Deskripsi
Manufacturer
Mylan Laboratories SAS
Registraction Number
MAL20021413ACZ
Content & Ingredients
- Active Ingredient: Each tablet contains 100 mg of fluvoxamine maleate.
- Inactive Ingredients: Mannitol (E421), maize starch, pregelatinised starch, sodium stearyl fumarate, colloidal anhydrous silica, hypromellose, polyethylene glycol 6000, talc, titanium dioxide (E171).
Indications
- Major Depressive Disorder (MDD): For the treatment of depressive illness and the symptoms of depressive disorder.
- Obsessive-Compulsive Disorder (OCD): For the treatment of symptoms of obsessive-compulsive disorder.
Dosage & Administration
Depression:
- Starting Dose: 50 or 100 mg once daily in the evening.
- Dose Adjustment: Increase gradually to an effective dose, typically 100 mg per day.
- Maximum Dose: Up to 300 mg per day, with doses above 150 mg divided into 2 or 3 doses.
- Duration: Continue for at least 6 months after recovery from a depressive episode.
Obsessive-Compulsive Disorder:
- Adults:
- Starting Dose: 50 mg per day for 3–4 days.
- Effective Dose: Usually between 100 mg and 300 mg per day.
- Administration: Doses up to 150 mg can be given as a single dose; doses above 150 mg should be divided into 2 or 3 doses.
- Children (8 years and older) and Adolescents:
- Starting Dose: 25 mg per day, preferably at bedtime.
- Dose Adjustment: Increase every 4–7 days by 25 mg increments.
- Effective Dose: Usually between 50 mg and 200 mg per day.
- Maximum Dose: Do not exceed 200 mg per day.
- Administration: Total daily doses above 50 mg should be divided into 2 doses; the larger dose should be given at bedtime.
General Instructions:
- Swallow tablets whole with water; do not chew.
- Avoid abrupt discontinuation; taper gradually to reduce withdrawal symptoms.
- Monitor for side effects and consult a doctor if any adverse reactions occur.
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