Equetro

Equetro

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Questions & Answers

Side Effects & Adverse Reactions

There is currently no warning information available for this product. We apologize for any inconvenience.

Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

1.1 Acute Manic or Mixed Episodes associated with Bipolar I Disorder

EQUETRO is indicated for treatment of patients with acute manic or mixed episodes associated with bipolar I disorder.

The efficacy of EQUETRO in acute mania was established in 2 randomized, double-blind, placebo-controlled, 3-week studies in adult patients meeting DSM-IV criteria for bipolar I disorder who had an acute manic or mixed episode [see Clinical Studies (14.1)]. The effectiveness of EQUETRO 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 for extended periods should periodically re-evaluate the long-term risks and benefits of the drug for the individual patient.

History

There is currently no drug history available for this drug.

Other Information

EQUETRO (carbamazepine) is a mood stabilizer available for oral administration as 100 mg, 200 mg, and 300 mg extended-release capsules of carbamazepine, USP. Carbamazepine is a white to off-white powder, practically insoluble in water and soluble in alcohol and in acetone. Its molecular weight is 236.27. The chemical name is 5H-dibenz[b,f]azepine-5-carboxamide, and the structural formula is:

equetro-01

EQUETRO® is a multi-component capsule formulation consisting of three different types of beads: immediate-release beads, extended-release beads, and enteric-release beads. The three bead types are combined in a specific ratio to provide twice-daily dosing of EQUETRO®.

Inactive ingredients: citric acid, colloidal silicon dioxide, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, povidone, sodium lauryl sulfate, talc, triethyl citrate, and other ingredients.

The 100 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and Titanium Dioxide, and are imprinted with white ink; the 200 mg capsule shells contain gelatin-NF, Yellow Iron Oxide, FD&C Blue #2, and Titanium Dioxide, and are imprinted with white ink; and the 300 mg capsule shells contain gelatin-NF, FD&C Blue #2, Yellow Iron Oxide, and Titanium Dioxide, and are imprinted with white ink.

Equetro Manufacturers


  • Validus Pharmaceuticals Llc
    Equetro (Carbamazepine) Capsule, Extended Release [Validus Pharmaceuticals Llc]

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