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Trazodone Hydrochloride (Trazodone Hydrochloride)

Trade Name : Trazodone Hydrochloride

NCS HealthCare of KY, Inc dba Vangard Labs

TABLET

Strength 150 mg/1

TRAZODONE HYDROCHLORIDE Serotonin Reuptake Inhibitor [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Trazodone Hydrochloride (Trazodone Hydrochloride) which is also known as Trazodone Hydrochloride and Manufactured by NCS HealthCare of KY, Inc dba Vangard Labs. It is available in strength of 150 mg/1 per ml. Read more

Trazodone Hydrochloride (Trazodone 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.

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 trazodone 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. Trazodone hydrochloride tablets are not approved for use in pediatric patients .
  • WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
  • See full prescribing information for complete boxed warning.
  • Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants for major depressive disorder (MDD) and other psychiatric disorders. Trazodone is not approved for use in pediatric patients (5.1).
  • Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (MDD) in adults. The efficacy of trazodone hydrochloride tablets has been established in trials with the immediate release formulation of trazodone n
  • Trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder ().
  • Efficacy was established in trials of trazodone immediate release formulation in patients with major depressive disorder ().
  • The dosage should be initiated at a low-dose and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. Trazodone hydrochloride tablets should be taken shortly after a meal or light snack.
  • Dose Selection
  • An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every 3 to 4 days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (i.e., more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses
  • Maintenance Treatment
  • The efficacy of trazodone hydrochloride tablets for the maintenance treatment of MDD has not been evaluated. While there is no body of evidence available to answer the question of how long a patient treated with trazodone hydrochloride tablets should continue the drug, it is generally recommended that treatment be continued for several months after an initial response. Patients should be maintained on the lowest effective dose and be periodically reassessed to determine the continued need for maintenance treatment.
  • Important Administration Instructions
  • Trazodone hydrochloride tablets are scored to provide flexibility in dosing.
  • Trazodone hydrochloride tablets can be swallowed whole or administered as a half tablet by breaking the tablet along the score line.
  • Starting dose: 150 mg in divided doses daily. May be increased by 50 mg per day every three to four days. Maximum dose: 400 mg per day in divided doses ().
  • Trazodone hydrochloride tablets should be taken shortly after a meal or light snack ().
  • Tablets should be swallowed whole or broken in half along the score line, and should not be chewed or crushed ().
  • When discontinued, gradual dose reduction is recommended ().
  • Trazodone Hydrochloride Tablets USP are available in the following strengths:
  • 50 mg: White, round, compressed tablet, debossed u201cPLIVA 433u201d on one side and scored on the other side.
  • 100 mg: White, round, compressed tablet, debossed u201cPLIVA 434u201d on one side and scored on the other side.
  • 150 mg: White, trapezoid, flat-faced, beveled edge tablet, scored and debossed as u201cPLIVAu201d bisect u201c441u201d on one side and tri-scored and debossed as u201c50u201d in each section on the other side.
  • Bisectable tablets of 50 mg, 100 mg and 150 mg ().
  • None.
  • None ().
  • No data
  • Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicidal thinking and behavior ().
  • Serotonin Syndrome or Neuroleptic Malignant Syndrome-Like Reactions: Have been reported with antidepressants. Discontinue trazodone hydrochloride tablets and initiate supportive treatment (, ).
  • Activation of Mania/Hypomania: Screen for bipolar disorder and monitor for mania/hypomania ().
  • QT Prolongation: Increases the QT interval. Avoid use with drugs that also increase the QT interval and in patients with risk factors for prolonged QT interval ().
  • Use in Patients With Heart Disease: Use with caution in patients with cardiac disease ().
  • Orthostatic Hypotension and Syncope: Have occurred. Warn patients of risk and symptoms of hypotension ().
  • Abnormal Bleeding: May increase the risk of bleeding. Use with NSAIDs, aspirin, or other drugs that affect coagulation may compound this risk (, ).
  • Interaction With MAOIs: Do not use concomitantly or within 14 days of monoamine oxidase inhibitors (, ).
  • Priapism: Has occurred. Warn male patients of this risk and how/when to seek medical attention ().
  • Hyponatremia: Can occur in association with SIADH ().
  • Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Advise patients to use caution when operating machinery ().
  • Angle-Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ()
  • Discontinuation Symptoms: May occur with abrupt discontinuation and include anxiety and sleep disturbance. Upon discontinuation, taper trazodone hydrochloride tablets and monitor for symptoms ().
  • The following serious adverse reactions are described elsewhere in the labeling:
  • The most common adverse reactions (reported in u2265 5% and at twice the rate of placebo) are:
  • Somnolence/sedation, dizziness, constipation, vision blurred.
  • Table 2
  • Most common adverse reactions (incidence u2265 5% and twice that of placebo) are: somnolence/sedation, dizziness, constipation, vision blurred ().
  • To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or [email protected]; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
  • MAOIs
  • MAOIs should not be used within 14 days of trazodone n
  • Central Nervous System (CNS) Depressants
  • Trazodone may enhance the response to alcohol, barbiturates, and other CNS depressants.
  • Cytochrome P450 3A4 Inhibitors
  • In vitro n- [see Warnings and Precautions ()]
  • Cytochrome P450 Inducers (e.g., Carbamazepine)
  • Carbamazepine induces CYP3A4. Following coadministration of carbamazepine 400 mg per day with trazodone 100 mg to 300 mg daily, carbamazepine reduced plasma concentrations of trazodone and m-chlorophenlypiperazine (an active metabolite) by 76% and 60% respectively, compared to pre-carbamazepine values. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking both drugs.
  • Digoxin and Phenytoin
  • Increased serum digoxin or phenytoin levels have been reported in patients receiving trazodone concurrently with either of these drugs. Monitor serum levels and adjust dosages as needed.
  • Serotonergic Drugs
  • Based on the mechanism of action of trazodone and the potential for serotonin syndrome, caution is advised when trazodone is coadministered with other drugs that may affect the neurotransmitter systems [].
  • NSAIDs, Aspirin, or Other Drugs Affecting Coagulation or Bleeding
  • Due to a possible association between serotonin modulating drugs and gastrointestinal bleeding, patients should be monitored for and cautioned about the potential risk of bleeding associated with the concomitant use of trazodone and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding [s].
  • Warfarin
  • There have been reports of altered (either increased or decreased) prothrombin times in taking both warfarin and trazodone.
  • CNS Depressants: Trazodone may enhance effects of alcohol, barbiturates, or other CNS depressants ().
  • CYP3A4 Inhibitors: May necessitate lower dose of trazodone hydrochloride tablets ().
  • CYP3A4 Inducers (e.g., Carbamazepine): May necessitate higher dose of trazodone hydrochloride tablets ().
  • Digoxin or Phenytoin: Monitor for increased serum levels ().
  • Warfarin: Monitor for increased or decreased prothrombin time ().
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm ().
  • Nursing Mothers: Use with caution ().
  • Pediatric Patients: Trazodone hydrochloride tablets are not approved in pediatric patients ().
  • Renal or Hepatic Impairment: Use with caution (, ).
  • No data
  • No data
  • Trazodone hydrochloride, USP is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride, USP is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4, 3-a]pyridin-3(2)-one hydrochloride. It is a white, odorless crystalline powder which is freely soluble in water. The structural formula is represented as follows:
  • CHClNO u2022 HCl M. W. 408.33
  • Each tablet, for oral administration, contains 50 mg, 100 mg or 150 mg of trazodone hydrochloride, USP. In addition, each tablet contains colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
  • No data
  • No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving trazodone in daily oral doses up to 300 mg/kg for 18 months.
  • The efficacy and safety of trazodone hydrochloride was established from trials of the trazodone immediate release formulation in the treatment of major depressive disorder.
  • Trazodone Hydrochloride Tablets USP are available as follows:
  • 50 mg: White, round, compressed tablet, debossed u201cPLIVA 433u201d on one side and scored on the other side.
  • 100 mg: White, round, compressed tablet, debossed u201cPLIVA 434u201d on one side and scored on the other side.
  • 150 mg: White, trapezoid, flat-faced, beveled edge tablet, scored and debossed as u201cPLIVAu201d bisect u201c441u201d on one side and tri-scored and debossed as u201c50u201d in each section on the other side. Available in blistercards of 30 tablets (NDC 0615-8155-39).
  • Directions for using the correct score when breaking the tablet please refer to the following:
  • -
  • -
  • -
  • -
  • 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).
  • KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
  • See FDA-approved Medication Guide
  • Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with trazodone hydrochloride and should counsel them in its appropriate use.
  • Patients should be warned that:
  • Patients should be counseled that:
  • Important Administration Instructions:
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. F 3/2016
  • Trazodone Hydrochloride (traz' oh done hye'' droe klor' ide) Tablets USP
  • Read the Medication Guide that comes with trazodone hydrochloride tablets before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk to your healthcare provider or pharmacist if there is something you do not understand or you want to learn about trazodone hydrochloride tablets.
  • What is the most important information I should know about trazodone hydrochloride tablets?
  • Antidepressant medicines, depression or other serious mental illnesses, and suicidal thoughts or actions: Talk to your healthcare provider about:
  • Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.
  • What else do I need to know about antidepressant medicines?
  • Never stop an antidepressant medicine without first talking to a healthcare provider
  • Antidepressants are medicines used to treat depression and other illnesses.
  • Antidepressant medicines have other side effects
  • Antidepressant medicines can interact with other medicines.
  • What are trazodone hydrochloride tablets?
  • Trazodone hydrochloride tablets are a prescription medicine used to treat major depressive disorder in adults.
  • What should I tell my healthcare provider before taking trazodone hydrochloride tablets?
  • Before you take trazodone hydrochloride tablets tell your healthcare provider if you:
  • Tell your healthcare provider about all the medicines you take
  • Using trazodone hydrochloride tablets with certain other medicines can affect each other causing serious side effects.
  • Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.
  • How should I take trazodone hydrochloride tablets?
  • What should I avoid while taking trazodone hydrochloride tablets?
  • What are the possible side effects of trazodone hydrochloride tablets?
  • Trazodone hydrochloride tablets can cause serious side effects or death. See u201cWhat is the most important information I should know about trazodone hydrochloride tablets?u201d
  • Serious side effects include:
  • Get medical help right away, if you have any of the symptoms listed above.
  • The most common side effects of trazodone hydrochloride tablets include:
  • Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
  • These are not all the possible side effects of trazodone hydrochloride tablets. For more information, ask your healthcare provider or pharmacistn
  • Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
  • How should I store trazodone hydrochloride tablets?
  • Keep trazodone hydrochloride tablets and all medicines out of the reach of children.
  • General information about the safe and effective use of trazodone hydrochloride tablets.
  • Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use trazodone hydrochloride tablets for a condition for which it was not prescribed. Do not give trazodone hydrochloride tablets to other people, even if they have the same symptoms that you have. It may harm them.
  • This Medication Guide summarizes the most important information about trazodone hydrochloride tablets. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about trazodone hydrochloride tablets that is written for health professionalsn
  • For more information, call 1-888-838-2872.
  • What are the ingredients in trazodone hydrochloride tablets?
  • Active ingredient: trazodone hydrochloride
  • Inactive ingredients: colloidal silicon dioxide, lactose anhydrous, magnesium stearate, microcrystalline cellulose and sodium starch glycolate.
  • This Medication Guide has been approved by the U.S. Food and Drug Administration.
  • Manufactured In Croatia By:
  • PLIVA HRVATSKA d.o.o.
  • Zagreb, Croatia
  • Manufactured For:
  • TEVA PHARMACEUTICALS USA, INC.
  • North Wales, PA 19454
  • Rev. C 3/2016
  • No data

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