Pharmacological Class:
Serotonin and norepinephrine reuptake inhibitor.
Active Ingredient(s):
Desvenlafaxine 50mg, 100mg; ext-rel tabs.
Company
Par Pharmaceutical, Inc.
Indication(s):
Major depressive disorder.
Pharmacology:
The exact mechanism of the antidepressant action of Khedezla is unknown, but is thought to be related to the potentiation of serotonin and norepinephrine in the central nervous system, through inhibition of their reuptake.
Clinical Trials:
The efficacy of desvenlafaxine as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies, at doses of 50–400mg/day in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for major depressive disorder.
In the first study, patients received 100mg (n=114), 200mg (n=116), or 400mg (n=113) of desvenlafaxine once daily, or placebo (n=118). In a second study, patients received either 200mg (n=121) or 400mg (n=124) of desvenlafaxine once daily, or placebo (n=124). In two additional studies, patients received 50mg (n=150 and n=164) or 100mg (n=147 and n=158) of desvenlafaxine once daily, or placebo (n=150 and n=161).
Desvenlafaxine showed superiority over placebo as measured by improvement in the 17-item Hamilton Rating Scale for Depression (HAM-D17) total score in four studies and overall improvement, as measured by the Clinical Global Impressions Scale - Improvement (CGI-I) in three of the four studies. In studies directly comparing 50mg/day and 100mg/day, there was no suggestion of a greater effect with the higher dose. Adverse reactions and discontinuations were more frequent at higher doses.
Analyses of the relationships between treatment outcome and age and treatment outcome and gender did not suggest any differential responsiveness on the basis of these patient characteristics.
Legal Classification:
Rx
Adults:
Swallow whole. 50mg once daily. Moderate renal impairment: max 50mg/day. Severe renal impairment (CrCl <30mL/min), ESRD: max 50mg every other day. Do not give supplemental dose after dialysis. Moderate-to-severe hepatic impairment: max 100mg/day. Withdraw gradually.
Children:
Not established.
Contraindication(s):
Allow ≥14 days after MAOI discontinuance before starting desvenlafaxine; allow ≥7 days after desvenlafaxine discontinuance before starting an MAOI. Concomitant linezolid, IV methylene blue.
Warnings/Precautions:
Increased risk of suicidal thinking and behavior in children, adolescents, and young adults; monitor for clinical worsening or unusual changes. Monitor for emergence of serotonin syndrome; discontinue if occurs. Pre-existing hypertension. Monitor BP before and during treatment; consider dose reduction or discontinuation if elevated BP persists. Cardio- or cerebrovascular disease. Increased risk of bleeding events. Increased intraocular pressure or risk of angle-closure glaucoma; monitor. History of mania/hypomania. Severe renal dysfunction. Seizure disorder. Reeva luate periodically. Write ℞ for smallest practical amount. Elderly. Pregnancy (Cat.C; avoid in 3rd trimester). Nursing mothers: not recommended.
Interaction(s)
See Contraindications. Avoid alcohol, concomitant venlafaxine, other forms of desvenlafaxine. Increased risk of serotonin syndrome with other serotonergic drugs (eg, triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's Wort) or with drugs that impair serotonin metabolism (eg, MAOIs, linezolid, IV methylene blue). Increased risk of bleeding with concomitant NSAIDs, aspirin, anticoagulants; monitor. May be affected by CYP2D6 substrates.
Adverse Reaction(s)
Nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, specific male sexual dysfunction; rare: hyponatremia (esp. in elderly), interstitial lung disease, eosinophilic pneumonia, serotonin syndrome, mydriasis.
How Supplied:
Tabs—30, 90
LAST UPDATED:
10/22/2013
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