Fluvoxaminedrug info

24 HR fluvoxamine maleate 150 MG Extended Release Oral Capsule

What it is used for

Fluvoxamine maleate extended-release capsules is a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD).

Efficacy was demonstrated in: One 12-week study fluvoxamine maleate extended-release capsules in adults. Two 10-week studies with immediate-release (IR) fluvoxamine tablets in adults and one 10-week study with IR fluvoxamine tablets in children and adolescents. One maintenance study with IR fluvoxamine tablets.

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 years 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 ]).

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 4, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Fluvoxamine maleate extended-release capsules, for oral administration, contain fluvoxamine maleate, USP a selective serotonin (5-HT) reuptake inhibitor (SSRI) belonging to the chemical series, the 2-aminoethyl oxime ethers of aralkylketones. Fluvoxamine maleate, USP is chemically designated as 5-methoxy-4'-(trifluoromethyl) valerophenone-(E)-O-(2-aminoethyl)oxime maleate (1:1) and has the empirical formula C 15 H 21 O 2 N 2 F 3

C 4 H 4 O 4. Its molecular weight is 434.41. The structural formula is: Fluvoxamine maleate, USP 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, USP each capsule contains the following inactive ingredients: ethyl cellulose, hydroxypropyl cellulose, hypromellose, sugar spheres (which contain sucrose and corn starch), triethyl citrate, and talc. The capsule shell contains gelatin, titanium dioxide, black iron oxide, iron oxide yellow, FD&C Blue No. 1 and sodium lauryl sulfate. The capsule shell is printed with black ink. The black ink contains shellac, propylene glycol, potassium hydroxide, and black iron oxide. Fluvoxamine maleate extended-release capsules are gluten-free. structure

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 4, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

This page reproduces regulatory text for reference. It is not medical advice, and KenyRx is not a pharmacy or a prescriber. Talk to a doctor or pharmacist about whether a medicine is right for you.

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