Label: LEVOTHYROXINE SODIUM tablet
- NDC Code(s): 47781-640-10, 47781-640-90, 47781-643-10, 47781-643-90, view more
- Packager: Alvogen, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 31, 2024
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HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use LEVOTHYROXINE SODIUM TABLETS safely and effectively. See full prescribing information for LEVOTHYROXINE SODIUM TABLETS ...
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Table of ContentsTable of Contents
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BOXED WARNING
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WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS
Thyroid hormones, including Levothyroxine Sodium Tablets, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.
In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.
Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects[see Adverse Reactions (6), Drug Interactions (7.7), and Overdosage (10)].
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1 INDICATIONS AND USAGEHypothyroidism - Levothyroxine Sodium Tablets are indicated in adult and pediatric patients, including neonates, as a replacement therapy in primary (thyroidal), secondary (pituitary), and ...
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2 DOSAGE AND ADMINISTRATION2.1 Important Administration Instructions - Administer Levothyroxine Sodium Tablets as a single daily dose, on an empty stomach, one-half to one hour before breakfast. Administer Levothyroxine ...
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3 DOSAGE FORMS AND STRENGTHSLevothyroxine Sodium Tablets, in the shape of caplet, are available as follows (Table 4): Table 4. Levothyroxine Sodium Tablets Tablet Strengths and Identifying Features - Tablet ...
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4 CONTRAINDICATIONSLevothyroxine Sodium Tablets are contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.4)].
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5 WARNINGS AND PRECAUTIONS5.1 Serious Risks Related to Overtreatment or Undertreatment with Levothyroxine Sodium Tablets - Levothyroxine Sodium Tablets have a narrow therapeutic index. Overtreatment or undertreatment ...
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6 ADVERSE REACTIONSAdverse reactions associated with Levothyroxine Sodium Tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5) and Overdosage (10)] ...
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7 DRUG INTERACTIONS7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics - Many drugs can exert effects on thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism ...
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8 USE IN SPECIFIC POPULATIONS8.1 Pregnancy - Risk Summary - The clinical experience, including data from postmarketing studies, in pregnant women treated with oral levothyroxine to maintain euthyroid state have not reported ...
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10 OVERDOSAGEThe signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5) and Adverse Reactions (6)]. In addition, confusion and disorientation may occur. Cerebral ...
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11 DESCRIPTIONLevothyroxine Sodium Tablets are L-thyroxine (T4) and contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'-tetraiodothyronine sodium salt. Synthetic T4 is chemically ...
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12 CLINICAL PHARMACOLOGY12.1 Mechanism of Action - Thyroid hormones exert their physiologic actions through control of DNA transcription and protein synthesis. Triiodothyronine (T3) and L-thyroxine (T4) diffuse into the ...
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13 NONCLINICAL TOXICOLOGY13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Long-term carcinogenicity studies in animals to evaluate the carcinogenic potential of levothyroxine have not been performed. Studies ...
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16 HOW SUPPLIED/STORAGE AND HANDLINGHow Supplied - Levothyroxine Sodium Tablets, in the shape of caplet are supplied as follows (Table 11): Table 11. Levothyroxine Sodium Tablet Presentations - Strength - (mcg)ColorTablet ...
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17 PATIENT COUNSELING INFORMATIONInform the patient of the following information to aid in the safe and effective use of Levothyroxine Sodium Tablets: Dosing and Administration - Instruct patients to take Levothyroxine ...
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SPL UNCLASSIFIED SECTIONManufactured by: LLOYD, Inc. Shenandoah, IA 51601 USA - Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA - PI640-01
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25 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-640-90 - Levothyroxine Sodium Tablets, USP - 25 mcg - 90 Tablets - Rx Only
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50 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-643-90 - Levothyroxine Sodium Tablets, USP - 50 mcg - 90 Tablets - Rx Only
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75 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-646-90 - Levothyroxine Sodium Tablets, USP - 75 mcg - 90 Tablets - Rx Only
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88 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-649-90 - Levothyroxine Sodium Tablets, USP - 88 mcg - 90 Tablets - Rx Only
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100 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-651-90 - Levothyroxine Sodium Tablets, USP - 100 mcg - 90 Tablets - Rx Only
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112 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-654-90 - Levothyroxine Sodium Tablets, USP - 112 mcg - 90 Tablets - Rx Only
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125 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-657-90 - Levothyroxine Sodium Tablets, USP - 125 mcg - 90 Tablets - Rx Only
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137 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-659-90 - Levothyroxine Sodium Tablets, USP - 137 mcg - 90 Tablets - Rx Only
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150 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-662-90 - Levothyroxine Sodium Tablets, USP - 150 mcg - 90 Tablets - Rx Only
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175 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-665-90 - Levothyroxine Sodium Tablets, USP - 175 mcg - 90 Tablets - Rx Only
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200 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-668-90 - Levothyroxine Sodium Tablets, USP - 200 mcg - 90 Tablets - Rx Only
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300 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANELNDC 47781-671-90 - Levothyroxine Sodium Tablets, USP - 300 mcg - 90 Tablets - Rx Only
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