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DESVENLAFAXINE Succinate Extended Release Tablets (GREENSTONE LLC)

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DESVENLAFAXINE Succinate Extended Release Tablets (GREENSTONE LLC) Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show...

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1 INDICATIONS AND USAGE

Desvenlafaxine is indicated for the treatment of adults with major depressive disorder (MDD) [see Clinical Studies (14)].

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2 DOSAGE AND ADMINISTRATION

2.1 General Instructions for Use

The recommended dose for desvenlafaxine is 50 mg once daily, with or without food. The 50 mg dose is both...

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3 DOSAGE FORMS AND STRENGTHS

  • 25 mg Tablet: tan, square pyramid tablet debossed with "W" over "25" on the flat side
  • 50 mg Tablet: light pink, square pyramid tablet debossed with "W" over "50" on the flat side...
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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...
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5 WARNINGS AND PRECAUTIONS

5.1 Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients

Patients with MDD, both adult and pediatric, may experience...

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6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label.

  • Hypersensitivity [see

    6.1 Clinical Studies Experience...

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7 DRUG INTERACTIONS

7.1 Drugs Having Clinically Important Interactions with Desvenlafaxine

Table 8: Clinically Important Drug Interactions with...
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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Pregnancy Exposure Registry

There is...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Desvenlafaxine is not a controlled substance.

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10 OVERDOSAGE

10.1 Human Experience with Overdosage

There is limited clinical trial experience with desvenlafaxine succinate overdosage in humans. However,...

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11 DESCRIPTION

Desvenlafaxine is an extended-release tablet for oral administration that contains desvenlafaxine succinate, a structurally novel SNRI for the treatment of MDD. Desvenlafaxine (O-desmethylvenlafaxine) is the...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

The exact mechanism of the antidepressant action of desvenlafaxine is unknown, but is thought to be related to the...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

Major Depressive Disorder

The efficacy of desvenlafaxine as a treatment for depression was established in four 8-week...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Desvenlafaxine Extended-Release Tablets are available as follows:

25 mg, tan, square pyramid tablet debossed with "W" (over) "25" on the flat side

 
NDC 59762-...
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MEDICATION GUIDE
Desvenlafaxine Succinate
Extended-Release Tablets
This Medication Guide has been approved by the U.S. Food and Drug Administration....
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