Each film coated table contains :
Sildenafil citrate 144 mg. equivalent to lOOmg. sildenafil.
Inactive ingredients :
Calcium hydogen phosphate, Magnesium stearate, Microcrystalline cellulose. Crosscarmellose Sodium. Hypromellose. Lactose. indigo Carmine Aluminum lake, Triacetin. Titanium dioxide.
Film coated tablets
Sildenafil, the active ingredient of orgodenafil is used for erectile dysfunction During sexual srirnulnrion, nitric oxide (NO) is released in the corpus cavernosum.
Sildenafil enhances the effect of nitric oxide (NO) by selectivity inhibiting phosphodiesterase type 5 (PDES), which is responsible for the degradation of
cyclic guanosine monophosphate (c GMP)in the corpus cavernosum. As a result. c GMP levels increase. producing smooth muscle relaxation and allowing inflow of blood in corpus cavernosum which promote erection. The effect of sildenafil is dose
dependent and lasts for up to 4 hours. Sildenafil has no effect in the absence of sexual stimulation.
Sildenafil is rapidly absorbed after oral administration, with absolute bioavailbiliry of about 40%.Its pharmacokinetics’ are dose- proportional over the
recommended dose range. It is eliminated predominantly by hepatic metabolism (mainly cytochrome P450 3A4) and is converted to an active metabclite with properties similar to the parent. sildenafil. The concomitant use of potent cytochrome P450 3A4 inhibitors (e.g. Erythromycin. ketoconazole. itraconazcle) as well the nonspecific CYP inhibitor, cimetidine, is associated with increased plasma levels of sildenafil. Both sildenafil and metabolite have terminal half of about 4 hours.
sildenafil is indicated for treatment of erectile dysfunction.
DOSAGE AND DIRECTIONS FOR USE:
The recommended dose is 50mg. taken as needed approximately one hour before sexual activity. Based on efficacy and toleration, the dose may be increased 10 LOOmg. the maximum recommended dose is IOOmg. The maximum recommended dosing frequency is once per day.
Hypersensitivity to any component of the tablet patients who are using organic nitrates.
SIDE EFFECTS :
The adverse reaction are generally transient and mild to moderate in nature including headache. dyspepsia. flushing. nasal congestion, blurred vision, sensitivity
to light, dizziness and rash.
Concomitant administration of microsomal enzyme inhibitors such as cimetidine. ketoconazole, and erythromycin increase sildenafil plasma level sildenafrl potenteiates the hypotensive effect in patients on antihypertensive therapy.
PERGNANCY AND LACTATION:
Not used for women at all.
PRECUTION & WARNINGS:
Physical examination should be undertaken to diagnose erectile dysfunction before any treatment with sildenafil, the cardiovascular status must be considered 10 avoid cardiac risk associated with Sexual activities. The drug should be taken with
caution in patient with anatomical and other deformity of the penis (such as sickle cell anemia, multiple myeloma or leukemia) and patients with bleeding disorders. active peptic ulcers and retinitis pigmentose. Sildenafil proved to be non-carcinogenic when administrated to rats and mice and impairment of fertility was reported in rats given sildenafit.
Cartoon box contain one (A I/Pvc) of 3 film coated tablets. with inner leaflet.
Store in a dry place at temperature not exceeding 30 C
keep OUl of reach of children.
INSTRUCTIONS FOR PAITENTS :
THIS IS A MEDICAMENT:
– Medicament is a product with affects your health, and its consumption contrary to instructions is dangerous for you.
– Follow strictly the prescription of the doctor. the method of use and the instructions of the pharmacist who sold the medicament.
– The doctor and the pharmacist are experts in medicine. its benefit s and risks.
– Do no! bey yourself-interrupt the period of treatment prescribed for you.
– Do not repeat the same prescription without consulting your doctor.
– Keep all medicines out of the (each of children.
ORGANO PHARMACEUTICAL & CHEMICAL