Drug information on Fluvator (50 mg) (Fluvoxamine) from Torrent Pharmaceuticals Ltd.

Medical Condition(s) for which Fluvator (50 mg) may be prescribed

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•  Most Common: Nausea, sleeplessness, drowsiness, headache, weakness, vomiting, nervousness, agitation and dizziness.

•  Body as a Whole : Flu-like syndrome, chills and uneasiness.

•  Heart: Palpitations and fainting.

•  Gastrointestinal: Diarrhea, constipation, indigestion, loss of appetite, vomiting, dry mouth, flatulence, tooth disorder, difficulty in swallowing, gastrointestinal bleeding and blood in stool.

•  Blood: Anemia and bruising.

•  Metabolic: Weight gain and weight loss.

•  Central Nervous System: Tremor, anxiety, dilatation of blood vessels, agitation, decrease in sexual activity, depression, decreased muscle tone, epilepsy, abnormal dreams, twitching, over active and mood elevation.

•  Respiratory : Upper respiratory tract infection, difficulty in breathing, yawn and nosebleed.

•  Skin:Sweating and hives.

•  Genitourinary:Abnormal ejaculation, urinary frequency, urinary retention, impotence, sexual dysfunction, blood in urine, prolonged menstrual period and vaginal bleeding.

Adult: Oral- Depression- Initial: 50-100 mg/day, up to 300 mg/day if needed.
Obsessive compulsive disorder- 50 mg once daily, may increase slowly. Max: 300 mg/day.
Social anxiety disorder- Extended release initial: 100 mg once daily. Max: 300 mg/day.

It comes as a tablet to take by mouth, with or without food.

♦It should not to be administered with thioridazine, terfenadine, astemizole, cisapride, pimozide, aloestron, tizanidine, use of MAOI's omitantly with or within 14 days of treatment with this medication, linezolid or intravenous methylene blue and patients with hypersensitivity.

• Caution should be exercised in patients with history of epilepsy, heart, kidney, adrenal, or liver disease, smoking, alcohol abuse, depression, suicidal thoughts, low sodium in blood, dehydration, ulcer, elderly, children, during pregnancy and breastfeeding.

• Avoid alcohol consumption and smoking.

• It may cause dizziness, drowsiness, or lightheadedness, do not drive a car or operate machinery while taking this medication.

• ♦Patient may develop with increased risk of Serotonin Syndrome with the following symptoms: restlessness, diarrhea, fast heart beat, incoordination, nausea, vomiting. If it is so consult with your healthcare provider.

It may cause loss of appetite and weight loss in children; monitor weight and growth in children while taking this drug.

Store it at room temperature (25°C), protect from light and moisture.

♦ Safety Labeling Changes Approved By FDA