Priligy

Dapoxetine HCl

Premature ejaculation.

Adult men 18-64 yr 30 mg 1-3 hr prior to sexual activity. Max: 60 mg once daily.

May be taken with or without food: Swallow whole w/ a glass of water.

Hypersensitivity. Significant pathological cardiac conditions eg, heart failure NYHA class II-IV, conduction abnormalities eg, AV block or sick sinus syndrome, ischemic heart or valvular disease. History of mania or severe depression, syncope. Concomitant use w/ MAOI, thioridazine, SSRIs, serotonergic medicinal/herbal products or w/in 14 days of discontinuation. Concomitant treatment w/ potent CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir. Moderate & severe hepatic impairment.

Not to be used in men w/ erectile dysfunction & using PDE5 inhibitors. Not to be used in psychiatric disorders, schizophrenia & co-morbid depression. Syncope, dizziness, lightheadedness. Ensure to maintain adequate hydration. Avoid use in patients w/ history of documented or suspected orthostatic reaction. Perform orthostatic test & evaluate men w/ underlying signs & symptoms of depression prior to therapy. Poor CYP2D6 metabolizer. Major depressive disorder & other psychiatric disorders. Not to be used in patients w/ history of mania/hypomania or bipolar disorder. Avoid use in patients w/ unstable epilepsy. Monitor patients w/ controlled epilepsy. History of bleeding or coagulation disorders; documented outflow obstruction, valvular heart disease, carotid stenosis & CAD, raised IOP & risk of angle-closure glaucoma. Avoid abrupt w/drawal. Combination w/ recreational drugs, alcohol; concomitant use w/ moderate CYP3A4 inhibitors, potent CYP2D6 inhibitors, atypical antipsychotics & phenothiazines, ASA, NSAIDs, antiplatelets or anticoagulants, α-adrenergic receptor antagonists, nitrates, antiepileptics, antidepressants, antipsychotics, anxiolytics, sedative hypnotics. Mild to moderate renal impairment & not recommended in severe renal impairment. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. May affect ability to drive or operate machinery. Childn <18 yr. Elderly ≥65 yr.

Syncope & orthostatic hypotension. Dizziness, headache; nausea; diarrhoea, insomnia, fatigue.

Reduced clearance w/ CYP2D6, CYP3A4 & flavin monooxygenase I inhibitors. Increased C_max & AUC w/ ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, fluoxetine. Increased exposure by erythromycin, clarithromycin, fluconazole, amprenavir, fosamprenavir, aprepitant, verapamil, diltiazem. Reduced orthostatic tolerance & resulted in orthostatic hypotension w/ PDE5 inhibitors, α-adrenergic receptor antagonists. Increased C_max & AUC of desipramine. Deceased AUC_inf of midazolam. Bleeding abnormalities w/ SSRIs. Increased somnolence & significantly decreased self-rated alertness w/ ethanol.

Drugs for Erectile Dysfunction & Ejaculatory Disorders

G04BX14 - dapoxetine ; Belongs to the class of other urologicals.

B