Nefazodone Hydrochloride description, usages, side effects, indications, overdosage, supplying and lots more!

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Nefazodone Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING









NEFAZODONE HYDROCHLORIDE DESCRIPTION



Nefazodone Hydrochloride







CLINICAL PHARMACOLOGY


PHARMACODYNAMICS





PHARMACOKINETICS








Distribution


Protein Binding


Effect of Food


Renal Disease


Liver Disease


Age/Gender Effects



Clinical Efficacy Trial Results

Studies in Outpatients With Depression




Studies inInpatients


Studies ofRelapse Prevention in Patients Recently Recovered (Clinically) From Depression


Comparisons of Clinical Trial Results


Uses

INDICATIONS AND USAGE





NEFAZODONE HYDROCHLORIDE CONTRAINDICATIONS





WARNINGS

Clinical Worsening and Suicide Risk











Screening Patients for Bipolar Disorder


Hepatotoxicity








Potential for Interaction With Monoamine Oxidase Inhibitors



Interaction With Triazolobenzodiazepines


Triazolam


Alprazolam


Potential Terfenadine, Astemizole, Cisapride, and Pimozide Interactions


Interaction With Carbamazepine


PRECAUTIONS

General

Hepatotoxicity


Postural Hypotension


Activation of Mania/Hypomania


Seizures


Priapism


Use in Patients With Concomitant Illness



INFORMATION FOR PATIENTS




Clinical Worsening and Suicide Risk


Hepatotoxicity


Time to Response/Continuation


Interference With Cognitive and Motor Performance


Pregnancy


Nursing


Concomitant Medication


Alcohol


Allergic Reactions


Visual Disturbances


LABORATORY TESTS



DRUG INTERACTIONS

Drugs Highly Bound to Plasma Protein



CNS-Active Drugs















Cimetidine


Theophylline


Cardiovascular-Active Drugs






Immunosuppressive Agents


Pharmacokinetics of Nefazodone inPoor Metabolizers'and Potential Interaction With Drugs That Inhibit and/or Are Metabolized by Cytochrome P450 Isozymes




Electroconvulsive Therapy (ECT)


CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Impairment of Fertility


PREGNANCY

Teratogenic Effects

Pregnancy category C


LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE



Geriatric Use



NEFAZODONE HYDROCHLORIDE ADVERSE REACTIONS

Associated With Discontinuation of Treatment


Incidence in Controlled Trials

Commonly Observed Adverse Events in Controlled Clinical Trials


Adverse Events Occurring at an Incidence of 1% or More Among Nefazodone-Treated Patients









Dose Dependency of Adverse Events


*
*
Visual Disturbances


Vital Sign Changes


Weight Changes


Laboratory Changes


ECG Changes


Other Events Observed During the Premarketing Evaluation of Nefazodone
















Postintroduction Clinical Experience


DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence



OVERDOSAGE

Human Experience



Overdosage Management





DOSAGE & ADMINISTRATION



Initial Treatment


Dosage for Elderly or Debilitated Patients


Maintenance/Continuation/Extended Treatment


Switching Patients to or From a Monoamine Oxidase Inhibitor


HOW SUPPLIED









REFERENCES







INFORMATION FOR PATIENTS






  • ●Yellowing of the skin or whites of eyes (jaundice)
  • ●Unusually dark urine
  • ●Loss of appetite that lasts several days or longer
  • ●Nausea
  • ●Abdominal (lower stomach) pain
  • ●People who currently have liver problems should not take nefazodone.





  • ●are taking Seldane(pimozide), used to treat Tourette(carbamazepine), used to control seizures.
  • ●currently have liver problems.
  • ●are taking or have taken within the last 14 days one of the medicines for depression known as monoamine oxidase inhibitors (MAOIs), such as Nardilor Parnate
  • ●Be sure to tell your doctor if you

  • ●are taking any other medicine, vitamin supplement, or herbal remedy, including those sold without a prescription (over-the-counter);
  • ●have heart problems or have had a heart attack or stroke;
  • ●have had manic episodes (extreme agitation or excitability);
  • ●have ever attempted suicide;
  • ●have had convulsions (seizures);
  • ●are pregnant or breast-feeding.
  • ●How should I take nefazodone?

  • ●It may take a while for you to feel that nefazodone is working. You may not feel the full effect for several weeks. Once you feel better, it is important to keep taking nefazodone as directed by your doctor.
  • ●If you miss a dose of nefazodone, skip that dose and continue with your regular schedule. Never take 2 doses at the same time.
  • ●If you think that you have taken more nefazodone than prescribed, contact your doctor, local poison control center, or emergency room right away.
  • ●What should I avoid while taking nefazodone?

  • ●Before taking nefazodone, tell your doctor about any medicines you are taking, including vitamin supplements, herbal remedies, and any non-prescription (over-the-counter) medicines. Some of these medicines may affect how nefazodone works and should not be used in combination without talking to your doctor.
  • ●Do not drink alcoholic beverages while taking nefazodone.
  • ●Tell your doctor if you are pregnant, planning to become pregnant, or become pregnant while taking nefazodone. It is not known whether nefazodone can harm your unborn baby.
  • ●Talk with your doctor before taking nefazodone if you are breast-feeding. It is not known whether nefazodone can pass through your breast milk to the baby.
  • ●What are the possible side effects of nefazodone?



  • ●Unusually dark urine
  • ●Loss of appetite that lasts several days or longer
  • ●Severe nausea
  • ●Abdominal (lower stomach) pain
  • ●Rash or hives
  • ●Seizure (convulsion)
  • ●Fainting
  • ●Erection that lasts too long
  • ●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.










PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

















Nefazodone Hydrochloride




Nefazodone Hydrochloride

Nefazodone Hydrochloride

Nefazodone Hydrochloride TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-292(NDC:0093-1024)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
NEFAZODONE HYDROCHLORIDE NEFAZODONE 100 mg

Inactive Ingredients

Ingredient Name Strength
SILICON DIOXIDE
MAGNESIUM STEARATE
cellulose, microcrystalline
SODIUM STARCH GLYCOLATE TYPE A POTATO
povidone

Product Characteristics

Color Size Imprint Code Shape
white 12 mm 1024;93 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-292-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076037 2011-06-08


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