Pristiq

Pristiq

desvenlafaxine

Manufacturer:

Pfizer

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Desvenlafaxine
Indications/Uses
Dosage/Direction for Use
50 mg once daily. Adjust dose gradually at intervals not <7 days. Max: 200 mg daily. Moderate renal impairment (24-hr CrCl 30-50 mL/min) 50 mg daily. Severe renal impairment (24-hr CrCl <30 mL/min) or ESRD Initially 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.
Administration
May be taken with or without food: Take at the same time each day. Swallow whole, do not divide/crush/chew/dissolve tab.
Contraindications
Hypersensitivity to desvenlafaxine succinate or venlafaxine HCl. Concomitant use w/ MAOIs (eg, linezolid or methylene blue IV) or w/in at least 14 days of discontinuing treatment w/ MAOIs.
Special Precautions
Appropriately monitor & closely observe patients for clinical worsening, suicidality & unusual changes in behavior especially during the initial few mth of a drug therapy course or at times of dose changes. Not approved for use in treating bipolar depression; screen patients w/ depressive symptoms for risk of bipolar disorder prior to initiating treatment. Monitor 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. Immediately discontinue concomitant use w/ serotonergic or antidopaminergic agents including antipsychotics & initiate supportive symptomatic treatment if serotonin syndrome or NMS-like reactions occurs. Concomitant use w/ serotonin precursors (eg, tryptophan) is not recommended. Regularly monitor BP; control preexisting HTN before initiating treatment. Patients w/ underlying conditions that might be compromised by increased BP. May increase risk of bleeding events; concomitant use w/ aspirin, NSAIDs, warfarin & other anticoagulants. Monitor patients w/ raised IOP or those at risk of acute narrow-angle glaucoma. Patients w/ history or family history of mania or hypomania. Patients w/ recent history of MI, unstable heart disease, uncontrolled HTN or cerebrovascular disease. Consider measuring serum lipids during treatment. Monitor patients when discontinuing treatment; gradual dose reduction is recommended. Patients w/ seizure disorder. Consider discontinuation & institute appropriate medical intervention in patients w/ symptomatic hyponatremia. Not to be used concomitantly w/ other venlafaxine- or desvenlafaxine-containing products. Possible ILD & eosinophilic pneumonia. May cause sexual dysfunction symptoms. Carefully evaluate patients for history of drug abuse & observe for 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 (particularly during 3rd trimester due to risks & complications in exposed neonates) & lactation. Not indicated for use in childn <18 yr. Elderly.
Adverse Reactions
Insomnia; headache, dizziness, somnolence; nausea, dry mouth; hyperhidrosis. Decreased appetite; w/drawal syndrome, anxiety, nervousness, abnormal dreams, irritability, decreased libido, anorgasmia; tremor, paraesthesia, attention disturbance, dysgeusia; blurred vision, mydriasis; vertigo, tinnitus; tachycardia, palpitations; increased BP, hot flush; yawning; diarrhoea, vomiting, constipation; rash; musculoskeletal stiffness; erectile dysfunction, delayed ejaculation; fatigue, asthenia, chills, feeling jittery; abnormal LFT, increased/decreased wt.
Drug Interactions
Combination w/ other CNS-active drugs. Increased risk of serotonin syndrome w/ MAOIs, serotonergic drugs. May potentiate risk of bleeding w/ NSAIDs or aspirin; altered anticoagulant effects including increased bleeding w/ warfarin. 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. False +ve urine immunoassay screening test for phencyclidine & amphetamine.
MIMS Class
Antidepressants
ATC Classification
N06AX23 - desvenlafaxine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Pristiq XR tab 50 mg
Packing/Price
28's
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