Venlafaxine Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- VENLAFAXINE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- PHARMACODYNAMICS
- PHARMACOKINETICS
- INDICATIONS & USAGE
- VENLAFAXINE HYDROCHLORIDE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- LABORATORY TESTS
- DRUG INTERACTIONS
- CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
- PREGNANCY
- LABOR & DELIVERY
- NURSING MOTHERS
- PEDIATRIC USE
- GERIATRIC USE
- VENLAFAXINE HYDROCHLORIDE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- SPL MEDGUIDE
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
Suicidality and Antidepressant DrugsClinical Worsening and Suicide RiskInformation for PatientsPediatric Use
VENLAFAXINE HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
CLINICAL TRIALSPHARMACODYNAMICS
PHARMACOKINETICS
Age and Gender
DOSAGE AND ADMINISTRATION
Liver Disease
DOSAGE AND ADMINISTRATION
Renal Disease
DOSAGE AND ADMINISTRATION
INDICATIONS & USAGE
CLINICAL TRIALS
CLINICAL TRIALS
VENLAFAXINE HYDROCHLORIDE CONTRAINDICATIONS
DOSAGE AND ADMINISTRATION
WARNINGS
Clinical Worsening and Suicide RiskPRECAUTIONSDOSAGE AND ADMINISTRATION
Screening Patients for Bipolar Disorder
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
PRECAUTIONSDrug Interactions
CONTRAINDICATIONS
PRECAUTIONSDrug Interactions
PRECAUTIONSDrug Interactions
Sustained Hypertension
Mydriasis
Information for Patients).
PRECAUTIONS
GeneralDiscontinuation of Treatment with Venlafaxine Hydrochloride Tablets
DOSAGE AND ADMINISTRATION
Anxiety and Insomnia
Changes in Weight
Pediatric Patients
Changes in Appetite).
The risks associated with longer-term venlafaxine hydrochloride extended-release capsules use were assessed in an open-label study of children and adolescents who received venlafaxine hydrochloride extended-release capsules for up to six months. The children and adolescents in the study had increases in weight that were less than expected based on data from age- and sex-matched peers. The difference between observed weight gain and expected weight gain was larger for children (<12 years old) than for adolescents (>12 years old).
Changes in Height
Changes in Appetite
Pediatric Patients
Activation of Mania/Hypomania
Hyponatremia
PRECAUTIONSGeriatric Use
Seizures
Abnormal Bleeding
Serum Cholesterol Elevation
ADVERSE REACTIONS
Interstitial Lung Disease and Eosinophilic Pneumonia
Use in Patients with Concomitant Illness
DOSAGE AND ADMINISTRATION
INFORMATION FOR PATIENTS
Clinical Worsening and Suicide Risk
Interference with Cognitive and Motor Performance
Pregnancy
Nursing
Mydriasis
WARNINGS
Concomitant Medication
Serotonin SyndromeCNS-Active Drugs
Abnormal Bleeding
Alcohol
Allergic Reactions
LABORATORY TESTS
DRUG INTERACTIONS
Alcohol
Cimetidine
Diazepam
Haloperidol
Lithium
CNS-Active Drugs
Drugs Highly Bound to Plasma Protein
Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)
Drugs that Inhibit Cytochrome P450 Isoenzymes
Ketoconazole
CYP3A4 Inhibitors
Drugs Metabolized by Cytochrome P450 Isoenzymes
Imipramine
Metoprolol
WARNINGS
Risperidone
CYP3A4
Indinavir
CYP1A2
CYP2C9
CYP2C19
Diazepam
Monoamine Oxidase Inhibitors
CONTRAINDICATIONS
CNS-Active Drugs
Serotonergic Drugs
Serotonin SyndromeSerotonin SyndromeSerotonin Syndrome
Triptans
Serotonin Syndrome
Electroconvulsive Therapy
Postmarketing Spontaneous Drug Interaction Reports
ADVERSE REACTIONS, Postmarketing Reports
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
CarcinogenesisMutagenicity
Impairment of Fertility
PREGNANCY
Teratogenic EffectsPregnancy Category CNon-teratogenic Effects
CNS-Active DrugsDOSAGE AND ADMINISTRATION
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
BOX WARNINGWARNINGS, Clinical Worsening and Suicide RiskPRECAUTIONS , General,Changes in HeightChanges in Weight
WARNINGS, Sustained HypertensionSerum Cholesterol Elevation
GERIATRIC USE
HyponatremiaCLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION
VENLAFAXINE 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 Venlafaxine Hydrochloride Tablets -Treated Patients
*
*
Dose Dependency of Adverse Events
Adaptation to Certain Adverse Events
Vital Sign Changes
WARNINGS
Laboratory Changes
Serum Cholesterol Elevation
ECG Changes
Use in Patients with Concomitant Illness
Other Events Observed During the Premarketing Evaluation of Venlafaxine
Postmarketing Reports
DRUG ABUSE AND DEPENDENCE
Controlled Substance ClassPhysical and Psychological Dependence
DOSAGE AND ADMINISTRATION
OVERDOSAGE
Human ExperienceManagement of Overdosage
DOSAGE & ADMINISTRATION
Initial TreatmentPRECAUTIONSGeneralUse in Patients with Concomitant Illness
Special Populations
Treatment of Pregnant Women During the Third Trimester
PRECAUTIONS
Dosage for Patients with Hepatic Impairment
CLINICAL PHARMACOLOGY
Dosage for Patients with Renal Impairment
CLINICAL PHARMACOLOGY
Dosage for Elderly Patients
Maintenance Treatment
CLINICAL TRIALS
Discontinuing Venlafaxine Hydrochloride Tablets
PRECAUTIONS
SWITCHING PATIENTS TO OR FROM A MONOAMINE OXIDASE INHIBITOR
CONTRAINDICATIONS
HOW SUPPLIED
STORAGE AND HANDLING
SPL MEDGUIDE
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● all risks and benefits of treatment with antidepressant medicines
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● all treatment choices for depression or other serious mental illness
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● What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions?
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● Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
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● 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.
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● 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:
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● 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.
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● 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.
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● Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child's healthcare provider for more information.
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● Please address medical inquiries to, (MedicalAffairs@zydususa.com) Tel.: 1-877-993-8779.
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● Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Venlafaxine HydrochlorideVenlafaxine Hydrochloride TABLET
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
