Dapoxetine

Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) which increases the level of serotonin in the nervous system to increase the time taken to ejaculate and improve control over ejaculation. The mechanism of action of Dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre-and post synaptic receptors. Dapoxetine is rapidly absorbed with maximum plasma concentrations occurring approximately 1-2 hours after tablet intake. It has a rapid elimination with a terminal half life of approximately 19 hours.

• Premature ejaculation (men 18 to 64 years of age)

The mechanism of action of Dapoxetine in premature ejaculation is presumed to be linked to the inhibition of neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre-and post synaptic receptors. Dapoxetine is rapidly absorbed with maximum plasma concentrations occurring approximately 1-2 hours after tablet intake. It has a rapid elimination with a terminal half life of approximately 19 hours.

Dapoxetine inhibits neuronal reuptake of serotonin, increasing serotonin levels in the nervous system, which prolongs the time to ejaculation and improves control over ejaculation.

Adult (18-64 years): Initial dose 30 mg, taken approximately 1-3 hours before sexual activity. May be increased to 60 mg if needed. Maximum once every 24 hours. Review treatment after 4 weeks (6 doses) and at least every 6 months thereafter.

Take 1-3 hours before sexual activity, with or without food. Swallow the tablet whole, do not chew, crush or break it.

If you miss a dose of Dapoxetine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose. Do not double the dose.

Common: Headache, dizziness, drowsiness, nausea, vomiting, diarrhea, insomnia, dry mouth, fatigue, increased sweating, restlessness, erectile dysfunction (<4%), loss of libido (<1%).

May affect driving ability (drowsiness, dizziness, difficulty concentrating, blurred vision). Avoid alcohol. Caution in patients with history of seizures, depression, psychiatric disorders. Rise slowly due to orthostatic hypotension. Caution with PDE5 inhibitors and alpha-adrenergic receptor antagonists. Caution in patients with bleeding or coagulation disorders.

Hypersensitivity; significant cardiac conditions (heart failure NYHA II-IV, conduction abnormalities, ischemic heart disease, valvular disease); concomitant use with MAOIs or within 14 days of discontinuation; concomitant use with thioridazine or within 14 days of discontinuation; concomitant use with serotonergic medicinal/herbal products or within 14 days of discontinuation; moderate to severe hepatic impairment; children below 18 years; age 65 years and over (limited data).

Potential serious reactions with MAOIs; inhibits metabolism of thioridazine; risk of serotonergic effects with serotonergic agents; possible reduction of clearance with CYP2D6, CYP3A4 & FMO1 inhibitors; increased exposure with potent & moderate CYP3A4 inhibitors; possible reduced orthostatic tolerance with PDE5 inhibitors & alpha-blockers; caution with warfarin; avoid alcohol.

It is unsafe to consume alcohol with Dapoxetine (may increase dizziness, drowsiness, slow reflexes, syncope risk).

Dapoxetine is not indicated for use in women. Information regarding use during pregnancy is not available. Please consult your doctor.

Dapoxetine is not indicated for use in women. It is not known whether dapoxetine or its metabolites are excreted in human breast milk.

Should not be used in individuals below 18 years of age.

Safety and efficacy have not been established in patients aged 65 years and over (limited data).

Renal impairment: Caution is advised in mild or moderate renal impairment. Not recommended in severe renal impairment.

Hepatic impairment: Contraindicated in moderate and severe hepatic impairment.

No case of overdose has been reported. Up to 240 mg daily showed no unexpected adverse events. Symptoms of SSRI overdose may include somnolence, GI disturbances, tachycardia, tremor, agitation, and dizziness.

Store below 30°C, protected from light and moisture. Keep out of reach of children.

Dapoxetine