Drug ID: 1d00000085
Drug Name: Amitriptyline
Generic Names: Trixide | Tryptomec (75mg) | Amsha Plus (12.5 mg) | Amizep | Tridep (75 mg) | Amiclozor | Goldep SR (25mg) | Amilite (75mg) | Amiwel -Plus | Eliwel (75mg) | Latiln (50 mg) | Normaline Plus | Relidep Plus-H | Gentrip SR (50mg) | Amypres -C | Amiline (25mg) | Tryptomer (75mg) | Tryline Plus | Amitop (25 mg) | Axtrip (25 mg) | Amilite H | Limbival | Amichlor | Triplex (25 mg) | Anitryp (25 mg) | Crypton (10 mg) | Latilin (10 mg) | Cotrip (10 mg) | Febl -Forte | Eptanol - C | Elavil | Endep | Vanatrip | More
Legal Status: Non opioid prescription only
Indication for Mother: Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.
Recommended Dose: Adult: Oral- Depression- Initial:50-75 mg/day; up to 150 mg/day if needed. Max: 300 mg/day in severe cases.
Neuropathic pain- Initial: 10-25 mg/day at night, up to 75 mg/day if needed.
Migraine prophylaxis- Initial: 10 mg/day at night. Maintenance: 50-75 mg/day at night.
Recommended In: This medication is a tricyclic antidepressant, prescribed for depression. It is also prescribed for migraine and nerve pain. It corrects the imbalance of chemical substances acting on the nervous system.
Directions For Use: It comes as a tablet, to take by mouth, with or without food.
Storage: Store it at room temperature, and in an airtight container. Keep away from children.
Dosage Forms: Tablet
Side Effects: Body as a Whole- Lupus-like syndrome.
Liver- Liver failure.
Heart - Heart attack, stroke, nonspecific ECG changes, heart block, irregular heartbeat, low/high blood pressure, fainting, fast heart rate and palpitations.
Central Nervous System - Coma, seizures, hallucinations, delusions, confusion, disorientation, in coordination, unsteadiness, tremors, nerve disease, numbness, tingling, involuntary movements, poor concentration, excitement, anxiety, sleeplessness, restlessness, abnormal dreams, drowsiness, dizziness, weakness, fatigue and headache.
Allergic - Skin rash, hives, photosensitivity, swelling of the face and tongue.
Blood - Bone marrow depression including decreased blood cell counts and bruising.
Gastrointestinal - Nausea, vomiting, loss of appetite, mouth ulcer, peculiar taste and diarrhea.
Eye and ENT - Blurred vision, dim vision, increased eye pressure, dilatation of pupil and dry mouth.
Genitourinary - Testicular swelling and breast enlargement in males, spontaneous flow of milk from the nipple in females, increased or decreased sexual drive, impotence, urinary retention and lowered blood sugar levels.
Miscellaneous - Hair loss, weight gain or loss, urinary frequency and increased sweating.
In Case of Overdose: Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after tricyclic antidepressant overdose; therefore, hospital monitoring is required as soon as possible.
Critical manifestations of overdose include: cardiac dysrhythmias, severe hypotension, convulsions, and CNS depression, including coma. Changes in the electrocardiogram, particularly in QRS axis or width, are clinically significant indictors of tricyclic antidepressant toxicity.
Other signs of overdose may include: impaired myocardial contractility, confusion, disturbed concentration, transient visual hallucinations, dilated pupils, disorders of ocular motility, agitation, hyperactive reflexes, polyradiculoneuropathy, stupor, drowsiness, muscle rigidity, vomiting, hypothermia, hyperpyrexia.
General: Obtain an ECG and immediately initiate cardiac monitoring. Protect the patient's airway, establish and intravenous line, and initiate gastric decontamination. A minimum of 6 hours of observation with cardiac monitoring and observation for signs of CNS or respiratory depression, hypotension, cardiac dysrhythmias and/or conduction blocks, and seizures is necessary. If signs of toxicity occur at any time during this period, extended monitoring is required. There are case reports of patients succumbing to fatal dysrhythmias late after overdose; these patients had clinical evidence of significant poisoning prior to death, and most received inadequate gastrointestinal decontamination. Monitoring of plasma drug levels should not guide management of the patient.
Gastrointestinal Decontamination: All patients suspected of tricyclic antidepressant overdose should receive gastrointestinal decontamination. This should include large volume gastric lavage followed by activated charcoal. If consciousness is impared, the airway should be secured prior to lavage. Emesis is contraindicated.
Cardiovascular: A maximal limb-lead QRS duration of ?0.10 seconds may be the best indication of the severity of the overdose. Intravenous sodium bicarbonate should be used to maintain the serum pH in the range of 7.45-7.55. If the pH response is inadequate, hyperventilation may also be used. Concomitant use of hyperventilation and sodium bicarbonate should be done with extreme caution, with frequent pH monitoring. A pH >7.60 or a pCO2 <20 mmHg is undesirable. Dysrhythmias unresponsive to sodium bicarbonate therapy/hyperventilation may respond to lidocaine, bretylium or phenytoin. Type IA and IC antiarrhythmics are generally contraindicated (e.g., quinidine, disopyramide, and procainamide).
In rare instances, hemoperfusion may be beneficial in acute refractory cardiovascular instability in patients with acute toxicity. However, hemodialysis, peritoneal dialysis, exchange transfusions, and forced diuresis generally have been reported as ineffective in tricyclic antidepressant poisoning.
CNS: In patients with CNS depression, early intubation is advised because of the potential for abrupt deterioration. Seizures should be controlled with benzodiazepines, or if these are ineffective other anticonvulsants (e.g., phenobarbital, phenytoin). Physostigmine is not recommended except to treat life-threatening symptoms that have been unresponsive to other therapies, and then only in consultation with a poison control center.
Psychiatric Follow-up: Since overdosage is often deliberate, patients may attempt suicide by other means during the recovery phase. Psychiatric referral may be appropriate.
Pediatric Management: The principles of management of pediatric and adult overdosages are similiar. It is strongly recommended that the physician contact the local poison control center for specific pediatric treatment.
Avoid If: Caution should be exercised in patients with history of irregular heartbeat, heart disease, chest pain, liver disease, prostate problems, overactive thyroid, urinary retention, suicidal thoughts, alcohol addiction, any allergy, who are taking other medications, elderly, during pregnancy and breastfeeding.
It may cause dizziness, drowsiness or blurred vision, do not drive a car or operate machinery, get up slowly from bed while taking this medication.
Avoid alcohol consumption.
Patient may develop with involuntary muscle movements; if it so consult with your doctor immediately.
Avoid prolonged exposure to sunlight.
It may cause heatstroke, protect from hot weather.
Contraindicated in patients who are taking antihistamines, or who have taken MAOIs within the last 14days and hypersensitivity.
This medication may develop with increased risk of suicidal thoughts in children and teenagers; watch them carefully.
Monitor blood sugar level regularly while taking this medication.
Drug Interaction: The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide). While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition. The extent to which SSRI-TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved. Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
Monoamine Oxidase Inhibitors: Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram.
When amitriptyline HCl is given with anticholinergic agents or sympathomimetic drugs, including epinephrine combined with local anesthetics, close supervision and careful adjustment of dosages are required.
Hyperpyrexia has been reported when amitriptyline HCl is administered with anticholinergic agents or with neuroleptic drugs, particularly during hot weather.
Paralytic ileus may occur in patients taking tricyclic antidepressants in combination with anticholinergic-type drugs.
Cimetidine is reported to reduce hepatic metabolism of certain tricyclic antidepressants, thereby delaying elimination and increasing steady-state concentrations of these drugs.
Caution is advised if patients receive large doses of ethchlorvynol concurrently. Transient delirium has been reported in patients who were treated with one gram of ethchlorvynol and 75 - 150 mg of amitriptyline HCl.