Sertraline Hydrochloride
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- SERTRALINE HYDROCHLORIDE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- SERTRALINE 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
- SERTRALINE HYDROCHLORIDE ADVERSE REACTIONS
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- SPL MEDGUIDE
- INACTIVE INGREDIENT
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
Warnings: Clinical Worsening and Suicide RiskPrecautions: Information for PatientsPrecautions: Pediatric Use
SERTRALINE HYDROCHLORIDE DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacodynamicsPharmacokinetics
Systemic Bioavailability
Metabolism
Protein Binding
PRECAUTIONS
Pediatric Pharmacokinetics
DOSAGE AND ADMINISTRATION
Age
Liver Disease
PRECAUTIONSDOSAGE AND ADMINISTRATION
Renal Disease
PRECAUTIONS
Clinical Trials
Major Depressive Disorder
Premenstrual Dysphoric Disorder (PMDD)
INDICATIONS & USAGE
Major Depressive DisorderClinical Trials under CLINICAL PHARMACOLOGY
Clinical Trials under CLINICAL PHARMACOLOGY
Premenstrual Dysphoric Disorder (PMDD)
Clinical Trials under CLINICAL PHARMACOLOGY
DOSAGE AND ADMINISTRATION
SERTRALINE HYDROCHLORIDE CONTRAINDICATIONS
WARNINGSPRECAUTIONSWARNINGS
Clinical Worsening and Suicide RiskAgeDrug-Placebo Difference in Number of Cases of SuicidalityRangeper 1000 Patients Treated
PRECAUTIONSDOSAGE AND ADMINISTRATIONDiscontinuation of Treatment
Screening Patients for Bipolar Disorder
CONTRAINDICATIONSWARNINGSPotential for Interaction with Monoamine Oxidase Inhibitors
Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)- like Reactions:
PRECAUTIONS
GeneralActivation of Mania/Hypomania
Weight Loss
Seizure
Discontinuation of Treatment with Sertraline
DOSAGE AND ADMINISTRATION
Abnormal Bleeding
Weak Uricosuric Effect
Use in Patients with Concomitant Illness
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION
CLINICAL PHARMACOLOGY
Interference with Cognitive and Motor Performance
Information for Patients
Hyponatremia
GERIATRIC USE
Platelet Function
INFORMATION FOR PATIENTS
Clinical Worsening and Suicide Risk
LABORATORY TESTS
DRUG INTERACTIONS
Potential Effects of Coadministration of Drugs Highly Bound to Plasma ProteinsCimetidine
CNS Active Drugs
CONTRAINDICATIONS
Monoamine Oxidase Inhibitors
CONTRAINDICATIONSWARNINGS
Drugs Metabolized by P450 3A4
Drugs Metabolized by P450 2D6
Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder under PRECAUTIONS
Serotonergic Drugs
WARNINGS-Serotonin SyndromePRECAUTIONSDrug Interactions
Triptans
WARNINGSSerotonin Syndrome
Sumatriptan
Tricyclic Antidepressant Drugs Effective in the Treatment of Major Depressive Disorder (TCAs)
Drugs Metabolized by P450 2D6 under PRECAUTIONS
Hypoglycemic Drugs
Atenolol
Digoxin
Microsomal Enzyme Induction
Drugs That Interfere With Hemostasis (Non-selective NSAIDs, Aspirin, Warfarin, etc.)
Electroconvulsive Therapy
Alcohol
CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
CarcinogenesisMutagenesis
Impairment of Fertility
PREGNANCY
Pregnancy Category CPregnancy-Nonteratogenic Effects
WARNINGS
DOSAGE AND ADMINISTRATION
LABOR & DELIVERY
NURSING MOTHERS
PEDIATRIC USE
BOX WARNINGWARNINGSClinical Worsening and Suicide RiskPharmacokineticsCLINICAL PHARMACOLOGY
ADVERSE REACTIONS
WARNINGSClinical Worsening and Suicide Risk
GERIATRIC USE
ADVERSE REACTIONSPRECAUTIONS, Hyponatremia
SERTRALINE HYDROCHLORIDE ADVERSE REACTIONS
Incidence in Placebo-Controlled Trials
Percentage of Patients Reporting EventMajor DepressivePMDDPMDD Luteal PhaseDisorder/Other*Daily DosingDosing (2)Body System/SertralinePlaceboSertralinePlaceboSertralinePlaceboAdverse EventHCl(N=853)HCl(N=122)HCl(N=127)(N=861)(N=121)(N=136)Autonomic Nervous System DisordersCenter. & Periph. Nerv. System DisordersGeneralGastrointestinal DisordersPsychiatric Disorders
Associated with Discontinuation in Placebo-Controlled Clinical Trials
AdverseMajor DepressivePMDDPMDD LutealEventDisorder/Other*Daily DosingPhase Dosing(N=861)(N=121)(N=136)
Male and Female Sexual Dysfunction with SSRIs
Adverse EventSertralinePlacebo
Other Adverse Events in Pediatric Patients
Other Events Observed During the Premarketing Evaluation of Sertraline Hydrochloride
PRECAUTIONS
Laboratory Tests
Other Events Observed During the Post marketing Evaluation of Sertraline Hydrochloride
DRUG ABUSE AND DEPENDENCE
Controlled Substance ClassPhysical and Psychological Dependence
OVERDOSAGE
Human ExperienceOverdose Management
DOSAGE & ADMINISTRATION
Initial TreatmentDosage for Adults
Major Depressive Disorder and Obsessive-Compulsive Disorder
Premenstrual Dysphoric Disorder
Clinical Trials under CLINICAL PHARMACOLOGY
Maintenance/Continuation/Extended Treatment
Major Depressive Disorder
Clinical Trials under CLINICAL PHARMACOLOGY
Premenstrual Dysphoric Disorder
Switching Patients to or from a Monoamine Oxidase Inhibitor
CONTRAINDICATIONSWARNINGS
Special Populations
Dosage for Hepatically Impaired Patients
CLINICAL PHARMACOLOGYPRECAUTIONS
Treatment of Pregnant Women During the Third Trimester
PRECAUTIONS
Discontinuation of Treatment with Sertraline
PRECAUTIONS
HOW SUPPLIED
SPL MEDGUIDE
INACTIVE INGREDIENT
INACTIVE INGREDIENTSMAGNESIUM STEARATE
CELLULOSE, MICROCRYSTALLINE
POLYETHYLENE GLYCOL
SODIUM STARCH GLYCOLATE TYPE A POTATO
TITANIUM DIOXIDE
POLYVINYL ALCOHOL
POVIDONE K30
TALC
FERRIC OXIDE YELLOW
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Sertraline HydrochlorideSertraline Hydrochloride TABLET, FILM COATED
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
