byrd DC. Drug interactions between linezolid and selective serotonin reuptake inhibitors: case report involving sertraline and review of the literature. Pharmacotherapy. 2006; 26:269-76. [PubMed 16466332]



20. Hachem RY, Hicks K, Huen A et al. Myelosuppression and serotonin syndrome associated with concurrent use of linezolid and selective seotonin reuptake inhibitors in bone marrow transplant recipients. CID. 2003; 37:e8-11.



21. Sola CL, Bostwick JM, Hart DA et al. Anticipating potential linezolid-SSRI interactions in the general hospital setting: an MAOI in disguise. Mayo Clin Proc. 2006; 81:330-4. [PubMed 16529136]



22. Taylor JJ, Wilson JW, Estes LL. Linezolid and serotonergic drug interactions: a retrospective survey. CID. 2006; 43:180-7.



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  • Lexapro Prescribing Information (FDA)

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