Desvenlafaxine 50 mg/1
Desvenlafaxine Succinate · TABLET, EXTENDED RELEASE · Bryant Ranch Prepack
Desvenlafaxine is a tablet, extended release containing desvenlafaxine succinate at 50 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.
Key Facts
- Brand Name
- Desvenlafaxine
- Generic Name
- Desvenlafaxine Succinate
- NDC Code (Product)
63629-7525- Manufacturer
- Bryant Ranch Prepack
- Strength
- 50 mg/1
- Dosage Form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204003
- Marketing Start
- 03/01/2017
Recall History
Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Pfizer Us Pharmaceutical Group
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg Pristiq.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Desvenlafaxine extended-release tablets are indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES (14)].
Dosage & Administration
2.1 General Instructions for Use The recommended dose for desvenlafaxine extended-release tablets is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. Desvenlafaxine extended-release tablets should be taken at approximately the same time each day. Tablets must be swallowed whole with fluid and not divided, crushed, chewed, or dissolved. In clinical studies, doses of 10 mg to 400 mg per day were studied. In clinical studies, doses of 50 mg to 400 mg per day were shown to be effective, although no additional benefit was demonstrated at doses greater than 50 mg per day and adverse reactions and discontinuations were more frequent at higher doses. The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment. When discontinuing therapy, gradual dose reduction is recommended whenever possible to minimize discontinuation symptoms [see DOSAGE AND ADMINISTRATION (2.5)and WARNINGS AND PRECAUTIONS (5.7)]. 2.2 Dosage Recommendations for Patients with Renal Impairment The maximum recommended dose in patients with moderate renal impairment (24-hr creatinine clearance [ClCr] = 30 to 50 mL/min, Cockcroft-Gaul…
Contraindications
Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine extended-release tablets formulation. Angioedema has been reported in patients treated with desvenlafaxine extended-release tablets [see ADVERSE REACTIONS (6.1)] . The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine extended-release tablets or within 7 days of stopping treatment with desvenlafaxine extended-release tablets is contraindicated because of an increased risk of serotonin syndrome. The use of desvenlafaxine extended-release tablets within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated [see DOSAGE AND ADMINISTRATION (2.7)and WARNINGS AND PRECAUTIONS (5.2)]. Starting desvenlafaxine extended-release tablets in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see DOSAGE AND ADMINISTRATION (2.8)and WARNINGS AND PRECAUTIONS (5.2)].
Drug Interactions
7.1 Drugs Having Clinically Important Interactions with Desvenlafaxine Extended-Release Tablets Table 8: Clinically Important Drug Interactions with Desvenlafaxine Extended-Release Tablets Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SSRIs and SNRIs including desvenlafaxine extended-release tablets with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of desvenlafaxine extended-release tablets is contraindicated: With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with desvenlafaxine extended-release tablets. Within 14 days of stopping an MAOI intended to treat psychiatric disorders. In a patient who is being treated with linezolid or intravenous methylene blue. [see DOSAGE AND ADMINISTRATION (2.7), CONTRAINDICATIONS (4)and WARNINGS AND PRECAUTIONS (5.2)]. Examples selegiline, tranylcypromine, isocarboxazid, phenelzine, linezolid, methylene blue Other Serotonergic Drugs Clinical Impact Concomitant use of desvenlafaxine extended-release tablets with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when desvenlafax…
Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the label. Hypersensitivity [see CONTRAINDICATIONS (4)] Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [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)] Interstitial Lung Disease and Eosinophilic Pneumonia [see WARNINGS AND PRECAUTIONS (5.10)] Sexual Dysfunction [see WARNINGS AND PRECAUTIONS (5.11)] 6.1 Clinical Studies Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. Patient Exposure Desvenlafaxine e…
Frequently Asked Questions
What is Desvenlafaxine used for?
Desvenlafaxine contains Desvenlafaxine Succinate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.
Is Desvenlafaxine a controlled substance?
Desvenlafaxine is not classified as a controlled substance by the DEA.
What is the generic name for Desvenlafaxine?
The generic name for Desvenlafaxine is Desvenlafaxine Succinate. There are 6 other brand versions of Desvenlafaxine Succinate.
What is the NDC code for Desvenlafaxine 50 mg/1?
The NDC (National Drug Code) for Desvenlafaxine 50 mg/1 is 63629-7525, listed by Bryant Ranch Prepack.