Sagent Pharmaceuticals

Levothyroxine sodium anhydrous

Generic

Generic for Levothyroxine sodium

ID: 25021046810

NaN

Reviews

LEVOTHYROXINE SODIUM ANHYDROUS 100 UG 5ML INJECTION 2502146810

📜 Prescription Required

FORM

Injection

STRENGTH

100 ug/5mL

QUANTITY

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TL;DR — Quick Summary

Key facts from the full medication guide below

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS 1 INDICATIONS AND USAGE 2 DOSAGE AND ADMINISTRATION 2.1 Dosage 2.2 Dosing in the Elderly and in Patients with Cardiovascular Disease

🩺What it's for

Levothyroxine Sodium for Injection is indicated for the treatment of myxedema coma. Important Limitations of Use: The relative bioavailability between Levothyroxine Sodium for Injection and oral levothyroxine products has not been established. Caution should be used when switching patients from oral levothyroxine products to Levothyroxine Sodium for Injection as accurate dosing conversion has not been studied. Levothyroxine Sodium is an L-thyroxine product.

💊How to take it

An initial intravenous loading dose of Levothyroxine Sodium for Injection between 300 to 500 mcg followed by once daily intravenous maintenance doses between 50 and 100 mcg should be administered, as clinically indicated, until the patient can tolerate oral therapy. (2.1) Reconstitute the lyophilized Levothyroxine Sodium for Injection by aseptically adding 5 mL of 0.9% Sodium Chloride Injection, USP. Shake vial to ensure complete mixing. Reconstituted drug product is preservative free.

ℹ️Common side effects

Excessive doses of levothyroxine can predispose to signs and symptoms compatible with hyperthyroidism. The signs and symptoms of thyrotoxicosis include, but are not limited to: exophthalmic goiter, weight loss, increased appetite, palpitations, nervousness, diarrhea, abdominal cramps, sweating, tachycardia, increased pulse and blood pressure, cardiac arrhythmias, angina pectoris, tremors, insomnia, heat intolerance, fever, and menstrual irregularities.

⚠️Serious risks

Thyroid hormones, including Levothyroxine Sodium for Injection, should not be used for the treatment of obesity or for weight loss. (5.3) Larger doses may produce serious or even life-threatening manifestations of toxicity. (6) WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including Levothyroxine Sodium for Injection, should not be used for the treatment of obesity or for weight loss.

📋Interactions & cautions

Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine Sodium for Injection. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs [see Pharmacokinetics (12.3)].

📦Storage & missed dose

Store dry product at 20 to 25 C (68 to 77 F). [See USP Controlled Room Temperature.] Protect from light. Discard any unused portion. Sterile, Nonpyrogenic, Preservative-free, Lyophilized.The container closure is not made with natural rubber latex. SAGENT Mfd.

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Drug Interactions A listing of drug interaction with T4 is provided in the following tables, although it may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected. Table 2: Drugs That May Alter T4 and T3 Serum Transport Without Affecting free T4 Concentration (Euthyroidism) Drugs That May Increase Serum TBG Concentration Drugs That May Decrease Serum TBG Concentration ClofibrateEstrogen-containing oral contraceptivesEstrogens (oral)Heroin/Methadone5-FluorouracilMitotaneTamoxifen Androgens/Anabolic SteroidsAsparaginaseGlucocorticoidsSlow-Release Nicotinic Acid Drugs That May Cause Protein-Binding Site Displacement Potential impact: Administration of these agents with levothyroxine results in an initial transient increase in FT4. Continued administration results in a decrease in serum T4 and normal FT4 and TSH concentrations and, therefore, patients are clinically euthyroid. Salicylates (>2 g/day) Salicylates inhibit binding of T4 and T3 to TBG and transthyretin. An initial increase in serum FT4 is followed by return of FT4 to normal levels with sustained therapeutic serum salicylate concentrations, although total-T4 levels may decrease by as much as 30%. Other drugs:Furosemide (>80 mg IV)HeparinHydantoinsNon-Steroidal Anti-inflammatory DrugsFenamatesPhenylbutazone Table 3: Drugs That May Alter Hepatic Metabolism of T4 (Hypothyroidism) Potential impact: Stimulation of hepatic microsomal drug-metabolizing enzyme activity may cause increased hepatic degradation of levothyroxine, resulting in increased levothyroxine requirements. Drug or Drug Class CarbamazepineHydantoins Phenytoin and carbamazepine reduce serum protein binding of levothyroxine, and total- and free- T4 may be reduced by 20% to 40%, but most patients have normal serum TSH levels and are clinically euthyroid. Other drugs:PhenobarbitalRifampin Table 4: Drugs That May Decrease Conversion of T4 to T3 Potential impact: Administration of these enzyme inhibitors decreases the peripheral conversion of T4 to T3, leading to decreased T3 levels. However, serum T4 levels are usually normal but may occasionally be slightly increased. Drug or Drug Class Effect Beta-adrenergic antagonists(e.g., Propranolol >160 mg/day) In patients treated with large doses of propranolol (>160 mg/day), T3 and T4 levels change slightly, TSH levels remain normal, and patients are clinically euthyroid. It should be noted that actions of particular beta-adrenergic antagonists may be impaired when the hypothyroid patient is converted to the euthyroid state. Glucocorticoids(e.g., Dexamethasone 4 mg/day) Short-term administration of large doses of glucocorticoids may decrease serum T3 concentrations by 30% with minimal change in serum T4 levels. However, long-term glucocorticoid therapy may result in slightly decreased T3 and T4 levels due to decreased TBG production (see above). Other drug: Amiodarone