Trade Name: AMIT TABLET 10 MG
Generic Name: Amitriptylline Hydrochloride USP

Presentation:

Amit10: Each film coated tablet contains Amitriptyline hydrochloride USP 10 mg.
Amit25: Each film coated tablet contains Amitriptyline hydrochloride USP 25 mg. 

Indications:

¨ Depressive illness: particularly where sedation is required.
¨ Nocturnal Enuresis in children.
¨ Prophylaxis of Migraine.
¨ Tension Headach.
¨ Chronic Pain

Dosage & administration:

Depression: Initially 75 mg (Elderly and Adolescents 30-75 mg) daily in divided doses or as a single dose at bedtime increased gradually as necessary to 150-200 mg; Child under 16 years not recommended for depression.

Nocturnal Enuresis: Child 7-10 years 10-20 mg, 11-16 years 25-50 mg at night; max. period of treatment (including gradual withdrawal) 3 months-full physical examination before further course.

Prophylaxis of Migraine: 100 mg daily.

Tension Headache: 10-25 mg three times daily.

Precautions:

Cardiac disease (particularly with arrhythmias), history of epilepsy, hepatic impairment (avoid if severe), thyroid disease, history of mania, psychoses (may aggravate psychotic symptoms), angle closure glaucoma, history of urinary retention, concurrent electro convulsive therapy.

Side effects:

Anticholinergic: Excessive perspiration, dry mouth, blurred vision, hyperpyrexia, urinary retention and urinary tract dilatation.

Cardiovascular reactions: Hypotension, syncope, postural hypertension, hypertension, tachycardia, palpitations, myocardial infarction, etc.

CNS and Neuromuscular: Confusional states, disturbed concentration, disorientation, delusions, etc.

Allergic: Skin rash, urticaria, photosensitization, etc.

Haematological: Bone-marrow depression.

Gastrointestinal: Nausea, epogastric distress, vomiting, anorexia, stomatitis, unpleasant taste, weight loss, diarrhoea, constipation, etc.

Endocrine: Testicular swelling, gynaecomastia, breast enlargement, galactorrhoea, etc.

Contraindication:

Recent myocardial infarction, arrhythmias (particularly heart block), manic phase, severe liver disease.

Drug interactions:

TCA enhances the sedative effect of alcohol and opioid analgesics. When TCA is used with Moxifloxacin or Terfenadine, it increases the risk of ventricular arrhythmias. Disulfirum and cimetidine inhibit the metabolism of Amitriptyline. When TCA is used with diuretics, it enhances the risk of postural hypertension.

Pregnancy and lactation:

Not recommended in pregnancy and lactation.

Commercial Pack:

Amit 10: Each box contains 10 strips of 10 tablets.

Amit 25: Each box contains 10 strips of 10 tablets.