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Drug Catalog - Product Detail

LEVOTHYROXINE SODIUM,USP TB 0.1MG 1000

NDC Mfr Size Str Form
00781-5184-10 SANDOZ 1000 100MCG TABLET
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Description
DESCRIPTION Levothyroxine sodium tablets, USP contains synthetic crystalline L-3,3’,5,5’-tetraiodothyronine sodium salt [levothyroxine (T 4 ) sodium]. Synthetic T 4 is identical to that produced in the human thyroid gland. Levothyroxine (T 4 ) sodium has an empirical formula of C 15 H 10 I 4 N NaO 4 x H 2 O, molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown: Magnesium Stearate, NF; Microcrystalline Cellulose, NF; Colloidal Silicone Dioxide, NF; Sodium Starch Glycolate, NF. The following are the color additives by tablet strength: Strength (mcg) Color Additive(s) 25 FD&C Yellow No. 6 Aluminum Lake 50 None 75 FD&C Blue No. 2 Aluminum Lake D&C Red No. 27 Aluminum Lake 88 FD&C Blue No. 1 Aluminum Lake D&C Yellow No. 10 Aluminum Lake D&C Red No. 30 Aluminum Lake 100 D&C Yellow No. 10 Aluminum Lake D&C Red Lake Blend (D&C Red No. 27 Lake and D&C Red No. 30 Lake) 112 D&C Red No. 27 Aluminum Lake D&C Red No. 30 Aluminum Lake 125 FD&C Yellow No. 6 Aluminum Lake FD&C Red No. 40 Aluminum Lake FD&C Blue No. 1 Aluminum Lake 137 FD&C Blue No. 1 Aluminum Lake 150 FD&C Blue No. 2 Aluminum Lake 175 D&C Red No. 27 Aluminum Lake D&C Red No. 30 Aluminum Lake FD&C Blue No. 1 Aluminum Lake 200 D&C Yellow No. 10 Aluminum Lake D&C Red No. 27 Aluminum Lake 300 D&C Yellow No. 10 Aluminum Lake FD&C Yellow No. 6 Aluminum Lake FD&C Blue No. 1 Aluminum Lake MM1
How Supplied
HOW SUPPLIED Levothyroxine sodium tablets, USP are supplied as scored, color coded potency marked tablets as follows: 25 mcg, capsule shape tablets, orange color, on one side debossed with "25"; on the other side bisected and debossed with "GG" to the left of the bisect and "331" to the right: NDC 0781-5180-92 Bottle of 90’s NDC 0781-5180-01 Bottle of 100’s NDC 0781-5180-10 Bottle of 1000’s 50 mcg, capsule shape tablets, white color, on one side debossed with "50"; on the other side bisected and debossed with "GG" to the left of the bisect and "332" to the right: NDC 0781-5181-92 Bottle of 90’s NDC 0781-5181-01 Bottle of 100’s NDC 0781-5181-10 Bottle of 1000’s 75 mcg, capsule shape tablets, dark blue color, on one side debossed with "75"; on the other side bisected and debossed with "GG" to the left of the bisect and "333" to the right: NDC 0781-5182-92 Bottle of 90’s NDC 0781-5182-01 Bottle of 100’s NDC 0781-5182-10 Bottle of 1000’s 88 mcg, capsule shape tablets, olive green color, on one side debossed with "88"; on the other side bisected and debossed with "GG" to the left of the bisect and "334" to the right: NDC 0781-5183-92 Bottle of 90’s NDC 0781-5183-01 Bottle of 100’s NDC 0781-5183-10 Bottle of 1000’s 100 mcg, capsule shape tablets, yellow color, on one side debossed with "100"; on the other side bisected and debossed with "GG" to the left of the bisect and "335" to the right: NDC 0781-5184-92 Bottle of 90’s NDC 0781-5184-01 Bottle of 100’s NDC 0781-5184-10 Bottle of 1000’s 112 mcg, capsule shape tablets, rose color, on one side debossed with "112"; on the other side bisected and debossed with "GG" to the left of the bisect and "336" to the right: NDC 0781-5185-92 Bottle of 90’s NDC 0781-5185-01 Bottle of 100’s NDC 0781-5185-10 Bottle of 1000’s 125 mcg, capsule shape tablets, brown color, on one side debossed with "125"; on the other side bisected and debossed with "GG" to the left of the bisect and "337" to the right: NDC 0781-5186-92 Bottle of 90’s NDC 0781-5186-01 Bottle of 100’s NDC 0781-5186-10 Bottle of 1000’s 137 mcg, capsule shape tablets, turquoise color, on one side debossed with "137"; on the other side bisected and debossed with "GG" to the left of the bisect and "330" to the right: NDC 0781-5191-92 Bottle of 90’s NDC 0781-5191-01 Bottle of 100’s NDC 0781-5191-10 Bottle of 1000’s 150 mcg, capsule shape tablets, blue color, on one side debossed with "150"; on the other side bisected and debossed with "GG" to the left of the bisect and "338" to the right: NDC 0781-5187-92 Bottle of 90’s NDC 0781-5187-01 Bottle of 100’s NDC 0781-5187-10 Bottle of 1000’s 175 mcg, capsule shape tablets, lilac color, on one side debossed with "175"; on the other side bisected and debossed with "GG" to the left of the bisect and "339" to the right: NDC 0781-5188-92 Bottle of 90’s NDC 0781-5188-01 Bottle of 100’s NDC 0781-5188-10 Bottle of 1000’s 200 mcg, capsule shape tablets, pink color, on one side debossed with "200"; on the other side bisected and debossed with "GG" to the left of the bisect and "340" to the right: NDC 0781-5189-92 Bottle of 90’s NDC 0781-5189-01 Bottle of 100’s NDC 0781-5189-10 Bottle of 1000’s 300 mcg, capsule shape tablets, green color, on one side debossed with "300"; on the other side bisected and debossed with "GG" to the left of the bisect and "341" to the right: NDC 0781-5190-92 Bottle of 90’s NDC 0781-5190-01 Bottle of 100’s NDC 0781-5190-10 Bottle of 1000’s
Indications & Usage
INDICATIONS & USAGE 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
DOSAGE & ADMINISTRATION 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 Levothyroxine sodium tablets, USP 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 ). Levothyroxine sodium tablets, USP are administered as a single daily dose, preferably one-half to one-hour before breakfast. Levothyroxine sodium tablets, USP should be taken at least 4 hours apart from drugs that are known to interfere with its absorption (see PRECAUTIONS, Drug Interactions ). Levothyroxine sodium tablets, USP should be taken with a full glass of water, (see Information for Patients ). Due to the long half-life of levothyroxine, the peak therapeutic effect at a given dose of Levothyroxine sodium tablets, USP may not be attained for 4-6 weeks. Caution should be exercised when administering Levothyroxine sodium tablets, USP to patients with underlying cardiovascular disease, to the elderly, and to those with concomitant adrenal insufficiency (see PRECAUTIONS ). 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 who are at low risk of coronary artery disease. 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-T 4 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 ). Levothyroxine sodium tablets, USP 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 sodium 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 T 4 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.