Extra Super Vardalast (White Dragon Horse)

How Vardenafil works Vardenafil is a phosphodiesterase (PDE-5) inhibitor. It works in erectile dysfunction by increasing blood flow to the penis by relaxing the muscles in penile blood vessels. It helps to get an erection only if the person is sexually stimulated.

NAME AND STRENGTH OF ACTIVE INGREDIENT(S):

Each film coated tablet contains:

Vardenafil

40 mg

Dapoxetine Hydrochloride

Eqv. to Dapoxetine

100 mg

Colours: Red Oxide of Iron & Titanium Dioxide

PHARMACOLOGICAL CLASSIFICATION:

Urologicals Urologicals, Drugs used in erectile dysfunction (Vardenafil) & Other Urologicals – Premature Ejaculation (Dapoxetine)

PHARMACODYNAMICS/PHARMACOKINETICS:

Pharmacodynamics:

Vardenafil is an oral therapy for the improvement of erectile function in men with erectile dysfunction. In the natural Setting, i.e., with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis.

Dapoxetine is a short-acting medication for the treatment of premature ejaculation in men.

Pharmacokinetics:

Vardenafil:

Absorption:

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

Distribution:

The mean steady state volume of distribution for vardenafil is 208 1, indicating distribution into the tissues. Biotransformation:

Vardenafil in tablets is metabolised predominantly by hepatic metabolism via cytochrome P450 (CYP) isoform 3A4 with some contribution from CYP3A5 and CYP2C isoforms

Elimination:

The total body clearance of vardenafil is 56 Uh with a resultant terminal half-life of approximately 4-5 hours.

Dapoxetine hydrochloride:

Dapoxetine is rapidly absorbed with maximum plasma concentrations (Cmax) occurring approximately 1-2 hours after tablet intake.

Absorption:

Distribution

Dapoxetine has a mean steady state volume of distribution of 162 L. Biotransformation

In vitro studies suggest that dapoxetine is cleared by multiple enzyme systems in the liver and kidneys, primarily CYP2D6, CYP3A4, and flavin monooxygenase (FMO1).

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

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