TRAZODONE HYDROCHLORIDE- trazodone tablet

Trazodone Hydrochloride by

Drug Labeling and Warnings

Trazodone Hydrochloride by is a Prescription medication manufactured, distributed, or labeled by Rebel Distributors Corp.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Occasional sinus bradycardia has occurred in long-term studies.

In addition to the relatively common (i.e., greater than 1%) untoward events enumerated above, the following adverse events have been reported to occur in association with the use of trazodone HCl in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.

Post Introduction Reports: Although the following adverse reactions have been reported in trazodone HCl users, the causal association has neither been confirmed nor refuted.

Voluntary reports received since market introduction include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestatis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism (see WARNINGS and PRECAUTIONS, Information for Patients; some patients have required surgical intervention), pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo, and weakness.

Cardiovascular system effects which have been reported include the following: conduction block orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, and ventricular ectopic activity, including ventricular tachycardia (see WARNINGS).

  • OVERDOSAGE

    Animal Oral LD50: The oral LD50 of the drug is 610 mg/kg in mice, 486 mg/kg in rats, and 560 mg/kg in rabbits.

    Signs and Symptoms: Death from overdose has occurred in patients ingesting trazodone HCl and other drugs concurrently (namely, alcohol; alcohol + chloral hydrate + diazepam; amobarbital; chlordiazepoxide; or meprobamate).

    The most severe reactions reported to have occurred with overdose of trazodone HCl alone have been priapism, respiratory arrest, seizures, and EKG changes. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions (see ADVERSE REACTIONS).

    Treatment

    There is no specific antidote for trazodone HCl. Treatment should be symptomatic and supportive in the case of hypotension or excessive sedation. Any patient suspected of having taken an overdose should have the stomach emptied by gastric lavage. Forced diuresis may be useful in facilitating elimination of the drug.

  • DOSAGE AND ADMINISTRATION

    The dosage should be initiated at a low level 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 HCl should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week with optimal antidepressant effects typically evident within two weeks. Twenty-five percent of those who respond to trazodone HCl require more than two weeks (up to four weeks) of drug administration.

    Usual Adult Dosage: An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four 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: Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.

    Although there has been no systematic evaluation of the efficacy of trazodone beyond 6 weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.

  • HOW SUPPLIED

    Trazodone Hydrochloride Tablets, USP:

    50 mg - White, round, scored tablets in bottles of 30, 60, 90, 120

    Debossed: PLIVA 433

    100 mg - White, round, scored tablets in bottles of 30, 60, 90

    Debossed: PLIVA 434

    150 mg - White, trapezoidal-shaped tablets, bisected one side to yield two 75 mg units (Debossed PLIVA 441); trisected the other side to yield three 50 mg units (Debossed 50 in each triangular segment); in bottles of 60, 90

    Dispense in a tight, light-resistant container.

    Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].

  • REFERENCES

    (a) Williams JBW, Ed: Diagnostic and Statistical Manual of Mental Disorders lll, American Psychiatric Association, May, 1980. (b) Lue TF, Physiology of erection and pathophysiology of impotence. In: Wash PC, Retik AB, Stamey TA, Vaughan ED, eds. Campbell’s Urology. Sixth edition. Philadelphia: W.B. Saunders: 1992: 722-725. (c) Goldstein I, Krane RJ, Diagnosis and therapy of erectile dysfunction. In: Wash PC. Retik AB, Stamey TA, Vaughan ED, eds. Campbell’s Urology. Sixth edition. Philadelphia: W.B. Saunders: 1992: 3071-3072. (d) Yealy DM, Hogya PT: Priapism. Emerg Med Clin North Am, 1988: 6:509-520. (e) Banos JE, Bosch F, Farre M. Drug-induced priapism, its aetiology, incidence and treatment. Med Toxicol Adverse Drug Exp. 1989: 4:46-58. (f) O’Brien WM, O’Connor KP, Lynch JH. Priapism: current concepts. Ann Emerg Med. 1989: 980-983. (g) Bardin ED, Krieger JN. Pharmacological priapism: comparison of trazodone- and papaverine-associated cases. Int Urol Nephrol. 1990: 22:147-152.

  • Medication Guide

    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:

    all risks and benefits of treatment with antidepressant medicines

    all treatment choices for depression or other serious mental illness

    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. These include people who have (or have a family history of) bipolar illness (also called manic-depressive illness) or suicidal thoughts or actions.

    3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?

    Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.

    Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.

    Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.

    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:

    thoughts about suicide or dying new or worse irritability
    attempts to commit suicide acting aggressive, being angry, or violent
    new or worse depression acting on dangerous impulses
    new or worse anxiety an extreme increase in activity and talking (mania)
    feeling very agitated or restless other unusual changes in behavior or mood
    panic attacks
    trouble sleeping (insomnia)

    What else do I need to know about antidepressant medicines?

    Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.

    Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.

    Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.

    Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.

    Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information.

    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.

    Mfg by PLIVA® Hrvatska d.o.o., Zagreb Croatia for PLIVA®, Inc.
    Pomona, NY 10970
    Dist. by Barr Laboratories, Inc., Pomona, NY 10970

    Revised January 2008

    BR-433, 434, 441

    Z21-0433

    c/n.1

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

    FLEXIDOSE® is a registered trademark of PLIVA®, Inc. for its tablets. The trapezoidal shaped tablet is a trademark and original design of PLIVA® Inc.

  • Principal Display Panel

    Trazodone HCl 50mg

  • Principal Display Panel

    Trazodone HCl 100mg

  • Principal Display Panel

    Trazodone HCl 150mg

  • INGREDIENTS AND APPEARANCE
    TRAZODONE HYDROCHLORIDE 
    trazodone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 21695-133(NDC:50111-433)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE50 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize9mm
    FlavorImprint Code PLIVA;433
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 21695-133-3030 in 1 BOTTLE
    2NDC: 21695-133-6060 in 1 BOTTLE
    3NDC: 21695-133-9090 in 1 BOTTLE
    4NDC: 21695-133-72120 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07152312/11/1987
    TRAZODONE HYDROCHLORIDE 
    trazodone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 21695-134(NDC:50111-434)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE100 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore2 pieces
    ShapeROUNDSize11mm
    FlavorImprint Code PLIVA;434
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 21695-134-3030 in 1 BOTTLE
    2NDC: 21695-134-6060 in 1 BOTTLE
    3NDC: 21695-134-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07152412/11/1987
    TRAZODONE HYDROCHLORIDE 
    trazodone tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 21695-135(NDC:50111-441)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRAZODONE HYDROCHLORIDE (UNII: 6E8ZO8LRNM) (TRAZODONE - UNII:YBK48BXK30) TRAZODONE HYDROCHLORIDE150 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    Product Characteristics
    ColorwhiteScore3 pieces
    ShapeTRAPEZOIDSize19mm
    FlavorImprint Code PLIVA;441
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 21695-135-6060 in 1 BOTTLE
    2NDC: 21695-135-9090 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07152503/09/1988
    Labeler - Rebel Distributors Corp. (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp.118802834RELABEL, REPACK

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