Desvenlafaxine Succinate 50 mg/1
Desvenlafaxine Succinate · TABLET, FILM COATED, EXTENDED RELEASE · Lupin Pharmaceuticals, Inc.
Desvenlafaxine succinate is a prescription antidepressant medication used to treat major depressive disorder. It comes as an extended-release tablet taken by mouth.
Key Facts
- Brand Name
- Desvenlafaxine Succinate
- Generic Name
- Desvenlafaxine Succinate
- NDC Code (Product)
68180-592- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 50 mg/1
- Dosage Form
- TABLET, FILM COATED, EXTENDED RELEASE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204172
- Marketing Start
- 03/01/2017
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Desvenlafaxine extended-release tablet is indicated for the treatment of adults with major depressive disorder (MDD) [see CLINICAL STUDIES ( 14 )]. Desvenlafaxine extended-release tablet, is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of adults with major depressive disorder (MDD) ( 1 ).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION • Recommended dose: 50 mg once daily with or without food ( 2.1 ). • There was no evidence that doses greater than 50 mg per day confer any additional benefit ( 2.1 ). • The 25 mg per day dose is intended for a gradual reduction in dose when discontinuing treatment or dosing in severe renal and end-stage renal disease patients ( 2.1 ). • Discontinuation: Reduce dose gradually whenever possible ( 2.1 ). • Take tablets whole; do not divide, crush, chew, or dissolve ( 2.1 ). • Moderate renal impairment: Maximum dose 50 mg per day ( 2.2 ). • Severe renal impairment and end-stage renal disease: Maximum dose 25 mg per day or 50 mg every other day ( 2.2 ). • Moderate to severe hepatic impairment: Maximum dose 100 mg per day ( 2.3 ). 2.1 General Instructions for Use The recommended dose for desvenlafaxine extended-release tablets are 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 40…
Contraindications
4 CONTRAINDICATIONS • Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the desvenlafaxine formulation. Angioedema has been reported in patients treated with desvenlafaxine [see ADVERSE REACTIONS ( 6.1 )]. • The use of MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of stopping treatment with desvenlafaxine is contraindicated because of an increased risk of serotonin syndrome. The use of desvenlafaxine 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 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 )]. • Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or any excipients in the desvenlafaxine formulation ( 4 ). • Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with desvenlafaxine or within 7 days of st…
Drug Interactions
7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with Desvenlafaxine Table 8: Clinically Important Drug Interactions with Desvenlafaxine Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SSRIs and SNRIs including desvenlafaxine with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of desvenlafaxine is contraindicated: ● With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with desvenlafaxine. ● 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 with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when desvenlafaxine is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin sy…
Adverse Reactions
6 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 [see WARNINGS AND PRECAUTIONS ( 5.11 )] Most common adverse reactions (incidence ≥5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual fu…
Frequently Asked Questions
What is Desvenlafaxine Succinate used for?
Desvenlafaxine succinate is a prescription antidepressant medication used to treat major depressive disorder. It comes as an extended-release tablet taken by mouth.
Is Desvenlafaxine Succinate a controlled substance?
Desvenlafaxine Succinate is not classified as a controlled substance by the DEA.
What is the generic name for Desvenlafaxine Succinate?
The generic name for Desvenlafaxine Succinate is Desvenlafaxine Succinate. There are 8 other brand versions of Desvenlafaxine Succinate.
What is the NDC code for Desvenlafaxine Succinate 50 mg/1?
The NDC (National Drug Code) for Desvenlafaxine Succinate 50 mg/1 is 68180-592, listed by Lupin Pharmaceuticals, Inc..