Preparation
Fulfeel Tablet: Each film-coated tablet contains Sildenafil Citrate INN equivalent to Sildenafil INN 50 mg.
Indication
Fulfeel is indicated for the treatment of erectile dysfunction. Sexual stimulation is required for the effectiveness of Fulfeel.
Contraindication
Sildenafil is contraindicated in patients receiving nitrates, in patients in whom vasodilation or sexual activity are inadvisable or in patients with a previous history of non-arteritic anterior ischaemic optic neuropathy. It is contraindicated in hypotension (avoid if systolic blood pressure below 90 mmHg), recent stroke, unstable angina and myocardial infarction.
Dosage & Administration
The recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, Fulfeel may be taken anywhere from 4 hours to 0.5 hour before sexual activity. Based on effectiveness and toleration, the dose may be increased to a maximum recommended dose of 100 mg or decreased to 25 mg. The maximum recommended dosing frequency is once per day. Onset of action may be delayed if taken with food.
Side Effect
The most commonly reported adverse reactions in clinical studies among Sildenafil treated patients were headache, flushing, dyspepsia, visual disorders, nasal congestion, dizziness and visual color distortion.
Precaution
Sildenafil should be used with caution in cardiovascular disease, left ventricular outflow obstruction, anatomical deformation of the penis (e.g. angulation, cavernosal fibrosis, Peyronie\'s disease) and in those with a predisposition to priapism (e.g. in sickle-cell disease, multiple myeloma, or leukaemia). Concomitant treatment with a phosphodiesterase type-5 inhibitor and an alpha-blocker can increase the risk of postural hypotension-initiate treatment with a phosphodiesterase type-5 inhibitor (at a low dose) only once the patient is stable on the alpha-blocker.
Drug Interaction
Use in pregnancy and lactation: Pregnancy category B.
Use in children and adolescents: Sildenafil is not indicated for individuals below 18 years of age.
Use in elderly patients: Dosage adjustment is not required in elderly patients.
Use in patients with impaired renal function: Since Sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance < 30 ml/min) a 25 mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.
Use in patients with impaired hepatic function: Since Sildenafil clearance is reduced in patients with hepatic impairment (e.g. cirrhosis) a 25 mg dose should be considered. Based on efficacy and toleration, the dose may be increased to 50 mg and 100 mg.
Presentation
Hypotensive effects can be enhanced if Sildenafil is co-administered with alpha-blockers (avoid alpha-blockers for 4 hours after Sildenafil), Amlodipine, Nicorandil, Nitrates (avoid concomitantuse). Co-administration of Sildenafil with Atazanavir increases the side effects. Plasma concentration of Sildenafil is increased if it is co-administered with Bosentan, Cimetidine, Clarithromycin, Erythromycin, Fosamprenavir, Grapefruit Juice, Indinavir, Itraconazole, Ketoconazole, Nelfinavir, Ritonavir, Telithromycin. Etravirine reduces plasma concentration of Sildenafil.
Contraindications
Fulfeel Tablet: Each box containing 2X4\'s tablets in blister pack.
