LEVOXYL Tablet (2020)

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Pfizer Laboratories Div Pfizer Inc

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BOXED WARNING SECTION

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS Thyroid hormones, including LEVOXYL, either alone or with other therapeutic agents, should not be used for the treatment of obesity or ...

1. Indications and Usage

Hypothyroidism LEVOXYL is indicated in pediatric and adult patients as a replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. ...

2. Dosage and Administration

2.1 General Administration Information Administer LEVOXYL tablets orally as a single daily dose, on an empty stomach, one-half to one hour before breakfast with a full glass of water to avoid choking or ...

3. Dosage Forms and Strengths

LEVOXYL tablets are oval, color-coded and, potency marked available as follows: Strength (mcg) Color Tablet Markings 25 Orange 25 50 White 50 75 Purple 75 88 Olive 88 100 Yellow ...

4. Contraindications

Levothyroxine is contraindicated in patients with uncorrected adrenal insufficiency [see Warnings and Precautions (5.3)].

5. Warnings and Precautions

5.1 Cardiac Adverse Reactions in the Elderly and in Patients with Underlying Cardiovascular Disease Overtreatment with levothyroxine may cause an increase in heart rate, cardiac wall thickness, and cardiac ...

6. Adverse Reactions

Common adverse reactions with LEVOXYL therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions (5.4), Overdosage (10)]. They include the following: ...

7. Drug Interactions

7.1 Drugs Known to Affect Thyroid Hormone Pharmacokinetics Many drugs can exert effects on thyroid hormone pharmacokinetics (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target ...

8.1. Pregnancy

Risk Summary Experience with levothyroxine use in pregnant women, including data from post-marketing studies, have not reported increased rates of major birth defects or miscarriages (see Data) ...

8.2. Lactation

Risk Summary Limited published studies report that levothyroxine is present in human milk. However, there is insufficient information to determine the effects of levothyroxine on the breastfed infant and ...

8.4. Pediatric Use

The initial dose of LEVOXYL varies with age and body weight. Dosing adjustments are based on an assessment of the individual patients clinical and laboratory parameters [see Dosage and Administration ...

8.5. Geriatric Use

Because of the increased prevalence of cardiovascular disease among the elderly, initiate LEVOXYL at less than the full replacement dose [see Dosage and Administration (2.3), Warnings and Precautions ...

10. Overdosage

The signs and symptoms of overdosage are those of hyperthyroidism [see Warnings and Precautions (5.4), Adverse Reactions (6)]. In addition, confusion and disorientation may occur. Cerebral embolism, ...

11. Description

LEVOXYL contains the active ingredient, levothyroxine, asynthetic crystalline levothyroxine (T4) in sodium salt form. It is chemically designated as L-3,3',5,5'-tetraiodothyronine monosodium hydrate. Synthetic ...

12.1. 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 cell nucleus and bind to thyroid ...

12.2. Pharmacodynamics

Oral levothyroxine sodium is a synthetic T4 hormone that exerts the same physiologic effect as endogenous T4, thereby maintaining normal T4 levels when a deficiency is present.

12.3. Pharmacokinetics

Absorption Absorption of orally administered T4 from the gastrointestinal tract ranges from 40% to 80%. The majority of the levothyroxine dose is absorbed from the jejunum and upper ileum. The relative ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Animal studies have not been performed to evaluate the carcinogenic potential, mutagenic potential or effects on fertility of levothyroxine sodium.

16.1. How Supplied

LEVOXYL (levothyroxine sodium) tablets are oval, color-coded and, potency marked available as follows: Strength (mcg) Color Tablet Markings NDC bottles of 100 NDC bottles of 1000 25 Orange 25 ...

16.2. Storage and Handling

Store between 68°F–77°F (20°C–25°C) with excursions permitted between 59°F–86°F (15°C–30°C). Store LEVOXYL away from heat, moisture, and light.

17. Patient Counseling Information

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Dosing and Administration: Instruct patients to take LEVOXYL only as directed ...