Protriptyline Hydrochloride (Protriptyline Hydrochloride)

Trade Name : Protriptyline Hydrochloride

West-Ward Pharmaceuticals Corp.

TABLET

Strength 5 mg/1

PROTRIPTYLINE 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 Protriptyline Hydrochloride (Protriptyline Hydrochloride) which is also known as Protriptyline Hydrochloride and Manufactured by West-Ward Pharmaceuticals Corp.. It is available in strength of 5 mg/1 per ml. Read more

Protriptyline Hydrochloride (Protriptyline 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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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
  • 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 protriptyline hydrochloride 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. Protriptyline hydrochloride is not approved for use in pediatric patients. (See : , : , and : .)
  • Protriptyline HCl is -methyl-5H dibenzo[]-cycloheptene-5-propanamine hydrochloride. Its molecular formula is CHNu2022HClu00a0and its structural formula is:
  • Protriptyline hydrochloride, a dibenzocycloheptene derivative, has a molecular weight of 299.84. It is a white crystalline powder that is freely soluble in water and soluble in dilute HCl. Protriptyline Hydrochloride Tablets USP are available for oral administration containing either 5 mg or 10 mg of protriptyline hydrochloride USP. Each tablet contains the following inactive ingredients: anhydrous lactose, colloidal silicon dioxide, magnesium stearate and microcrystalline cellulose.
  • Protriptyline hydrochloride is an antidepressant agent. The mechanism of its antidepressant 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.
  • Protriptyline has been found in some studies to have a more rapid onset of action than imipramine or amitriptyline. The initial clinical effect may occur within one week. Sedative and tranquilizing properties are lacking. The rate of excretion is slow.
  • Protriptyline hydrochloride is indicated for the treatment of symptoms of mental depression in patients who are under close medical supervision. Its activating properties make it particularly suitable for withdrawn and anergic patients.
  • Protriptyline hydrochloride is contraindicated in patients who have shown prior hypersensitivity to it.
  • It should not be given concomitantly with a monoamine oxidase inhibiting compound. Hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressant and monoamine oxidase inhibiting drugs simultaneously. When it is desired to substitute protriptyline for a monoamine oxidase inhibitor, a minimum of 14 days should be allowed to elapse after the latter is discontinued. Protriptyline should then be initiated cautiously with gradual increase in dosage until optimum response is achieved.
  • Protriptyline hydrochloride is contraindicated in patients taking cisapride because of the possibility of adverse cardiac interactions including prolongation of the QT interval, cardiac arrhythmias and conduction system disturbances.
  • This drug should not be used during the acute recovery phase following myocardial infarction.
  • No data
  • No data
  • 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, the pharmacological similarities among the tricyclic antidepressant drugs require that each of the reactions be considered when protriptyline is administered. Protriptyline is more likely to aggravate agitation and anxiety and produce cardiovascular reactions such as tachycardia and hypotension.
  • Cardiovascular:
  • Psychiatric:
  • Neurological:
  • Anticholinergic:
  • Allergic:
  • Hematologic:
  • Gastrointestinal:
  • Endocrine:
  • Other:
  • Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.
  • Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate tricyclic antidepressant overdose. As management of overdose 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.
  • Protriptyline Hydrochloride Tablets USP
  • 5 mg tablets are supplied as a round, white, biconvex tablet debossed with product identification u201c54u201d over u201c306u201d on one side and plain on the other.
  • NDC 0054-0210-25: Bottle of 100 Tablets
  • 10 mg tablets are supplied as a round, white, biconvex tablet debossed with product identification u201c54u201d over u201c694u201d on one side and plain on the other.
  • NDC 0054-0211-25: Bottle of 100 Tablets
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F). [See USP Controlled Room Temperature.] Dispense in a tight, child-resistant container as defined in the USP/NF.
  • Metabolic studies indicate that protriptyline is well absorbed from the gastrointestinal tract and is rapidly sequestered in tissues. Relatively low plasma levels are found after administration, and only a small amount of unchanged drug is excreted in the urine of dogs and rabbits. Preliminary studies indicate that demethylation of the secondary amine moiety occurs to a significant extent, and that metabolic transformation probably takes place in the liver. It penetrates the brain rapidly in mice and rats, and moreover that which is present in the brain is almost all unchanged drug.
  • Studies on the disposition of radioactive protriptyline in human test subjects showed significant plasma levels within 2 hours, peaking at 8 to 12 hours, then declining gradually.
  • Urinary excretion studies in the same subjects showed significant amounts of radioactivity in 2 hours. The rate of excretion was slow. Cumulative urinary excretion during 16 days accounted for approximately 50% of the drug. The fecal route of excretion did not seem to be important.
  • ULTRAM is a registered trademark of Ortho-McNeil Pharmaceutical Inc.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10004773/05
  • Revised March 2016
  • 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 approvedu00a0by the U.S. Food and Drug Administration for all antidepressants.
  • Distr. by: n
  • Pharmaceuticals Corp.
  • Eatontown, NJ 07724
  • 10004773/05
  • Revised March 2016
  • No data
  • No data

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