venlafaxine hydrochloride, extended release 225 mg/1
venlafaxine hydrochloride, extended release · TABLET · Edenbridge Pharmaceuticals LLC.
venlafaxine hydrochloride, extended release is a prescription tablet containing venlafaxine hydrochloride, extended release at 225 mg/1, taken oral. Manufactured by Edenbridge Pharmaceuticals LLC..
Key Facts
- Brand Name
- venlafaxine hydrochloride, extended release
- Generic Name
- venlafaxine hydrochloride, extended release
- NDC Code (Product)
42799-963- Manufacturer
- Edenbridge Pharmaceuticals LLC.
- Strength
- 225 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA209193
- Drug Class
- Norepinephrine Uptake Inhibitors [MoA]; Serotonin Uptake Inhibitors [MoA]
- Marketing Start
- 03/15/2023
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.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
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 Tablets are a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for: Major Depressive Disorder (MDD) ( 1.1 ) Social Anxiety Disorder (SAD) ( 1.2 ) 1.1 Major Depressive Disorder Venlafaxine Hydrochloride Extended-Release Tablets are indicated for the treatment of major depressive disorder (MDD). Efficacy of venlafaxine in MDD was shown in both short-term trials and a longer-term trial in MDD [see Clinical Studies ( 14.1 )] . A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two-week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation. …
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Venlafaxine Hydrochloride Extended-Release Tablets should be administered in a single dose with food either in the morning or in the evening at approximately the same time each day. Each tablet should be swallowed whole with fluid and not divided, crushed, chewed, or placed in water. Initial Treatment ( 2.1 ) Indication Starting Dose Dose Increase Maximum Dose Major Depressive Disorder 75 mg/day (in some patients, 37.5 mg/day for 4-7 days) 75 mg/day increments at intervals of 4 days or longer 225 mg/day Social Anxiety Disorder 75 mg/day No benefit at higher doses 75 mg/day Venlafaxine Hydrochloride Extended-Release Tablets should be taken as a single daily dose with food in either the morning or evening at the same time each day. ( 2 ) Discontinuation: Gradual; individualized as necessary. ( 2.4 ) 2.1 Initial Treatment Major Depressive Disorder For most patients, the recommended starting dose for Venlafaxine Hydrochloride Extended-Release Tablets is 75 mg/day, administered in a single dose. In the clinical trials establishing the efficacy of venlafaxine hydrochloride extended-release capsules in moderately depressed outpatients, the initial dose of venla…
Contraindications
4 CONTRAINDICATIONS Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with venlafaxine hydrochloride extended-release tablets or within 7 days of stopping treatment with Venlafaxine Hydrochloride Extended-Release Tablets. Do not use venlafaxine hydrochloride extended-release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start venlafaxine hydrochloride extended-release tablets in a patient who is being treated with linezolid or intravenous methylene blue ( 4.1 ). 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with Venlafaxine Hydrochloride Extended-Release Tablets or within 7 days of stopping treatment with Venlafaxine Hydrochloride Extended-Release Tablets is contraindicated because of an increased risk of serotonin syndrome. The use of Venlafaxine Hydrochloride Extended-Release Tablets within 14 days of stopping, an MAOI intended to treat psychiatric disorders is also contraindicated [ see Dosage and Administration ( 2.6 ), and Warnings and Precautions ( 5.2 )] . Starting Venlafaxine Hydrochloride Extended-Release Tablets in a patient wh…
Drug Interactions
7 DRUG INTERACTIONS MAOIs: concomitant use contraindicated. ( 4 ) Avoid MAOIs 14 days before starting venlafaxine and 7 days after stopping venlafaxine. ( 5.2 ) Cimetidine: Caution in patients with pre-existing hypertension, in elderly patients and patients with hepatic dysfunction. ( 7.2 ) Haloperidol: Increase in haloperidol AUC and C max . ( 7.4 ) Ketoconazole: Increase in venlafaxine and O-desmethylvenlafaxine AUC and C max . Caution when using venlafaxine with substances that inhibit both CYP2D6 and CYP3A4. ( 7.7 ) Metoprolol: Possibly reduced blood pressure lowering effect despite increased metoprolol plasma levels. Caution should be exercised with co-administration of venlafaxine and metoprolol. ( 7.8 ) CNS-active drugs: Caution when using venlafaxine with such drugs. ( 7.10 ) Serotonergic drugs (e.g., triptans, SSRIs, other SNRIs, linezolid, lithium, tramadol, or St. John's Wort): Potential for serotonin syndrome. Careful patient observation advised. ( 7.10 ) Tryptophan supplements: Concomitant use not recommended. ( 7.10 ) 7.1 Alcohol A single dose of ethanol (0.5 g/kg) had no effect on the pharmacokinetics of venlafaxine or O‑desmethylvenlafaxine (ODV) when venlafaxine wa…
Adverse Reactions
6 ADVERSE REACTIONS Major Depressive Disorder - Adverse events in short-term studies that occurred in at least 5% of the patients receiving venlafaxine extended-release capsules and at a rate at least twice that of the placebo group were abnormal ejaculation, gastrointestinal complaints (nausea, dry mouth, and anorexia), CNS complaints (dizziness, somnolence, and abnormal dreams), and sweating. ( 6 ) Social Anxiety Disorder -Adverse events in short-term studies that occurred in at least 5% of the patients receiving venlafaxine extended-release capsules and at a rate at least twice that of the placebo group were asthenia, gastrointestinal complaints (anorexia, dry mouth, nausea), CNS complaints (anxiety, insomnia, libido decreased, nervousness, somnolence, dizziness), abnormalities of sexual function (abnormal ejaculation, orgasmic dysfunction, impotence), yawn, sweating, and abnormal vision. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Edenbridge Pharmaceuticals, LLC at 1-877-381-3336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Studies Experience Data Sources The information included in subsection "Adverse Findings Observed in Short-Term, Placebo-Control…
Frequently Asked Questions
What is venlafaxine hydrochloride, extended release used for?
venlafaxine hydrochloride, extended release contains venlafaxine hydrochloride, extended release. It is a tablet taken oral. Consult your doctor for specific uses.
Is venlafaxine hydrochloride, extended release a controlled substance?
venlafaxine hydrochloride, extended release is not classified as a controlled substance by the DEA.
What is the generic name for venlafaxine hydrochloride, extended release?
The generic name for venlafaxine hydrochloride, extended release is venlafaxine hydrochloride, extended release. There are no other listed brand versions of venlafaxine hydrochloride, extended release.
What is the NDC code for venlafaxine hydrochloride, extended release 225 mg/1?
The NDC (National Drug Code) for venlafaxine hydrochloride, extended release 225 mg/1 is 42799-963, listed by Edenbridge Pharmaceuticals LLC..
Other venlafaxine hydrochloride, extended release Dosages
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
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