Amitriptyline Hydrochloride (Amitriptyline Hydrochloride)

Trade Name : Amitriptyline Hydrochloride

Major Pharmaceuticals

TABLET, FILM COATED

Strength 25 mg/1

AMITRIPTYLINE HYDROCHLORIDE Tricyclic Antidepressant [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) which is also known as Amitriptyline Hydrochloride and Manufactured by Major Pharmaceuticals. It is available in strength of 25 mg/1 per ml. Read more

Amitriptyline Hydrochloride (Amitriptyline Hydrochloride) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • No data
  • Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of amitriptyline hydrochloride tablets or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Amitriptyline hydrochloride tablets are not approved for use in pediatric patients (see , , and ).
  • Amitriptyline hydrochloride, USP, a dibenzocycloheptadiene derivative, is a white, or practically white, odorless, crystalline compound which is freely soluble in water and alcohol.
  • It is designated chemically as 10,11-Dihydro-N,N-dimethyl-5-dibenzo[a,d] cycloheptene-u0394, u03b3-propylamine hydrochloride. It has the following structural formula:
  • Each tablet for oral administration contains 10, 25, 50, 75, 100, or 150 mg amitriptyline hydrochloride, USP. Inactive ingredients include colloidal silicon dioxide, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose (monohydrate), magnesium stearate, microcrystalline cellulose, polyethylene glycol, pregelatinized starch (corn) and titanium dioxide. The also includes D&C Red #27 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Blue #1 Aluminum Lake; u2013 D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake; u2013 FD&C Blue #2 Aluminum Lake, D&C Yellow #10 Aluminum Lake and FD&C Red #40 Aluminum Lake; u2013 D&C Red #7 Calcium Lake and FD&C Blue #2 Aluminum Lake; u2013 D&C Red #30 Aluminum Lake and D&C Yellow #10 Aluminum Lake; u2013 D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake and FD&C Red #40 Aluminum Lake.
  • Amitriptyline hydrochloride 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.
  • Amitriptyline 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 amitriptyline.
  • For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.
  • Amitriptyline hydrochloride 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 hydrochloride, a minimum of 14 days should be allowed to elapse after the former is discontinued. Amitriptyline hydrochloride should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.
  • Amitriptyline hydrochloride should not be given with cisapride due to the potential for increased QT interval and increased risk for arrhythmia.
  • This drug is not recommended for use during the acute recovery phase following myocardial infarction.
  • No data
  • 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 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.
  • Amitriptyline hydrochloride should be used with caution in patients with impaired liver function.
  • 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.
  • 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.
  • No data
  • Amitriptyline hydrochloride tablets, USP for oral administration are available as:
  • 25 mg:
  • Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-0201-61
  • 50 mg:
  • Cartons of 100 tablets (10 tablets each blister pack x 10) NDC 0904-0202-61
  • Store at 20u00ba to 25u00baC (68u00ba to 77u00baF) [see USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container.
  • KEEP OUT OF THE REACH OF CHILDREN.
  • Studies in man following oral administration of C-labeled drug indicated that amitriptyline is rapidly absorbed and metabolized. Radioactivity of the plasma was practically negligible, although significant amounts of radioactivity appeared in the urine by 4 to 6 hours and one-half to one-third of the drug was excreted within 24 hours.
  • Amitriptyline is metabolized by N-demethylation and bridge hydroxylation in man, rabbit, and rat. Virtually the entire dose is excreted as glucuronide or sulfate conjugate of metabolites, with little unchanged drug appearing in the urine. Other metabolic pathways may be involved.
  • Ayd FJ Jr: Amitriptyline therapy for depressive reactions. Psychosomatics 1960;1:320-325.
  • Diamond S: Human metabolizer of amitriptyline tagged with carbon 14.Curr Ther Res, Mar 1965, pp170-175.
  • Dorfman W: Clinical experiences with amitriptyline: A preliminary report. Psychosomatics 1960;1:153-155.
  • Fallette JM, Stasney CR, Mintz AA: Amitriptyline poisoning treated with physostigmine. South MedJ 1970;63:1492-1493.
  • 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.
  • Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeutic study, Springfield study. Springfield, Ill, Charles C. Thomas, 1965.
  • Jenike MA: Treatment of Affective Illness in the Elderly with Drugs and Electroconvulsive Therapy. J Geriatr Psychiatry 1989;22(1):77-112.
  • Klerman GL, Cole JO: Clinical pharmacology of imipramine and related antidepressant compounds. Int J Psychiatry 1976;3:267-304.
  • 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.
  • McConaghy N, Joffe AD, Kingston WA, et al: Correlation of clinical features of depressed outpatients with response to amitriptyline and protriptyline. Br J Psychiatry 1968;114:103-106.
  • 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.
  • Slovis T, Ott J, Teitelbaum D, et al: Physostigmine therapy in acute tricyclic antidepressant poisoning. Clin Toxicol 1971;4:451-459.
  • Symposium on depression with special studies of a new antidepressant, amitriptyline. Dis Nerv Syst, (Sect 2) May 1961, pp 5-56.
  • Amitriptyline Hydrochloride Tablets, USPn- (a-mee-TRIP-ti-leen)
  • Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions
  • Read the Medication Guide that comes with you or your family memberu2019s antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. n
  • What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
  • Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
  • What else do I need to know about antidepressant medicines?
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.
  • For Medication Guides, please visit www.us.sandoz.com or call 1-800-507-2130.
  • Manufactured by
  • Sandoz Inc.
  • Princeton, NJ 08540
  • Distributed By:
  • MAJORu00ae PHARMACEUTICALS
  • 17177 N Laurel Park Dr., Suite 233
  • Livonia, MI 48152
  • Rev. August 2018
  • MF1486REV08/18
  • Amitriptyline Hydrochloride Tablets, USP
  • 25 mg
  • 100 Tablets
  • Amitriptyline Hydrochloride Tablets, USP
  • 50 mg
  • 100 Tablets

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