Most, but not all, of these men had heart problems before taking this medicine.
In the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days.
Contact your doctor right away if you have an erection that lasts more than 4 hours.
There was no effect on sperm motility or morphology after single 100 mg oral doses of Viagra in healthy volunteers.
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Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins.
If you are over 65, have liver or kidney problems, or are taking erythromycin, ketoconazole, itraconazole, ritonavir, or saquinavir a dose of 25 milligrams may be sufficient.
Pregnancy, Nursing Mothers and Pediatric Use Viagra is not indicated for use in newborns, children, or women.
Do not take Viagra if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, Minitran, Deponit, Transderm-Nitro), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket), or recreational drugs such as amyl nitrate or nitrite ("poppers").
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.
This is called erectile dysfunction if it becomes a frequent problem.
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nausea, nervousness, nightmares, restless sleep, shakiness, slurred speech, and unusual tiredness or weakness; bone pain; breast enlargement; chest pain; chills; confusion; convulsions (seizures); coughing up blood; deafness; decrease in amount of urine or in frequency of urination; dizziness or lightheadedness, especially when getting up from a lying or sitting position; dry eyes; dry mouth; dryness, redness, scaling, or peeling of the skin; eye pain; fainting or faintness; fast, irregular, or pounding heartbeat; feeling of something in the eye; groups of skin lesions with swelling; headache (severe or continuing); heart failure; hives; increase in size of pupil; increased sweating; increased thirst; itching of skin; low blood pressure; lower back or side pain; migraine headache; nausea (severe or continuing); nervousness; numbness of hands; painful, swollen joints; redness, itching, or tearing of eyes; shortness of breath or troubled breathing; skin paleness; skin rash; skin ulcers; sore throat and fever or
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PREGNANCY and BREAST-FEEDING: Viagra is not approved for use in women.
The usual dose is 50 milligrams.
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This could happen even when you are not having sex.
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5 mmHg), (see CLINICAL PHARMACOLOGY: Pharmacodynamics).
In the nonpregnant rat the AUC at this dose was about 20 times human AUC.
The concomitant use of potent cytochrome P450 3A4 inhibitors (e.
There are no adequate and well-controlled studies of sildenafil in pregnant women.
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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.
This is called erectile dysfunction if it becomes a frequent problem.
Most, but not all, of these men had heart problems before taking this medicine.
Viagra had no effect on ritonavir pharmacokinetics (see DOSAGE AND ADMINISTRATION).
Ask your health care provider any questions you may have about how to use Viagra .
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The following events occurred in <2% of patients in controlled clinical trials; a causal relationship to Viagra is uncertain.
If you have questions about side effects, contact your health care provider.
A prolonged erection (priapism) can damage the penis.
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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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Contraindications Consistent with its known effects on the nitric oxide/cGMP pathway (see CLINICAL PHARMACOLOGY), Viagra was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are using organic nitrates, either regularly and/or intermittently, in any form is therefore contraindicated.
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Viagra improved these aspects of sexual function: frequency, firmness and maintenance of erections; frequency of orgasm; frequency and level of desire; frequency, satisfaction and enjoyment of intercourse; and overall relationship satisfaction.
Most, but not all, of these men had heart problems before taking this medicine.
Musculoskeletal: arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.
Mean sildenafil plasma concentrations measured after the administration of a single oral dose of 100 mg to healthy male volunteers is depicted below: Figure 1: Mean Sildenafil Plasma Concentrations in Healthy Male Volunteers.
In addition, in a study performed in healthy male volunteers, coadministration of the HIV protease inhibitor saquinavir, also a CYP3A4 inhibitor, at steady state (1200 mg tid) with Viagra (100 mg single dose) resulted in a 140% increase in sildenafil Cmax and a 210% increase in sildenafil AUC.
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).
It is intended for use only by men who have a condition called erectile dysfunction.
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A total dose of 40 mg sildenafil was administered by four intravenous infusions.
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This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket).
These doses represent, respectively, about 20 and 40 times the MRHD on a mg/m2 basis in a 50 kg subject.
Do not take Viagra more than once per day.
Effects of Viagra on Blood Pressure Single oral doses of sildenafil (100 mg) administered to healthy volunteers produced decreases in sitting blood pressure (mean maximum decrease in systolic/diastolic blood pressure of 8.
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This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina.
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Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg of Viagra, therefore the effects are not related to dose or plasma levels within this dosage range.
Metabolism and Excretion Sildenafil is cleared predominantly by the CYP3A4 (major route) and CYP2C9 (minor route) hepatic microsomal isoenzymes.
Patients on multiple antihypertensive medications were included in the pivotal clinical trials for Viagra.
This includes nitroglycerin (Nitrostat, Nitrolingual, Nitro-Dur, Nitro-Bid, and others), isosorbide dinitrate (Dilatrate-SR, Isordil, Sorbitrate), and isosorbide mononitrate (Imdur, ISMO, Monoket).
Viagra may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects.
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.
An extra patient leaflet is available with Viagra .
Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted.
Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Viagra.
Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Viagra.
Consideration should be given to the following: - Patients should be stable on alpha-blocker therapy prior to initiating a PDE5 inhibitor.
Viagra is an oral drug for male impotence, also known as erectile dysfunction (ED).
Viagra is usually taken only when needed, 30 minutes to 1 hour before sexual activity.
No significant interactions were shown with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolized by CYP2C9.
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Viagra is only for patients with erectile dysfunction.
The concomitant administration of the protease inhibitor ritonavir substantially increases serum concentrations of sildenafil (11-fold increase in AUC).
The changes from baseline in scoring on the two end point questions (frequency of successful penetration during sexual activity and maintenance of erections after penetration) were highly statistically significantly in favor of Viagra.
Diary data indicated that on Viagra, 48% of intercourse attempts were successful versus 12% on placebo.
This lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses or plasma levels (see Pharmacodynamics).
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After the man is done having sex, this extra blood flows out of the penis back into the body.
It is not known if the medicine is safe for use in these patients Conditions causing thickened blood or slower blood flow, including leukemia; multiple myeloma (tumors of the bone marrow); or polycythemia, sickle cell disease, and thrombocythemia (blood problems) or Priapism (history of)—Although sildenafil does not cause priapism (erection lasting longer than 6 hours), patients with these conditions have an increased risk of priapism and it could occur while using sildenafil Heart or blood disease—Sexual activity increases the heart rate and blood flow and can increase the chance of problems occurring for some patients who use any type of medicine, including sildenafil, that increases sexual ability Kidney problems (severe) or Liver problems (severe)—Chance of problems occurring may be increased.
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Both of these subjects were protocol violators, one due to a low baseline standing SBP, and the other due to baseline orthostatic hypotension.
In many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients.
It is important that you tell all of your healthcare providers that you take sildenafil .