Sildenafil (Generic Viagra®) 25mg-100mg

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However, VIAGRA may be taken anywhere from

Route of administration

It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors, to the patient's underlying vascular risk factors or anatomical defects, to a combination of these factors, or to other factors (see PRECAUTIONS/Information for Patients ). 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 and severities were increased. In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine. For most patients, the recommended dose is 50 mg taken, as needed, approximately 1 hour before sexual activity. 4 hours to 0.5 hour before sexual activity.

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Based on effectiveness and toleration, the dose may be increased to

Country Legal Classification Over-the-counter (OTC) Prescription Required Notes
USA Prescription-only No Yes Controlled medication
UK Prescription-only No Yes Available at pharmacies with prescription
Australia Prescription-only No Yes Restricted sale

a maximum recommended dose of 100 mg or decreased to 25 mg.

About the Company

There were three subjects who had a standing SBP of less than 85 mmHg. All three were taking VIAGRA 100 mg, and all three reported mild adverse events at the time of reductions in standing SBP, including vasodilation and lightheadedness. There were four subjects with a decrease from baseline in standing systolic BP greater than 30mmHg following VIAGRA 100 mg, one subject with a decrease from baseline in standing systolic BP greater than 30 mmHg following placebo and one subject with a decrease from baseline in standing systolic BP greater than 30 mmHg following both VIAGRA and placebo. While there were no severe adverse events potentially related to blood pressure reported in this study, one subject reported moderate vasodilatation after both VIAGRA 50 mg and 100 mg. There were no episodes of syncope reported in this study.

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When VIAGRA 100 mg oral was coadministered with amlodipine, 5 mg or 10 mg oral, to hypertensive patients, the mean additional reduction on supine blood pressure was 8 mmHg systolic and 7 mmHg diastolic. No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9. VIAGRA (50 mg) did not potentiate the increase in bleeding time caused by aspirin (150 mg). VIAGRA (50 mg) did not potentiate the hypotensive effect of alcohol in healthy volunteers with mean maximum blood alcohol levels of 0.08%. In a study of healthy male volunteers, sildenafil (100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. The maximum recommended dosing frequency is once per day.

Further information

The nature of the adverse events in flexible-dose studies, which more closely reflect the recommended dosage regimen, was similar to that for fixed-dose studies. When VIAGRA was taken as recommended (on an as-needed basis) in flexible-dose, placebo-controlled clinical trials, the following adverse events were reported: Abnormal Vision: Mild and transient, predominantly color tinge to vision, but also increased sensitivity to light or blurred vision. In these studies, only one patient discontinued due to abnormal vision. Other adverse reactions occurred at a rate of greater than 2%, but equally common on placebo: respiratory tract infection, back pain, flu syndrome, and arthralgia. In fixed-dose studies, dyspepsia (17%) and abnormal vision (11%) were more common at 100 mg than at lower doses.

Generic Name

At doses above the recommended dose range, adverse events were similar to those detailed above but generally were reported more frequently. The following events occurred in less than 2% of patients in controlled clinical trials; a causal relationship to VIAGRA is uncertain. Reported events include those with a plausible relation to drug use; omitted are minor events and reports too imprecise to be meaningful: Body as a whole: face edema, photosensitivity reaction, shock, asthenia, pain, chills, accidental fall, abdominal pain, allergic reaction, chest pain, accidental injury. Metabolic and Nutritional: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. Respiratory: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum increased, cough increased. The following factors are associated with

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increased plasma levels of sildenafil: age

greater than 65 (40% increase in

Mechanism of action

In the nonpregnant rat the AUC at this dose was about 20 times human AUC. There are no adequate and well-controlled studies of sildenafil in pregnant women. Healthy elderly volunteers (65 years or over) had a reduced clearance of sildenafil (see CLINICAL PHARMACOLOGY: Pharmacokinetics in Special Populations ). Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered (see DOSAGE AND ADMINISTRATION ). VIAGRA was administered to over 3700 patients (aged 19–87 years) during pre-marketing clinical trials worldwide.

Related treatment guides

Over 550 patients were treated for longer than one year. In placebo-controlled clinical studies, the discontinuation rate due to adverse events for VIAGRA (2.5%) was not significantly different from placebo (2.3%). The adverse events were generally transient and mild to moderate in nature. In trials of all designs, adverse events reported by patients receiving VIAGRA were generally similar. In fixed-dose studies, the incidence of some adverse events increased with dose. AUC), hepatic impairment (e.g., cirrhosis, 80%),

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Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis. Serious cardiovascular, cerebrovascular, and vascular events, including myocardial infarction, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension, subarachnoid and intracerebral hemorrhages, and pulmonary hemorrhage have been reported post-marketing in temporal association with the use of VIAGRA. Most, but not all, of these patients had preexisting cardiovascular risk factors. 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 VIAGRA without sexual activity. Others were reported to have occurred hours to days after the use of VIAGRA and sexual activity.

Dosage questions

It is not possible to determine whether these events are related directly to VIAGRA, to sexual activity, to the patient's underlying cardiovascular disease, to a viagra jelly sachets uk combination of these factors, or to other factors (see WARNINGS for further important cardiovascular information). Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including VIAGRA. In some of the cases, medical conditions and other factors were reported that may have also played a role in the otologic adverse events. In many cases, medical follow-up information was limited. It is not possible to determine whether these reported events are related directly to the use of VIAGRA, to the patient's underlying risk factors for hearing loss, a combination of these factors, or to other factors (see PRECAUTIONS, Information for Patients ). severe renal impairment (creatinine clearance less

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Other events reported post-marketing to have been observed in temporal association with VIAGRA and not listed in the clinical trial adverse reactions section above include: Nervous: seizure, seizure recurrence, anxiety, and transient global amnesia. Urogenital: prolonged erection, priapism (see WARNINGS ), 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. Non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision including permanent loss of vision, has been reported rarely post-marketing in temporal association with the use of phosphodiesterase type 5 (PDE5) inhibitors, including VIAGRA. Most, but not all, of these patients had underlying anatomic or vascular risk factors for developing NAION, including but not necessarily limited to: low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. than 30 mL/min, 100%), and concomitant

use of potent cytochrome P450 3A4

inhibitors [ketoconazole, itraconazole, erythromycin (182%), saquinavir (210%)].