Levothroid

Levothroid is part of the drug class:

• Thyroid hormones

Store levothyroxine away from heat, moisture, and light.

Keep this and all medicines out of the reach of children.

Adverse reactions associated with levothyroxine therapy are primarily those of hyperthyroidism due to therapeutic overdosage (see PRECAUTIONS and OVERDOSAGE). They include the following:

General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating;

Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia;

Musculoskeletal: tremors, muscle weakness;

Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest;

Respiratory: dyspnea;

Gastrointestinal: diarrhea, vomiting, abdominal cramps and elevations in liver function tests;

Dermatologic: hair loss, flushing;

Endocrine: decreased bone mineral density; Reproductive: menstrual irregularities, impaired fertility.

Pseudotumor cerebri and slipped capital femoral epiphysis have been reported in children receiving levothyroxine therapy. Overtreatment may result in craniosynostosis in infants and premature closure of the epiphyses in children with resultant compromised adult height.

Seizures have been reported rarely with the institution of levothyroxine therapy.

Inadequate levothyroxine dosage will produce or fail to ameliorate the signs and symptoms of hypothyroidism.

Hypersensitivity reactions to inactive ingredients have occurred in patients treated with thyroid hormone products. These include urticaria, pruritus, skin rash, flushing, angioedema, various GI symptoms (abdominal pain, nausea, vomiting and diarrhea), fever, arthralgia, serum sickness and wheezing. Hypersensitivity to levothyroxine itself is not known to occur.

Read the entire FDA prescribing information for Levothroid (Levothyroxine Sodium)

In the U.S.

• Levothroid
• Levoxyl
• Synthroid
• Tirosint
• Tirosint-Sol
• Unithroid

Available Dosage Forms:

• Capsule, Liquid Filled
• Tablet
• Solution

Therapeutic Class: Thyroid Supplement

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

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 or blood vessel problems, which may require caution and an adjustment in the dose for patients receiving levothyroxine.

Pregnancy

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 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 is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Clomipramine
• Desipramine
• Dibenzepin
• Doxepin
• Imipramine
• Ketamine
• Lofepramine
• Maprotiline
• Melitracen
• Midodrine
• Mirtazapine
• Nortriptyline
• Opipramol
• Protriptyline
• Tianeptine
• Trimipramine

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.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Calcium Acetate
• Calcium Carbonate
• Calcium Citrate
• Cholestyramine
• Chromium
• Ciprofloxacin
• Colesevelam
• Conjugated Estrogens
• Dexlansoprazole
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Eltrombopag
• Esomeprazole
• Esterified Estrogens
• Estradiol
• Estriol
• Estrone
• Estropipate
• Fosphenytoin
• Imatinib
• Iron
• Kelp
• Lansoprazole
• Lanthanum Carbonate
• Lopinavir
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Omeprazole
• Pantoprazole
• Patiromer
• Phenytoin
• Rabeprazole
• Rifampin
• Rifapentine
• Ritonavir
• Sevelamer
• Simvastatin

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 this medicine 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 this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Enteral Nutrition
• Soybean

Other Medical Problems

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

• Adrenal gland insufficiency (underactive adrenal gland), untreated or
• Heart attack, acute or recent or
• Thyrotoxicosis (overactive thyroid), untreated—Should not be used in patients with these conditions.

• Adrenal problems or
• Anemia, pernicious or
• Angina (severe chest pain), history of or
• Blood clotting problems, or history of or
• Diabetes or
• Heart or blood vessel disease (eg, coronary artery disease, heart failure), history of or
• Heart rhythm problems (eg, arrhythmia, atrial fibrillation), history of or
• Osteoporosis, history of or
• Pituitary gland problems—Use with caution. May make these conditions worse.

• Patients who have trouble swallowing capsules (including children younger than 6 years of age)—Tirosint® should not be given in these patients.

Rx ONLY

Levothyroxine sodium is used for the following indications:

Hypothyroidism

As replacement or supplemental therapy in congenital or acquired hypothyroidism of any etiology, except transient hypothyroidism during the recovery phase of subacute thyroiditis. Specific indications include: primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) hypothyroidism and subclinical hypothyroidism. Primary hypothyroidism may result from functional deficiency, primary atrophy, partial or total congenital absence of the thyroid gland, or from the effects of surgery, radiation, or drugs, with or without the presence of goiter.

Pituitary TSH Suppression

In the treatment or prevention of various types of euthyroid goiters (see WARNINGS and PRECAUTIONS), including thyroid nodules (see WARNINGS and PRECAUTIONS), subacute or chronic lymphocytic thyroiditis (Hashimoto's thyroiditis), multinodular goiter (see WARNINGS and PRECAUTIONS) and, as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

Levothyroxine is contraindicated in patients with untreated subclinical (suppressed serum TSH level with normal T3 and T4 levels) or overt thyrotoxicosis of any etiology and in patients with acute myocardial infarction. Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency since thyroid hormones may precipitate an acute adrenal crisis by increasing the metabolic clearance of glucocorticoids (see PRECAUTIONS). Levothroid® is contraindicated in patients with hypersensitivity to any of the inactive ingredients in Levothroid® tablets (see DESCRIPTION, Inactive Ingredients.)

The signs and symptoms of overdosage are those of hyperthyroidism (see PRECAUTIONS and ADVERSE REACTIONS). In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures have occurred in a child ingesting 18 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium.

Treatment of Overdosage

Levothyroxine sodium should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur.

This may be a life-threatening emergency, therefore, symptomatic and supportive therapy should be instituted immediately. If not contraindicated (e.g., by seizures, coma, or loss of the gag reflex), the stomach should be emptied by emesis or gastric lavage to decrease gastrointestinal absorption. Activated charcoal or cholestyramine may also be used to decrease absorption. Central and peripheral increased sympathetic activity may be treated by administering β-receptor antagonists, e.g., propranolol, provided there are no medical contraindications to their use. Provide respiratory support as needed; control congestive heart failure and arrhythmia; control fever, hypoglycemia, and fluid loss as necessary. Large doses of antithyroid drugs (e.g., methimazole or propylthiouracil) followed in one to two hours by large doses of iodine may be given to inhibit synthesis and release of thyroid hormones. Glucocorticoids may be given to inhibit the conversion of T4 to T3. Plasmapheresis, charcoal hemoperfusion and exchange transfusion have been reserved for cases in which continued clinical deterioration occurs despite conventional therapy. Because T4 is highly protein bound, very little drug will be removed by dialysis.

NDC 0456-1320-01

Levothroid®
(levothyroxine sodium tablets, USP)

25 mcg

Rx only

100 Tablets

LOT NO.

EXP.

Rev. 06-11

NDC 0456-1327-01

Levothroid®
(levothyroxine sodium tablets, USP)

200 mcg

Rx only

100 Tablets

LOT NO.

EXP.

Rev. 06-11