Sidalip Force (Pink Crystal)

This product is suitable for the treatment of premature ejaculation (PE) and erectile dysfunction (ED) in men aged 18 to 64 years old.

Composition:

Each film coated tablet contains

Sildenafil Citrate USP

120 mg

Eq. to Sildenafil

Dapoxetine Hydrochloride

Eq. to Dapoxetine

120 mg.

Excipients

q.s.

Colour: Erythrosine

PHARMACOLOGICAL CLASSIFICATION:

Sildenafil-Erectile dysfunction Dapoxetine-Premature ejaculation

PHARMACODYNAMICS/PHARMACOKINETICS:

Pharmacodynamics:

Sildenafil + Dapoxetine is a combination of two medicines: Sildenafil and Dapoxetine, which treatsmale erectile dysfunction and premature ejaculation. Sidenafil is a phosphodiesterase type 5 (PDE 5) Inhibitor which works by increasing blood flow to the penis during sexual stimulation and enables its erection following sexual stimulation. Dapoxetine is a selective serotonin reuptake inhibitor (SSRI) which increases the level of serotonin in nerves to increase the time taken to ejaculate and improve control over ejaculation.

Pharmacokinetics:

Sildenafil

Sildenafil is rapidly absorbed. Maximum observed plasma concentrations are reached within 30 to 120 minutes (median 60 minutes) of oral dosing in the fasted state.

The mean steady state volume of distribution for sildenafil is 1051, indicating distribution into the tissues. After a single oral dose of 100 mg, the mean maximum total plasma concentration of sildenafil. is approximately 440 ng/ml The total body clearance of sildenafil is 41 Uh with a resultant terminal phase half life of 3-5h.

Dapoxetine

Dapoxetine is rapidly absorbed with maximum plasma concentrations occurring approximately 1-2 or tablet intake. The absolute bioavailability is 42%. hours after t More than 99% of Dapoxetine is bound to human serum proteins.

The metabolites of Dapoxetine were primarily eliminated in the urine as conjugates. Unchanged active substance was not detected in the urine.

INDICATIONS: Sildenafil & Dapoxetine tablet is used in the treatment of erectile dysfunction and premature ejaculation.

RECOMMENDED DOSE:

The recommended dose is 1 tablet taken as needed approximately one hour before sexual activity. Do not take it more than once every 24 hours or every day.

MODE OF ADMINISTRATION: Tablet for oral administration

CONTRA-INDICATIONS: Hypersensitivity to Sildenafil/dapoxetine or of any of the constituents in the product.

WARNING AND PRECAUTION:

Amedical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underfying causes, before pharmacological treatment is considered. Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable (eg. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure).

Sildenafil should not be used in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDES inhibitor exposure.

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