dapoxetine Tablets, film coated 30 mg

Dossier type
Dossier status
Ready to file
Country of origin
Saudi Arabia
GMP approvals
Saudi Arabia
Manufacturer #20796

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Dapoxetine is used for the treatment of premature ejaculation (PE) in men 18–64 years old. Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and therefore promoting ejaculatory delay. It is part of the selective serotonin reuptake inhibitor (SSRI) family of medicines. Dapoxetine was created as an antidepressant but it differs from other SSRIs, in that it is absorbed and eliminated rapidly in the body. Its key advantage is the fast-acting property, which makes it ideally suited for the treatment of PE but not as an antidepressant.
Dapoxetine is sold under the brand name Priligy amongst others. The USA-based Furiex Pharmaceuticals reached an agreement with ALZA Corp and Janssen Pharmaceutica in May 2012 to market Dapoxetine in the USA, Japan and Canada, while Menarini bought the selling the rights to market in Europe, Africa, Latin America and Middle East.
Eli Lilly pharmaceutical company created Dapoxetine. However, later it was sold to Johnson & Johnson in 2003 and submitted a new drug application to the FDA for the treatment of premature ejaculation in 2004. It is sold in several European and Asian countries and Mexico.

Forms and dose:

In preventing Premature Ejaculation in Adult men aged 18 to 64 years, the recommended starting dose is 30 mg, taken as needed. Note that the drug should be taken approximately 1 to 3 hours before sexual activity. This medicine is not for continuous daily use and used only when sexual activity is anticipated. Do not take it more frequently than once a day. The doctors will conduct an appraisal of individual benefit-risk after the first four weeks or 6 doses of treatment.

The price of Dapoxetine:

In the USA, the consumers have to pay around USD09 for a supply of 1mL for injection. Where the supply of 25mg tablets costs USD 70, 50mg cost USD 120 and the price of 100mg is USD 210 for a month’s supply. In India, the prices are significantly lower at 6 tablets of 30mg costing as low as USD 2.

How does Dapoxetine work?

Dapoxetine is a potent selective serotonin reuptake inhibitor (SSRI), much higher than its major human metabolites, desmethyldapoxetine and didesmethyldapoxetine. Ejaculation is caused by the sympathetic nervous system. Originating in the ejaculatory pathway, this spinal reflex centre is mediated by the brain stem. This is influenced initially by nuclei in the brain called medial preoptic and paraventricular nuclei. Dapoxetine inhibits the neuronal reuptake of serotonin and the subsequent potentiation of the neurotransmitter's action at pre- and postsynaptic receptors.

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