No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.
This could happen even when you are not having sex.
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Renal Insufficiency In volunteers with mild (CLcr=50–80 mL/min) and moderate (CLcr=30–49 mL/min) renal impairment, the pharmacokinetics of a single oral dose of Viagra (50 mg) were not altered.
At the end of the long-term study, 88% of patients reported that Viagra improved their erections.
Viagra will not prevent pregnancy.
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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.
Sildenafil at recommended doses has no effect in the absence of sexual stimulation.
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This could happen even when you are not having sex.
If you miss a dose of Viagra and you still intend to engage in sexual activity, take it as soon as you remember.
If an erection lasts for a long time (more than 6 hours), it can permanently damage your penis.
Viagra will not prevent pregnancy.
Make sure you tell your doctor if you have any other medical problems, especially: Age greater than 50 years or Coronary artery disease or Diabetes or Hyperlipidemia (excess of lipids in the blood) or Hypertension (high blood pressure) or Low cup to disc ratio (“crowded disc”) or Smoking—These conditions may increase risk for a serious eye problem called NAION.
When a single 100 mg dose of Viagra was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
If Viagra is prescribed to patients taking ritonavir, caution should be used.
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Viagra can decrease blood flow to the optic nerve of the eye, causing sudden vision loss.
Depending on how and when the drug works for you, an interval of one-half hour to as much as 4 hours may prove ideal.
The decrease in sitting blood pressure was most notable approximately 1–2 hours after dosing, and was not different than placebo at 8 hours.
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To decrease the chance of adverse events in patients taking ritonavir, a decrease in sildenafil dosage is recommended (see Drug Interactions, ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION).
The penis cannot fill with enough blood.
If an erection lasts more than 4 hours, seek treatment immediately.
The manufacturer recommends a maximum of 1 dose per day (1 dose every 2 days for those taking ritonavir).
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Although not all of these side effects may occur, if they do occur they may need medical attention.
Do not store in the bathroom.
Read this information carefully before you start taking Viagra.
If you are taking a protease inhibitor, your dose may be adjusted (please see Finding the Right Dose for You).
Do not use this medication without telling your doctor if you are breast-feeding a baby.
An evaluation of visual function at doses up to twice the maximum recommended dose revealed no effects of Viagra on visual acuity, intraocular pressure, or pupillometry.
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.
If you do not get the results you expect, talk with your doctor.
If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
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.
In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of Viagra 50 mg and resolving after approximately 7.
Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite ("poppers").
There were no subjects treated with Viagra 25 mg who had a standing SBP < 85mmHg.
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.
In addition, N-desmethyl metabolite AUC and Cmax values significantly increased 200% and 79% respectively in subjects with severe renal impairment compared to subjects with normal renal function.
However, sildenafil has not been shown to cause birth defects or other problems in animal studies.
It is intended for use only by men who have a condition called erectile dysfunction.
One randomized, double-blind, placebo-controlled, crossover, flexible-dose (up to 100 mg) study of patients with erectile dysfunction resulting from spinal cord injury (n=178) was conducted.
Therefore, age >65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil.
Analysis of the safety database showed no apparent difference in the side effect profile in patients taking Viagra with and without antihypertensive medication.
Contact your doctor or seek emergency medical attention if your erection is painful or lasts longer than 4 hours.
Physicians should advise patients of the potential for Viagra to augment the blood pressure lowering effect of alpha-blockers and anti-hypertensive medications.
The adverse events were generally transient and mild to moderate in nature.
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Sildenafil has not been studied in pregnant women.
After the man is done having sex, this extra blood flows out of the penis back into the body.
Symptoms of a stroke may include confusion, vision or speech changes, one-sided weakness, or fainting.
Therefore, age >65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil.
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Cardiovascular: angina pectoris, AV block, migraine, syncope, tachycardia, palpitation, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, abnormal electrocardiogram, cardiomyopathy.
4 on placebo; similarly, group mean success rates (total successes divided by total attempts) were about 66% on Viagra vs about 20% on placebo.
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.
Before taking Viagra, tell your doctor about all other medications you use for erectile dysfunction, or if you are using any of the following medications: an antibiotic such as clarithromycin (Biaxin), clotrimazole (Mycelex Troche), dalfopristin/quinupristin (Synercid), erythromycin (E.
Before prescribing Viagra, it is important to note the following: Caution is advised when Phosphodiesterase Type 5 (PDE5) inhibitors are co-administered with alpha-blockers.
Sit or lie down at the first sign of any of these effects.
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Viagra must never be used by men who are taking medicines that contain nitrates of any kind, at any time.
After sex is over, the erection goes away.
Viagra may not work as quickly if you take it with a high-fat meal.
Do not take extra medicine to make up the missed dose.
Taking Viagra approximately 1 hour before sexual activity works best for most men.
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.
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Do not use more of it and do not use it more often than your doctor ordered.
Special senses Cases of sudden decrease or loss of hearing have been reported postmarketing in temporal association with the use of PDE5 inhibitors, including Viagra.
In fixed-dose studies, dyspepsia (17%) and abnormal vision (11%) were more common at 100 mg than at lower doses.
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In vivo studies Three double-blind, placebo-controlled, randomized, two-way crossover studies were conducted to assess the interaction of Viagra with doxazosin, an alpha-adrenergic blocking agent.
By controlling the enzyme phosphodiesterase, sildenafil helps to maintain an erection that is produced when the penis is stroked.
Both sildenafil and the metabolite have terminal half lives of about 4 hours.
At the end of the long-term study, 88% of patients reported that Viagra improved their erections.
Store at room temperature Side effects cannot be anticipated.
If an erection lasts for a long time (more than 6 hours), it can permanently damage your penis.
The penis then expands and hardens.
No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.
Therefore, age >65, hepatic impairment and severe renal impairment are associated with increased plasma levels of sildenafil.
Viagra®, an oral therapy for erectile dysfunction, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5).
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Based on the pharmacokinetic profile of a single 100 mg oral dose given to healthy normal volunteers, the plasma levels of sildenafil at 24 hours post dose are approximately 2 ng/mL (compared to peak plasma levels of approximately 440 ng/mL) (see CLINICAL PHARMACOLOGY: Pharmacokinetics and Metabolism).
Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise.
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Combining Viagra with these drugs can cause a severe drop in blood pressure.
In these two subjects, hypotension was reported as a moderately severe adverse event, beginning at approximately 1 hour after administration of Viagra 50 mg and resolving after approximately 7.
In cases of overdose, standard supportive measures should be adopted as required.
However, Viagra is not for everyone.
Studies in vitro have shown that sildenafil is selective for PDE5.
Viagra is only for patients with erectile dysfunction.
Consideration should be given to the following: - Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.
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 a single 100 mg dose of Viagra was administered with erythromycin, a specific CYP3A4 inhibitor, at steady state (500 mg bid for 5 days), there was a 182% increase in sildenafil systemic exposure (AUC).
One patient discontinued the study prematurely due to an adverse event of hypotension following dosing with Viagra 50 mg.
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Follow your doctor's instructions.
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Contact your doctor or seek medical attention right away if you experience these symptoms.
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Viagra relaxes muscles and increases blood flow to particular areas of the body.
Viagra had no effect on ritonavir pharmacokinetics (see DOSAGE AND ADMINISTRATION).
Subgroup analyses of responses to a global improvement question in patients with psychogenic etiology in two fixed-dose studies (total n=179) and two titration studies (total n=149) showed 84% of Viagra patients reported improvement in erections compared with 26% of placebo.
Physicians should warn patients that prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of Viagra.
Store at room temperature Side effects cannot be anticipated.
Sildenafil is used to treat men who have erectile dysfunction (also called sexual impotence).
Avoid using other medicines to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to your doctor.
If needed, your doctor may increase your daily dose.