VEGWANA 100 mg

Uro-genital drugs

  • Chemical Composition

    Sildenafil Base 100 mg

  • Packing

    4Coated Tablets

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Mechanism Of Action The physiological mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation. NO then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but enhances the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum. When sexual stimulation causes local release of NO, inhibition of PDE5 by sildenafil causes increased levels of cGMP in the corpus cavernosum, resulting in smooth muscle relaxation and inflow of blood to the corpus cavernosum. Sildenafil at recommended doses has no effect in the absence of sexual stimulation. Studies in vitro have shown that sildenafil is selective for PDE5. Its effect is more potent on PDE5 than on other known phosphodiesterases (>80-fold for PDE1, >l,000-fold for PDE2, PDE3, and PDE4). The approximately 4000-fold selectivity for PDE5 versus PDE3 is important because that PDE is involved in control of cardiac contractility. Sildenafil is only about 10-fold as potent for PDE5 compared to PDE6, an enzyme found in the retina; this lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses or plasma levels.
INDICATIONS VEGWANA is indicated for the treatment of erectile dysfunction. The studies that established benefits demonstrated improvements in success rates for sexual intercourse Compared with placebo.
CONTRAINDICATIONS Use of VEGWANA is contraindicated in patients with a known hypersensitivity to any components of the tablet.Consistent with its known effects on the nitric oxide/cGMP/ pathway. N.B.: Sildenafil was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently using organic nitrates in any form is therefore contraindicated.
Side EFFECTS When VEGWANA was taken as recommended (on an as-needed basis) the following adverse events were reported:Headache l6 %, Flushing 10%, Dyspepsia 7 %, Nasal Congestion 4 %, Urinary Tract Infection 3 %, Abnormal Vision 3%, Diarrhea 3 %, Dizziness 2 %, Rash 2 %. Other adverse reactions occurred at rate of>2% such as respiratory tract infection, back pain, flu syndrome and arthralgia. VEGWANA caused some rare cases such as: allergic reaction, face edema, photosensitivity reaction, migraine, tachycardia, angina pectoris, palpitation, heart failure, abnormal electrocardiogram, glossitis, stomatitis, vomiting, anemia, leukopenia, thirst, gout, arthritis, myalgia, neuralgia, parcsthesia, tremor, vertigo, depression, dyspenea, laryngitis, pharyngitis, pruritis, dermatitis, nocturia, urinary frequency, urinary incontinence, genital edema.
WARNINGS A thorough medical history and physical examination should be undertaken to diagnose erectile dysfunction, determine potential underlying causes, and identify appropriate treatment. There is a degree of cardiac risk associated with sexual activity; therefore, physicians may wish to consider the cardiovascular status of their patients prior to initiating any treatment for erectile dysfunction. Agents for the treatment of erectile dysfunction 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 Slindafil with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended. Slindafil has no effect on bleeding time when taken alone or with aspirin. In vitro studies with human platelets indicate that sildenafil potentiates the anti-aggregatory effect of sodium nitroprusside (a nitric oxide donor). There is no safety information on the administration of Slindafil to patients with bleeding disorders or active peptic ulceration. Therefore, Slindafil should be administered with caution to these patients. A minority of patients with the inherited condition retinitis pigmentosa have genetic disorders of retinal phosphodiesterases. There is no safety information on the administration of Slindafil to patients with retinitis pigmentosa. Therefore, Slindafil should be administered with caution to these patients.
DRUG INTERACTIONS Effects of Other Drugs on Sildenafil: Population data from patients in clinical trials did indicate a reduction in sildenafil clearance when it was co-administered with CYP3A4 inhibitors (such as ketoconazole, erythromycin, cimetidine). It can be expected that concomitant administration of CYP3A4 inducers, such as rifampin, will decrease plasma levels of sildenafil. Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of sildenafil. Pharmacokinetic data from patients in clinical trials showed no effect on sildenafil pharmacokinetics of CYP2C9 inhibitors (such as tolbutamide, warfarin), CYP2D6 inhibitors (such as selective serotonin reuptake inhibitors, tricyclic anlidepressan(s), thiazides and related diuretics, ACE inhibitors, and calcium channel blockers. Effects of Sildenafil on Other Drugs: No significant interactions were shown with tolbutamide (250mg) or warfarin (40mg), both of which are metabolized by CYP2C9. Sildenafil did not potentiate the increase in bleeding time caused by aspirin (150mg). No interaction was seen when Product was co-administered with amlodipine in hypertensive patients.
Pregnancy And lactations Sildenafil is contraindicated in infants, children and women.
Dosage And Administration For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity.However, VEGWANA may be taken any time 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. N.B. :The maximum recommended dosing frequency is once per day .The following factors are associated with increased plasma levels of sildenafil: age >65 (40% increase in AUC), hepatic impairment (e.g. cirrhosis, 80%), severe renal impairment (creatinine clearance <30ml/min, 100%), and concomitant use of potent cytochrome P450 3A4 inhibitors (erythromycin, ketoconazole, itraconazole, 200%). Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 5mg should be considered in these patients. N.B.: 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.
OVERDOSE In studies with healthy volunteers of single doses up to 800 mg, adverse events were similar to those seen at lower doses but incidence rates were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenaill is highly bound to plasma proteins and it is not eliminated in the urine.
Storage Conditions - store below 30°C in a dry place - keep out of reach of children