levothyroxine sodium

WARNING: NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Boxed Warning section

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 )] .

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Levothyroxine Sodium Tablets, in the shape of caplet are available as follows: Tablet Strength Tablet Color Tablet Markings 25 mcg Orange "T|4" and "25" 50 mcg White "T|4" and "50" 75 mcg Violet "T|4" and "75" 88 mcg Mint Green "T|4" and "88" 100 mcg Yellow "T|4" and "100" 112 mcg Rose "T|4" and "112" 125 mcg Brown "T|4" and "125" 137 mcg Deep Blue "T|4" and "137" 150 mcg Light Blue "T|4" and "150" 175 mcg Lilac "T|4" and "175" 200 mcg Pink "T|4" and "200" 300 mcg Green "T|4" and "300"

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Adverse reactions associated with Levothyroxine Sodium Tablets therapy are primarily those of hyperthyroidism due to therapeutic overdosage [see Warnings and Precautions ( 5 ) , Overdosage ( 10 )] . They include the following: • General: fatigue, increased appetite, weight loss, heat intolerance, fever, excessive sweating • Central nervous system: headache, hyperactivity, nervousness, anxiety, irritability, emotional lability, insomnia • Musculoskeletal: tremors, muscle weakness, muscle spasm • Cardiovascular: palpitations, tachycardia, arrhythmias, increased pulse and blood pressure, heart failure, angina, myocardial infarction, cardiac arrest • Respiratory: dyspnea • Gastrointestinal: diarrhea, vomiting, abdominal cramps, elevations in liver function tests • Dermatologic: hair loss, flushing, rash • Endocrine: decreased bone mineral density • Reproductive: menstrual irregularities, impaired fertility Seizures have been reported rarely with the institution of levothyroxine therapy.

7 DRUG INTERACTIONS

DRUG INTERACTIONS SECTION

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

10 OVERDOSAGE

OVERDOSAGE SECTION

The 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 embolism, shock, coma, and death have been reported. Seizures occurred in a 3-year-old child ingesting 3.6 mg of levothyroxine. Symptoms may not necessarily be evident or may not appear until several days after ingestion of levothyroxine sodium. Reduce the Levothyroxine Sodium Tablets dose or discontinue temporarily if signs or symptoms of overdosage occur. Initiate appropriate supportive treatment as dictated by the patient's medical status. For current information on the management of poisoning or overdosage, contact the National Poison Control Center at 1-800-222-1222 or www.poison.org.

11 DESCRIPTION

DESCRIPTION SECTION

Levothyroxine Sodium Tablets contain the active ingredient, levothyroxine, a synthetic crystalline L-3,3',5,5'- tetraiodothyronine in sodium salt form. Synthetic T4 is identical in chemical structure to the T 4 produced in the human thyroid gland. Levothyroxine (T4) sodium has an empirical formula of C 15 H 10 I 4 NNaO 4 ∙ x H 2 O (where x = 5), molecular weight of 798.86 g/mol (anhydrous), and structural formula as shown: Levothyroxine Sodium Tablets for oral administration are available in the following strengths: 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. Each levothyroxine sodium tablet contains the inactive ingredients butylatedhydroxy toluene, calcium phosphate dibasic dihydrate, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate, and color additive(s). Table 6 provides a listing of the color additives by tablet strength: Table 6. Levothyroxine Sodium Tablets Color Additives Strength (mcg) Color additive(s) 25 FD&C Yellow No. 6 Aluminum Lake Note – FD&C Yellow No. 6 is orange in color. 50 None 75 FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake 88 FD&C Blue No. 1 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*, D&C Yellow No. 10 Aluminum Lake 100 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake* 112 D&C Red No. 27 & 30 Aluminum Lake 125 FD&C Yellow No. 6 Aluminum Lake*, FD&C Red No. 40 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake 137 FD&C Blue No. 1 Aluminum Lake 150 FD&C Blue No. 2 Aluminum Lake 175 FD&C Blue No. 1 Aluminum Lake, D&C Red No. 27 & 30 Aluminum Lake 200 FD&C Red No. 40 Aluminum Lake 300 D&C Yellow No. 10 Aluminum Lake, FD&C Yellow No. 6 Aluminum Lake*, FD&C Blue No. 1 Aluminum Lake

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

16 HOW SUPPLIED/STORAGE AND HANDLING

HOW SUPPLIED SECTION

Levothyroxine Sodium Tablets, in the shape of caplet are supplied as follows: Strength (mcg) Color Tablet Markings NDC# for bottles of 30 NDC# for bottles of 60 NDC# for bottles of 90 75 mcg Violet "T|4" and "75" 71205-353-30 71205-353-60 71205-353-90 137 mcg Deep Blue "T|4" and "137" 71205-354-30 71205-354-60 71205-354-90

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

Inform the patient of the following information to aid in the safe and effective use of Levothyroxine Sodium Tablets:

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Manufactured by: LLOYD, Inc. Shenandoah, IA 51601 USA Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA Relabeled and Repackaged by: Proficient Rx LP Thousand Oaks, CA 91320 PI640-00 Rev. 05/2019

75 mcg, 30's Bottle Label - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-353-30 Levothyroxine Sodium Tablets, USP 75 mcg 30 Tablets Rx Only

137 mcg, 90's Bottle Label - PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71205-354-90 Levothyroxine Sodium Tablets, USP 137 mcg 90 Tablets Rx Only