Levothyroxine Sodium Capsules

Dosage Forms And Strengths

TIROSINT Capsules: 13 mcg, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg.

TIROSINT Capsules are amber-colored, round/biconvex capsules that contain a viscous amber-colored liquid.

Storage And Handling

TIROSINT (levothyroxine sodium) capsules are amber-colored, round/biconvex capsules that contain a viscous amber-colored liquid. They are supplied as follows:

Boxes of 28 capsules, consisting of 4 blisters with 7 capsules each. The dosage strength on each box is clearly identified in several locations, and is associated with a distinct color. The color of the circles on the blister is the same color as on the box. Each blister pack contains 7 capsules placed in individual cavities labeled with the dosage strength, the product name (Tirosint), and an abbreviation for the day of the week on which the capsule is taken.

Do not separate the individual cavities containing the drug from the intact blister as important information may be lost (i.e., manufacturer/distributor names, distributor contact phone number, lot number, and expiration date), and do not remove the individual capsules from blister packaging until ready to use.

Table 7: TIROSINT Packaging Description

Store at 25°C (77°F); excursions permitted to 15°>-30°> (59-86°>F) [See USP Controlled Room Temperature]. TIROSINT capsules should be protected from heat, light and moisture.

Manufactured for Akrimax Pharmaceuticals, LLC by: IBSA Institut Biochimique SA, 6903 Lugano, Switzerland. Distributed by: Akrimax Pharmaceuticals, LLC,Cranford, NJ07016 USA. Revised: March 2012

Included as part of the PRECAUTIONS section.

The signs and symptoms of overdosage are those of hyperthyroidism. [See WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS] In addition, confusion and disorientation may occur. Cerebral embolism, shock, coma, and death have been reported. Seizures have 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.

Levothyroxine sodium should be reduced in dose or temporarily discontinued if signs or symptoms of overdosage occur.

To obtain up-to-date information about the treatment of overdose, a good resource is the certified Regional Poison Control Center. In managing overdosage, consider the possibility of multiple drug overdoses, interaction among drugs, and unusual drug kinetics in the patient.

In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's medical status.