Drug information on Asert (100 mg) (Sertraline) from Nicholas Piramal India Ltd.

Medical Condition(s) for which Asert (100 mg) may be prescribed

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•  Heart: Palpitations, chest pain; increased coagulation times, slow heart beat, AV block, abnormal heart rhythms, QT-interval prolongation, fast heart beat.

•  Central Nervous System:Headache, sleep disorder, drowsiness, dizziness, fatigue, general discomfort, tremor, increased libido, agitation, nervousness, anxiety, aggressive reaction, hyperactivity, tingling, weakness.

•  Skin: Sweating, rash, photosensitivity, inflammatory destruction of blood vessels.

•  Eye and ENT:Abnormal vision, tinnitus, blindness, cataract, inflammation of the optic nerve.

•  Gastrointestinal:Nausea, diarrhea, dry mouth, upset stomach, abdominal pain, loss of appetite, constipation, vomiting, increased appetite, inflammation of pancreas.

•  Genitourinary: Abnormal ejaculation, sexual dysfunction, urinary incontinence, impotence, potentially harmful, acute renal failure.

•  Blood: Purple or discolorations on the skin, lowered white blood cell count, blood disorder, lupus-like syndrome, reduction in the number of red cells, serum sickness, decrease in platelets.

•  Liver: Elevated liver enzymes, increased bilirubin, liver enlargement, jaundice, liver failure.

•  Metabolic: Increased weight, high blood sugar, low thyroid level.

•  Respiratory: Nose bleed, inflammation of sinus, runny nose. •  Miscellaneous: Pain, fever, pain, weight loss; back pain, muscle pain, yawning, anaphylaxis.

PO- The dose in depression and obsessive- compulsive syndrome is 50mg/day, which can be increased as per requirement to up to 200 mg/day. The recommended dose in children is 25 mg/day.

This medication available in the form of tablet and a concentrate liquid to be taken by mouth, with or without food.

Contraindicated in patients are taking or have taken linezolid, methylene blue, a monoamine oxidase inhibitor (MAOI), selegiline, or St. John's wort within the last 14 days, and hypersensitivity.

• Caution should be exercised in patients with history of hypomania and seizure disorders, liver or kidney damage, heart disease, recent heart attack, bleeding disorders, diabetes and angle-closure glaucoma.

• Discontinue treatment if seizures develop or if there is an increase in seizure frequency.

• Monitor for signs of clinical worsening, suicidality and unusual changes in behavior especially during the initial treatment period or when there are dosage adjustments.

• ♦ 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.

Withdrawal should be gradual.Consult your doctor during pregnancy and breastfeeding.

Oral: Store at 15-30°C.

♦ Safety Labeling Changes Approved By FDA