In the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days.
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.
It is not possible to determine whether these events are related directly to the PDE5 inhibitors, to other diseases or medications, to other factors, or to a combination of factors.
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Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including Viagra.
Its effect is more potent on PDE5 than on other known phosphodiesterases (10-fold for PDE6, >80-fold for PDE1, >700-fold for PDE2, PDE3, PDE4, PDE7, PDE8, PDE9, PDE10, and PDE11).
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.
Also use cautiously if you have a genital problem or deformity such as Peyronie's disease.
The mean subject age in this study was 66.
To avoid low blood pressure, do not take the 50-milligram or 100-milligram dose of Viagra within 4 hours of taking an alpha-blocking drug such as Cardura.
Viagra relaxes muscles and increases blood flow to particular areas of the body.
Therefore, when Viagra is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating Viagra treatment and Viagra should be initiated at the lowest dose.
When vasodilators are used in combination, an additive effect on blood pressure may be anticipated.
Heart attack, stroke, irregular heart beats, and death have been reported rarely in men taking Viagra.
It is not meant to take the place of your doctor's instructions.
An erection will not occur just by taking a pill.
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PDE5 inhibitors, including Viagra, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects.
Special Senses: sudden decrease or loss of hearing, mydriasis, conjunctivitis, photophobia, tinnitus, eye pain, ear pain, eye hemorrhage, cataract, dry eyes.
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.
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To avoid low blood pressure, do not take the 50-milligram or 100-milligram dose of Viagra within 4 hours of taking an alpha-blocking drug such as Cardura.
For sildenafil, the following should be considered: Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to sildenafil.
The studies that established benefit demonstrated improvements in success rates for sexual intercourse compared with placebo.
Avoid using other medicines to treat impotence, such as alprostadil (Caverject, Muse, Edex) or yohimbine (Yocon, Yodoxin, others), without first talking to your doctor.
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Follow your doctor's orders or the directions on the label .
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In the third study, a single oral dose of Viagra 100 mg or matching placebo was administered in a 3-period crossover design to 20 generally healthy males with BPH.
Viagra is not for regular use.
Some medical conditions may interact with Viagra .
Do not use Viagra without telling your doctor if you are pregnant or plan to become pregnant during treatment.
In addition, patients were asked a global efficacy question and an optional partner questionnaire was administered.
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
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.
Some of these side effects are more likely to occur with higher doses.
If a subject did not successfully complete this first dosing period, he was discontinued from the study.
Check with your doctor if any of these most COMMON side effects persist or become bothersome: Diarrhea; dizziness; flushing; headache; heartburn; mild, temporary vision changes (eg, blue/green color tint to vision, blurred vision, sensitivity to light); stuffy nose; upset stomach.
Pregnancy—Sildenafil is not indicated for use in women.
When you are taking sildenafil, it is especially important that your health care professional know if you are taking any of the following: Alpha-blockers (medicine for high blood pressure—Sildenafil when taken together with an alpha-blocker medicine may cause very low blood pressure.
Therefore, when Viagra is co-administered with alpha-blockers, patients should be stable on alpha-blocker therapy prior to initiating Viagra treatment and Viagra should be initiated at the lowest dose.
Do not take Viagra more than once per day.
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If Viagra is prescribed to patients taking ritonavir, caution should be used.
Following a review of the data from these first 4 subjects (details provided below), the Viagra dose was reduced to 25 mg.
Ask your doctor or pharmacist if you do not understand any of this information or if you want to know more about Viagra.
Pregnancy—Sildenafil is not indicated for use in women.
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The mean steady state volume of distribution (Vss) for sildenafil is 105 L, indicating distribution into the tissues.
Since higher plasma levels may increase both the efficacy and incidence of adverse events, a starting dose of 25 mg should be considered (see DOSAGE AND ADMINISTRATION).
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.
It is not known if Viagra is found in breast milk.
This is called erectile dysfunction if it becomes a frequent problem.
In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.
Figure 3 shows that regardless of the baseline levels of function, subsequent function in patients treated with Viagra was better than that seen in patients treated with placebo.
Heat or moisture may cause the medicine to break down.
Do not use Viagra without telling your doctor if you are pregnant or plan to become pregnant during treatment.
If you experience these symptoms, stop taking Viagra and contact a doctor right away.
Viagra should be used with caution in patients with anatomical deformation of the penis (such as angulation, cavernosal fibrosis or Peyronie's disease), or in patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia).
Viagra had no effect on saquinavir pharmacokinetics.
Pulmonary veno-occlusive disease (high blood pressure in the blood vessels of the lungs)—May make heart problems worse in patients with this serious condition Special patient directions come with sildenafil.
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.
You could be having a serious side effect of Viagra.
Others were reported to have occurred hours to days after the use of Viagra and sexual activity.
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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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.
In volunteers with severe (CLcr=<30 mL/min) renal impairment, sildenafil clearance was reduced, resulting in approximately doubling of AUC and Cmax compared to age-matched volunteers with no renal impairment.
Absorption and Distribution Viagra is rapidly absorbed.
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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).
Skin and Appendages: urticaria, herpes simplex, pruritus, sweating, skin ulcer, contact dermatitis, exfoliative dermatitis.
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Urogenital: prolonged erection, priapism (see WARNINGS), and hematuria.
Take Viagra exactly as it was prescribed for you.
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Be sure to tell your doctor if you: have ever had any heart problems (e.
If Viagra gives you an allergic reaction, do not use it again.
Patients who are taking this medicine for pulmonary arterial hypertension may also need to be started at a lower dose.
This is called an erection.
If this is not treated right away, it could lead to permanent sexual problems such as impotence.
Viagra can cause mild, temporary lowering of your blood pressure.
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Nitrates are found in many prescription medicines that are used to treat angina (chest pain due to heart disease) such as: nitroglycerin (sprays, ointments, skin patches or pastes, and tablets that are swallowed or dissolved in the mouth) isosorbide mononitrate and isosorbide dinitrate (tablets that are swallowed, chewed, or dissolved in the mouth) Nitrates are also found in recreational drugs such as amyl nitrate or nitrite ("poppers").
Possible food and drug interactions when taking Viagra If Viagra is taken with certain other drugs, the effects of either could be increased, decreased, or altered.
Studies have produced relevant data on the effects of Viagra on cardiac output.
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).
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Single doses of antacid (magnesium hydroxide/aluminum hydroxide) did not affect the bioavailability of Viagra.
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Use Viagra with caution.
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.
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Based upon measurements of sildenafil in semen of healthy volunteers 90 minutes after dosing, less than 0.
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This medicine can cause serious side effects in patients with heart problems.
If Viagra gives you an allergic reaction, do not use it again.
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The titration studies, in which most patients received 100 mg, showed similar results.
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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.
It is not known if Viagra is found in breast milk.
Follow your doctor's orders or the directions on the label .
Men with untreated ED had relatively low baseline scores for all aspects of sexual function measured (again using a 5-point scale) in the IIEF.
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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 many of the studies, of both fixed dose and titration designs, daily diaries were kept by patients.
Musculoskeletal: arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis.
The concomitant use of potent cytochrome P450 3A4 inhibitors (e.