Why it is prescribed :
This medication is an antidepressant, prescribed for depression. It is also used to treat bedwetting in children. It increases the amount of certain natural substances in the brain.
When it is not to be taken (Contraindications): ♦
Contraindicated in patients with recovery period after a heart attack, who are taking MAOIs, linezolid or intravenous methylene blue
Category C :
Animal studies have shown adverse effects on the fetus and there are no appropriate studies in pregnant women, but potential benefits may allow the use of the drug in pregnant women despite the potential for risks.
Dosage & When it is to be taken (Indications):
Adult: PO- Initial dose: 100 mg per day given in 3 to 4 divided doses.
Pediatric Dose for Primary Nocturnal Enuresis: Initial dose: 25 mg per day orally 1 hour before bedtime.
How it should be taken :
It comes as a tablet and capsule to take by mouth, with or without food.
Warnings and Precautions :
Caution should be exercised in patients with history of increased eye pressure, prostate enlargement, difficulty in urinating, seizures, overactive thyroid, liver, kidney or heart disease, any allergy, who are taking other medications, during pregnancy and breast feeding.
It may cause drowsiness or dizziness, do not drive a car or operate machinery while taking this medication.
Avoid alcohol consumption and smoking while taking this medication.
Avoid exposure to sunlight; otherwise it may cause skin sensitivity.
♦Patient may develop Serotonin Syndrome with the following symptoms: increased heart rate, shivering, sweating, dilated pupils.
Side Effects :
Low/high blood pressure, fast heart rate, palpitations, heart attack, abnormal heart rhythm, heart block, ECG changes, heart failure and stroke.
Confusion, hallucinations, disorientation, anxiety, restlessness, agitation, sleeplessness, abnormal dreams and irritable mood.
Central Nervous System
Numbness, tingling, incoordination, tremors, seizures, alterations in EEG patterns and ringing in the ear.
Blurred vision, visual disturbances and dilatation of pupil.
Skin rash, hives, itching, photosensitization, swelling in the face and tongue and fever.
Bone marrow depression.
Nausea, vomiting, dry mouth, loss of appetite, constipation, stomach upset, diarrhea, intestinal obstruction, mouth ulcer, abdominal cramps and black tongue.
Breast enlargement in the male, spontaneous milk secretion in the female, increased or decreased sexual drive, impotence, testicular swelling, elevation or depression of blood sugar levels, urinary retention and dilation of the urinary tract.
Jaundice and hair loss.
Other Precautions :
Avoid excess dosage.
Storage Conditions :
Store it at room temperature (20° to 25°C), and in an airtight container. Keep away from children.
Schedule : H
Prescription drugs - Drugs to be sold only under the prescription of a Registered Medical Practitioner.
♦ Safety Labeling Changes Approved By FDA