Drug ID: 1d00000086
Drug Name: Amitriptyline and Perphenazine
Generic Names: Duo-Vil 2-10 | Etrafon | Triavil | PMS-Levazine | Triptazine
Legal Status: Non opioid prescription only
Indication for Mother: Category N
Not yet classified.
Recommended Dose: Adults - Oral- Initially, usual dose is 2 to 4 mg perphenazine with 10 to 50 mg amitriptyline 3 to 4 times daily.
Recommended In: This medication is a phenothiazine and tricyclic antidepressant combination, prescribed for anxiety and depression. Serotonin and noradrenaline reabsorption prevent by Amitriptyline where as Perphenazine blocks a variety of receptors in the brain.
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. Protect unit-dose packages from excessive moisture.
Dosage Forms: Tablet |
Side Effects: Heart - High/low blood pressure, slow/fast heart rate, fainting, heart arrest, poor blood circulation, abnormal heart rhythm, lightheadedness, faintness, dizziness, EKG changes and palpitations.
Central Nervous System - Sedation, movement disorder, restlessness, rigidity, drowsiness, headache, weakness, anxiety, agitation, mania, exacerbation of psychosis, dizziness, tremor, fatigue, slurring of speech, sleeplessness, vertigo, seizures, abnormalities of CSF proteins, excitement, catatonic-like states, lethargy, hyperactivity and abnormal dreams.
Skin - Photosensitivity reaction, pigmentation, dry skin, inflammation, hives, rash, skin disorder, pimples and itching.
Eye and ENT - Increased eye pressure, photophobia, nose inflammation, inflammation of pharynx, ringing in the ear, blurred vision, nasal congestion, and dilatation of pupil.
Gastrointestinal - Indigestion, intestinal obstruction, constipation, nausea, vomiting, loss of appetite, diarrhea, peculiar taste, dry mouth or throat.
Genitourinary - Urinary retention, impotence, sexual dysfunction, menstrual irregularities and night time urination.
Blood - Abnormal decrease in white blood cells, eosinophilia, anemia, bruising and decrease in platelets.
Liver - Jaundice.
Metabolic - Increase or decrease in blood sugar.
Respiratory - Asthma, difficulty in breathing and cough.
Miscellaneous - Increased appetite, weight and thirst, breast enlargement in males and milk secretion in women.
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 breast cancer, seizures, asthma or other breathing problems, trouble in urinating, alcohol abuse, depression, suicidal thoughts, lung infection, heart disease, Reye syndrome, Parkinson disease, increased eye pressure, high/low blood pressure, any allergy, who are taking other medications, elderly, children, during pregnancy and breastfeeding.
It may cause drowsiness, dizziness or fainting, do not drive a car or operate machinery while taking this medication.
Avoid alcohol consumption.
Avoid exposure to sunlight; otherwise it may cause sunburn.
It may cause heatstroke, protect from hot weather.
This medication may develop increased risk of suicidal thoughts in children and teenagers; watch them carefully.
Patient may develop with increased risk of neuroleptic malignant syndrome (NMS) with the following symptoms: fever, muscle tightness, confusion, abnormal thinking, fast or irregular heartbeat; and sweating. If it so consult with your doctor.
Etrafon should not be discontinued suddenly. Dosage should be tapered gradually, especially following long-term treatment, to minimize withdrawal symptoms.
When a medication containing perphenazine is taken for a long time, patients are advised to take a riboflavin (vitamin B2) supplement.
Patient may develop with involuntary muscle movements; if it so consult with your doctor immediately.
Contraindicated in patients with brain damage, blood disorders, liver damage, recent heart attack, blood disorder, who are taking depressants, who have taken monoamine oxidase inhibitor (MAOI) within last 14 days and hypersensitivity.
Drug Interaction: Amitriptyline
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.
Patients on large doses of a phenothiazine drug who are undergoing surgery should be watched carefully for possible hypotensive phenomena. Moreover, reduced amounts of anesthetics or central nervous system depressants may be necessary.
Since phenothiazines and central nervous system depressants (opiates, analgesics, antihistamines, barbiturates) can potentiate each other, less than the usual dosage of the added drug is recommended and caution is advised when they are administered concomitantly.
Use with caution in patients who are receiving atropine or related drugs because of additive anticholinergic effects and also in patients who will be exposed to extreme heat or organic phosphate insecticides.
The use of alcohol should be avoided, since additive effects and hypotension may occur. Patients should be cautioned that their response to alcohol may be increased while they are being treated with ETRAFON (perphenazine and amitriptyline) Tablets. The risk of suicide and the danger of overdose may be increased in patients who use alcohol excessively due to its potentiation of the drug's effect.