Generic Name and Formulations:
Desvenlafaxine 50mg, 100mg; ext-rel tabs.

Company:
Par Pharmaceutical, Inc.
Indications for KHEDEZLA:
Major depressive disorder.

Adult Dose for KHEDEZLA:
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's Dose for KHEDEZLA:
Not established.

Pharmacological Class:
Serotonin and norepinephrine reuptake inhibitor.

Contraindications:
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.

Interactions:
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 Reactions:
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