Venlafaxine Hydrochloride 150 mg/1
VENLAFAXINE HYDROCHLORIDE · CAPSULE, EXTENDED RELEASE · A-S Medication Solutions
Venlafaxine Hydrochloride is a capsule, extended release containing venlafaxine hydrochloride at 150 mg/1, taken oral. Manufactured by A-S Medication Solutions.
Key Facts
- Brand Name
- Venlafaxine Hydrochloride
- Generic Name
- VENLAFAXINE HYDROCHLORIDE
- NDC Code (Product)
50090-7323- Manufacturer
- A-S Medication Solutions
- Strength
- 150 mg/1
- Dosage Form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA214654
- Marketing Start
- 09/07/2022
Recall History
Caraco Pharmaceutical Laboratories, Ltd.
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Caraco Pharmaceutical Laboratories, Ltd.
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Caraco Pharmaceutical Laboratories, Ltd.
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Sun Pharma Global Inc.
Failed Dissolution Specifications; 12 month stability time point
Golden State Medical Supply Inc.
Failed Dissolution Specifications: Out-of-specification results in retained sample.
McKesson Packaging Services
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Aurobindo Pharma USA Inc
Failed Tablet/Capsule Specifications: Some bottles contain punctured, and/or clumped/melted capsules.
Osmotica Pharmaceutical Corp
Failed Dissolution Specification:12 hour time point at 18 months of product shelf life.
Zydus Pharmaceuticals (USA) Inc
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Zydus Pharmaceuticals USA Inc
Failed Tablet/Capsule Specifications: Pharmacist complaint of an excessive amount of broken and/or chipped tablets in the bottle.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Venlafaxine hydrochloride extended-release capsules are indicated in adults for the treatment of: Major Depressive Disorder (MDD) [see Clinical Studies (14.1) ] Generalized Anxiety Disorder (GAD) [see Clinical Studies (14.2) ] Social Anxiety Disorder (SAD) [see Clinical Studies (14.3) ] Panic Disorder (PD) [see Clinical Studies (14.4) ] Venlafaxine hydrochloride extended-release capsules are a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with: Major Depressive Disorder ( MDD ) ( 1 ) Generalized Anxiety Disorder ( GAD ) ( 1 ) Social Anxiety Disorder ( SAD ) ( 1 ) Panic Disorder ( PD ) ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Indication Starting Dose Target Dose Maximum Dose MDD ( 2.2 ) 37.5 to 75 mg/day 75 mg/day 225 mg/day GAD ( 2.3 ) 37.5 to 75 mg/day 75 mg/day 225 mg/day SAD ( 2.4 ) 75 mg/day 75 mg/day 75 mg/day PD ( 2.5 ) 37.5 mg/day 75 mg/day 225 mg/day Take once daily with food. Capsules should be taken whole; do not divide, crush, chew, or dissolve ( 2.1 ). When discontinuing treatment, reduce the dose gradually ( 2.10 , 5.7 ). Renal impairment: reduce the total daily dose by 25% to 50% in patients with renal impairment. Reduce the total daily dose by 50% or more in patients undergoing dialysis or with severe renal impairment ( 2.9 ). Hepatic impairment: reduce the daily dose by 50% in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment or hepatic cirrhosis, it may be necessary to reduce the dose by more than 50% ( 2.8 ). 2.1 General Administration Information Administer venlafaxine hydrochloride extended-release capsules as a single dose with food, either in the morning or in the evening at approximately the same time each day [see Clinical Pharmacology (12.3) ] . Swallow capsules whole with fluid. Do not divide, crush, chew,…
Contraindications
4 CONTRAINDICATIONS Venlafaxine hydrochloride extended-release capsules are contraindicated in patients: with known hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate or to any excipients in the formulation [see Adverse Reactions (6.2) ] . taking, or within 14 days of stopping, MAOIs (including the MAOIs linezolid and intravenous methylene blue) because of the risk of serotonin syndrome [see Dosage and Administration (2.11) , Warnings and Precautions (5.2) , and Drug Interactions (7.1) ] . Hypersensitivity to venlafaxine hydrochloride, desvenlafaxine succinate, or any excipients in the venlafaxine hydrochloride extended-release capsules formulation ( 4 ). Concomitant use of monoaminoxidase inhibitors (MAOIs) or within 14 days of discontinuing an MAOI ( 4 , 5.2 , 7.1 ).
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with Venlafaxine Hydrochloride Extended-Release Capsules Table 15: Clinically Important Drug Interactions with Venlafaxine Hydrochloride Extended-Release Capsules Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SNRIs, including venlafaxine hydrochloride extended-release capsules, with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of venlafaxine hydrochloride extended-release capsules is contraindicated in patients taking MAOIs, including MAOIs such as linezolid or intravenous methylene blue [see Dosage and Administration (2.11) , Contraindications (4) and Warnings and Precautions (5.2) ]. Other Serotonergic Drugs Clinical Impact Concomitant use of venlafaxine hydrochloride extended-release capsules with other serotonergic drugs (including other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St.John's Wort) increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when venlafaxine hydrochloride extended-release capsules is used concomitantly with other dr…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Hypersensitivity [see Contraindications (4) ] Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1) ] Serotonin Syndrome [see Warnings and Precautions (5.2) ] Elevated Blood Pressure [see Warnings and Precautions (5.3) ] Increased Risk of Bleeding [see Warnings and Precautions (5.4) ] Angle-Closure Glaucoma [see Warnings and Precautions (5.5) ] Activation of Mania/Hypomania [see Warnings and Precautions (5.6) ] Discontinuation Syndrome [see Warnings and Precautions (5.7) ] Seizure [see Warnings and Precautions (5.8) ] Hyponatremia [see Warnings and Precautions (5.9) ] Weight and Height Changes in Pediatric Patients [see Warnings and Precautions (5.10) ] Appetite Changes in Pediatric Patients [see Warnings and Precautions (5.11) ] Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.12) ] Sexual Dysfunction [see Warnings and Precautions (5.13) ] Most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo): nausea, somnolence, dry mouth, sweating, abnormal ejaculation…
Frequently Asked Questions
What is Venlafaxine Hydrochloride used for?
Venlafaxine Hydrochloride contains VENLAFAXINE HYDROCHLORIDE. It is a capsule, extended release taken oral. Consult your doctor for specific uses.
Is Venlafaxine Hydrochloride a controlled substance?
Venlafaxine Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Venlafaxine Hydrochloride?
The generic name for Venlafaxine Hydrochloride is VENLAFAXINE HYDROCHLORIDE. There are 6 other brand versions of VENLAFAXINE HYDROCHLORIDE.
What is the NDC code for Venlafaxine Hydrochloride 150 mg/1?
The NDC (National Drug Code) for Venlafaxine Hydrochloride 150 mg/1 is 50090-7323, listed by A-S Medication Solutions.