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Levo-T

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Levo-T

INDICATIONS

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.

DOSAGE AND ADMINISTRATION

General Principles

The goal of replacement therapy is to achieve and maintain a clinical and biochemical euthyroid state. The goal of suppressive therapy is to inhibit growth and/or function of abnormal thyroid tissue. The dose of Levo-T™ (levothyroxine sodium tablets) that is adequate to achieve these goals depends on a variety of factors including the patient's age, body weight, cardiovascular status, concomitant medical conditions, including pregnancy, concomitant medications, and the specific nature of the condition being treated (see WARNINGS and PRECAUTIONS). Hence, the following recommendations serve only as dosing guidelines. Dosing must be individualized and adjustments made based on periodic assessment of the patient's clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests).

Levo-T™ (levothyroxine sodium tablets) should be taken in the morning on an empty stomach, at least one-half hour before any food is eaten. Levo-T™ (levothyroxine sodium tablets) should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS: DRUG INTERACTIONS).

Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of levothyroxine sodium may not be attained for 4-6 weeks.

Caution should be exercised when administering Levo-T™ (levothyroxine sodium tablets) to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS).

Specific Patient Populations

Hypothyroidism in Adults and in Children in Whom Growth and Puberty are Complete (see WARNINGS and PRECAUTIONS, Laboratory Tests)

Therapy may begin at full replacement doses in otherwise healthy individuals less than 50 years old and in those older than 50 years who have been recently treated for hyperthyroidism or who have been hypothyroid for only a short time (such as a few months). The average full replacement dose of levothyroxine sodium is approximately 1.7 mcg/kg/day (e.g., 100-125 mcg/day for a 70 kg adult). Older patients may require less than 1 mcg/kg/day. Levothyroxine sodium doses greater than 200 mcg/day are seldom required. An inadequate response to daily doses ≥ 300 mcg/day is rare and may indicate poor compliance, malabsorption, and/or drug interactions.

For most patients older than 50 years or for patients under 50 years of age with underlying cardiac disease, an initial starting dose of 25-50 mcg/day of levothyroxine sodium is recommended, with gradual increments in dose at 6-8 week intervals, as needed. The recommended starting dose of levothyroxine sodium in elderly patients with cardiac disease is 12.5-25 mcg/day, with gradual dose increments at 4-6 week intervals. The levothyroxine sodium dose is generally adjusted in 12.5-25 mcg increments until the patient with primary hypothyroidism is clinically euthyroid and the serum TSH has normalized.

In patients with severe hypothyroidism, the recommended initial levothyroxine sodium dose is 12.5-25 mcg/day with increases of 25 mcg/day every 2-4 weeks, accompanied by clinical and laboratory assessment, until the TSH level is normalized.

In patients with secondary (pituitary) or tertiary (hypothalamic) hypothyroidism, the levothyroxine sodium dose should be titrated until the patient is clinically euthyroid and the serum free-T4 level is restored to the upper half of the normal range.

Pediatric Dosage - Congenital or Acquired Hypothyroidism (see PRECAUTIONS, Laboratory Tests)

General Principles

In general, levothyroxine therapy should be instituted at full replacement doses as soon as possible. Delays in diagnosis and institution of therapy may have deleterious effects on the child's intellectual and physical growth and development.

Undertreatment and overtreatment should be avoided (see PRECAUTIONS, Pediatric Use).

Levo-T™ (levothyroxine sodium tablets) may be administered to infants and children who cannot swallow intact tablets by crushing the tablet and suspending the freshly crushed tablet in a small amount (5-10 mL or 1-2 teaspoons) of water. This suspension can be administered by spoon or dropper. DO NOT STORE THE SUSPENSION. Foods that decrease absorption of levothyroxine, such as soybean infant formula, should not be used for administering levothyroxine sodium tablets. (See PRECAUTIONS, Drug-Food Interactions).

Newborns

The recommended starting dose of levothyroxine in newborn infants is 10-15 mcg/kg/day. A lower starting dose (e.g., 25 mcg/day) should be considered in infants at risk for cardiac failure, and the dose should be increased in 4-6 weeks as needed based on clinical and laboratory response to treatment. In infants with very low ( < 5 mcg/dL) or undetectable serum T4 concentrations, the recommended initial starting dose is 50 mcg/day of levothyroxine sodium.

Infants and Children

Levothyroxine therapy is usually initiated at full replacement doses, with the recommended dose per body weight decreasing with age (see TABLE 3). However, in children with chronic or severe hypothyroidism, an initial dose of 25 mcg/day of levothyroxine sodium is recommended with increments of 25 mcg every 2-4 weeks until the desired effect is achieved.

Hyperactivity in an older child can be minimized if the starting dose is one-fourth of the recommended full replacement dose, and the dose is then increased on a weekly basis by an amount equal to one-fourth the full-recommended replacement dose until the full recommended replacement dose is reached.

Table 3: Levothyroxine Sodium Dosing Guidelines for Pediatric Hypothyroidism

AGE Daily Dose Per Kg Body Weighta
0-3 months 10-15 mcg/kg/day
3-6 months 8-10 mcg/kg/day
6-12 months 6-8 mcg/kg/day
1-5 years 5-6 mcg/kg/day
6-12 years 4-5 mcg/kg/day
> 12 years but growth and puberty incomplete 2-3 mcg/kg/day
Growth and puberty complete 1.7 mcg/kg/day

a The dose should be adjusted based on clinical response and laboratory parameters (see PRECAUTIONS, Laboratory Tests and Pediatric Use).

Pregnancy- Pregnancy may increase levothyroxine requirements (see PREGNANCY).

Subclinical Hypothyroidism- If this condition is treated, lower levothyroxine sodium dose (e.g., 1 mcg/kg/day) than that used for full replacement may be adequate to normalize the serum TSH level. Patients who are not treated should be monitored yearly for changes in clinical status and thyroid laboratory parameters.

TSH Suppression in Well-differentiated Thyroid Cancer and Thyroid Nodules - The target level for TSH suppression in these conditions has not been established with controlled studies. In addition, the efficacy of TSH suppression for benign nodular disease is controversial. Therefore, the dose of Levo-T™ (levothyroxine sodium tablets) used for TSH suppression should be individualized based on the specific disease and the patient being treated. In the treatment of well differentiated (papillary and follicular) thyroid cancer, levothyroxine is used as an adjunct to surgery and radioiodine therapy. Generally, TSH is suppressed to < 0.1 mU/L, and this usually requires a levothyroxine sodium dose of greater than 2 mcg/kg/day. However, in patients with high-risk tumors, the target level for TSH suppression may be 0.01 mU/L. In the treatment of benign nodules and nontoxic multinodular goiter, TSH is generally suppressed to a higher target (e.g., 0.1-0.5 mU/L for nodules and 0.5-1.0 mU/L for multinodular goiter) than that used for the treatment of thyroid cancer. Levothyroxine sodium is contraindicated if the serum TSH is already suppressed due to the risk of precipitating overt thyrotoxicosis (see CONTRAINDICATIONS, WARNINGS and PRECAUTIONS).

Myxedema Coma - Myxedema coma is a life-threatening emergency characterized by poor circulation and hypometabolism, and may result in unpredictable absorption of levothyroxine sodium from the gastrointestinal tract. Therefore, oral thyroid hormone drug products are not recommended to treat this condition. Thyroid hormone products formulated for intravenous administration should be administered.

HOW SUPPLIED

Levo-T™ (Levothyroxine Sodium Tablets, USP) are supplied as scored, color coded potency-marked tablets as follows:

25 mcg, orange, round tablets, bisected and debossed on one side “25/M” and “/Z” on the other side:

NDC 64909-106-21 Bottle of 90's
NDC 64909-106-07 Bottle of 100's
NDC 64909-106-09 Bottle of 1000's
NDC 64909-106-50 Bottle of 5,000's

50 mcg, white, round tablets, bisected and debossed on one side “50/M” and “/Z” on the other side:

NDC 64909-114-21 Bottle of 90's
NDC 64909-114-07 Bottle of 100's
NDC 64909-114-09 Bottle of 1000's
NDC 64909-114-50 Bottle of 5000's

75 mcg, violet, round tablets, bisected and debossed on one side “75/M” and “/Z” on the other side:

NDC 64909-107-21 Bottle of 90's
NDC 64909-107-07 Bottle of 100's
NDC 64909-107-09 Bottle of 1000's
NDC 64909-107-50 Bottle of 5000's

88 mcg, olive green, round tablets, bisected and debossed on one side “88/M” and “/Z” on the other side:

NDC 64909-115-21 Bottle of 90's
NDC 64909-115-07 Bottle of 100's
NDC 64909-115-09 Bottle of 1000's
NDC 64909-115-50 Bottle of 5000's

100 mcg, yellow, round tablets, bisected and debossed on one side “100/M” and “/Z” on other side:

NDC 64909-109-21 Bottle of 90's
NDC 64909-109-07 Bottle of 100's
NDC 64909-109-09 Bottle of 1000's
NDC 64909-109-50 Bottle of 5000's

112 mcg, rose, round tablets, bisected and debossed on one side “112/M” and “/Z” on the other side:

NDC 64909-116-21 Bottle of 90's
NDC 64909-116-07 Bottle of 100's
NDC 64909-116-09 Bottles of 1000's
NDC 64909-116-50 Bottle of 5000's

125 mcg, brown, round tablets, bisected and debossed on one side “125/M” and “/Z” on the other side:

NDC 64909-110-21 Bottle of 90's
NDC 64909-110-07 Bottle of 100's
NDC 64909-110-09 Bottle of 1000's
NDC 64909-110-50 Bottle of 5000's

150 mcg, blue, round tablets, bisected and debossed on one side “150/M” and “/Z” on the other side:

NDC 64909-117-21 Bottle of 90's
NDC 64909-117-07 Bottle of 100's
NDC 64909-117-09 Bottle of 1000's
NDC 64909-117-50 Bottle of 5000's

175 mcg, lilac, round tablets, bisected and debossed “175/M”and “/Z” on the other side:

NDC 64909-111-21 Bottle of 90's
NDC 64909-111-07 Bottle of 100's
NDC 64909-111-09 Bottle of 1000's
NDC 64909-111-50 Bottle of 5000's

200 mcg, pink, round tablets, bisected and debossed “200/M” and “/Z” on the other side:

NDC 64909-119-21 Bottle of 90's
NDC 64909-119-07 Bottle of 100's
NDC 64909-119-09 Bottle of 1000's
NDC 64909-119-50 Bottle of 5000's

300 mcg, green, round tablets, bisected and debossed “300/M” and “/Z” on the other side:

NDC 64909-112-21 Bottle of 90's
NDC 64909-112-07 Bottle of 100's
NDC 64909-112-09 Bottle of 1000's
NDC 64909-112-50 Bottle of 5000's

Store at controlled room temperature 20° to 25°C (68° to 77°F) with excursions between 15° and 30°C (59° and 86°F) permitted. Dispense in a tight, light-resistant container with a child-resistant closure.

Manufactured for: Zoetica Pharmaceutical Corporation, Cranbury, NJ 08512. Manufactured by: MOVA PHARMACEUTICAL CORPORATION, Caguas, Puerto Rico 00725. USA. Issued 2/02. FDA revision date: 6/10/2008

Last reviewed on RxList: 7/10/2008
This monograph has been modified to include the generic and brand name in many instances.

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