(levothyroxine sodium)

Prescribing Information
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HIGHLIGHTS OF PRESCRIBING INFORMATION

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LEVOXYL safely and effectively. See full prescribing information for LEVOXYL.

LEVOXYL® (levothyroxine sodium) tablets, for oral use
Initial U.S. Approval: 2001

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

See full prescribing information for complete boxed warning.

  • Thyroid hormones, including LEVOXYL, should not be used for the treatment of obesity or for weight loss.
  • Doses beyond the range of daily hormonal requirements may produce serious or even life-threatening manifestations of toxicity (6, 7.7, 10).

INDICATIONS AND USAGE

LEVOXYL is L-thyroxine (T4) indicated in pediatric and adult patients for:

  • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. (1)
  • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer. (1)

Limitations of Use:

-
Not indicated for suppression of benign thyroid nodules and nontoxic diffuse goiter in iodine-sufficient patients. (1)
-
Not indicated for treatment of hypothyroidism during the recovery phase of subacute thyroiditis. (1)

DOSAGE AND ADMINISTRATION

  • Administer once daily, on an empty stomach, one-half to one hour before breakfast with a full glass of water. (2.1)
  • Administer at least 4 hours before or after drugs that are known to interfere with absorption. (2.1)
  • Evaluate the need for dose adjustments when regularly administering within one hour of certain foods that may affect absorption. (2.1)
  • Starting dose depends on a variety of factors, including age, body weight, cardiovascular status, concomitant medical conditions (including pregnancy), concomitant medications, co-administered food, and the specific nature of the condition being treated. Peak therapeutic effect may not be attained for 4 to 6 weeks. (2.2)
  • See full prescribing information for dosing in specific patient populations. (2.3)
  • Adequacy of therapy determined with periodic monitoring of TSH and/or T4 as well as clinical status. (2.4)

DOSAGE FORMS AND STRENGTHS

Tablets: 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg (3)

CONTRAINDICATIONS

Uncorrected adrenal insufficiency. (4)

WARNINGS AND PRECAUTIONS

  • Cardiac adverse reactions in the elderly and in patients with underlying cardiovascular disease: Initiate LEVOXYL at less than the full replacement dose because of the increased risk of cardiac adverse reactions, including atrial fibrillation. (2.3, 5.1, 8.5)
  • Myxedema coma: Do not use oral thyroid hormone drug products to treat myxedema coma. (5.2)
  • Acute adrenal crisis in patients with concomitant adrenal insufficiency: Treat with replacement glucocorticoids prior to initiation of LEVOXYL treatment. (5.3)
  • Prevention of hyperthyroidism or incomplete treatment of hypothyroidism: Proper dose titration and careful monitoring is critical to prevent the persistence of hypothyroidism or the development of hyperthyroidism. (5.4)
  • Worsening of diabetic control: Therapy in patients with diabetes mellitus may worsen glycemic control and result in increased antidiabetic agent or insulin requirements. Carefully monitor glycemic control after starting, changing, or discontinuing thyroid hormone therapy. (5.5)
  • Decreased bone mineral density associated with thyroid hormone over-replacement: Over-replacement can increase bone resorption and decrease bone mineral density. Give the lowest effective dose. (5.6)

ADVERSE REACTIONS

Common adverse reactions for LEVOXYL are primarily those of hyperthyroidism due to therapeutic overdosage: arrhythmias, myocardial infarction, dyspnea, muscle spasm, headache, nervousness, irritability, insomnia, tremors, muscle weakness, increased appetite, weight loss, diarrhea, heat intolerance, menstrual irregularities, and skin rash. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to LEVOXYL. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy may require the use of higher doses of levothyroxine. (2.3, 8.1)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 12/2018

Medication Guide

MEDICATION GUIDE

Patient Information
LEVOXYL® (Lev-OX-il)
(levothyroxine sodium)
tablets, for oral use
This Patient Information has been approved by the U.S. Food and Drug AdministrationIssued:Dec 2018

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

  • Do not use LEVOXYL to treat weight problems or weight loss.
  • Do not take more LEVOXYL than your healthcare provider prescribes for you to take. Over dosage or taking too much LEVOXYL may cause life-threatening side effects or death.
What is LEVOXYL?
LEVOXYL is a prescription medicine that contains a hormone called levothyroxine, which is similar to the hormone produced by your thyroid gland. LEVOXYL is used to treat children and adults:
  • to replace or give extra levothyroxine in people whose thyroid does not produce enough of this hormone.
  • who need surgery and radioiodine therapy to manage a type of thyroid cancer called well-differentiated thyroid cancer.
LEVOXYL should not be used to treat people who are recovering from swelling of the thyroid gland (thyroiditis) and whose bodies do not produce enough levothyroxine for a short time.
Do not use LEVOXYL if your adrenal glands are not working well and you have not been treated for this problem.
Before you take LEVOXYL, tell your healthcare provider about all of your medical conditions, including if you:
  • have or had heart problems.
  • have or had thyroid nodules.
  • have adrenal or pituitary gland problems.
  • have any food or drug allergies.
  • have a low red blood cell count (anemia).
  • have diabetes.
  • have weak bones (osteoporosis).
  • have or had a history of blood clotting problems.
  • have recently received radiation therapy with iodine (such as I-131).
  • are pregnant or plan to become pregnant. Your healthcare provider may need to increase your LEVOXYL while you are pregnant.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. LEVOXYL may affect the way other medicines work, and other medicines may affect how LEVOXYL works. You can ask your healthcare provider or pharmacist for a list of medicines that interact with LEVOXYL.
Tell every healthcare provider including your dentist who treats you that you are taking LEVOXYL before any surgery.
How should I take LEVOXYL?
  • Take LEVOXYL exactly as your healthcare provider tells you to take it.
  • Your healthcare provider will tell you how much LEVOXYL to take each day.
  • Take your dose of LEVOXYL on an empty stomach, at least 30 minutes to 1 hour before breakfast with a full glass of water to avoid choking or gagging.
  • Giving LEVOXYL to infants and children who cannot swallow tablets:
    • Crush the tablet.
    • Place the freshly crushed tablet in a small amount (5 mL to 10 mL or 1 teaspoon to 2 teaspoons) of water.
    • Immediately give the medicine by spoon or dropper.
    • Do not store the mixed medicine. Do not give in foods that decrease the absorption of LEVOXYL, such as soybean-based infant formula.
  • Your healthcare provider may change your dose if needed.
  • Certain medicines can interfere with how LEVOXYL is absorbed by your body. Take or give LEVOXYL:
    • at least 4 hours before or after medicines that contain calcium carbonate or iron (ferrous sulfate).
    • at least 4 hours before medicines that contain bile acid sequestrants or ion exchange resins.
Know the medicines that you take. Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.
  • Certain foods and drinks including soybean flour, cotton seed meal, walnuts, grapefruit juice and dietary fiber can affect your treatment and dose of LEVOXYL. Talk to your healthcare provider if you eat or drink these foods.
  • Your healthcare provider should do certain blood tests while you are taking LEVOXYL and may change your daily dose of LEVOXYL as needed. You should not stop taking LEVOXYL or change your dose unless your healthcare provider tells you to.
  • It may take weeks before you notice your symptoms getting better. Keep using this medicine even if you feel well.
  • You may have to take medicine for the rest of your life to replace the thyroid hormone your body cannot produce.
  • If you take too much LEVOXYL or overdose, call your healthcare provider or poison control center at 1-800-222-1222, or go to the nearest hospital emergency room right away.
What are the possible side effects of LEVOXYL?
LEVOXYL can cause serious side effects, including:
  • heart problems. You may experience an increased heart rate, chest pain and irregular heartbeat. Your risk of developing heart problems may be greater if you are elderly, have heart problems, or if you take too much LEVOXYL. Your healthcare provider may reduce your dose or stop treatment with LEVOXYL for a while if you develop heart problems.
  • worsening diabetic control. If you are a diabetic, it may be harder to control your blood sugar levels causing hyperglycemia while taking LEVOXYL. Check your blood sugar levels closely after starting, changing, or stopping treatment with LEVOXYL, and tell your healthcare provider if there are any changes. Your healthcare provider may have to change your diabetes treatment plan.
  • weak or brittle bones. Your risk of developing weak or brittle bones may be greater if you are post-menopausal and are taking high doses of LEVOXYL for a long period.
The most common side effects of LEVOXYL include:
  • irregular heartbeat
  • chest pain
  • shortness of breath
  • leg cramps
  • headache
  • nervousness
  • hives or skin rash
  • irritability
  • sleep problems (insomnia)
  • tremors
  • muscle weakness
  • change in appetite
  • weight loss
  • vomiting
  • diarrhea
  • sweating a lot
  • heat intolerance
  • fever
  • changes in menstrual period
Other side effects may include:
  • partial hair loss during the first months of treatment with LEVOXYL. This usually lasts a short period of time.
These are not all the possible side effects of LEVOXYL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How do I store LEVOXYL?
  • Store LEVOXYL at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store LEVOXYL away from heat, light and moisture.
  • Keep LEVOXYL and all other medicines out of the reach of children.
General information about the safe and effective use LEVOXYL.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use LEVOXYL for a condition for which it was not prescribed. Do not give your LEVOXYL to other people, even if they have the same symptoms that you have. It may harm them.
You can ask your healthcare provider or pharmacist for information about LEVOXYL that was written for health professionals.
What are the ingredients in LEVOXYL?
Active ingredient: levothyroxine sodium
Inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, calcium sulfate dihydrate, sodium bicarbonate, coloring additives.
Gluten content: This product is gluten-free.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.

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LAB-0710-1.0
December 2018
For more information, go to www.levoxyl.com, or call 1-866-295-7600

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