Devert-50/Devert-100

Devert-50/Devert-100

desvenlafaxine

Manufacturer:

Torrent Pharmaceuticals

Distributor:

Torrent
Concise Prescribing Info
Contents
Desvenlafaxine
Indications/Uses
Acute & maintenance treatment of major depressive disorder.
Dosage/Direction for Use
Adult 50 mg once daily, taken at approx same time each day. Max dose: 200 mg/day. Patient w/ severe renal impairment (CrCl 15-29 mL/min) or ESRD 50 mg every other day, moderate renal impairment (CrCl 30-50 mL/min) 50 mg every day. No additional doses after dialysis.
Administration
May be taken with or without food: Do not chew/open/crush tab.
Contraindications
Hypersensitivity to desvenlafaxine succinate or venlafaxine HCl. Combination w/ MAOI. Use of MAOI 7 days after stopping desvenlafaxine treatment or use of desvenlafaxine w/in 14 days after stopping MAOI treatment.
Special Precautions
Adequately screen patients if at risk of bipolar disorder prior to initiation of treatment. Not approved for use in treating bipolar depression. Reports of mania/hypomania activation; mydriasis; increases in BP; seizures; hyponatremia &/or SIADH; ILD & eosinophilic pneumonia (rare); dose-related elevations in fasting serum total cholesterol, LDL-C, & triglycerides. Can increase risk of bleeding events. Monitor & closely observe patients for clinical worsening, suicidality, & unusual changes in behavior, especially during initial few mth of course of drug therapy, or at times of dose changes. Monitor patient w/ raised IOP or those at risk of narrow/closed angle glaucoma. Regularly monitor BP. Consider measuring serum lipids during treatment. Patients w/ history of mania/hypomania; medical conditions that might be compromised by increased BP; history of seizures. Gradual reduction in dose rather than abrupt cessation is recommended whenever possible. Concomitant use of other serotonergic drugs (including SSRIs, SNRIs, & triptans), drugs which impair metabolism of serotonin (eg, MAOIs, including reversible MAOIs eg, linezolid & IV methylene blue), antipsychotics or other dopamine antagonists. Not recommended w/ serotonin precursors (eg, tryptophan supplements). May impair judgment, thinking or motor skills; caution w/ operating hazardous machinery, including automobiles. Dose escalation >100 mg/day is not recommended in patients w/ hepatic impairment. Exposure to SNRIs in mid to late pregnancy may increase risk of pre-eclampsia, & exposure to SNRIs near delivery may increase risk for postpartum hemorrhage. Use in pregnancy only if benefits outweigh possible risks. Reports of complications (including need for resp support, tube feeding or prolonged hospitalization) in neonates exposed to SNRIs or SSRIs late in the 3rd quarter. Decide whether to discontinue nursing or discontinue therapy, taking into account the importance of the drug to the mother. Not indicated for use in any ped population. Use in geriatric patients requires dose consideration due to possible reduced renal clearance.
Adverse Reactions
Insomnia; headache, dizziness, drowsiness; nausea, dry mouth; hyperhidrosis. Decreased appetite; w/drawal syndrome, anxiety, nervousness, abnormal dreams, irritability, decreased libido, anorgasmia; tremor, paresthesia, attention disorder, dysgeusia; blurred vision, mydriasis; vertigo, tinnitus; tachycardia, palpitations; increased BP, hot flushes, yawning; constipation, diarrhea, vomiting; rash; musculoskeletal stiffness; erectile dysfunction, delayed ejaculation; fatigue, asthenia, chills, feelings of nervousness; abnormal LFT, wt gain/loss.
Drug Interactions
Reports of adverse reactions w/ MAOIs. Risk of serotonin syndrome w/ other agents that affect 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 which impair metabolism of serotonin (eg, MAOIs, including linezolid & methylene blue) or serotonin precursors (eg, tryptophan supplements). Increased Cmax & AUC of CYP2D6 substrates (eg, desipramine, atomoxetine, dextromethorphan, metoprolol, nebivolol, perphenazine, & tolterodine) which may result to increased risk of toxicity of CYP2D6 substrate drug. Avoid alcohol consumption. Concomitant use w/ other CNS-active drugs. May have false +ve result on urine immunoassay screening test for phencyclidine & amphetamine.
MIMS Class
Antidepressants
ATC Classification
N06AX23 - desvenlafaxine ; Belongs to the class of other antidepressants.
Presentation/Packing
Form
Devert-100 CR tab 100 mg
Packing/Price
30's (P3,000/box)
Form
Devert-50 CR tab 50 mg
Packing/Price
30's (P2,250/box)