A. Menarini


Agencia Lei Va Hong


A. Menarini
Concise Prescribing Info
Dapoxetine HCl
Treatment of premature ejaculation (PE) in men 18-64 yr as an on-demand treatment before anticipated sexual activity. Patients must meet all the following criteria: an intravaginal ejaculatory latency time (IELT) 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; & a history of premature ejaculation in the majority of intercourse attempts over the prior 6 mth.
Dosage/Direction for Use
Adult men 18-64 yr Initially 30 mg, taken as needed approx 1-3 hr prior to sexual activity. If response is insufficient & patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, dose may be increased to a max 60 mg as needed 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 (AV block or sick sinus syndrome), significant ischemic heart disease, significant valvular disease, history of syncope. History of mania or severe depression. Concomitant treatment w/ MAOIs, thioridazine, SSRIs, serotonin-norepinephrine re-uptake inhibitors (SNRIs), TCAs or other medicinal/herbal products w/ serotonergic effects, potent CYP3A4 inhibitors. Moderate & severe hepatic impairment.
Special Precautions
Not intended for continuous daily use. Not for treatment of ejaculation-delaying effects in men w/o PE. Do not use in men w/ erectile dysfunction who are using PDE5 inhibitors. Risk of orthostatic hypotension; syncope w/ or w/o prodromal symptoms; bleeding abnormalities; withdrawal effects. Potential to lower seizure threshold. Patients w/ underlying CV disease; history of mania/hypomania or bipolar disorder; underlying signs & symptoms of depression; raised IOP or patients at risk of angle closure glaucoma. Not indicated for psychiatric disorders. Rare hereditary problems of galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption. Do not use in combination w/ recreational drugs or alcohol. Concomitant use w/ medicinal products w/ vasodilatation properties; moderate CYP3A4 inhibitors. Caution when increasing dose to 60 mg in patients concomitantly taking potent CYP2D6 inhibitors, or those known to be of CYP2D6 poor metabolizer genotype. Caution in mild or moderate renal impairment. Not recommended in patients w/ severe renal impairment. Minor or moderate influence on the ability to drive & use machines. Not indicated for use in women. Should not be used in childn <18 yr. Elderly ≥65 yr.
Adverse Reactions
Dizziness, headache; nausea. Insomnia, anxiety, agitation, restlessness, decreased libido, abnormal dreams; somnolence, attention disturbance, tremor, paraesthesia; blurred vision; tinnitus; flushing; sinus congestion, yawning; GI disturbances; hyperhidrosis; erectile dysfunction; fatigue, irritability; increased BP.
Drug Interactions
Potential serious reactions w/ MAOIs. Elevated levels of thioridazine. Risk of serotonin-associated effects w/ serotonergic medicinal/herbal products (including MAOIs, L-tryptophan, triptans, tramadol, linezolid, SSRIs, SNRIs, lithium & St. John's wort prep). Caution when co-administered w/ CNS-active medicinal products (eg, antiepileptics, antidepressants, antipsychotics, anxiolytics, sedative hypnotics). Possible reduction of clearance w/ CYP2D6, CYP3A4 & flavin monooxygenase 1 (FMO1) inhibitors. Increased exposure w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, grapefruit juice); 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. Increased plasma conc of desipramine & other drugs metabolized by CYP2D6. Decreased AUCinf of midazolam (CYP3A4 substrate). Caution w/ concomitant warfarin chronic therapy. Increased somnolence & decreased alertness w/ alcohol.
ATC Classification
G04BX14 - dapoxetine ; Belongs to the class of other urologicals.
Priligy FC tab 30 mg
Priligy FC tab 60 mg
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