Nefazodone Hydrochloride (Nefazodone Hydrochloride)

US NDC LINE: 0093-1024

Trade Name: Nefazodone Hydrochloride

Following information is meant for : Wholesalers, Suppliers, Exporters, Doctors, CROs, Comparator Supplies, Hospitals, MOH Tender Supplies, Generic, Brand, Cooperate Sourcing, India, Institutional Buyers.

Manufacturer: Teva Pharmaceuticals USA, Inc.

Presentation: TABLET

Strength: 100 mg/1

Storage and handling

NEFAZODONE HYDROCHLORIDE Serotonin Reuptake Inhibitor [EPC]

  • No data
  • Suicidality and Antidepressant Drugs
  • 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 nefazodone 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. Nefazodone hydrochloride tablets are not approved for use in pediatric patients (see WARNINGS, Clinical Worsening and Suicide Risk; PRECAUTIONS, Information for Patients; and PRECAUTIONS, Pediatric Use).
  • Before prescribing nefazodone hydrochloride tablets, the physician should be thoroughly familiar with the details of this prescribing information.
  • Warning
  • Cases of life-threatening hepatic failure have been reported in patients treated with nefazodone hydrochloride tablets. The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000 to 300,000 patient-years of nefazodone hydrochloride treatment. The total patient-years is a summation of each patientu2019s duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (see WARNINGS).
  • Ordinarily, treatment with nefazodone hydrochloride tablets should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.
  • Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur.
  • Nefazodone hydrochloride tablets should be discontinued if clinical signs or symptoms suggest liver failure (see PRECAUTIONS, Information for Patients). Patients who develop evidence of hepatocellular injury such as increased serum AST or serum ALT levels u2265 3 times the upper limit of NORMAL, while on nefazodone hydrochloride tablets should be withdrawn from the drug. These patients should be presumed to be at increased risk for liver injury if nefazodone hydrochloride is reintroduced. Accordingly, such patients should not be considered for re-treatment.
  • Nefazodone hydrochloride tablets USP are an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI).
  • Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one monohydrochloride. The structural formula is:
  • CHCINOu2022HCl M.W. 506.5
  • Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water.
  • Nefazodone hydrochloride tablets USP are supplied as capsule-shaped tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose, sodium starch glycolate and povidone. Additionally, the 50 mg tablets include ferric oxide red as a colorant, the 150 mg tablets include ferric oxide red and yellow as colorants, and the 200 mg tablets include ferric oxide yellow as a colorant.
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  • Nefazodone hydrochloride tablets are indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see ). In many cases, this would lead to the conclusion that other drugs should be tried first.
  • The efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see ).
  • A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks). It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
  • The efficacy of nefazodone in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label nefazodone treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see ). Although remitted patients were followed for as long as 36 weeks in the study cited (i.e., 52 weeks total), the physician who elects to use nefazodone for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
  • Coadministration of terfenadine, astemizole, cisapride, pimozide, or carbamazepine with nefazodone hydrochloride is contraindicated (see and ).
  • Nefazodone hydrochloride tablets are contraindicated in patients who were withdrawn from nefazodone because of evidence of liver injury (see ). Nefazodone hydrochloride tablets are also contraindicated in patients who have demonstrated hypersensitivity to nefazodone hydrochloride, its inactive ingredients, or other phenylpiperazine antidepressants.
  • The coadministration of triazolam and nefazodone causes a significant increase in the plasma level of triazolam (see and ), and a 75% reduction in the initial triazolam dosage is recommended if the two drugs are to be given together. Because not all commercially available dosage forms of triazolam permit a sufficient dosage reduction, the coadministration of triazolam and nefazodone should be avoided for most patients, including the elderly.
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  • When deciding among the alternative treatments available for depression, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see ).
  • Nefazodone hydrochloride tablets USP, 50 mg, are light-pink to pink (mottled), capsule-shaped, beveled-edged tablets, debossed u201c7178u201d on one side and debossed u201c93u201d on the other side. They are available in bottles of 100. (NDC 0093-7178-01)
  • Nefazodone hydrochloride tablets USP, 100 mg, are white to off-white, capsule-shaped tablets, debossed u201c1024u201d on one side and scored on the other side with a debossed u201c93u201d on one side of the score. They are available in bottles of 60. (NDC 0093-1024-06)
  • Nefazodone hydrochloride tablets USP, 150 mg, are peach (mottled), capsule-shaped tablets, debossed u201c7113u201d on one side and scored on the other side with a debossed u201c93u201d on one side of the score. They are available in bottles of 60. (NDC 0093-7113-06)
  • Nefazodone hydrochloride tablets USP, 200 mg, are light-yellow to yellow (mottled), capsule-shaped tablets, debossed u201c1025u201d on one side and debossed u201c93u201d on the other side. They are available in bottles of 60. (NDC 0093-1025-06)
  • Nefazodone hydrochloride tablets USP, 250 mg, are white to off-white, capsule-shaped tablets, debossed u201c1026u201d on one side and debossed u201c93u201d on the other side. They are available in bottles of 60. (NDC 0093-1026-06)
  • Store at 20u00b0 to 25u00b0C (68u00b0 to 77u00b0F) [See USP Controlled Room Temperature].
  • Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).
  • Manufactured In Israel By:
  • TEVA PHARMACEUTICAL IND. LTD.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. N 9/2015
  • NEFAZODONE (nef AY zoe done) HYDROCHLORIDE TABLETS USP
  • Rx only
  • Read this information completely before using nefazodone.
  • What is the most important information that I should know about nefazodone?
  • Rarely, people who take nefazodone can develop serious liver problems. because you may be developing a liver problem:
  • People who currently have liver problems should not take nefazodone.
  • What is nefazodone?
  • Nefazodone is a medicine used to treat depression. Nefazodone is thought to treat depression by correcting an imbalance in the amounts of certain natural chemicals, such as serotonin and norepinephrine, which are in your brain.
  • Who should not take nefazodone?
  • Do take nefazodone if you
  • Be sure to tell your doctor if you
  • How should I take nefazodone?
  • What should I avoid while taking nefazodone?
  • What are the possible side effects of nefazodone?
  • The most common side effects of nefazodone are sleepiness, dry mouth, nausea, dizziness, constipation, weakness, lightheadedness, problems with vision, and confusion.
  • Call your doctor right away if you have any of the following side effects:
  • Tell your doctor right away about any side effects that you have or discomfort that you experience. Do not change your dose or stop taking nefazodone without talking with your doctor first.
  • Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Your doctor has prescribed nefazodone for you and you alone. Do not give nefazodone to other people even if they have the same condition. It may harm them.
  • This leaflet provides a summary of the most important information about nefazodone. If you would like more information, talk with your doctor or pharmacist. You can ask for information about nefazodone that is written for healthcare professionals.
  • Seldane is a registered trademark of Hoechst Marion Roussel Inc. (now Aventis Pharmaceuticals).
  • Hismanal and Propulsid are registered trademarks of Janssen Pharmaceutica Products, L.P.
  • Nardil is a registered trademark of Parke-Davis.
  • Parnate is a registered trademark of SmithKline Beecham Pharmaceuticals.
  • Halcion is a registered trademark of Pharmacia & Upjohn.
  • Orap is a registered trademark of Gate Pharmaceuticals, a division of TEVA Pharmaceuticals USA.
  • Tegretol is a registered trademark of Novartis Pharmaceuticals Corporation.
  • Manufactured In Israel By:
  • TEVA PHARMACEUTICAL IND. LTD.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. B 9/2015
  • This Patient Information Leaflet has been approved by the U.S. Food and Drug Administration.
  • Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions
  • Rx only
  • Read the Medication Guide that comes with your 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?
  • 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
  • 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions.
  • 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
  • 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.
  • Manufactured In Israel By:
  • TEVA PHARMACEUTICAL IND. LTD.
  • Jerusalem, 9777402, Israel
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. G 9/2015
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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Nefazodone Hydrochloride (Nefazodone Hydrochloride) which is also known as Nefazodone Hydrochloride and Manufactured by Teva Pharmaceuticals USA, Inc.. It is available in strength of 100 mg/1 per ml.

Nefazodone Hydrochloride (Nefazodone 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.

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