Trimipramine Maleate (Trimipramine Maleate)

Trade Name : Trimipramine Maleate

Breckenridge Pharmaceutical, Inc.

CAPSULE

Strength 25 mg/1

TRIMIPRAMINE MALEATE 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 Trimipramine Maleate (Trimipramine Maleate) which is also known as Trimipramine Maleate and Manufactured by Breckenridge Pharmaceutical, Inc.. It is available in strength of 25 mg/1 per ml. Read more

Trimipramine Maleate (Trimipramine Maleate) 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.

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About GNH

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
  • 25 mg, 50 mg and 100 mg
  • Rx only
  • 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 trimipramine maleate capsules 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. Trimipramine maleate capsules are not approved for use in pediatric patients. (See n n n , n n n , and n n n )n n n
  • Trimipramine maleate is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form).
  • Molecular Formula: Cn n n Hn n n Nn n n u2219 Cn n n Hn n n On n n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Molecular Weight: 410.5n nn
  • Trimipramine maleate capsules contain trimipramine maleate equivalent to 25 mg, 50 mg, or 100 mg of trimipramine as the base. The inactive ingredients present are lactose monohydrate and magnesium stearate. The capsule shell contains D&C Yellow 10 (25 mg), FD&C Blue 1 (25 mg, 50 mg and 100 mg), FD&C Yellow 6 (25 mg, 50 mg), D&C Red 28 (50 mg), FD&C Red 40 (50 mg), gelatin and titanium dioxide. The capsules are imprinted in black ink that contains shellac glaze, iron oxide black, propylene glycol and ammonium hydroxide.
  • Trimipramine maleate is prepared as a racemic mixture which can be resolved into levorotatory and dextrorotatory isomers. The asymmetric center responsible for optical isomerism is marked in the formula by an asterisk. Trimipramine maleate is an almost odorless, white or slightly cream-colored, crystalline substance, melting at 140u00b0-144u00b0 C. It is very slightly soluble in ether and water, is slightly soluble in ethyl alcohol and acetone, and freely soluble in chloroform and methanol at 20u00b0 C.
  • Trimipramine maleate capsules are an antidepressant with an anxiety-reducing sedative component to its action. The mode of action of trimipramine maleate capsules on the central nervous system is not known. However, unlike amphetamine-type compounds it does not act primarily by stimulation of the central nervous system. It does not act by inhibition of the monoamine oxidase system.
  • The single-dose pharmacokinetics of trimipramine were evaluated in a comparative study of 24 elderly subjects and 24 younger subjects; no clinically relevant differences were demonstrated based on age or gender.
  • Trimipramine maleate capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression.
  • No data
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  • Note: The pharmacological similarities among the tricyclic antidepressants require that each of the reactions be considered when trimipramine maleate capsules areu00a0administered. Some of the adverse reactions included in this listing have not in fact been reported with trimipramine maleate capsules.
  • Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance.
  • Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. It is not possible to prescribe a single dosage schedule of trimipramine maleate capsulesu00a0that will be therapeutically effective in all patients. The physical psychodynamic factors contributing to depressive symptomatology are very complex; spontaneous remissions or exacerbations of depressive symptoms may occur with or without drug therapy. Consequently, the recommended dosage regimens are furnished as a guide which may be modified by factors such as the age of the patient, chronicity and severity of the disease, medical condition of the patient, and degree of psychotherapeutic support.
  • Most antidepressant drugs have a lag period of ten days to four weeks before a therapeutic response is noted. Increasing the dose will not shorten this period but rather increase the incidence of adverse reactions.
  • OVERDOSAGEn n n n
  • 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
  • Distributed by:n n Breckenridge Pharmaceutical, Inc.n n Berlin, CT 06037n
  • Manufactured by:n n Rivopharm SAn n 6928, Manno, Switzerlandn
  • To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
  • Revised: May 2020
  • Trimipramine Maleate (trye-MIP-ra-meen MAL-ee-ate) Capsules
  • Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions
  • 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.
  • Talk to your, or your family member's, healthcare provider about:
  • 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:
  • Arrayn- Visual Problems
  • Who should not take trimipramine maleate capsules?
  • What else do I need to know about antidepressant medicines?
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • Revised May 2019
  • Distributed by:n nBreckenridge Pharmaceutical, Inc.n nBerlin, CT 06037n
  • Manufactured by:n nRivopharm SAn n6928, Manno, Switzerlandn
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