Fresenius Kabi USA, LLC

Levothyroxine sodium

Brand

Generic: Levothyroxine sodium

ID: 63323088510

NaN

Reviews

LEVOTHYROXINE SODIUM 20 UG ML INJECTION 6332388510

📜 Prescription Required

FORM

Injection

STRENGTH

20 ug/mL

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 SPL UNCLASSIFIED SECTION 2 DOSAGE AND ADMINISTRATION 2.1 Dosage

🩺What it's for

Levothyroxine Sodium Injection is indicated for the treatment of myxedema coma. Levothyroxine Sodium Injection is L-thyroxine (T4) indicated in adult patients for the treatment of myxedema coma. (1) Limitations of Use: Not recommended as a substitute for oral levothyroxine sodium because the relative bioavailability of Levothyroxine Sodium Injection to oral levothyroxine sodium has not been established and there is a risk of inaccurate dose conversion.

💊How to take it

Consider the age, general physical condition, cardiac risk factors, and clinical severity of myxedema and duration of myxedema symptoms when determining dosages of Levothyroxine Sodium Injection. (2.1) Start with lower doses in elderly patients and in patients with underlying cardiovascular disease. (2.1) The recommended loading dose is 300 mcg to 500 mcg administered intravenously.

ℹ️Common side effects

Overtreatment with Levothyroxine Sodium Injection may cause arrhythmias, tachycardia, myocardial ischemia and infarction, or worsening of congestive heart failure and death, particularly in patients with cardiovascular disease and in elderly patients. Start with lower doses in elderly patients and in patients with underlying cardiovascular disease and monitor patients after administration of Levothyroxine Sodium Injection for cardiac adverse reactions.

⚠️Serious risks

Thyroid hormones, including Levothyroxine Sodium Injection, should not be used for the treatment of obesity or for weight loss. Larger doses may produce serious or even life threatening manifestations of toxicity. (6,10) WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including Levothyroxine Sodium Injection, should not be used for the treatment of obesity or for weight loss. Larger doses may produce serious or even life threatening manifestations of toxicity.

📋Interactions & cautions

See full prescribing information for drugs that affect thyroid hormone pharmacokinetics and metabolism (e.g., synthesis, secretion, catabolism, protein binding, and target tissue response) that may alter the therapeutic response to Levothyroxine Sodium Injection.

📦Storage & missed dose

Levothyroxine Sodium Injection is a clear, colorless solution available as follows: NDC Total Strength per Total Volume Concentration 63323-885-10 100 mcg per 5 mL 20 mcg per mL 63323-890-10 200 mcg per 5 mL 40 mcg per mL 63323-895-10 500 mcg per 5 mL 100 mcg per mL Protect from light in the original vial in a carton and store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. The unopened vial may be stored for up to 24 hours exposed to indoor lighting outside of the carton.

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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 Injection (see Tables 1-3). Table 1: Drugs That May Alter T4 and Triiodothyronine (T3) Serum Transport Without Effecting Free Thyroxine (FT4) Concentration (Euthyroidism) Drug or Drug Class Effect ClofibrateEstrogen-containing oral contraceptivesEstrogens (oral)Heroin / Methadone5-FluorouracilMitotaneTamoxifen These drugs may increase serum thyroxine-binding globulin (TBG) concentration. Androgens / Anabolic SteroidsAsparaginaseGlucocorticoidsSlow-Release Nicotinic Acid These drugs may decrease serum TBG concentration. Potential impact (below): 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. 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:CarbamazepineFurosemide (> 80 mg IV)HeparinHydantoinsNon-Steroidal Anti-inflammatory Drugs- Fenamates These drugs may cause protein-binding site displacement. Furosemide has been shown to inhibit the protein binding of T4 to TBG and albumin, causing an increase free T4 fraction in serum. Furosemide competes for T4-binding sites on TBG, prealbumin, and albumin, so that a single high dose can acutely lower the total T4 level. 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. Closely monitor thyroid hormone parameters. Table 2: 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 Effect PhenobarbitalRifampin Phenobarbital has been shown to reduce the response to thyroxine. Phenobarbital increases L-thyroxine metabolism by inducing uridine 5'-diphospho-glucuronosyltransferase (UGT) and leads to a lower T4 serum levels. Changes in thyroid status may occur if barbiturates are added or withdrawn from patients being treated for hypothyroidism. Rifampin has been shown to accelerate the metabolism of levothyroxine. Table 3: 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 drugs:Amiodarone Amiodarone inhibits peripheral conversion of levothyroxine (T4) to triiodothyronine (T3) and may cause isolated biochemical changes (increase in serum free-T4, and decreased or normal free-T3) in clinically euthyroid patients.