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

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Venlafaxine Hydrochloride

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

Suicidality and Antidepressant Drugs
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 venlafaxine hydrochloride extended-release capsules 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 beyone 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 assoicated 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 teh need for close observation and communication with the prescriber. Venlafaxine hydrochloride extended-release capsules are not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk,PRECAUTIONS: Information for Patients, andPRECAUTIONS: Pediatric Use)

VENLAFAXINE HYDROCHLORIDE DESCRIPTION


Venlafaxine Hydrochloride




CLINICAL PHARMACOLOGY

Pharmacodynamics


Pharmacokinetics


Absorption




Metabolism and Excretion



Special Populations

DOSAGE AND ADMINISTRATION





DOSAGE AND ADMINISTRATION

DOSAGE AND ADMINISTRATION

Clinical Trials

Major Depressive Disorder







Generalized Anxiety Disorder





Social Anxiety Disorder (Social Phobia)



Panic Disorder






INDICATIONS & USAGE

Major Depressive Disorder

Clinical Trials

Clinical Trials
Clinical TrialsDOSAGE AND ADMINISTRATION

Generalized Anxiety Disorder

Clinical Trials

DOSAGE AND ADMINISTRATION

Social Anxiety Disorder


Clinical Trials
DOSAGE AND ADMINISTRATION

Panic Disorder


CLINICAL PHARMACOLOGY, Clinical TrialsDOSAGE AND ADMINISTRATION

VENLAFAXINE HYDROCHLORIDE CONTRAINDICATIONS


WARNINGS

WARNINGS

Clinical Worsening and Suicide Risk

Table 1




All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.


PRECAUTIONSDOSAGE AND ADMINISTRATION, Discontinuation of Treatment with Venlafaxine Hydrochloride Extended-Release Capsules
Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers

Screening Patients for Bipolar Disorder


Potential for Interaction with Monoamine Oxidase Inhibitors
Adverse reactions, some of which were serious, have been reported in patients who have recently been discontinued from a monoamine oxidase inhibitor (MAOI) and started on venlafaxine, or who have recently had venlafaxine therapy discontinued prior to initiation of an MAOI. These reactions have included tremor, myoclonus, diaphoresis, nausea, vomiting, flushing, dizziness, hyperthermia with features resembling neuroleptic malignant syndrome, seizures, and death. In patients receiving antidepressants with pharmacological properties similar to venlafaxine in combination with an MAOI, there have also been reports of serious, sometimes fatal, reactions. For a selective serotonin reuptake inhibitor, these reactions have included hyperthermia, rigidity, myoclonus, autonomic instability with possible rapid fluctuations of vital signs, and mental status changes that include extreme agitation progressing to delirium and coma. Some cases presented with features resembling neuroleptic malignant syndrome. Severe hyperthermia and seizures, sometimes fatal, have been reported in association with the combined use of tricyclic antidepressants and MAOIs. These reactions have also been reported in patients who have recently discontinued these drugs and have been started on an MAOI. The effects of combined use of venlafaxine and MAOIs have not been evaluated in humans or animals. Therefore, because venlafaxine is an inhibitor of both norepinephrine and serotonin reuptake, it is recommended that venlafaxine hydrochloride extended-release capsules not be used in combination with an MAOI, or within at least 14 days of discontinuing treatment with an MAOI. Based on the half-life of venlafaxine, at least 7 days should be allowed after stopping venlafaxine before starting an MAOI.

Serotonin Syndrome or Neuroleptic Malignant Syndrome (NMS)-like Reactions
PRECAUTIONS, Drug Interactions
CONTRAINDICATIONSWARNINGS, Potential for Interaction with Monoamine Oxidase Inhibitors
PRECAUTIONS, Drug Interactions
PRECAUTIONS, Drug Interactions


Sustained Hypertension
Table 2
Table 3








Elevations in Systolic and Diastolic Blood Pressure
Table 4




Mydriasis
PRECAUTIONS, Information for Patients

PRECAUTIONS

General

Discontinuation of Treatment with venlafaxine hydrochloride extended-release capsules


DOSAGE AND ADMINISTRATION

Insomnia and Nervousness
Table 5







Changes in Weight




PRECAUTIONS, General, Changes in Appetite


Changes in Height



Changes in Appetite





Activation of Mania/Hypomania


Hyponatremia
PRECAUTIONS, Geriatric Use


Seizures


Abnormal Bleeding



Serum Cholesterol Elevation
ADVERSE REACTIONS-Laboratory Changes

Interstitial Lung Disease and Eosinophilic Pneumonia


Use in Patients With Concomitant Illness






DOSAGE AND ADMINISTRATION

INFORMATION FOR PATIENTS

complete text of the Medication Guide




Interference with Cognitive and Motor Performance


Concomitant Medication

WARNINGS, Serotonin SyndromePRECAUTIONS, Drug Interactions, CNS-Active Drugs
PRECAUTIONS, Abnormal Bleeding

Alcohol


Allergic Reactions


Pregnancy


Nursing


Mydriasis
WARNINGS

LABORATORY TESTS



DRUG INTERACTIONS



Alcohol


Cimetidine


Diazepam


Haloperidol


Lithium
CNS-Active Drugs

Drugs Highly Bound to Plasma Proteins


Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin)


Drugs that Inhibit Cytochrome P450 Isoenzymes

Metabolism and ExcretionCLINICAL PHARMACOLOGY





Drugs Metabolized by Cytochrome P450 Isoenzymes





WARNINGS









Diazepam

Monoamine Oxidase Inhibitors
CONTRAINDICATIONSWARNINGS

CNS-Active Drugs


WARNINGS, Serotonin SyndromeWARNINGS, Serotonin SyndromeWARNINGS, Serotonin Syndrome

WARNINGS, Serotonin Syndrome

Electroconvulsive Therapy


Postmarketing Spontaneous Drug Interaction Reports
ADVERSE REACTIONS, Postmarketing Reports

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

Carcinogenesis


Mutagenesis


Impairment of Fertility


PREGNANCY

Teratogenic Effects - Pregnancy Category C


Non-teratogenic Effects
PRECAUTIONS-Drug Interactions-CNS-Active DrugsDOSAGE AND ADMINISTRATION

LABOR & DELIVERY



NURSING MOTHERS



PEDIATRIC USE

BOX WARNINGWARNINGS, Clinical Worsening and Suicide Risk

PRECAUTIONS, General, Changes in HeightChanges in Weight
WARNINGS, Sustained HypertensionPRECAUTIONS, General, Serum Cholesterol Elevation

GERIATRIC USE

PRECAUTIONS, Hyponatremia
CLINICAL PHARMACOLOGYDOSAGE AND ADMINISTRATION

VENLAFAXINE HYDROCHLORIDE ADVERSE REACTIONS

Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Venlafaxine Hydrochloride Extended-Release CapsulesOther Adverse Events Observed During the Premarketing Evaluation of Venlafaxine Hydrochloride Tablets and Venlafaxine Hydrochloride Extended-Release CapsulesWARNINGSPRECAUTIONS

Adverse Findings Observed in Short-Term, Placebo-Controlled Studies with Venlafaxine Hydrochloride Extended-Release Capsules

Adverse Events Associated with Discontinuation of Treatment
Table 6



Adverse Events Occurring at an Incidence of 2% or More Among Venlafaxine Hydrochloride Extended-Release Capsule-Treated Patients
Tables 7 89 10
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side effect incidence rate in the population studied.
Commonly Observed Adverse Events fromTables 7,8,9, and10:

Major Depressive Disorder
Note in particular the following adverse events that occurred in at least 5% of the venlafaxine hydrochloride extended-release capsule patients and at a rate at least twice that of the placebo group for all placebo-controlled trials for the major depressive disorder indication (Table 7): Abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating. In the two U.S. placebo-controlled trials, the following additional events occurred in at least 5% of venlafaxine hydrochloride extended-release capsule-treated patients (n = 192) and at a rate at least twice that of the placebo group: Abnormalities of sexual function (impotence in men, anorgasmia in women, and libido decreased), gastrointestinal complaints (constipation and flatulence), CNS complaints (insomnia, nervousness, and tremor), problems of special senses (abnormal vision), cardiovascular effects (hypertension and vasodilatation), and yawning.

Generalized Anxiety Disorder
Note in particular the following adverse events that occurred in at least 5% of the venlafaxine hydrochloride extended-release capsule patients and at a rate at least twice that of the placebo group for all placebo-controlled trials for the GAD indication (Table 8): Abnormalities of sexual function (abnormal ejaculation and impotence), gastrointestinal complaints (nausea, dry mouth, anorexia, and constipation), problems of special senses (abnormal vision), and sweating.

Social Anxiety Disorder
Note in particular the following adverse events that occurred in at least 5% of the venlafaxine hydrochloride extended-release capsule patients and at a rate at least twice that of the placebo group for the 5 placebo-controlled trials for the Social Anxiety Disorder indication (Table 9): Asthenia, gastrointestinal complaints (anorexia, constipation, dry mouth, nausea), CNS complaints (insomnia, libido decreased, nervousness, somnolence, tremor), abnormalities of sexual function (abnormal ejaculation, impotence), yawn, and sweating.
In the 6-month trial, the following adverse events occurred twice as often in the 150-225 mg/day venlafaxine hydrochloride extended-release capsule group compared to the 75 mg/day venlafaxine hydrochloride extended-release capsule group and placebo: vasodilation, libido decreased, tremor, yawn, abnormal vision, and impotence.

Panic Disorder
Note in particular the following adverse events that occurred in at least 5% of the venlafaxine hydrochloride extended-release capsule patients and at a rate at least twice that of the placebo group for 4 placebo-controlled trials for the panic disorder indication (Table 10): gastrointestinal complaints (anorexia, constipation, dry mouth), CNS complaints (somnolence, tremor), abnormalities of sexual function (abnormal ejaculation), and sweating.

Table 7 Treatment-Emergent Adverse Event Incidence in Short-Term Placebo-Controlled Venlafaxine Hydrochloride Extended-Release Capsule Clinical Trials in Patients with Major Depressive Disorder1,2
1 Incidence, rounded to the nearest %, for events reported by at least 2% of patients treated with venlafaxine hydrochloride extended-release capsules, except the following events which had an incidence equal to or less than placebo: abdominal pain, accidental injury, anxiety, back pain, bronchitis, diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, pain, palpitation, rhinitis, and sinusitis. 2 <1% indicates an incidence greater than zero but less than 1%. 3 Mostlyhot flashes.4 Mostlyvivid dreams,nightmares,andincreased dreaming.5 Mostlyblurred visionanddifficulty focusing eyes.6 Mostlydelayed ejaculation.7 Incidence is based on the number of male patients. 8 Mostlydelayed orgasmoranorgasmia.9 Incidence is based on the number of female patients.% Reporting EventBody System Preferred TermVenlafaxine hydrochloride extended-release capsules (n = 357)Placebo (n = 285)Body as a WholeAsthenia8%7%Cardiovascular SystemVasodilatation34%2%Hypertension4%1%Digestive SystemNausea31%12%Constipation8%5%Anorexia8%4%Vomiting4%2%Flatulence4%3%Metabolic/NutritionalWeight Loss3%0%Nervous SystemDizziness20%9%Somnolence17%8%Insomnia17%11%Dry Mouth12%6%Nervousness10%5%Abnormal Dreams47%2%Tremor5%2%Depression3%<1%Paresthesia3%1%Libido Decreased3%<1%Agitation3%1%Respiratory SystemPharyngitis7%6%Yawn3%0%SkinSweating14%3%Special SensesAbnormal Vision54%<1%Urogenital SystemAbnormal Ejaculation16%<1%(male)6,7Impotence74%<1%Anorgasmia (female)8,93%<1%
Table 8 Treatment-Emergent Adverse Event Incidence in Short-Term Placebo-Controlled Venlafaxine Hydrochloride Extended-Release Capsule Clinical Trials in GAD Patients1,2
1 Adverse events for which the venlafaxine hydrochloride extended-release capsules reporting rate was less than or equal to the placebo rate are not included. These events are: abdominal pain, accidental injury, anxiety, back pain, diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, myalgia, pain, palpitation, pharyngitis, rhinitis, tinnitus, and urinary frequency. 2 <1% means greater than zero but less than 1%. 3 Mostlyhot flashes.4 Mostlyvivid dreams,nightmares,andincreased dreaming.5 Mostlyblurred visionanddifficulty focusing eyes.6 Includesdelayed ejaculationandanorgasmia.7 Percentage based on the number of males (venlafaxine hydrochloride extended-release capsules = 525, placebo = 220). 8 Includesdelayed orgasm,abnormal orgasm,andanorgasmia.9 Percentage based on the number of females (venlafaxine hydrochloride extended-release capsules = 856, placebo = 335).% Reporting EventBody System Preferred TermVenlafaxine hydrochloride extended-release capsules (n = 1381)Placebo (n = 555)Body as a WholeAsthenia12%8%Cardiovascular SystemVasodilatation34%2%Digestive SystemNausea35%12%Constipation10%4%Anorexia8%2%Vomiting5%3%Nervous SystemDizziness16%11%Dry Mouth16%6%Insomnia15%10%Somnolence14%8%Nervousness6%4%Libido Decreased4%2%Tremor4%<1%Abnormal Dreams43%2%Hypertonia3%2%Paresthesia2%1%Respiratory SystemYawn3%<1%SkinSweating10%3%Special SensesAbnormal Vision55%<1%Urogenital SystemAbnormal Ejaculation6,711%<1%Impotence75%<1%Orgasmic Dysfunction (female)8,92%0%
Table 9 Treatment-Emergent Adverse Event Incidence in Short-Term Placebo-Controlled Venlafaxine Hydrochloride Extended-Release Capsule Clinical Trials in Social Anxiety Disorder Patients1,2
1 Adverse events for which the venlafaxine hydrochloride extended-release capsules reporting rate was less than or equal to the placebo rate are not included. These events are: arthralgia, back pain, dysmenorrhea, flu syndrome, infection, pain, pharyngitis, rhinitis, and upper respiratory infection. 2 <1% means greater than zero but less than 1%. 3 Mostlyhot flashes.4 Mostlydecreased appetiteandloss of appetite.5 Mostlyvivid dreams,nightmares,andincreased dreaming.6 Mostlyblurred vision.7 Includesdelayed ejaculationandanorgasmia.8 Percentage based on the number of males (venlafaxine hydrochloride extended-release capsules = 454, placebo = 357). 9 Includesabnormal orgasmandanorgasmia.10 Percentage based on the number of females (venlafaxine hydrochloride extended-release capsules = 365, placebo = 338).% Reporting EventBody System Preferred TermVenlafaxine hydrochloride extended-release capsules (n = 819)Placebo (n = 695)Body as a WholeHeadache38%34%Asthenia19%9%Abdominal Pain6%4%Accidental Injury4%3%Cardiovascular SystemHypertension5%3%Vasodilatation33%2%Palpitation3%1%Digestive SystemNausea31%9%Anorexia417%2%Constipation9%3%Diarrhea8%6%Dyspepsia7%6%Vomiting3%2%Metabolic/NutritionalWeight Loss2%<1%Nervous SystemInsomnia24%8%Somnolence20%8%Dry Mouth17%4%Dizziness16%8%Nervousness10%5%Libido Decreased8%2%Anxiety5%4%Tremor5%2%Agitation3%1%Abnormal Dreams53%<1%Twitching3%<1%Respiratory SystemYawn5%<1%SkinSweating13%4%Special SensesAbnormal Vision64%2%Urogenital SystemAbnormal Ejaculation7,819%<1%Impotence86%<1%Orgasmic Dysfunction9,105%<1%
Table 10 Treatment-Emergent Adverse Event Incidence in Short-Term Placebo-Controlled Venlafaxine Hydrochloride Extended-Release Capsule Clinical Trials in Panic Disorder Patients1,2
1 Adverse events for which the venlafaxine hydrochloride extended-release capsules reporting rate was less than or equal to the placebo rate are not included. These events are: abdominal pain, abnormal vision, accidental injury, anxiety, back pain, diarrhea, dysmenorrhea, dyspepsia, flu syndrome, headache, infection, nervousness, pain, paresthesia, pharyngitis, rash, rhinitis, and vomiting. 2 <1% means greater than zero but less than 1%. 3 Mostlyhot flushes.4 Mostlydecreased appetiteandloss of appetite.5 Includesdelayed or retarded ejaculationandanorgasmia.6 Percentage based on the number of males (venlafaxine hydrochloride extended-release capsule = 335, placebo = 238). 7 Includesanorgasmiaanddelayed orgasm.8 Percentage based on the number of females (venlafaxine hydrochloride extended-release capsules = 666, placebo = 424).% Reporting EventBody System Preferred TermVenlafaxine hydrochloride extended-release capsule (n = 1001)Placebo (n = 662)Body as a WholeAsthenia10%8%Cardiovascular SystemHypertension4%3%Vasodilatation33%2%Digestive SystemNausea21%14%Dry mouth12%6%Constipation9%3%Anorexia48%3%Nervous SystemInsomnia17%9%Somnolence12%6%Dizziness11%10%Tremor5%2%Libido Decreased4%2%SkinSweating10%2%Urogenital SystemAbnormal Ejaculation5,68%<1%Impotence64%<1%Orgasmic Dysfunction7,82%<1%
Vital Sign Changes
Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled major depressive disorder trials was associated with a mean final on-therapy increase in pulse rate of approximately 2 beats per minute, compared with 1 beat per minute for placebo. Venlafaxine hydrochloride extended-release capsules treatment for up to 8 weeks in premarketing placebo-controlled GAD trials was associated with a mean final on-therapy increase in pulse rate of approximately 2 beats per minute, compared with less than 1 beat per minute for placebo. Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled Social Anxiety Disorder trials was associated with a mean final on-therapy increase in pulse rate of approximately 3 beats per minute, compared with an increase of 1 beat per minute for placebo. Venlafaxine hydrochloride extended-release capsules treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with a mean final on-therapy increase in pulse rate of approximately 1 beat per minute, compared with a decrease of less than 1 beat per minute for placebo. (See theSustained HypertensionandElevations in Systolic and Diastolic Blood Pressuresections ofWARNINGSfor effects on blood pressure.)
In a flexible-dose study, with venlafaxine hydrochloride tablet (immediate release) doses in the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean pulse was increased by about 2 beats per minute compared with a decrease of about 1 beat per minute for placebo.

Laboratory Changes
Serum Cholesterol
Venlafaxine hydrochloride extended-release capsule treatment for up to 12 weeks in premarketing placebo-controlled trials for major depressive disorder was associated with a mean final on-therapy increase in serum cholesterol concentration of approximately 1.5 mg/dL compared with a mean final decrease of 7.4 mg/dL for placebo. Venlafaxine hydrochloride extended-release capsule treatment for up to 8 weeks and up to 6 months in premarketing placebo-controlled GAD trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 1.0 mg/dL and 2.3 mg/dL, respectively while placebo subjects experienced mean final decreases of 4.9 mg/dL and 7.7 mg/dL, respectively. Venlafaxine hydrochloride extended-release capsule treatment for up to 12 weeks and up to 6 months in premarketing placebo-controlled Social Anxiety Disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 7.9 mg/dL and 5.6 mg/dL, respectively, compared with mean final decreases of 2.9 and 4.2 mg/dL, respectively, for placebo. Venlafaxine hydrochloride extended-release capsule treatment for up to 12 weeks in premarketing placebo-controlled panic disorder trials was associated with mean final on-therapy increases in serum cholesterol concentration of approximately 5.8 mg/dL compared with a mean final decrease of 3.7 mg/dL for placebo.
Patients treated with venlafaxine hydrochloride tablets (immediate release) for at least 3 months in placebo-controlled 12-month extension trials had a mean final on-therapy increase in total cholesterol of 9.1 mg/dL compared with a decrease of 7.1 mg/dL among placebo-treated patients. This increase was duration dependent over the study period and tended to be greater with higher doses. Clinically relevant increases in serum cholesterol, defined as 1) a final on-therapy increase in serum cholesterolmg/dL from baseline and to a valuemg/dL, or 2) an average on-therapy increase in serum cholesterolmg/dL from baseline and to a valuemg/dL, were recorded in 5.3% of venlafaxine-treated patients and 0.0% of placebo-treated patients (seePRECAUTIONS-General-Serum Cholesterol Elevation).

Serum Triglycerides
Venlafaxine hydrochloride extended-release capsule treatment for up to 12 weeks in pooled premarketing Social Anxiety Disorder trials was associated with a mean final on-therapy increase in fasting serum triglyceride concentration of approximately 8.2 mg/dL, compared with a mean final increase of 0.4 mg/dL for placebo. Venlafaxine hydrochloride extended-release capsule treatment for up to 6 months in a premarketing Social Anxiety Disorder trial was associated with a mean final on-therapy increase in fasting serum triglyceride concentration of approximately 11.8 mg/dL, compared with a mean final on-therapy increase of 1.8 mg/dL for placebo.
Venlafaxine hydrochloride extended-release capsule treatment for up to 12 weeks in pooled premarketing Panic Disorder trials was associated with a mean final on-therapy increase in fasting serum triglyceride concentration of approximately 5.9 mg/dL, compared with a mean final increase of 0.9 mg/dL for placebo. Venlafaxine hydrochloride extended-release capsule treatment for up to 6 months in a premarketing Panic Disorder trial was associated with a mean final on-therapy increase in fasting serum triglyceride concentration of approximately 9.3 mg/dL, compared with a mean final on-therapy decrease of 0.3 mg/dL for placebo.

ECG Changes
In a flexible-dose study, with venlafaxine hydrochloride tablet (immediate release) doses in the range of 200 to 375 mg/day and mean dose greater than 300 mg/day, the mean change in heart rate was 8.5 beats per minute compared with 1.7 beats per minute for placebo.
(See theUse in Patients with Concomitant Illnesssection ofPRECAUTIONS.)

Other Adverse Events Observed During the Premarketing Evaluation of Venlafaxine Hydrochloride Tablets and Venlafaxine Hydrochloride Extended-Release Capsules
During its premarketing assessment, multiple doses of venlafaxine hydrochloride extended-release capsules were administered to 705 patients in Phase 3 major depressive disorder studies and venlafaxine hydrochloride tablets were administered to 96 patients. During its premarketing assessment, multiple doses of venlafaxine hydrochloride extended-release capsules were also administered to 1381 patients in Phase 3 GAD studies, 819 patients in Phase 3 Social Anxiety Disorder studies, and 1314 patients in Phase 3 panic disorder studies. In addition, in premarketing assessment of venlafaxine hydrochloride tablets, multiple doses were administered to 2897 patients in Phase 2 to Phase 3 studies for major depressive disorder. The conditions and duration of exposure to venlafaxine in both development programs varied greatly, and included (in overlapping categories) open and double-blind studies, uncontrolled and controlled studies, inpatient (venlafaxine hydrochloride tablets only) and outpatient studies, fixed-dose, and titration studies. Untoward events associated with this exposure were recorded by clinical investigators using terminology of their own choosing. Consequently, it is not possible to provide a meaningful estimate of the proportion of individuals experiencing adverse events without first grouping similar types of untoward events into a smaller number of standardized event categories.
In the tabulations that follow, reported adverse events were classified using a standard COSTART-based Dictionary terminology. The frequencies presented, therefore, represent the proportion of the 7212 patients exposed to multiple doses of either formulation of venlafaxine who experienced an event of the type cited on at least one occasion while receiving venlafaxine. All reported events are included except those already listed inTables 7,8,9, and10and those events for which a drug cause was remote. If the COSTART term for an event was so general as to be uninformative, it was replaced with a more informative term. It is important to emphasize that, although the events reported occurred during treatment with venlafaxine, they were not necessarily caused by it.
Events are further categorized by body system and listed in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring on one or more occasions in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1000 patients; rare events are those occurring in fewer than 1/1000 patients.
Body as a whole - Frequent: chest pain substernal, chills, fever, neck pain; Infrequent: face edema, intentional injury, malaise, moniliasis, neck rigidity, pelvic pain, photosensitivity reaction, suicide attempt, withdrawal syndrome; Rare: appendicitis, bacteremia, carcinoma, cellulitis, granuloma.
Cardiovascular system - Frequent: migraine, tachycardia; Infrequent: angina pectoris, arrhythmia, bradycardia, extrasystoles, hypotension, peripheral vascular disorder (mainly cold feet and/or cold hands), postural hypotension, syncope; Rare: aortic aneurysm, arteritis, first-degree atrioventricular block, bigeminy, bundle branch block, capillary fragility, cerebral ischemia, coronary artery disease, congestive heart failure, heart arrest, hematoma, cardiovascular disorder (mitral valve and circulatory disturbance), mucocutaneous hemorrhage, myocardial infarct, pallor, sinus arrhythmia, thrombophlebitis.
Digestive system - Frequent: increased appetite; Infrequent: bruxism, colitis, dysphagia, tongue edema, eructation, esophagitis, gastritis, gastroenteritis, gastrointestinal ulcer, gingivitis, glossitis, rectal hemorrhage, hemorrhoids, melena, oral moniliasis, stomatitis, mouth ulceration; Rare: abdominal distension, biliary pain, cheilitis, cholecystitis, cholelithiasis, esophageal spasms, duodenitis, hematemesis, gastroesophageal reflux disease, gastrointestinal hemorrhage, gum hemorrhage, hepatitis, ileitis, jaundice, intestinal obstruction, liver tenderness, parotitis, periodontitis, proctitis, rectal disorder, salivary gland enlargement, increased salivation, soft stools, tongue discoloration.
Endocrine system - Rare: galactorrhoea, goiter, hyperthyroidism, hypothyroidism, thyroid nodule, thyroiditis.
Hemic and lymphatic system - Frequent: ecchymosis; Infrequent: anemia, leukocytosis, leukopenia, lymphadenopathy, thrombocythemia; Rare: basophilia, bleeding time increased, cyanosis, eosinophilia, lymphocytosis, multiple myeloma, purpura, thrombocytopenia.
Metabolic and nutritional - Frequent: edema, weight gain; Infrequent: alkaline phosphatase increased, dehydration, hypercholesteremia, hyperglycemia, hyperlipidemia, hypokalemia, SGOT (AST) increased, SGPT (ALT) increased, thirst; Rare: alcohol intolerance, bilirubinemia, BUN increased, creatinine increased, diabetes mellitus, glycosuria, gout, healing abnormal, hemochromatosis, hypercalcinuria, hyperkalemia, hyperphosphatemia, hyperuricemia, hypocholesteremia, hypoglycemia, hyponatremia, hypophosphatemia, hypoproteinemia, uremia.
Musculoskeletal system - Infrequent: arthritis, arthrosis, bone spurs, bursitis, leg cramps, myasthenia, tenosynovitis; Rare: bone pain, pathological fracture, muscle cramp, muscle spasms, musculoskeletal stiffness, myopathy, osteoporosis, osteosclerosis, plantar fasciitis, rheumatoid arthritis, tendon rupture.
Nervous system - Frequent: amnesia, confusion, depersonalization, hypesthesia, thinking abnormal, trismus, vertigo; Infrequent: akathisia, apathy, ataxia, circumoral paresthesia, CNS stimulation, emotional lability, euphoria, hallucinations, hostility, hyperesthesia, hyperkinesia, hypotonia, incoordination, libido increased, manic reaction, myoclonus, neuralgia, neuropathy, psychosis, seizure, abnormal speech, stupor, suicidal ideation; Rare: abnormal/changed behavior, adjustment disorder, akinesia, alcohol abuse, aphasia, bradykinesia, buccoglossal syndrome, cerebrovascular accident, feeling drunk, loss of consciousness, delusions, dementia, dystonia, energy increased, facial paralysis, abnormal gait, Guillain-Barre Syndrome, homicidal ideation, hyperchlorhydria, hypokinesia, hysteria, impulse control difficulties, motion sickness, neuritis, nystagmus, paranoid reaction, paresis, psychotic depression, reflexes decreased, reflexes increased, torticollis.
Respiratory system - Frequent: cough increased, dyspnea; Infrequent: asthma, chest congestion, epistaxis, hyperventilation, laryngismus, laryngitis, pneumonia, voice alteration; Rare: atelectasis, hemoptysis, hypoventilation, hypoxia, larynx edema, pleurisy, pulmonary embolus, sleep apnea.
Skin and appendages - Frequent: pruritus; Infrequent: acne, alopecia, contact dermatitis, dry skin, eczema, maculopapular rash, psoriasis, urticaria; Rare: brittle nails, erythema nodosum, exfoliative dermatitis, lichenoid dermatitis, hair discoloration, skin discoloration, furunculosis, hirsutism, leukoderma, miliaria, petechial rash, pruritic rash, pustular rash, vesiculobullous rash, seborrhea, skin atrophy, skin hypertrophy, skin striae, sweating decreased.
Special senses - Frequent: abnormality of accommodation, mydriasis, taste perversion; Infrequent: conjunctivitis, diplopia, dry eyes, eye pain, otitis media, parosmia, photophobia, taste loss; Rare: blepharitis, cataract, chromatopsia, conjunctival edema, corneal lesion, deafness, exophthalmos, eye hemorrhage, glaucoma, retinal hemorrhage, subconjunctival hemorrhage, hyperacusis, keratitis, labyrinthitis, miosis, papilledema, decreased pupillary reflex, otitis externa, scleritis, uveitis, visual field defect.
Urogenital system - Frequent: albuminuria, urination impaired; Infrequent: amenorrhea,* cystitis, dysuria, hematuria, kidney calculus, kidney pain, leukorrhea,* menorrhagia,* metrorrhagia,* nocturia, breast pain, polyuria, pyuria, prostatic disorder (prostatitis, enlarged prostate, and prostate irritability,* urinary incontinence, urinary retention, urinary urgency, vaginal hemorrhage,* vaginitis*; Rare: abortion,* anuria, breast discharge, breast engorgement, balanitis,* breast enlargement, endometriosis,* female lactation,* fibrocystic breast, calcium crystalluria, cervicitis,* orchitis,* ovarian cyst,* bladder pain, prolonged erection,* gynecomastia (male),* hypomenorrhea,* kidney function abnormal, mastitis, menopause,* pyelonephritis, oliguria, salpingitis,* urolithiasis, uterine hemorrhage,* uterine spasm,* vaginal dryness.*
* Based on the number of men and women as appropriate.

Postmarketing Reports
Adverse Events

Drug Interactions
There have been reports of elevated clozapine levels that were temporally associated with adverse events, including seizures, following the addition of venlafaxine. There have been reports of increases in prothrombin time, partial thromboplastin time, or INR when venlafaxine was given to patients receiving warfarin therapy.

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class


Physical and Psychological Dependence


DOSAGE AND ADMINISTRATION


OVERDOSAGE

Human Experience








Management of Overdosage





DOSAGE & ADMINISTRATION



Initial Treatment

Major Depressive Disorder
Clinical TrialsCLINICAL PHARMACOLOGY
PRECAUTIONS-General-Use in Patients with Concomitant Illness

Generalized Anxiety Disorder
Use in Patients with Concomitant IllnessPRECAUTIONS

Social Anxiety Disorder (Social Phobia)
Use in Patients with Concomitant IllnessPRECAUTIONS

Panic Disorder
Use in Patients with Concomitant IllnessPRECAUTIONS

Switching Patients from Venlafaxine Hydrochloride Tablets


Special Populations

Treatment of Pregnant Women During the Third Trimester
PRECAUTIONS

Patients with Hepatic Impairment
CLINICAL PHARMACOLOGY

Patients with Renal Impairment
CLINICAL PHARMACOLOGY

Elderly Patients


Maintenance Treatment

Clinical TrialsCLINICAL PHARMACOLOGY




Discontinuing Venlafaxine Hydrochloride Extended-Release Capsules
PRECAUTIONS

Switching Patients To or From a Monoamine Oxidase Inhibitor
CONTRAINDICATIONSWARNINGS

HOW SUPPLIED



  • ●     NDC 60505-3778-3, bottle of 30 capsules in unit of use package.
  • ●     NDC 60505-3778-9, bottle of 90 capsules in unit of use package.

  • ●     NDC 60505-3779-3, bottle of 30 capsules in unit of use package.
  • ●     NDC 60505-3779-9, bottle of 90 capsules in unit of use package.

  • ●     NDC 60505-3780-3, bottle of 30 capsules in unit of use package.
  • ●     NDC 60505-3780-9, bottle of 90 capsules in unit of use package.

STORAGE AND HANDLING



SPL MEDGUIDE

Antidepressant Medicines, Depression and Other Serious Mental Illnesses, and Suicidal Thoughts or Actions

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.
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:


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.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Venlafaxine Hydrochloride

Venlafaxine Hydrochloride

Venlafaxine Hydrochloride

Venlafaxine Hydrochloride CAPSULE, EXTENDED RELEASE

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-913(NDC:60505-3779)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
VENLAFAXINE HYDROCHLORIDE VENLAFAXINE 75 mg

Inactive Ingredients

Ingredient Name Strength
titanium dioxide
POWDERED CELLULOSE
GELATIN
ferric oxide red
ETHYLCELLULOSE (100 MPA.S)
HYPROMELLOSES
HYPROMELLOSE 2910 (6 MPA.S)

Product Characteristics

Color Size Imprint Code Shape
orange 20 mm EFFEXORXR;75 CAPSULE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-913-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020699 2012-03-14


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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