Desfoxine

Desfoxine

desvenlafaxine

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical
Concise Prescribing Info
Contents
Desvenlafaxine succinate monohydrate
Indications/Uses
Acute & maintenance treatment of major depressive disorder (MDD). Moderate to severe vasomotor symptoms (VMS) associated w/ menopause eg, hot flushes.
Dosage/Direction for Use
Adult MDD Recommended usual & maintenance dose: 50 mg once daily. May increase dose gradually at intervals of not <7 days. VMS associated w/ menopause Recommended dose: 100 mg once daily. Initially 50 mg daily for up to 7 days, & may adjust to the medicine before increasing to 100 mg daily. Hepatic impairment 50 mg once daily. Max: 100 mg daily. Moderate renal impairment (CrCl 30-50 mL/min) 50 mg once daily. Severe renal impairment (CrCl <30 mL/min) or ESRD 50 mg every other day.
Administration
May be taken with or without food: Take at approximately the same time each day. Swallow whole w/ fluid, do not divide/crush/chew/dissolve.
Contraindications
Hypersensitivity to desvenlafaxine succinate or venlafaxine HCl. Patient w/ concurrent or recent (ie, w/in 2 wk) therapy w/ MAOIs. Allow at least 2 wk between discontinuance of MAOI & treatment initiation, & at least 7 days between discontinuance of treatment & initiation of MAOI.
Special Precautions
Discontinue treatment immediately & concomitant serotonergic agents if signs of serotonin syndrome eg, mental status changes (agitation, hallucination, delirium, coma), autonomic instability (eg, tachycardia, labile BP, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (eg, tremor, rigidity, myoclonus, hyperreflexia), GI symptoms (eg, nausea, vomiting, diarrhea), &/or seizures arise. Discontinue treatment in patients w/ symptomatic hyponatremia. Monitor & closely observe for clinical worsening, suicidality, & unusual changes in behavior during initiation of therapy & dosage adjustment period. Monitor for suicide risks in patients w/ SNRIs regardless of indication. Control pre-existing HTN before treatment initiation & regulate BP monitoring. Increased risk of bleeding events; SIADH in elderly w/ concomitant use of diuretics. Patients w/ personal or family history of mania or hypomania; pre-existing HTN or other underlying conditions that may be compromised by increases in BP; elevated IOP or those at risk of angle-closure glaucoma; recent history of MI, unstable heart disease, uncontrolled HTN, tachyarrhythmias (eg, atrial fibrillation) or other CV/cerebrovascular conditions; seizure disorder; progressive dyspnea, cough, or chest discomfort. May cause mild pupillary dilation & can lead to episode of narrow-angle glaucoma. ILD & eosinophilic pneumonia. Gradually reduce dose & avoid abrupt discontinuation. Measure serum lipid conc during therapy. Serotonin syndrome may occur w/ other serotonergic agents (eg, triptans, TCAs, fentanyl, lithium, tramadol, buspirone, St. John's wort, tryptophan) or agents impairing serotonin metabolism (eg, MAOIs intended to treat psychiatric disorders, linezolid, methylene blue IV). Concurrent administration w/ aspirin, NSAIDs, warfarin, & other anticoagulants. Not recommended to give dose >100 mg daily in hepatic impairment. Pregnancy & lactation. Neonates exposed to SNRIs or SSRIs in 3rd trimester of pregnancy. Not for use in ped patients. Ped <18 yr. Elderly w/ reduced renal clearance.
Adverse Reactions
Hypersensitivity; decreased appetite, hyponatremia; insomnia, w/drawal syndrome, anxiety, nervousness, abnormal dreams, irritability, decreased libido, anorgasmia, depersonalization, abnormal orgasm, mania, hypomania, hallucination; headache, dizziness, somnolence, tremor, paraesthesia, attention disturbance, dysgeusia, syncope, extrapyramidal disorder, serotonin syndrome, convulsion; blurred vision, mydriasis; vertigo, tinnitus; tachycardia, palpitation; increased BP, hot flush, orthostatic hypotension, peripheral coldness; yawning, epistaxis; nausea, dry mouth, constipation, diarrhea, vomiting; hyperhidrosis, rash, alopecia, SJS, angioedema, photosensitivity reaction; musculoskeletal stiffness; urinary retention & hesitation, proteinuria; erectile & sexual dysfunction, delayed ejaculation, ejaculation disorder & failure; fatigue, asthenia, chills, feeling jittery; abnormal LFT, increased & decreased wt, increased blood cholesterol, triglycerides & prolactin.
Drug Interactions
Higher conc of drug metabolized by CYP2D6. Decreased conc of CYP2D6 metabolites. Lower exposure w/ drug metabolized by CYP3A4. Higher plasma conc w/ potent CYP3A4 inhibitors. Concomitant use w/ CNS-active drugs; MAOIs; serotonergic agents affecting serotonergic neurotransmitter system (including triptans, SSRIs, other SNRIs, lithium, sibutramine, fentanyl & its analogues, tramadol, dextromethorphan, tapentadol, meperidine, methadone, pentazocine or St. John's wort), drugs impairing serotonin metabolism (eg, MAOIs, including linezolid & methylene blue). Not recommended in concomitant use w/ serotonin precursors eg, tryptophan supplements. False +ve urine immunoassay screening tests for phencyclidine & amphetamine.
MIMS Class
Antidepressants
ATC Classification
N06AX23 - desvenlafaxine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Desfoxine XR-FC tab 50 mg
Packing/Price
4 × 7's
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