Wonder

Wonder

dapoxetine

Manufacturer:

Kusum

Distributor:

JDS
Concise Prescribing Info
Contents
Dapoxetine
Indications/Uses
Premature ejaculation (PE) in adult men 18-64 yr who meet all of the following criteria: Intravag ejaculatory latency time of <2 min; persistent or recurrent ejaculation w/ minimal sexual stimulation before, on, or shortly after penetration & before the patient wishes; marked personal distress or interpersonal difficulty as a consequence of PE; poor control over ejaculation; history of PE in majority of intercourse attempts over the prior 6 mth.
Dosage/Direction for Use
Adult men 18-64 yr Initially 30 mg as needed approx 1-3 hr prior to sexual activity. Dose may be increased to max of 60 mg if response is insufficient. Max frequency: once every 24 hr.
Administration
May be taken with or without food. Swallow whole w/ at least a full glass of water to avoid bitter taste.
Contraindications
Hypersensitivity. Heart failure (NYHA class II-IV); conduction abnormalities eg, AV block or sick sinus syndrome; significant ischemic heart & valvular disease; history of syncope, mania or severe depression. Concomitant treatment w/ MAOIs; thioridazine; SSRIs, SNRIs, TCAs or other medicinal/herbal products w/ serotonergic effects (eg, L-tryptophan, triptans, tramadol, linezolid, lithium, St. John's wort), potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir). Moderate & severe hepatic impairment.
Special Precautions
Use only as on-demand treatment before anticipated sexual activity; do not use to delay ejaculation in men undiagnosed w/ PE. Not intended for continuous daily use. Not to be used in men w/ erectile dysfunction who are using PDE5 inhibitors; patients w/ history of mania/hypomania or bipolar disorder; psychiatric disorders (eg, schizophrenia) or co-morbid depression. Discontinue if seizure develops; avoid in patients w/ unstable epilepsy; carefully monitor patients w/ controlled epilepsy. Syncope or its prodromal symptoms eg, nausea, dizziness/lightheadedness & diaphoresis. Increased risk of adverse CV outcomes from syncope in patients w/ underlying CV diseases. Patients w/ history of bleeding or coagulation disorders; raised IOP or at risk of angle closure glaucoma. Orthostatic hypotension; avoid use in patients w/ history of documented or suspected orthostatic reaction; do not rise quickly after prolonged lying or sitting. Avoid abrupt w/drawal. Evaluate men w/ underlying signs & symptoms of depression prior to treatment to rule out undiagnosed depressive disorders. Not to be used in combination w/ recreational drugs. Avoid alcohol intake. Possible reduced orthostatic tolerance in concomitant use w/ medicines w/ vasodilation properties eg, α-adrenergic receptor antagonists & nitrates. Concomitant use w/ moderate CYP3A4 inhibitors (restrict dose at 30 mg), potent CYP2D6 inhibitors or in patients known to be CYP2D6 poor metabolizer genotype if dose is increased to 60 mg. Concomitant use w/ medicines known to affect platelet function (eg, atypical antipsychotics & phenothiazines, ASA, NSAIDs, anti-platelets) or anticoagulants (eg, warfarin). Mild to moderate renal impairment; not recommended in severe renal impairment. Not to be taken by patients w/ rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May influence ability to drive & use machines. Not to be used in childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
Dizziness, headache; nausea. Anxiety, agitation, restlessness, insomnia, abnormal dreams, decreased libido; somnolence, disturbance in attention, tremor, paraesthesia; blurred vision; tinnitus; flushing; sinus congestion, yawning; diarrhoea, vomiting, constipation, abdominal & upper abdominal pain, dyspepsia, flatulence, stomach discomfort, abdominal distension, dry mouth; hyperhidrosis; erectile dysfunction; fatigue, irritability; increased BP.
Drug Interactions
Serious reactions w/ MAOIs (do not use concomitantly w/ MAOIs or w/in 14 days of MAOI discontinuation; not to be administered w/in 7 days of dapoxetine discontinuation). Inhibits metabolism of thioridazine (resulting to augmented QTc interval prolongation; do not use concomitantly w/ dapoxetine or w/in 14 days of thioridazine discontinuation; do not administer w/in 7 days of dapoxetine discontinuation). May lead to incidence of serotonin-associated effects w/ serotonergic medicinal/herbal products (including MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium & St. John's wort prep) (do not use concomitantly w/ MAOIs or w/in 14 days of MAOI discontinuation; not to be administered w/in 7 days of dapoxetine discontinuation). Caution in use w/ CNS-active medicinal products eg, antiepileptics, antidepressants, antipsychotics, anxiolytics, sedative hypnotics. Clearance may be reduced w/ CYP2D6, CYP3A4 & flavin monooxygenase 1 inhibitors. Increased exposure w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir & atazanavir) & moderate CYP3A4 inhibitors (eg, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem); potent CYP2D6 inhibitors (eg, fluoxetine). Possible reduced orthostatic tolerance w/ PDE5 inhibitors; α-adrenergic receptor antagonists. Warfarin (chronic therapy) & other medicines that affect coagulation &/or platelet function. Increased somnolence & decreased alertness w/ ethanol.
MIMS Class
Drugs for Erectile Dysfunction & Ejaculatory Disorders
ATC Classification
G04BX14 - dapoxetine ; Belongs to the class of other urologicals.
Presentation/Packing
Form
Wonder FC tab 30 mg
Packing/Price
1 × 4's
Form
Wonder FC tab 60 mg
Packing/Price
1 × 4's
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