Amitor HCl is an antidepressant with sedative effects. Its mechanism of action in man is not known. It is not a monoamine oxidase inhibitor and it does not act primarily by stimulation of the central nervous system.
Amitor inhibits the membrane pump mechanism responsible for uptake of norepinephrine and serotonin in adrenergic and serotonergic neurons. Pharmacologically, this action may potentiate or prolong neuronal activity since reuptake of these biogenic amines is important physiologically in terminating transmitting activity. This interference with reuptake of norepinephrine and/or serotonin is believed by some to underlie the antidepressant activity of Amitor.
Amitor is used for depressive illness, particularly with anxiety and nocturnal enuresis in children.
Amitor is also used to associated treatment for these conditions: Acute Depression, Anorexia Nervosa (AN), Attention Deficit Hyperactivity Disorder (ADHD), Bulimia Nervosa, Depression, Diabetic Neuropathies, Insomnia, Irritable Bowel Syndrome (IBS), Major Depressive Disorder (MDD), Migraine, Moderate Depression, Neuropathic Pain, Nocturnal Enuresis, Severe Depression, Sleep disorders and disturbances, Tension Headache, Moderate Agitation, Moderate Anxiety, Severe Anxiety, Severe agitation
|Other Names||Amitriptilina, Amitriptylin, Amitriptyline, Amitriptylinum|
Very highly protein bound (95%) in plasma and tissues .
|Therapeutic Class||Tricyclic Anti-depressant|
|Manufacturer||Torrent Pharmaceuticals Ltd, Opsonin Pharma Ltd|
|Available Country||India, Bangladesh|
|Last Updated:||June 23, 2021 at 9:10 am|
Table Of contents
- Adults: Initially 50-70 mg a day in divided dose or as a single dose at night at bed time.
- Elderly and adolescents: 25-50 mg daily in divided doses or as single dose at bed time. Dose can be increased gradually as necessary to a maximum of 150-200 mg. Usual maintenance dose is 50-100 mg daily.
- 6-10 years: 10-20 mg at bed time.
- 11-16 years: 25-50 mg at bed time for up to 3 months and gradually withdrawn.
- Cardiovascular reactions: Hypotension, syncope, postural hypotension, hypertension, tachycardia, palpitations, myocardial infarction, arrythmias, and heart block stroke.
- CNS and neuromuscular: Confusional states, disturbed concentration disorientation, delusions, and hallucinations.
- Anticholinergic: Dry mouth, blurred vision, mydriasis, increased intraoccular pressure, hyperplasia.
- Allergic: Skin rash, urticaria, and photosensitization.
- Haematological: Bone-marrow depression including agranulocytosis, leukopenia, eosinophilia, and thrombocytopenia.
- Gastrointestinal: Nausea, epigastric distress, vomiting anorexia, diarrhoea.
- Endocrine: Testicular swelling, gynaecomastia; breast enlargement, galactorrhoea.
- Other reaction: Dizziness, weakness, fatigue, headache, weight loss
Schizophrenic patients may develop increased symptoms of psychosis; patients with paranoid symptomatology may have an exaggeration of such symptoms. Depressed patients, particularly those with known manic-depressive illness, may experience a shift to mania or hypomania. In these circumstances the dose of Amitor may be reduced or a major tranquilizer such as perphenazine may be administered concurrently.
The possibility of suicide in depressed patients remains until significant remission occurs. Potentially suicidal patients should not have access to large quantities of this drug. Prescriptions should be written for the smallest amount feasible.
Concurrent administration of Amitor hydrochloride and electroshock therapy may increase the hazards associated with such therapy. Such treatment should be limited to patients for whom it is essential.
When possible, the drug should be discontinued several days before elective surgery. Both elevation and lowering of blood sugar levels have been reported. Amitor hydrochloride should be used with caution in patients with impaired liver function.
Monoamine oxidase inhibitors can potentiate the effects of Amitor.
Anticholinergic agents: Amitriptylin should not be given with symptomatic agents such as adrenaline, epinephrine, isoprenaline, noradrenaline.
CNS depressant: Amitor may enhance the response to alcohol, barbiturates.
Cemitidine: Cemitidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants.
- Avoid alcohol.
- Avoid St. John's Wort.
- Limit caffeine intake.
- Take with food. Food reduces irritation.
Volume of Distribution
The apparent volume of distribution (Vd)β estimated after intravenous administration is 1221 L±280 L; range 769-1702 L (16±3 L/kg) . It is found widely distributed throughout the body . Amitor and the main metabolite nortriptyline pass across the placental barrier and small amounts are present in breast milk .
The elimination half-life (t1⁄2 β) amitriptyline after peroral administration is about 25 hours (24.65 ± 6.31 hours; range 16.49-40.36 hours) .
The mean systemic clearance (Cls) is 39.24 ± 10.18 L/h (range: 24.53-53.73 L/h) . No clear effect of older age on the pharmacokinetics of amitriptyline has been determined, although it is possible that clearance may be decreased .
Pregnancy & Breastfeeding use
Pregnancy Category C. Amitor is not recommended during pregnancy, especially during the first and third trimester because the safety of Amitor has not been established yet.
Amitor is detectable in breast milk. Because of the serious adverse reactions in infants from Amitor, a decision should be made whether to continue breast feeding or discontinue the drug
Amitor is contraindicated in myocardial infarction; arrythmias, particularly heartblock of any degree; mania; severe liver disease. Initially sedation may effect the ability to drive or operate machinery. It should be used with caution in patients with a history of epilepsy, glaucoma, urinary retention, prostatic hypertrophy, constipation, cardiac disease, diabetes, pregnancy, hepatic impairment, thyroid disease, increased intraoccular pressure, psychoses (may aggravate mania).
Keep containers well closed and stored below 25˚ C, protected from light.