Amitriptyline Hydrochloride (Amitriptyline Hydrochloride)

Trade Name : Amitriptyline Hydrochloride

Aidarex Pharmaceuticals LLC

TABLET, FILM COATED

Strength 25 mg/1

AMITRIPTYLINE HYDROCHLORIDE Tricyclic Antidepressant [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

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 Aidarex Pharmaceuticals LLC. 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
  • 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 HCl is 3-(10,11-dihydro-5H-dibenzo [a,] cycloheptene-5-ylidene)-N,N-dimethyl-1-propanamine hydrochloride. Its empirical formula is CHNu2022HCl, and its structural formula is:
  • 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.
  • Amitriptyline HCl is supplied as 10 mg, 25 mg, 50 mg, 75 mg, 100 mg or 150 mg tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate, sodium starch glycolate and titanium dioxide. The 10 mg tablets also contain FD&C blue #1 lake. The 25 mg tablets also contain D&C yellow #10 lake and FD&C blue #2 lake. The 50 mg tablets also contain synthetic black iron oxide, synthetic red iron oxide and synthetic yellow iron oxide. The 75 mg tablets also contain FD&C yellow #6 lake. The 100 mg tablets also contain D&C red #33 lake and FD&C red #40 lake. The 150 mg tablets also contain FD&C blue #2 lake and FD&C yellow #6 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 the 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 a 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:
  • CNS and Neuromuscular:
  • Anticholinergic:
  • Allergic:
  • Hematologic:
  • Gastrointestinal:
  • Endocrine:
  • Other:
  • Withdrawal Symptoms:
  • These symptoms are not indicative of addiction. Rare instances have been reported of mania or hypomania occurring within 2 to 7 days following cessation of chronic therapy with tricyclic antidepressants.
  • Causal Relationship Unknown:
  • Body as a Whole:
  • Digestive:
  • Postmarketing Adverse Events:
  • Very rare cases of serotonin syndrome (SS) have been reported with amitriptyline hydrochloride in combination with other drugs that have a recognized association with SS.
  • Very rare cases of cardiomyopathy have been reported with amitriptyline.
  • 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.
  • Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.
  • 10 mg tablets are blue, round, unscored, film coated tablets, debossed u201c2101u201d on one side and debossed u201cVu201d on the reverse side. They are supplied as follows:
  • 25 mg tablets are yellow, round, unscored, film coated tablets, debossed u201c2102u201d on one side and debossed u201cVu201d on the reverse side. They are supplied as follows:
  • 50 mg tablets are beige, round, unscored, film coated tablets, debossed u201c2103u201d on one side and debossed u201cVu201d on the reverse side. They are supplied as follows:
  • 75 mg tablets are orange, round, unscored, film coated tablets, debossed u201c2104u201d and u201cVu201d. They are supplied as follows:
  • 100 mg tablets are mauve, round, unscored, film coated tablets, debossed u201c2105u201d and u201cVu201d. They are supplied as follows:
  • 150 mg tablets are blue, capsule shaped, unscored, film coated tablets, debossed u201c2106u201d on one side and debossed u201cVu201d on the reverse side. They are supplied as follows:
  • Storage: Store in a well-closed container. Store at 20u00b0-25u00b0C (68u00b0-77u00b0F) [see USP Controlled Room Temperature]. In addition, amitriptyline tablets must be protected from light and stored in a well-closed, light-resistant container.
  • 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. Psychosomaticsu00a0u00a0u00a0u00a0 1960;1:320u2013325.
  • Diamond S: Human metabolizer of amitriptyline tagged with carbon 14.u00a0u00a0u00a0u00a0 Curr Ther Res, Mar 1965, pp 170u2013175.
  • Dorfman W: Clinical experiences with amitriptyline: A preliminary report.u00a0u00a0u00a0u00a0 Psychosomatics 1960;1:153u2013155.
  • Fallette JM, Stasney CR, Mintz AA: Amitriptyline poisoning treated withu00a0u00a0u00a0u00a0 physostigmine. South Med J 1970;63:1492u20131493.
  • Hollister LE, Overall JE, Johnson M, et al: Controlled comparison ofu00a0u00a0u00a0u00a0 amitriptyline, imipramine and placebo in hospitalized depressedu00a0u00a0u00a0u00a0 patients. J Nerv Ment Dis 1964;139:370u2013375.
  • Hordern A, Burt CG, Holt NF: Depressive states: A pharmacotherapeuticu00a0u00a0u00a0u00a0 study, Springfield study. Springfield, Ill, Charles C. Thomas, 1965.
  • Jenike MA: Treatment of Affective Illness in the Elderly with Drugs andu00a0u00a0u00a0u00a0 Electroconvulsive Therapy. J Geriatr Psychiatry 1989; 22(1):77u2013112.
  • Klerman GL, Cole JO: Clinical pharmacology of imipramine and relatedu00a0u00a0u00a0u00a0 antidepressant compounds. Int J Psychiatry 1976;3:267u2013304.
  • Liu B, Anderson G, Mittman N, et al: Use of selective serotonin-reuptakeu00a0u00a0u00a0u00a0 inhibitors or tricyclic antidepressants and risk of hip fractures in elderlyu00a0u00a0u00a0u00a0 people. Lancet 1998; 351(9112):1303u20131307.
  • McConaghy N, Joffe AD, Kingston WA, et al: Correlation of clinical featuresu00a0u00a0u00a0u00a0 of depressed out-patients with response to amitriptyline andu00a0u00a0u00a0u00a0 protriptyline. Br J Psychiatry 1968;114:103u2013106.
  • McDonald IM, Perkins M, Marjerrison G, et al: A controlled comparison ofu00a0u00a0u00a0u00a0 amitriptyline and electroconvulsive therapy in the treatment ofu00a0u00a0u00a0u00a0 depression. Am J Psychiatry 1966;122:1427u20131431.
  • Slovis T, Ott J, Teitelbaum D, et al: Physostigmine therapy in acute tricyclicu00a0u00a0u00a0u00a0 antidepressant poisoning. Clin Toxicol 1971;4:451u2013459.
  • Symposium on depression with special studies of a new antidepressant,u00a0u00a0u00a0u00a0 amitriptyline. Dis Nerv Syst, (Sect 2) May 1961, pp 5u201356.
  • *Based on a maximum recommended amitriptyline dose of 150 mg/day or 3 mg/kg/day for a 50 kg patient.
  • **Hollister LE: Monitoring Tricyclic Antidepressant Plasma Concentrations. JAMA 1979; 241(23):2530u20132533.
  • Manufactured for:n n Huntsville, AL 35811
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • 8180153R11/11-R13
  • A SUPPLY OF MEDICATION GUIDES AS PRINTED AT THE END OF THIS INSERT IS AVAILABLE, FREE OF CHARGE, BY CALLING (800) 444u20134011.
  • Read the Medication Guide that comes with you or your family member's 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.u00a0You 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.
  • Manufactured for:n n Huntsville, AL 35811
  • Repackaged By :Aidarex Pharmaceuticals LLC,Corona, CA 92880
  • 8181699R4/09-R5
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