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Fluvoxamine Maleate Tablets

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Fluvoxamine Maleate Tablets

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Product description

Drug Name

Generic Name: Fluvoxamine Maleate Tablets

Composition Fluvoxamine Maleate

Description: Film-coated tablet, white to almost white after removing the film.

Indication: 1) Depression and related symptomatic diseases.

2) Obsessive Compulsive Disorders (OCD)

Strength: 50 mg

Usage and Dosage (For oral administration)

Depression

The recommended starting dose for Fluvoxamine Maleate Tablets (calculated by Fluvoxamine Maleate) is 50 mg or 100 mg, administered as a single daily dose at bed time. Increase up gradually to an effective dose. The regular dosage is 100 mg daily and could be adjusted carefully on an individual patient’ basis, some special cases can be increased up to 300 mg per day.

It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses.

As WHO requires, patients with depression should be treated for a sufficient period of at least 6 months after symptoms relieved.

The recommended dose of fluvoxamine for treatment of preventing depression recurrence is 100 mg.

Obsessive Compulsive Disorder (OCD)

The recommended starting dose for Fluvoxamine Maleate tablets is 50 mg per day for 3-4 days. The effective dosage is normally between 100-300 mg daily. Increase up to an effective dose gradually. The maximum dose for adult is 300 mg daily and for children over 8 years and adolescents is 200 mg daily. Doses up to 150 mg can be administered as a single daily dose at bedtime. It is advisable that a total daily dose of more than 150 mg is given in 2 or 3 divided doses.

If a good therapeutic response has been obtained, treatment can be continued at a dosage adjusted on an individual basis. Administer continually if there is no improvement within 10 weeks administration. While there are no systematic studies to answer the question of how long to continue fluvoxamine treatment. OCD is a chronic disease and it is reasonable to consider continuation beyond 10 weeks in responding patients. Dosage adjustments should be made carefully on an individual patient basis, to maintain the patients at the lowest effective dose. The need for treatment should be reassessed periodically. Behavioural psychotherapy can be considered to combine for treatment. Patients suffering from hepatic or renal insufficiency should start on a low dose and be carefully monitored.

Fluvoxamine tablets should be swallowed with water and without chewing or be taken following the doctor's instructions.

Contraindication

1) Fluvoxamine Maleate tablets are contraindicated in patients with a history of hypersensitivity to Fluvoxamine Maleate and any of the excipients.

2) Contraindicated in combination with monoamine oxidase inhibitors (MAOIs).

Treatment with fluvoxamine can be initiated if patients start to administer fluvoxamine from MAOIs:

- Two weeks after discontinuation of an irreversible MAOI, or

-The following day after discontinuation of a reversible MAOI (e.g. moclobemide).

3) At least one week should elapse between discontinuation of fluvoxamine and initiation of therapy with any MAOI.

Storage

Protect from light, store in well-closed containers.

Packaging

Packaging material: Aluminum press-through blister.