Equetro (Carbamazepine) - Indications and Dosage

INDICATIONS AND USAGE

EQUETRO^TM is indicated for the treatment of acute manic and mixed episodes associated with Bipolar I Disorder.

A manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. A mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities).

The efficacy of EQUETRO^TM in acute mania was established in 2 placebo-controlled, double-blind, 3-week studies in patients meeting DSM-IV criteria for Bipolar I Disorder who currently displayed an acute manic or mixed episode ( see CLINICAL PHARMACOLOGY ).

The effectiveness of EQUETRO^TM for longer-term use and for prophylactic use in mania has not been systematically evaluated in controlled clinical trials. Therefore, physicians who elect to use EQUETRO^TM for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION ).

DOSAGE AND ADMINISTRATION

The recommended initial dose of EQUETRO^TM is 400 mg/day given in divided doses, twice daily. The dose should be adjusted in 200 mg daily increments to achieve optimal clinical response. Doses higher than 1600mg/day have not been studied.

Monitoring of blood levels ( see PRECAUTIONS, Laboratory Tests ) may be useful for verification of drug compliance, assessing safety and determining the cause of toxicity including when more than one medication is being used.

The EQUETRO^TM capsules may be opened and the beads sprinkled over food, such as a teaspoon of applesauce or other similar food products if this method of administration is preferred. EQUETRO^TM capsules or their contents should not be crushed or chewed. EQUETRO^TM can be taken with or without meals.

HOW SUPPLIED

EQUETRO^TM (carbamazepine) extended-release capsules is supplied in three dosage strengths.

100 mg-Two-piece hard gelatin capsule yellow opaque cap with bluish green opaque body printed with the SPD417 on one end, SPD417 and 100 mg on the other in white ink

Supplied in bottles of 120....................................................................... NDC 54092-419-12

200 mg-Two-piece hard gelatin capsule yellow opaque cap with blue opaque body printed with the SPD417 on one end and SPD417 and 200 mg on the other in white ink

Supplied in bottles of 120 NDC 54092-421-12

300 mg-Two-piece hard gelatin capsule yellow opaque cap with blue body printed with the SPD417 on one end and SPD417 and 300 mg on the other in white ink

Supplied in bottles of 120 NDC 54092-423-12

Store at 25^o C (77^o F); excursions permitted to 15-30°C (59-86°F) [see USP controlled room temperature].

PROTECT FROM LIGHT AND MOISTURE.

Manufactured for:

Shire US Inc.

725 Chesterbrook Blvd, Wayne, PA 19087

© 2006 Shire US Inc.

419 1207 003

(REV 12/2006)