Levothyroxine Sodium (Synthetic Thyroid Hormone) Tablets

Description

Product Description: Levothyroxine Sodium Tablets contain the synthetic form of thyroxine, a thyroid hormone used to treat hypothyroidism, a condition characterized by an underactive thyroid gland. Levothyroxine is identical to the naturally occurring hormone produced by the thyroid gland and helps restore thyroid hormone levels in the body. These tablets provide a reliable and convenient method for thyroid hormone replacement therapy.

Indications and Usage: Levothyroxine Sodium Tablets are indicated for the treatment of hypothyroidism, including congenital hypothyroidism, primary hypothyroidism, and acquired hypothyroidism of any etiology. It is also used in the management of certain types of thyroid cancer, such as differentiated thyroid carcinoma, to suppress thyroid-stimulating hormone (TSH) secretion.

Dosage and Administration: The dosage of Levothyroxine Sodium Tablets varies depending on the patient's age, weight, and the severity of hypothyroidism. It is administered orally, usually once daily, on an empty stomach, preferably 30 minutes to 1 hour before breakfast. The dosage regimen should be individualized based on the patient's clinical response, serum TSH levels, and any underlying medical conditions.

Dosage Forms and Strengths: Levothyroxine Sodium Tablets are available in various strengths, including 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg.

Contraindications: Levothyroxine Sodium Tablets are contraindicated in patients with uncorrected adrenal insufficiency, untreated thyrotoxicosis, or hypersensitivity to levothyroxine or any of the excipients. It should not be used as a primary or adjunctive therapy in the treatment of obesity or weight loss.

Warnings and Precautions: Administration of Levothyroxine Sodium Tablets requires careful monitoring of the patient's clinical response and any signs of thyroid hormone excess or deficiency. It should be used with caution in patients with cardiovascular disease, diabetes mellitus, or adrenal insufficiency, as changes in thyroid hormone levels may exacerbate these conditions. Dosage adjustments may be necessary during pregnancy or lactation.

Adverse Reactions/Side Effects: Common adverse reactions associated with Levothyroxine Sodium Tablets include symptoms of hyperthyroidism, such as palpitations, tachycardia, weight loss, and heat intolerance. Other adverse effects may include headache, insomnia, diarrhea, and menstrual irregularities. Rare but serious adverse reactions may include cardiac arrhythmias, myocardial infarction, or exacerbation of angina.

Drug Interactions: Levothyroxine Sodium Tablets may interact with other medications that affect thyroid hormone metabolism or absorption, such as antacids, calcium carbonate, iron supplements, or certain antiseizure drugs. Concurrent use with drugs that induce hepatic enzymes, such as rifampin or phenytoin, may increase the metabolism of levothyroxine, leading to decreased efficacy. Close monitoring is recommended when administering levothyroxine with other medications affecting thyroid function.

Use In Specific Populations Description: The safety and efficacy of Levothyroxine Sodium Tablets in pediatric patients, geriatric patients, and pregnant or lactating women have been established. However, dosage adjustments may be necessary in these populations based on age, weight, and hormonal status. Close monitoring is recommended during pregnancy to ensure thyroid hormone levels remain within the therapeutic range.

How Supplied/Storage and Handling: Levothyroxine Sodium Tablets are supplied as oral tablets in various strengths. They should be stored at controlled room temperature between 20°C to 25°C (68°F to 77°F), protected from light and moisture. Do not freeze. Discard any unused portion of the tablets.