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TARO-VENLAFAXINE XR is a brand name for Venlafaxine, supplied as a capsule (extended release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TARO-VENLAFAXINE XR (venlafaxine hydrochloride extended-release capsules) is indicated for the symptomatic relief of: • Major depressive disorder. • Anxiety causing clinically significant distress in patients with generalized anxiety disorder (GAD). Anxiety or tension associated with the stress of everyday life…
Verbatim from this product's HC label. Tap a section to expand.
9 Discontinuation 11/2023 7 Warnings and Precautions 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 PART I: HEALTH PROFESSIONAL INFORMATION ...........................................................................
4 1 INDICATIONS ............................................................................................................................ 1 Pediatrics ................................................................................................................................
2 Geriatrics ................................................................................................................................ 4 2 CONTRAINDICATIONS ...............................................................................................................
4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................................... 5 4 DOSAGE AND ADMINISTRATION ...............................................................................................
1 Dosing Considerations ............................................................................................................ 2 Recommended Dose and Dosage Adjustment ........................................................................
4 Administration ........................................................................................................................ 5 Missed Dose............................................................................................................................
9 Discontinuation ............................................................................................................................. 8 5 OVERDOSAGE ...........................................................................................................................
9
2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. The adverse reaction rates observed in the clinical trials therefore, may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse reaction information from TARO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release Capsules) Page 24 of 81 clinical trials may be useful in identifying and approximating rates of adverse drug reactions in real-world use.
, incidence for immediate release formulation/venlafaxine hydrochloride extended- release capsules at least twice that for placebo), derived from the 2% incidence Table 4, were: Venlafaxine Immediate Release: asthenia, sweating, nausea, constipation, anorexia, vomiting, somnolence, dry mouth, dizziness, nervousness, anxiety, tremor, blurred vision, and abnormal ejaculation/orgasm and impotence in men.
Venlafaxine hydrochloride Extended-Release Capsules: abnormal dreams, anorexia, dizziness, dry mouth, nausea, nervousness, somnolence, sweating, and tremor as well as abnormal ejaculation/orgasm in men.
Incidence in Controlled Trials:
The table that follows (Table 4) enumerates adverse events that occurred at an incidence of 2% or more, and were more frequent than in the placebo group, among venlafaxine-treated depressed patients. Venlafaxine Immediate Release: patients participated in 4- to 8- week placebo-controlled trials in which doses in the range of 75 to 375 mg/day were administered.
Venlafaxine hydrochloride extended-release capsules: patients participated in 8- to 12-week placebo-controlled trials in which doses in the range of 75 to 225 mg/day were administered. Reported adverse events were classified using a standard COSTART-based Dictionary terminology.
, Psychiatric, Potential Association With Behavioural And Emotional Changes, Including Self-Harm). 2 Geriatrics Geriatrics (> 65 years of age): Caution should be exercised in treating geriatric patients. Evidence from clinical studies and experience suggests that use in the geriatric population is associated with no overall differences in effectiveness and safety compared to younger patients.
However, greater sensitivity of some older individuals cannot be ruled out. 2 CONTRAINDICATIONS TARO-VENLAFAXINE XR is contraindicated in patients: • Who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Taking concurrent monoamine oxidase inhibitors (MAOIs). 4 Drug-Drug Interactions). TARO-VENLAFAXINE XR should not be used within two weeks of terminating treatment with MAOIs.
Treatment with MAOIs should not be started until 2 weeks after discontinuation of TARO-VENLAFAXINE XR therapy. 4 Drug-Drug Interactions). Adverse reactions, some serious, have been reported when venlafaxine hydrochloride extended-release capsules therapy is initiated soon after discontinuing an MAOI and TARO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release Capsules) Page 5 of 81 when an MAOI is initiated soon after discontinuation of venlafaxine hydrochloride extended-release capsules.
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.
TARO-VENLAFAXINE XR is contraindicated in patients: • Who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
• Taking concurrent monoamine oxidase inhibitors (MAOIs). 4 Drug-Drug Interactions). TARO-VENLAFAXINE XR should not be used within two weeks of terminating treatment with MAOIs. Treatment with MAOIs should not be started until 2 weeks after discontinuation of TARO-VENLAFAXINE XR therapy.
4 Drug-Drug Interactions). Adverse reactions, some serious, have been reported when venlafaxine hydrochloride extended-release capsules therapy is initiated soon after discontinuing an MAOI and TARO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release Capsules) Page 5 of 81 when an MAOI is initiated soon after discontinuation of venlafaxine hydrochloride extended-release capsules.
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 hypothermia 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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Venlafaxine in Canada.
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The prescriber should be aware that the cited frequencies for venlafaxine hydrochloride extended-release capsules cannot be compared with figures obtained from other clinical investigations of venlafaxine tablets which involved different treatments, uses and investigators.
The cited figures for venlafaxine hydrochloride extended-release capsules, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and non-drug factors to the side effect incidence rate in the population studied.
Table 4:
Treatment-Emergent Adverse Experience Incidence in Placebo-Controlled Clinical Trials (Percentage)1 in Depressed Patients Body System/ Preferred Term Venlafaxine Immediate Release (n = 1033) Placebo (n = 609) Venlafaxine hydrochloride Extended- Release Capsules (n = 357) Placebo (n = 285) Body as a whole Headache 25 24 26 # 33 TARO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release Capsules) Page 25 of 81 Body System/ Preferred Term Venlafaxine Immediate Release (n = 1033) Placebo (n = 609) Venlafaxine hydrochloride Extended- Release Capsules (n = 357) Placebo (n = 285) Asthenia 12 6 8 7 Infection 6 5 6 # 9 Chills 3 <1 <1 1 Cardiovascular Vasodilatation 4 3 4 2 Increased blood pressure/hypertension 2 <1 4 1 Tachycardia 2 <1 <1 <1 Dermatological Sweating 12 3 14 3 Rash 3 2 1 1 Gastrointestinal Nausea 37 11 31 12 Constipation 15 7 8 5 Anorexia 11 2 8 4 Diarrhoea 8 7 8 # 9 Vomiting 6 2 4 2 Dyspepsia 5 4 7 # 9 Flatulence 3 2 4 3 Metabolic Weight loss 1 <1 3 0 Nervous Somnolence 23 9 17 8 Dry mouth 22 11 12 6 Dizziness 19 7 20 9 TARO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release Capsules) Page 26 of 81 Body System/ Preferred Term Venlafaxine Immediate Release (n = 1033) Placebo (n = 609) Venlafaxine hydrochloride Extended- Release Capsules (n = 357) Placebo (n = 285) Insomnia 18 10 17 11 Nervousness 13 6 10 5 Anxiety 6 3 2 # 5 Tremor 5 1 5 2 Abnormal Dreams 4 3 7 2 Hypertonia 3 2 1 0 Paraesthesia 3 2 3 1 Libido decreased 2 <1 3 <1 Agitation 2 <1 3 1 Depression 1 1 3 <1 Thinking abnormal 2 <1 <1 1 Respiration Pharyngitis 4 4 7 6 Yawn 3 0 3 0 Special Senses Abnormal vision 6 2 4 <1 Taste perversion 2 <1 1 <1 Urogenital system Abnormal ejaculation/ orgasm 122 <12 162 <12 Impotence 62 <1 2 42 <1 2 Anorgasmia <13 <1 3 33 <1 3 Urinary frequency 3 2 1 1 Urination impaired 2 <1 <1 0 1 Events reported by at least 2% of patients treated with venlafaxine immediate release/venlafaxine hydrochloride extended-release capsules are included, and are rounded to the nearest %.
Events for which TARO-VENLAFAXINE XR (Venlafaxine Hydrochloride Extended-Release Capsules) Page 27 of 81 the venlafaxine immediate release/venlafaxine hydrochloride extended-release capsules incidence was equal to or less than placebo included the following: abdominal pain, accidental injury, anxiety, back pain, bronchitis, diarrhea, dysmenorrhoea, dyspepsia, flu syndrome, headache, infection, pain, palpitation, rhinitis and sinusitis.
# Incidence greater than 2%, but active drug incidence less than incidence for placebo. 2 Incidence based on number of male patients (For venlafaxine immediate release: n = 439, Placebo: n = 245; For venlafaxine hydrochloride extended-release capsules: n = 126, Placebo: n = 108) 3 Incidence based on number of female patients (For venlafaxine immediate release: n = 594, Placebo: n = 364; For venlafaxine hydrochloride extended-release capsules: n = 231, Placebo: n = 177) Dose Dependency of Adverse Events: A comparison of adverse event rates in a fixed-dose study comparing venlafaxine immediate release tablets 75, 225, and 375 mg/day with placebo in depressed patients revealed a dose dependency for some of the more common adverse events associated with venlafaxine use, as shown in the table that follows (Table 5).
The rule for including events was to […]
Some cases presented with features resembling neuroleptic malignant syndrome. Severe hypothermia 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.
3 SERIOUS WARNINGS AND PRECAUTIONS BOX Increased risk of self-harm, harm to others, suicidal thinking and behavior with antidepressants use. Closely monitor all antidepressant-treated patients for clinical worsening and for emergence of agitation-type and/or suicidal thoughts and behaviors (see 7 WARNINGS AND PRECAUTIONS, Psychiatric, Potential Association With Behavioural And Emotional Changes, Including Self-Harm).
1 Pregnant Women). 2 Recommended Dose and Dosage Adjustment). • Long-term use of TARO-VENLAFAXINE XR: The physician who elects to use TARO- VENLAFAXINE XR for extended periods in the treatment of depression, GAD, social anxiety disorder, or panic disorder should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
2 Recommended Dose and Dosage Adjustment). • Switching Patients to or from a Monoamine Oxidase Inhibitor: TARO-VENLAFAXINE XR is contraindicated in patients taking concomitant MAOIs. At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with TARO-VENLAFAXINE XR.
In addition, at least 14 days should be allowed after stopping TARO-VENLAFAXINE XR before starting an MAOI (see 2 CONTRAINDICATIONS). 2 Recommended Dose and Dosage Adjustment Adults Major Depressive Disorder • The recommended dose for TARO-VENLAFAXINE XR is 75 mg/day, administered once daily with food, either in the morning or in the evening.
5 mg/day for 4-7 days to allow new patients to adjust to the medication before increasing to 75 mg/day. • Each capsule should be swallowed whole with water. It should not be divided, crushed, chewed, or placed in water. • While the relationship between dose and antidepressant response for venlafaxine hydrochloride extended-release capsules has not been adequately explored patients not responding to the initial 75 mg may benefit from dose increases.
Depending on tolerability and the need for further clinical effect, the dose should be increased by up to 75 mg/day up to a maximum of 225 mg/day as a single dose for moderately depressed outpatients. • Dose increments should be made at intervals of approximately 2 weeks or more, but not less than 4 days.
• There is very limited experience with venlafaxine hydrochloride extended-release capsules at doses higher than 225 mg/day, or in severely depressed inpatients. 5 mg/day administered as a single dose, taken with food, for 4-7 days.
• The usual dose is 75 mg/day administered as a single dose. • Subsequent dosage increments of up to 75 mg/day may be considered, if clinically warranted. • Dose increments should be made as needed […]