A. Menarini


Concise Prescribing Info
Dapoxetine HCl
Premature ejaculation in men 18-64 yr.
Dosage/Direction for Use
Adult (men) 18-64 yr Initially 30 mg approx 1-3 hr prior to sexual activity. Max: 60 mg approx 1-3 hr prior to sexual activity.
May be taken with or without food: Swallow whole w/ a full glass of water.
Hypersensitivity. Significant pathological cardiac conditions eg, heart failure (NYHA class II-IV), conduction abnormalities eg, AV block or sinus syndrome, ischemic heart or valvular disease; history of syncope, mania or severe depression. Concomitant treatment w/ MAOIs, thioridazine, SSRIs, SNRIs, TCAs, other medicinal/herbal products w/ serotonergic effects, potent CYP3A4 inhibitors. Moderate & severe hepatic impairment. Childn <18 yr.
Special Precautions
Not to be prescribed to men not been diagnosed w/ PE. Should not be used in men w/ erectile dysfunction who are using PDE5 inhibitors. Avoid use in patients w/ history of documented or suspected orthostatic hypotension. Increased risk of suicidal thinking & suicidality. Syncope or prodromal symptoms eg, dizziness or lightheadedness may occur. Underlying CV disease (eg, documented outflow obstruction, valvular heart disease, carotid stenosis & CAD). Not to be used in combination w/ recreational drugs w/ serotonergic activity eg, ketamine, methylenedioxymethamphetamine (MDMA), lysergic acid diethylamide (LSD) & w/ sedative properties eg, narcotics & benzodiazepines; alcohol. Patients taking vasodilators, moderate CYP3A4 inhibitors, potent CYP2D6 inhibitors. History of mania/hypomania or bipolar disorder. Discontinue use if symptoms of mania/hypomania or bipolar disorder, seizure & depression develops. Men w/ underlying signs & symptoms of depression should be evaluated prior to treatment. Not indicated for psychiatric disorders & not to be used in men w/ schizophrenia or suffering w/ co-morbid depression. Concomitant use w/ SSRIs, medicinal products affecting platelet function (eg, atypical antipsychotics & phenothiazines, acetylsalicylic acid, NSAIDs, antiplatelet agents) or anticoagulants (eg, warfarin). History of bleeding or coagulation disorders. Avoid abrupt discontinuation. Patients w/ raised IOP or at risk of angle-closure glaucoma. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Severe renal impairment. Pregnancy & lactation. 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, upper abdominal pain, dyspepsia, flatulence, stomach discomfort, abdominal distension, dry mouth; hyperhidrosis; erectile dysfunction; fatigue, irritability; increased BP.
Drug Interactions
Potential serious reactions w/ MAOIs. May inhibit metabolism of thioridazine. May lead to serotonin-associated effects w/ serotonergic medicinal/herbal products (including L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium & St. John's wort prep). CNS-active medicinal products (eg, antiepileptics, antidepressants, antipsychotics, anxiolytics, sedative hypnotics). Reduced clearance w/ CYP2D6, CYP3A4 & flavin monooxygenase 1 inhibitors. Increased exposure w/ potent (eg, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir & atazanavir) & moderate (eg, erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem) CYP3A4 inhibitors; potent CYP2D6 inhibitors. Possible reduced orthostatic tolerance w/ PDE5 inhibitors & α-adrenergic receptor antagonists. Increased plasma conc of desipramine & other drugs metabolized by CYP2D6. Decreased AUCinf of midazolam. Warfarin (chronic therapy). Increased somnolence & decreased alertness w/ ethanol.
ATC Classification
G04BX14 - dapoxetine ; Belongs to the class of other urologicals.
Priligy FC tab 30 mg
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