Fluvoxamine Maleate Extended-release

Fluvoxamine Maleate Extended-release

Fluvoxamine Maleate Extended-release Recall

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Questions & Answers

Side Effects & Adverse Reactions

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Legal Issues

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FDA Safety Alerts

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Manufacturer Warnings

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FDA Labeling Changes

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Uses

1.1 Obsessive Compulsive Disorder

Fluvoxamine maleate extended-release capsules are indicated for the treatment of obsessive compulsive disorder (OCD), as defined in the DSM-IV. Obsessive compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning.

The efficacy of fluvoxamine maleate extended-release capsules was demonstrated in one 12-week trial in adults with fluvoxamine maleate extended-release capsules as well as in two 10-week trials in adults and in one 10-week trial in children and adolescents (ages 8 to 17 years) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R (see CLINICAL STUDIES [14.1, 14.3]).

The efficacy of fluvoxamine for long-term use was established in one maintenance study in adults with immediate-release fluvoxamine tablets (see CLINICAL STUDIES [14.2]). The health care provider who elects to prescribe fluvoxamine maleate extended-release capsules for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION [2.4]).

History

There is currently no drug history available for this drug.

Other Information

Fluvoxamine maleate extended-release capsules are an extended-release capsule for oral administration that contains fluvoxamine maleate, a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones.

Fluvoxamine maleate is chemically designated as 5-methoxy-4’-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C15H21O2N2F3•C4H4O4. Its molecular weight is 434.41.

The structural formula is:

structural

Fluvoxamine maleate is a white to off-white, odorless, crystalline powder that is sparingly soluble in water, freely soluble in ethanol and chloroform, and practically insoluble in diethyl ether.

Fluvoxamine maleate extended-release capsules are available in 100 mg and 150 mg strengths for oral administration. In addition to the active ingredient, fluvoxamine maleate, each capsule contains the following inactive ingredients: black iron oxide, dehydrated alcohol, ethylcellulose, gelatin, hydroxypropyl cellulose, isopropyl alcohol, povidone, shellac, sugar spheres, talc, titanium dioxide, triethyl citrate, D&C Red No. 28, and FD&C Blue No. 1. The 100 mg strength also contains FD&C Blue No. 2, FD&C Red No. 40 and D&C Yellow No. 10.

Fluvoxamine Maleate Extended-release Manufacturers


  • Par Pharmaceutical, Inc.
    Fluvoxamine Maleate Extended-release (Fluvoxamine Maleate) Capsule, Extended Release [Par Pharmaceutical, Inc.]

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