Xtreme

Premature ejaculation

May be taken with or without food. Swallow tab whole & take w/ a full glass of water.

Oral Premature Ejaculation Adult: 18-64 yr Initially, 30 mg approx 1-3 hr before sexual activity, subsequent doses adjusted according to response. Max: 60 mg. Dose should not be taken more than once in 24 hr. Review treatment after 4 wk (6 doses) and at least 6 mthly thereafter. Hepatic Impairment: Moderate to severe: Contraindicated.

Patients with Renal Impairment: No dose adjustment is required but caution is advised in patients with mild or moderate renal impairment. Dapoxetine is not recommended for use in the patients with severe renal impairment.

Known hypersensitivity to dapoxetine HCl or to any of the excipients. Patients with significant pathological cardiac conditions [eg, heart failure (NYHA class II-IV), conduction abnormalities (2nd- or 3rd-degree AV block or sick sinus syndrome) not treated with a permanent pacemaker, significant ischemic heart disease or significant valvular disease]. Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with a MAOI. Similarly, a MAOI should not be administered within 7 days after Dapoxetine has been discontinued. Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine. Similarly, thioridazine should not be administered within 7 days after Dapoxetine has been discontinued. Concomitant treatment with serotonin re-uptake inhibitors [selective serotonin re-uptake inhibitors (SSRIs), serotonin-norepinephrine re-uptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products. Similarly these medicinal/herbal products should not be administered within 7 days after Dapoxetine has been discontinued.

Dapoxetine selectively inhibits the reuptake of serotonin. It has limited direct action at other neurotransmitter sites including muscarinic receptors.

General: Dapoxetine is only indicated in men with PE. Safety has not been established and there are no data on the ejaculation-delaying effects in men without PE. Use with Recreational Drugs: Patients should be advised not to use Dapoxetine in combination with recreational drugs. Recreational drugs with serotonergic activity eg, ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD) may lead to potentially serious reactions if combined with Dapoxetine. These reactions include, but are not limited to, arrhythmia, hyperthermia and serotonin syndrome. Use of Dapoxetine with recreational drugs with sedative properties eg, narcotics and benzodiazepines may further increase somnolence and dizziness. Ethanol: Combining alcohol with Dapoxetine may increase alcohol-related neurocognitive effects and may also enhance neurocardiogenic adverse events eg, syncope, thereby increasing the risk of accidental injury; therefore, patients should be advised to avoid alcohol while taking Dapoxetine. Possibly prodromal symptoms eg, nausea, dizziness/lightheadedness and diaphoresis were reported more frequently among patients treated with Dapoxetine compared to placebo. Orthostatic Hypotension: An orthostatic test should be performed before initiating therapy. In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine should be avoided. Dapoxetine is not indicated for psychiatric disorders and should not be used in men with these disorders eg, schizophrenia, or in those suffering with co-morbid depression, as worsening of symptoms associated with depression cannot be excluded. Withdrawal Effects: Abrupt discontinuation of chronically administered SSRIs used to treat chronic depressive disorders has been reported to result in the following symptoms: Dysphoric mood, irritability, agitation, dizziness, sensory disturbances (eg, paresthesias, electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia and hypomania.

Syncope characterized as loss of consciousness has been reported.The majority of cases occurred during the first 3 hrs after dosing, after the 1st dose or associated with study-related procedures in the clinic setting (eg, blood draw and orthostatic maneuvers and blood pressure measurements). Prodromal symptoms often preceded the syncope. Orthostatic hypotension has been reported in clinical trials. The most common adverse drug reactions (5%) reported during clinical trials were headache, dizziness, nausea, diarrhea, insomnia and fatigue. The most common events leading to discontinuation were nausea and dizziness.

Potential serious reactions w/ MAOIs. Inhibits metabolism of thioridazine. Risk of serotonergic-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. Possible reduction of 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/ PDE-5 inhibitors & ?-adrenergic receptor antagonists. Increases plasma conc of desipramine & other drugs metabolized by CYP2D6. Decreases AUCinf of midazolam. Warfarin (chronic therapy). Alcohol.