Drugplain

Pristiq Extended-Release 25 mg/1

desvenlafaxine succinate · TABLET, EXTENDED RELEASE · Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.

No Recall History
Plain English

Pristiq Extended-Release is a tablet, extended release containing desvenlafaxine succinate at 25 mg/1, taken oral. Manufactured by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..

Key Facts

Brand Name
Pristiq Extended-Release
Generic Name
desvenlafaxine succinate
NDC Code (Product)
0008-1210
Manufacturer
Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Strength
25 mg/1
Dosage Form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
NDA021992
Marketing Start
04/01/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective2,423 reports
nausea2,209 reports
headache1,770 reports
dizziness1,754 reports
anxiety1,632 reports
fatigue1,494 reports
insomnia1,454 reports
feeling abnormal1,377 reports
depression1,220 reports
drug withdrawal syndrome1,010 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE PRISTIQ is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14) ] . PRISTIQ 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 PRISTIQ is 50 mg once daily, with or without food. The 50 mg dose is both a starting dose and the therapeutic dose. PRISTIQ 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…

Contraindications

4 CONTRAINDICATIONS • Hypersensitivity to desvenlafaxine succinate, venlafaxine hydrochloride or to any excipients in the PRISTIQ formulation. Angioedema has been reported in patients treated with PRISTIQ [see Adverse Reactions (6.1) ] . • The use of MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ is contraindicated because of an increased risk of serotonin syndrome. The use of PRISTIQ 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 PRISTIQ 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 PRISTIQ formulation ( 4 ). • Serotonin Syndrome and MAOIs : Do not use MAOIs intended to treat psychiatric disorders with PRISTIQ or within 7 days of stopping treatment with PRISTIQ. Do not use PRISTIQ within 14 d…

Drug Interactions

7 DRUG INTERACTIONS 7.1 Drugs Having Clinically Important Interactions with PRISTIQ Table 8: Clinically Important Drug Interactions with PRISTIQ Monoamine Oxidase Inhibitors (MAOI) Clinical Impact The concomitant use of SSRIs and SNRIs including PRISTIQ with MAOIs increases the risk of serotonin syndrome. Intervention Concomitant use of PRISTIQ is contraindicated: • With an MAOI intended to treat psychiatric disorders or within 7 days of stopping treatment with PRISTIQ. • 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 PRISTIQ with other serotonergic drugs increases the risk of serotonin syndrome. Intervention Monitor for symptoms of serotonin syndrome when PRISTIQ is used concomitantly with other drugs that may affect the serotonergic neurotransmitter systems. If serotonin syndrome occurs, consider discontinuation of PRISTIQ an…

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 (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 function disorders ( 6.1 ). To report SUSPECT…

Frequently Asked Questions

What is Pristiq Extended-Release used for?

Pristiq Extended-Release contains desvenlafaxine succinate. It is a tablet, extended release taken oral. Consult your doctor for specific uses.

Is Pristiq Extended-Release a controlled substance?

Pristiq Extended-Release is not classified as a controlled substance by the DEA.

What is the generic name for Pristiq Extended-Release?

The generic name for Pristiq Extended-Release is desvenlafaxine succinate. There are 10 other brand versions of desvenlafaxine succinate.

What is the NDC code for Pristiq Extended-Release 25 mg/1?

The NDC (National Drug Code) for Pristiq Extended-Release 25 mg/1 is 0008-1210, listed by Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc..

Product NDC

0008-1210

Package NDC

0008-1210-30

Other Pristiq Extended-Release Dosages

Other Desvenlafaxine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)