Drug: Elavil

Amitriptyline HCl is 3-(10,11-dihydro-5H-dibenzo [a,d] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is C20H23N·HCl. Amitriptyline HCl, a dibenzocycloheptadiene derivative, has a molecular weight of 313.87. It is a white, odorless, crystalline compound which is freely soluble in water. Elavil (amitriptyline HCl) is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg tablets and as a sterile solution for intramuscular use. Inactive ingredients of the tablets are calcium phosphate, cellulose, colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose, magnesium stearate, starch, stearic acid, talc, and titanium dioxide. 10 mg amitriptyline HCl tablets also contain FD&C Blue 1. 25 mg amitriptyline HCl tablets also contain D&C Yellow 10, FD&C Blue 1, and FD&C Yellow 6. 50 mg amitriptyline HCl tablets also contain D&C Yellow 10, FD&C Yellow 6 and iron oxide. 75 mg amitriptyline HCl tablets also contain FD&C Yellow 6. 100 mg amitriptyline HCl tablets also contain FD&C Blue 2 and FD&C Red 40. 150 mg amitriptyline HCl tablets also contain FD&C Blue 2 and FD&C Yellow 6. Each Milliliter of the Sterile Solution Contains: Amitriptyline hydrochloride: 10 mg; Dextrose: 44 mg; Water for Injection, q.s.:1 ml Added as Preservatives: Methylparaben: 1.5 mg; Propylparaben: 0.2 mg

Source: http://www.rxlist.com

Within each category the following adverse reactions are listed in order of decreasing severity. Included in the listing are a few adverse reactions which have not been reported with this specific drug. However, pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when amitriptyline is administered. Cardiovascular: Myocardial infarction; stroke; nonspecific ECG changes and changes in AV conduction; heart block; arrhythmias; hypotension, particularly orthostatic hypotension; syncope; hypertension; tachycardia; palpitation. CNS and Neuromuscular: Coma; seizures; hallucinations; delusions; confusional states; disorientation; incoordination; ataxia; tremors; peripheral neuropathy; numbness, tingling, and paresthesias of the extremities; extrapyramidal symptoms including abnormal involuntary movements and tardive dyskinesia; dysarthria; disturbed concentration; excitement; anxiety; insomnia; restlessness; nightmares; drowsiness; dizziness; weakness; fatigue; headache; syndrome of inappropriate ADH (antidiuretic hormone) secretion; tinnitus; alteration in EEG patterns. Anticholinergic: Paralytic ileus; hyperpyrexia; urinary retention; dilatation of the urinary tract; constipation; blurred vision, disturbance of accommodation, increased ocular pressure, mydriasis; dry mouth. Allergic: Skin rash; urticaria; photosensitization; edema of face and tongue. Hematologic: Bone marrow depression including agranulocytosis, leukopenia, thrombocytopenia; purpura; eosinophilia. Gastrointestinal: Rarely hepatitis (including altered liver function and jaundice); nausea; epigastric distress; vomiting; anorexia; stomatitis; peculiar taste; diarrhea; parotid swelling; black tongue. Endocrine: Testicular swelling and gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido; impotence; elevation and lowering of blood sugar levels. Other: Alopecia; edema; weight gain or loss; urinary frequency; increased perspiration. Withdrawal Symptoms: After prolonged administration, abrupt cessation of treatment may produce nausea, headache, and malaise. Gradual dosage reduction has been reported to produce, within two weeks, transient symptoms including irritability, restlessness, and dream and sleep disturbance. These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2-7 days following cessation of chronic therapy with tricyclic antidepressants. Causal Relationship Unknown: Other reactions, reported under circumstances where a causal relationship could not be established, are listed to serve as alerting information to physicians: Body as a Whole: Lupus-like syndrome (migratory arthritis, positive ANA and rheumatoid factor). Digestive: Hepatic failure, ageusia. Read the Elavil (amitriptyline) Side Effects Center for a complete guide to possible side effectsLearn More »

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Oral Dosage Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Initial Dosage for Adults: For outpatients 75 mg of amitriptyline HCl a day in divided doses is usually satisfactory. If necessary, this may be increased to a total of 150 mg per day. Increases are made preferably in the late afternoon and/or bedtime doses. A sedative effect may be apparent before the antidepressant effect is noted, but an adequate therapeutic effect may take as long as 30 days to develop. An alternate method of initiating therapy in outpatients is to begin with 50 to 100 mg amitriptyline HCl at bedtime. This may be increased by 25 or 50 mg as necessary in the bedtime dose to a total of 150 mg per day. Hospitalized patients may require 100 mg a day initially. This can be increased gradually to 200 mg a day if necessary. A small number of hospitalized patients may need as much as 300 mg a day. Adolescent and Elderly Patients: In general, lower dosages are recommended for these patients. Ten mg 3 times a day with 20 mg at bedtime may be satisfactory in adolescent and elderly patients who do not tolerate higher dosages. Maintenance: The usual maintenance dosage of amitriptyline HCl is 50 to 100 mg per day. In some patients 40 mg per day is sufficient. For maintenance therapy the total daily dosage may be given in a single dose preferably at bedtime. When satisfactory improvement has been reached, dosage should be reduced to the lowest amount that will maintain relief of symptoms. It is appropriate to continue maintenance therapy 3 months or longer to lessen the possibility of relapse. Intramuscular Dosage Initially, 20 to 30 mg (2 to 3 ml) four times a day. When amitriptyline HCl injection is administered intramuscularly, the effects may appear more rapidly than with oral administration. When amitriptyline HCl injection is used for initial therapy in patients unable or unwilling to take amitriptyline HCl tablets, the tablets should replace the injection as soon as possible. Usage in Pediatric Patients: In view of the lack of experience with the use of this drug in children, it is not recommended at the present time for patients under 12 years of age. Plasma Levels: Because of the wide variation in the absorption and distribution of tricyclic antidepressants in body fluids, it is difficult to directly correlate plasma levels and therapeutic effect. However, determination of plasma levels may be useful in identifying patients who appear to have toxic effects and may have excessively high levels, or those in whom lack of absorption or noncompliance is suspected. Adjustments in dosage should be made according to the patient's clinical response and not on the basis of plasma levels.14

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Drugs Metabolized by P450 2D6 ¾ The biochemical activity of the drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the caucasian population (about 7-10% of caucasians are so called "poor metabolizers"); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African and other populations are not yet available. Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses. Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8-fold increase in plasma AUC of the TCA). In addition, certain drugs inhibit the activity of this isozyme and make normal metabolizers resemble poor metabolizers. An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy. 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). Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug. Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be coadministered with another drug known to be an inhibitor of P450 2D6. Monoamine Oxidase Inhibitors: (See CONTRAINDICATIONS.) Guanethidine or similarly acting compounds; thyroid medication; alcohol, barbiturates and other CNS depressants; and disulfiram (see WARNINGS.) 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. Clinically significant effects have been reported with the tricyclic antidepressants when used concomitantly with cimetidine. Increases in plasma levels of tricyclic antidepressants, and in the frequency and severity of side effects, particularly anticholinergic, have been reported when cimetidine was added to the drug regimen. Discontinuation of cimetidine in well-controlled patients receiving tricyclic antidepressants and cimetidine may decrease the plasma levels and efficacy of the antidepressants. 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. Read the Elavil Drug Interactions Center for a complete guide to possible interactions Learn More »

Source: http://www.rxlist.com

For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.

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Amitriptyline HCl is contraindicated in patients who have shown prior hypersensitivity to it. It should not be given concomitantly with monoamine oxidase inhibitors. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to replace a monoamine oxidase inhibitor with amitriptyline HCl, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline HCl should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. This drug is not recommended for use during the acute recovery phase following myocardial infarction. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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. Manifestations 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, or any of the symptoms listed under ADVERSE REACTIONS. Management 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

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Tablets: Elavil (amitriptyline) , 10 mg, are blue, round, film coated tablets, identified with "40" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 25 mg, are yellow, round, film coated tablets, identified with "45" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 50 mg, are beige, round, film coated tablets, identified with "41" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 75 mg, are orange, round, film coated tablets, identified with "42" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 100 mg, are mauve, round, film coated tablets, identified with "43" debossed on one side and "Elavil (amitriptyline) " on the other side.
Elavil (amitriptyline) , 150 mg, are blue, capsule shaped, film coated tablets, identified with "47" debossed on one side and "Elavil (amitriptyline) " on the other side. Injection: Elavil (amitriptyline) , 10 mg/ml, is a clear, colorless solution, and is supplied in 10 ml vials: Storage: Store amitriptyline HCl tablets in a well-closed container. Avoid storage at temperatures above 30°C (86°F). In addition, amitriptyline HCl tablets 10 mg must be protected from light and stored in a well-closed, light-resistant container. Protect amitriptyline HCl injection from freezing and avoid storage above 30°C (86°F).
REFERENCES 1. Ayd FJ Jr: Amitriptyline therapy for depressive reactions. Psychosomatics 1960;1:320-325.
2. Diamond S: Human metabolizer of amitriptyline tagged with carbon 14. Curr Ther Res, Mar 1965, pp 170-175.
3. Dorfman W: Clinical experiences with amitriptyline: A preliminary report. Psychosomatics 1960;1:153-155.
4. Fallette JM, Stasney CR, Mintz AA: Amitriptyline poisoning treated with physostigmine. South Med J 1970;63:1492-1493.
5. Hollister LE, Overall JE, Johnson M, et al: Controlled comparison of amitriptyline, imipramine and placebo in hospitalized depressed patients. J Nerv Ment Dis 1964;139:370-375.
6. Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeutic study, Springfield study. Springfield, III, Charles C. Thomas, 1965.
7. Jenike MA: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy. J Geriatr Psychiatry 1989;22(1):77-112.
8. Klerman GL, Cole JO: Clinical pharmacology of imipramine and related antidepressant compounds. Int J Psychiatry 1976;3:267-304.
9. Liu B, Anderson G, Mittman N, et al: Use of selective serotonin-reuptake inhibitors or tricyclic antidepressants and risk of hip fractures in elderly people. Lancet 1998;351(9112):1303-1307.
10. McConaghy N, Joffe AD, Kingston WR, et al: Correlation of clinical features of depressed outpatients with response to amitriptyline and protriptyline. Br J Psychiatry 1968;114:103-106.
11. McDonald IM, Perkins M, Marjerrison G, et al: A controlled comparison of amitriptyline and electroconvulsive therapy in the treatment of depression. Am J Psychiatry 1966;122:1427-1431.
12. Slovis T, Ott J, Teitelbaum, et al: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin Toxicol 1971;4:451-459.
13. Symposium on depression with special studies of a new antidepressant, amitriptyline. Dis Nerv Syst, (Sect 2) May 1961, pp 5-56.
14. Hollister LE: JAMA 1979;241:2350-2533. Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 amitriptyline 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 amitriptyline HCl 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. Amitriptyline HCl should be used with caution in patients with impaired liver function. Information for the Patients: Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Amitriptyline hydrochloride and should counsel them in its appropriate use. A patient Medication Guide about "Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions" is available for Amitriptyline hydrochloride. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Amitriptyline hydrochloride. Clinical Worsening and Suicide Risk: Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication. While on therapy with Amitriptyline hydrochloride, patients should be advised as to the possible impairment of mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Geriatric Use: Clinical experience has not identified differences in responses between elderly and younger patients. In general, dose election for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic function, concomitant disease and other drug therapy in elderly patients. Geriatric patients are particularly sensitive to the anticholinergic side effects of tricyclic antidepressants including amitriptyline HCl. Peripheral anticholinergic effects include tachycardia, urinary retention, constipation, dry mouth, blurred vision, and exacerbation of narrow-angle glaucoma. Central nervous system anticholinergic effects include cognitive impairment, psychomotor slowing, confusion, sedation, and delirium. Elderly patients taking amitriptyline HCl may be at increased risk for falls. Elderly patients should be started on low doses of amitriptyline HCl and observed closely (see DOSAGE AND ADMINISTRATION). Pediatric Use: Safety and effectiveness in the pediatric population have not been established (see BOX WARNING and WARNINGS: Clinical Worsening and Suicide Risk). Anyone considering the use of Amitriptyline in a child or adolescent must balance the potential risks with the clinical need.Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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