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Drug information contained herein may be time sensitive.
Subjects who had successfully completed the previous doxazosin interaction study (using Viagra 50 mg), including no significant hemodynamic adverse events, were allowed to skip dose period 1.
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The pattern of responses was similar for the other principal question, the ability to achieve an erection sufficient for intercourse.
This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket).
Viagra must never be used by men who are taking medicines that contain nitrates of any kind, at any time.
An erection will not occur just by taking a pill.
Viagra is usually taken about 1 hour before sexual activity; however, it may be taken anywhere from 4 hours to a half hour before sexual activity.
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Most, but not all, of these men had heart problems before taking this medicine.
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If you are taking protease inhibitors, such as for the treatment of HIV, your doctor may recommend a 25 mg dose and may limit you to a maximum single dose of 25 mg of Viagra in a 48 hour period.
Use Viagra with caution in the ELDERLY; they may be more sensitive to its effects.
An extra patient leaflet is available with Viagra .
The time course of effect was examined in one study, showing an effect for up to 4 hours but the response was diminished compared to 2 hours.
Patients who demonstrate hemodynamic instability on alpha-blocker therapy alone are at increased risk of symptomatic hypotension with concomitant use of PDE5 inhibitors.
Viagra is used as needed, so you are not likely to be on a dosing schedule.
Pharmacokinetics and Metabolism Viagra is rapidly absorbed after oral administration, with a mean absolute bioavailability of 41% (range 25–63%).
Physicians should advise patients of the potential for Viagra to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.
The results from this pilot study are shown in Table 1; the mean resting systolic and diastolic blood pressures decreased by 7% and 10% compared to baseline in these patients.
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Use it cautiously—if at all—if you've had a heart attack, stroke, or life-threatening heart irregularities within the past 6 months.
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When Viagra is taken with a high fat meal, the rate of absorption is reduced, with a mean delay in Tmax of 60 minutes and a mean reduction in Cmax of 29%.
If you have heart problems severe enough to make sexual activity a danger, you should avoid using Viagra.
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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) (see DOSAGE AND ADMINISTRATION).
However, Viagra may be taken anywhere from 4 hours to 0.
The patient addressed both questions at the final visit for the last 4 weeks of the study.
Viagra is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Viagra is not approved for use in women.
In fixed-dose studies, the incidence of some adverse events increased with dose.
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Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Viagra.
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In the second study, a single oral dose of Viagra 50 mg or matching placebo was administered in a 2-period crossover design to 20 generally healthy males with BPH.
Ask your health care provider if Viagra may interact with other medicines that you take.
Physicians should advise patients to stop use of all PDE5 inhibitors, including Viagra, and seek medical attention in the event of a sudden loss of vision in one or both eyes.
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Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
This medicine does not protect you against sexually transmitted diseases.
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Diary data in two of the studies (n=178) showed rates of successful intercourse per attempt of 70% for Viagra and 29% for placebo.
If you take any medicines that contain nitrates – either regularly or as needed – you should never take Viagra.
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If you experience a loss of vision in one or both eyes, stop using Viagra and seek medical attention immediately.
Sildenafil was not carcinogenic when administered to mice for 18–21 months at dosages up to the Maximum Tolerated Dose (MTD) of 10 mg/kg/day, approximately 0.
Viagra (sildenafil citrate) is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and 100 mg of sildenafil for oral administration.
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The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient.
Viagra may rarely cause a prolonged, painful erection.
Of the twenty subjects who were ultimately assigned to treatment, a total of 13 subjects successfully completed dose period 1, and seven had successfully completed the previous doxazosin study (using Viagra 50 mg).
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The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues.
Clinical Studies In clinical studies, Viagra was assessed for its effect on the ability of men with erectile dysfunction (ED) to engage in sexual activity and in many cases specifically on the ability to achieve and maintain an erection sufficient for satisfactory sexual activity.
If any develop or change in intensity, inform your doctor as soon as possible.
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5%) was not significantly different from placebo (2.
Alternatively, the medicine may be taken 30 minutes to 4 hours before sexual intercourse.
Viagra was evaluated primarily at doses of 25 mg, 50 mg and 100 mg in 21 randomized, double-blind, placebo-controlled trials of up to 6 months in duration, using a variety of study designs (fixed dose, titration, parallel, crossover).
This analysis was performed retrospectively, and was not powered to detect any pre-specified difference in adverse reactions.
Do not start using a new medication without telling your doctor.
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This is called an erection.
7 seconds for sildenafil (N=70) and placebo, respectively.
At 24 hours the plasma levels of sildenafil were still approximately 200 ng/mL, compared to approximately 5 ng/mL when sildenafil was dosed alone.
At the end of the long-term study, 88% of patients reported that Viagra improved their erections.
Viagra is to be used only by the patient for whom it is prescribed.
Other events 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.
Avoid drinking alcohol, which can increase some of the side effects of Viagra.
Remember that Viagra offers no protection from transmission of sexually transmitted diseases, such as HIV, the virus that causes AIDS.
When Viagra is co-administered with an alpha-blocker, patients should be stable on alpha-blocker therapy prior to initiating Viagra treatment and Viagra should be initiated at the lowest dose (see Drug Interactions).
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Decreased blood pressure, syncope, and prolonged erection were reported in some healthy volunteers exposed to high doses of sildenafil (200–800 mg).
Taking Viagra with a nitrate medicine can cause a serious decrease in blood pressure, leading to fainting, stroke, or heart attack.
Alert your doctor to the problem as soon as possible.
The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.
This patient had been taking minoxidil, a potent vasodilator, during the study.
The safety of Viagra is unknown in patients with bleeding disorders and patients with active peptic ulceration.
Although the interaction between other protease inhibitors and sildenafil has not been studied, their concomitant use is expected to increase sildenafil levels.
Special Senses: sudden decrease or loss of hearing, mydriasis, conjunctivitis, photophobia, tinnitus, eye pain, ear pain, eye hemorrhage, cataract, dry eyes.
Use Viagra as directed by your doctor.
Viagra is not recommended for use in CHILDREN; safety and effectiveness in children have not been confirmed.
It does not work in the absence of arousal.
Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.
It is important that you tell all of your healthcare providers that you take sildenafil .
In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and Viagra, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted (see Drug Interactions).
Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Viagra can decrease blood flow to the optic nerve of the eye, causing sudden vision loss.
After either oral or intravenous administration, sildenafil is excreted as metabolites predominantly in the feces (approximately 80% of administered oral dose) and to a lesser extent in the urine (approximately 13% of the administered oral dose).
This has occurred in a small number of people taking Viagra, most of whom also had heart disease, diabetes, high blood pressure, high cholesterol, or certain pre-existing eye problems, and in those who smoke or are over 50 years old.
Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Viagra has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.
Do not keep outdated medicine or medicine no longer needed.
Less common side effects that may occur are temporary changes in color vision (such as trouble telling the difference between blue and green objects or having a blue color tinge to them), eyes being more sensitive to light, or blurred vision.
It is especially important to check with your doctor before combining Viagra with the following: Viagra should not be used by women.
Physicians should advise patients to stop use of all PDE5 inhibitors, including Viagra, and seek medical attention in the event of a sudden loss of vision in one or both eyes.
For example: If you are older than age 65, or have serious liver or kidney problems, your doctor may start you at the lowest dose (25 mg) of Viagra.
If your dose is different, do not change it unless your doctor tells you to do so.
Viagra had no effect on ritonavir pharmacokinetics (see DOSAGE AND ADMINISTRATION).
Sildenafil was negative in in vitro bacterial and Chinese hamster ovary cell assays to detect mutagenicity, and in vitro human lymphocytes and in vivo mouse micronucleus assays to detect clastogenicity.
You could be having a serious side effect of Viagra.
Viagra has systemic vasodilatory properties and may augment the blood pressure lowering effect of other anti-hypertensive medications.
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Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides.
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The mean subject age was 66.
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During sexual activity, if you become dizzy or nauseated, or have pain, numbness, or tingling in your chest, arms, neck, or jaw, stop and call your doctor right away.
Patients who are taking this medicine for pulmonary arterial hypertension may also need to be started at a lower dose.
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Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Hepatic Insufficiency In volunteers with hepatic cirrhosis (Child-Pugh A and B), sildenafil clearance was reduced, resulting in increases in AUC (85%) and Cmax (47%) compared to age-matched volunteers with no hepatic impairment.
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Nervous: ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, somnolence, abnormal dreams, reflexes decreased, hypesthesia.
If you want more information or develop any side effects or symptoms you are concerned about, call your doctor.
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For the 19 subjects who received both Viagra and matching placebo, the placebo-subtracted mean maximum decreases from baseline (95% CI) in systolic blood pressure were as follows: Blood pressure was measured after administration of Viagra at the same times as those specified for the first doxazosin study.
Viagra - Clinical Pharmacology Mechanism of Action The physiologic mechanism of erection of the penis involves release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
Some of these side effects are more likely to occur with higher doses.
Sildenafil (sil-DEN-a-fil) belongs to a group of medicines that delay the enzymes called phosphodiesterases from working too quickly.