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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 Category	Explanation
All Trimesters	A	Adequate 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

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)

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More levothyroxine resources

Levothyroxine Side Effects (in more detail)
Levothyroxine Use in Pregnancy & Breastfeeding
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Levothyroxine Drug Interactions
Levothyroxine Support Group
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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)

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Thursday, September 15, 2016

levothyroxine