Pristiq

Major depressive disorder.

50 mg once daily. May increase dose gradually at intervals not <7 days. Max daily dose: 200 mg. Moderate renal impairment (24-hr CrCl 30-50 mL/min) 50 mg daily. Severe renal impairment (24-hr CrCl <30 mL/min) or ESRD 50 mg every other day. Supplemental doses should not be given to patient after dialysis. Hepatic impairment 50 mg daily. Dose escalation >100 mg daily is not recommended.

May be taken with or without food: Take at the same time each day. Swallow whole, do not divide/crush/chew/dissolve tab.

Hypersensitivity to desvenlafaxine succinate or venlafaxine HCl. Concomitant use w/ MAOIs or w/in at least 14 days of discontinuing treatment w/ MAOIs. Increased risk of serotonin syndrome w/ reversible MAOIs (eg, linezolid or methylene blue IV).

Appropriately monitor & closely observe patients for clinical worsening & suicidality; unusual changes in behavior especially when initiating therapy or during changes in dosage regimen. Not approved for use in treating bipolar depression; screen patients w/ depressive symptoms for risk of bipolar disorder prior to initiating treatment. Systematically & prospectively evaluate discontinuation symptoms in patients treated w/ Pristiq; gradual dose reduction is recommended rather than abrupt cessation. May cause sexual dysfunction symptoms. Patients w/ history or family history of mania/hypomania. Monitor for emergence of serotonin syndrome or NMS-like signs & symptoms. Carefully observe patients due to potential increased risk for serotonin syndrome particularly during treatment initiation & dose increases when used concomitantly w/ other serotonergic drugs including triptans, TCAs, opioids (eg, fentanyl, tramadol), lithium, buspirone, amphetamines, tryptophan & St. John's wort. Concomitant use w/ serotonin precursors (eg, tryptophan) is not recommended. Immediately discontinue concomitant use w/ serotonergic or antidopaminergic agents including antipsychotics & initiate supportive symptomatic treatment if serotonin syndrome or NMS-like reactions occur. Monitor patients w/ raised IOP or those at risk of acute narrow-angle glaucoma. Not to be used concomitantly w/ products containing venlafaxine HCl or desvenlafaxine succinate. Patients w/ underlying conditions that might be compromised by increased BP; regularly monitor BP. Patients w/ CV, cerebrovascular or lipid metabolism disorders; those w/ recent history of MI, unstable heart disease, uncontrolled HTN or cerebrovascular disease. Consider measuring serum lipids during treatment. Patients w/ seizure disorder. May increase risk of bleeding events; concomitant use w/ aspirin, NSAIDs, warfarin & other anticoagulants. Consider discontinuation & institute appropriate medical intervention in patients w/ symptomatic hyponatremia. Possible ILD & eosinophilic pneumonia. Carefully evaluate patients for history of drug abuse & observe signs of misuse/abuse of Pristiq. Patients operating hazardous machinery including automobiles; may impair judgment, thinking or motor skills. Doses should not be escalated in patients w/ moderate or severe renal impairment or ESRD. Pregnancy & lactation. Not indicated for childn <18 yr. Elderly.

Insomnia; headache, dizziness, somnolence; nausea, dry mouth; hyperhidrosis. Decreased appetite; w/drawal syndrome, anxiety, nervousness, abnormal dreams, irritability, decreased libido, anorgasmia; tremor, paresthesia, attention disturbance, dysgeusia; blurred vision, mydriasis; vertigo, tinnitus; tachycardia, palpitations; increased BP, hot flush; yawning; diarrhea, vomiting, constipation; rash; musculoskeletal stiffness; erectile dysfunction, delayed ejaculation; fatigue, asthenia, chills, feeling jittery; abnormal LFT, increased/decreased wt.

Combination w/ other CNS-active drugs. Concomitant use w/ agents that may affect serotonergic neurotransmitter system including triptans, SSRIs, other SNRIs, amphetamines, lithium, sibutramine, opioids (eg, fentanyl & its analogs, tramadol, dextromethorphan, tapentadol, meperidine, methadone, pentazocine) or St. John's wort; drugs that impair serotonin metabolism eg, MAOIs including linezolid & methylene blue or w/ serotonin precursors (eg, tryptophan supplements). Avoid alcohol consumption. Exposure may be increased by potent CYP3A4 inhibitors (eg, ketoconazole). May increase conc of CYP2D6-metabolized drugs (eg, desipramine) & decrease conc of its CYP2D6 metabolites. May decrease exposure of CYP3A4-metabolized drugs (eg, midazolam). Increased AUC of tamoxifen & aripiprazole. May potentiate risk of bleeding w/ NSAID or aspirin; altered anticoagulant effects including increased bleeding w/ warfarin. Possible false +ve urine immunoassay screening tests for phencyclidine & amphetamine.

Antidepressants

N06AX23 - desvenlafaxine ; Belongs to the class of other antidepressants.

POM