BIOVOXIN ER 100

BIOVOXIN ER 100

FLUVOXAMINE EXTENDED RELEASE 100MG TABLET

According to the DSM-IV, fluvoxamine maleate extended-release capsules are approved for the treatment of obsessive compulsive disorder (OCD). Obsessive compulsive disorder is characterised by recurring and persistent ego-dystonic ideas, thoughts, urges, or pictures (obsessions) and/or repeated, deliberate, and intentional behaviours (compulsions) that are perceived as excessive or irrational by the individual. The obsessions or compulsions are time-consuming, severely impair social or vocational functioning, and cause great misery.

One 12-week trial in adults with fluvoxamine maleate extended-release capsules, two 10-week trials in adults, and one 10-week trial in children and adolescents (ages 8 to 17) with immediate-release fluvoxamine tablets in outpatients with the diagnosis of OCD as defined in DSM-IV or DSM-III-R were used to demonstrate the efficacy of the medication.

In one maintenance research using immediate-release fluvoxamine pills on adults, the effectiveness of fluvoxamine for long-term usage was established (see Clinical Studies [14.2]). If a doctor decides to give a patient fluvoxamine maleate extended-release capsules for a longer length of time, they should regularly reevaluate the drug's potential long-term benefits for that specific patient.

Obsessive compulsive disorder (OCD), as described by the DSM-IV, is authorised for therapy with fluvoxamine maleate extended-release capsules. Obsessive compulsive disorder is characterised by recurring and persistent ego-dystonic thoughts, feelings, urges, or images (obsessions) and/or repeated, deliberate, and intentional behaviours (compulsions) that are seen by the individual as excessive or irrational. The obsessions or compulsions considerably hinder social or occupational functioning, create great anguish, and take up a lot of time.

In one maintenance research using immediate-release fluvoxamine pills on adults, the effectiveness of fluvoxamine for long-term usage was established (see Clinical Studies [14.2]). A doctor should frequently reassess the long-term efficacy of the medication for each patient before choosing to provide fluvoxamine maleate extended-release capsules (see Dosage and Administration [2.4]).

Fluvoxamine maleate extended-release capsules are available as:

Each #2 capsule weighs 100 mg of fluvoxamine maleate, USP, which is inscribed on the cap and body in black ink with the symbols ebfb06fd-figure-01 and 2848.

A significant range of structurally diverse pharmaceuticals and endogenous chemicals are subjected to oxidative biotransformation by many liver cytochrome P450 isoenzymes. Although some preliminary in vitro data are also available, the majority of the information on the interaction between fluvoxamine and the cytochrome P450 isoenzyme system has come from pharmacokinetic interaction studies carried out in healthy people. Fluvoxamine appears to inhibit several cytochrome P450 isoenzymes that are known to be involved in the metabolism of other drugs, such as CYP1A2 (e.g., warfarin, theophylline, propranolol, tizanidine), CYP2C9 (e.g., warfarin), and CYP3A4 based on the discovery of significant interactions of fluvoxamine with some of these drugs.

Fluvoxamine's metabolism is not well understood, and it has not been investigated how strong cytochrome P450 isoenzyme inhibitors, like ketoconazole, which inhibits CYP3A4, affect fluvoxamine metabolism.