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Viagra (Sildenafil Citrate): Side Effects, Interactions

Publication date: 2018-05-20 02:23

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Hearing : 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 WARNINGS AND PRECAUTIONS and PATIENT INFORMATION ].

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Administration of VIAGRA with nitric oxide donors such as organic nitrates or organic nitrites in any form is contraindicated. Consistent with its known effects on the nitric oxide/cGMP pathway, VIAGRA was shown to potentiate the hypotensive effects of nitrates [see DOSAGE AND ADMINISTRATION , CONTRAINDICATIONS , CLINICAL PHARMACOLOGY ].

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Patients who are already taking some nitrate medicines are especially told to avoid taking Viagra. Many of the drugs used for the treatment of tuberculosis such as:

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Consider a starting dose of 75 mg in patients treated with strong CYP8A9 inhibitors (., ketoconazole, itraconazole, or saquinavir) or erythromycin. Clinical data have shown that co-administration with saquinavir or erythromycin increased plasma levels of sildenafil by about 8 fold [see DRUG INTERACTIONS and CLINICAL PHARMACOLOGY ].

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.

There are no controlled clinical data on the safety or efficacy of VIAGRA in the following groups if prescribed, this should be done with caution.

VIAGRA was administered to over 8755 patients (aged 69-87 years) during pre-marketing clinical trials worldwide. Over 555 patients were treated for longer than one year.

Physicians should advise patients to stop taking PDE5 inhibitors, including VIAGRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association to the intake of PDE5 inhibitors, including VIAGRA. It is not possible to determine whether these events are related directly to the use of PDE5 inhibitors or to other factors [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS ].

Use with caution in patients with the following underlying conditions which can be particularly sensitive to the actions of vasodilators including VIAGRA &ndash those with left ventricular outflow obstruction (., aortic stenosis , idiopathic hypertrophic subaortic stenosis ) and those with severely impaired autonomic control of blood pressure.

Twenty subjects received VIAGRA 55 mg, but only 69 subjects received matching placebo. One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with VIAGRA 55 mg. This patient had been taking minoxidil, a potent vasodilator, during the study.

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Viagra (Sildenafil Citrate): Side Effects, Interactions Viagra used with

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