DOSAGE FORMS AND STRENGTHS

Therefore, treatments for erectile dysfunction, including Sildenafil, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

2.5 Dosage Adjustments in Special Populations

In a study of healthy male volunteers, co-administration of Sildenafil at steady state (80 mg t.i.d.) with endothelin receptor antagonist bosentan (a moderate inducer of CYP3A4, CYP2C9 and possibly of cytochrome P450 2C19) at steady state (125 mg b.i.d.) resulted in a 63% decrease of Sildenafil AUC and a 55% decrease in Sildenafil Cmax. Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Sildenafil. The AUC of the active metabolite, N-desmethyl Sildenafil, was increased 62% by loop and potassium-sparing diuretics and 102% by 16 nonspecific beta-blockers. Sildenafil is contraindicated in patient with hypersensitivity to any component of this medication. Sildenafil potentiates the hypotensive effects of nitrates, so it is contraindicated in patients who are using organic nitrates, either regularly or intermittently.

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Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of Sildenafil without sexual activity. Others were reported to have occurred hours to days after the use of Sildenafil and sexual activity. It is not possible to determine whether these events are related directly to Sildenafil, to sexual activity, to the patient's underlying 23 cardiovascular disease, to a combination of these factors, or to other factors.Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia.Urogenital: prolonged erection, priapism and hematuria.Special Senses: diplopia, temporary vision loss/decreased vision, ocular redness or bloodshot appearance, ocular burning, ocular swelling/pressure, increased intraocular pressure, retinal vascular disease or bleeding, vitreous detachment/traction, paramacular edema and epistaxis. There are no adequate and well-controlled studies of Sildenafil in pregnant women. Sildenafil is not indicated for use by women. Sildenafil has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg).

While this normally would be expected to be of little consequence in most patients, prior to

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prescribing Sildenafil, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely

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by such vasodilatory effects, especially in combination with sexual activity.Patients with the following underlying conditions can be

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Avoid using Rapid Fire 100mg Tablet with other erectile dysfunction or premature ejaculation medicines unless advised by your doctor. Tell your doctor if you have heart disease, liver or kidney disease, seizures, or bleeding disorders before using Rapid Fire 100mg Tablet. Sildenafil is indicated for the treatment of erectile dysfunction and pulmonary arterial hypertension. Sildenafil is a selective inhibitor of cyclic Guanosine Monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5) used for treatment of erectile dysfunction. Danafil (Sildenafil) enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum that results in smooth muscle relaxation and inflow of blood to the corpus cavernosum.

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Erectile dysfunction: For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. However, Sildenafil may be taken anywhere from 4 hours to 0.5 hour before sexual activity. The maximum recommended dosing frequency is once per day.The following factors are associated with increased plasma levels of Sildenafil: age >65, hepatic impairment, severe renal impairment, and concomitant use of potent cytochrome P450 3A4 inhibitors (ketoconazole, itraconazole, erythromycin, saquinavir). Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered in these patients. Sildenafil was shown to potentiate the hypotensive effects of nitrates and its administration in patients who use nitric oxide donors or nitrates in any form is therefore contraindicated. particularly sensitive to the actions of vasodilators including Sildenafil - those with left ventricular outflow obstruction (e.g.

Clinical Fact Box

When Sildenafil is co-administered with an alpha-blocker, patients should be stable on alphablocker therapy prior to initiating Sildenafil treatment and Sildenafil should be initiated at the lowest dose.Pulmonary arterial hypertension: The recommended dose of Vigorex 100 mg is 20 mg three times a day and should be taken approximately 4-6 hours apart, with or without food. Sildenafil may takes longer time to work if you take it with a heavy meal. Sildenafil metabolism is principally mediated by the cytochrome P450 (CYP) isoforms 3A4 (major route) and 2C9 (minor route). Therefore, inhibitors of these isoenzymes 15 may reduce Sildenafil clearance and inducers of these isoenzymes may increase Sildenafil clearance. Cimetidine (800 mg), a nonspecific CYP inhibitor, caused a 56% increase in plasma Sildenafil concentrations when coadministered with Sildenafil (50 mg) cenforce 200 uk to healthy volunteers.

Binding Characteristics

When a single 100 mg dose of Sildenafil was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 182% increase in Sildenafil systemic exposure (AUC). In addition, in a study performed in healthy male volunteers, co-administration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with Sildenafil (100 mg single dose) resulted in a 140% increase in Sildenafil Cmax and a 210% increase in Sildenafil AUC. Stronger CYP3A4 inhibitors such as ketoconazole or itraconazole would be expected to have still greater effects, and population data from patients in clinical trials did indicate a reduction in Sildenafil clearance when it was coadministered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, or cimetidine). In another study in healthy male volunteers, coadministration with the HIV protease inhibitor ritonavir, which is a highly potent P450 inhibitor, at steady state (500 mg bid) with Sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in Sildenafil Cmax and a 1000% (11-fold) increase in Sildenafil plasma AUC. This is consistent with ritonavir's marked effects on a broad range of P450 substrates. aortic stenosis, idiopathic hypertrophic subaortic stenosis) and those with severely impaired autonomic control of blood pressure.There is no controlled clinical

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data on the safety or efficacy of Sildenafil in the following groups; if prescribed, this should be done with caution. Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months; Patients with resting hypotension (BP <90/50) or hypertension (BP >170/110); Patients with cardiac

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Patients on multiple antihypertensive medications were included in the pivotal clinical trials for Sildenafil. In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and Sildenafil, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted. The safety of Sildenafil is unknown in patients with bleeding disorders and patients with active peptic ulceration. Sildenafil should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia). The safety and efficacy of combinations of Sildenafil with other treatments for erectile dysfunction have not been studied. failure or coronary artery disease causing unstable angina; Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases); Patients with sickle cell or related anemias.

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Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of Sildenafil.

If Sildenafil is prescribed to patients taking ritonavir, caution should be used.

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In animal study shows that Sildenafil has no evidence of teratogenicity or embryotoxicity. General: The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.Before prescribing Sildenafil, it is important to note the following: Caution is advised when Phosphodiesterase Type 5 (PDE5) inhibitors are co-administered with alpha-blockers. PDE5 inhibitors, including Sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood-pressure-lowering effects. When pills for womens libido vasodilators are used in combination, an additive effect on blood pressure may be anticipated. In some patients, concomitant use of these two drug classes can lower blood pressure significantly leading to symptomatic hypotension (e.g.

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dizziness, lightheadedness, fainting).Consideration should be given to the following: Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor. Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors. In those patients who are stable on alpha-blocker therapy, PDE5 inhibitors should be initiated at the lowest dose. A stepwise increase in alpha-blocker dose may be associated with further lowering of blood pressure when taking a PDE5 inhibitor. Sildenafil has systemic vasodilatory properties and may augment the blood pressure-lowering effect of other anti-hypertensive medications.