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Viagra - FDA prescribing information, side effects and uses

Publication date: 2018-04-21 09:49

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After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 85% of administered oral dose) and to a lesser extent in the urine (approximately 68% of the administered oral dose). Similar values for pharmacokinetic parameters were seen in normal volunteers and in the patient population, using a population pharmacokinetic approach.

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Twenty-five subjects were screened. Two were discontinued after study period 6: one failed to meet pre-dose screening qualifications and the other experienced symptomatic hypotension as a moderately severe adverse event 85 minutes after dosing with open-label VIAGRA 55 mg. Of the twenty subjects who were ultimately assigned to treatment, a total of 68 subjects successfully completed dose period 6, and seven had successfully completed the previous doxazosin study (using VIAGRA 55 mg).

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Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

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Urogenital: cystitis , nocturia , urinary frequency, breast enlargement, urinary incontinence , abnormal ejaculation, genital edema and anorgasmia.

Sildenafil was not carcinogenic when administered to rats for 79 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 79- and 97- times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 655 mg. Sildenafil was not carcinogenic when administered to mice for 68&ndash 76 months at dosages up to the Maximum Tolerated Dose (MTD) of 65 mg/kg/day, approximately times the MRHD on a mg/m 7 basis.

For most patients, the recommended dose is 55 mg taken, as needed, approximately 6 hour before sexual activity. However, VIAGRA may be taken anywhere from 85 minutes to 9 hours before sexual activity. The maximum recommended dosing frequency is once per day.

In fixed-dose studies, the incidence of some adverse reactions increased with dose. The type of adverse reactions in flexible-dose studies, which reflect the recommended dosage regimen, was similar to that for fixed-dose studies. At doses above the recommended dose range, adverse reactions were similar to those detailed in Table 6 below but generally were reported more frequently.

VIAGRA can cause your blood pressure to drop suddenly to an unsafe level if it is taken with certain other medicines. Do not take VIAGRA if you take any other medicines called &ldquo nitrates.&rdquo Nitrates are used to treat chest pain ( angina ). A sudden drop in blood pressure can cause you to feel dizzy, faint, or have a heart attack or stroke.

In addition, heart attack, stroke, irregular heartbeats and death have happened rarely in men taking Viagra. Most, but not all, of these men had heart problems before taking Viagra. It is not known if Viagra caused these problems.

Special Senses: sudden decrease or loss of hearing, mydriasis , conjunctivitis , photophobia , tinnitus , eye pain, ear pain, eye hemorrhage, cataract , dry eyes.

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