Product Information
Registration Status: ActivePRILIGY TABLET 30MG is approved to be sold in Singapore with effective from 2010-09-11. It is marketed by A. MENARINI SINGAPORE PTE LTD, with the registration number of SIN13880P.
This product contains Dapoxetine 30mg in the form of TABLET, FILM-COATED. It is approved for ORAL use.
This product is manufactured by JANSSEN-ORTHO LLC in PUERTO RICO, andMENARINI - VON HEYDEN GmbH in GERMANY.
It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.
Description
Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.
Indication
For the treatment of premature ejaculation.
Mechanism of Action
The drug's mechanism of action is thought to be related to inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes (5-HT(1A), 5-HT(1B), and 5-HT(2C)) have been postulated to mediate 5-HT's modulating activity on ejaculation.
Pharmacokinetics
- Absorption
- Rapidly absorbed.
- Distribution
- Metabolism
- Elimination
Active Ingredient/Synonyms
Dapoxetina | Dapoxetinum | Dapoxetine |
Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.