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VIAGRA WARNINGS

This information is NOT authored by doctors and it is NOT intended as medical advice that you should act upon. Always seek the advice of a qualified doctor. Please read disclaimer.

Sildenafil citrate has systemic vasodilatory properties that resulted in transient decreases in supine blood pressure in healthy volunteers (mean maximum decrease of 8.4/5.5 mmHg), While this normally would be expected to be of little consequence in most patients, prior to prescribing sildenafil citrate, physicians should carefully consider whether their patients with underlying cardiovascular disease could be affected adversely by such vasodilatory effects, especially in combination with sexual activity.

There is a potential for cardiac risk of sexual activity in patients with preexisting cardiovascular disease. Therefore, treatments for erectile dysfunction, including sildenafil citrate, should not be generally used in men for whom sexual activity is inadvisable because of their underlying cardiovascular status.

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

  • Patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months.
  • Patients with resting hypotension (BP <90/50) or hypertension (BP >170/110).
  • Patients with cardiac failure or coronary artery disease causing unstable angina.
  • Patients with retinitis pigmentosa (a minority of these patients have genetic disorders of retinal phosphodiesterases).

Prolonged erection greater than 4 hours and priapism (painful erections greater than 6 hours in duration) have been reported infrequently since market approval of sildenafil citrate. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

CIALIS WARNINGS

Like all medications, CIALIS may have some side effects. The most common side effects with CIALIS are headache, upset stomach, back pain, and muscle aches. These side effects usually go away after a few hours. Patients who get back pain and muscle aches usually get it 12 to 24 hours after taking CIALIS. Back pain and muscle aches usually go away by themselves within 48 hours. Call your doctor or other healthcare professional if side effects continue to bother you. Although a rare occurrence, men who experience an erection for more than 4 hours (priapism) should seek immediate medical attention.

CIALIS is not for everyone. If you take nitrates, often used for chest pain (also known as angina), or alpha-blockers (other than Flomax 0.4 mg once daily), prescribed for prostate problems or high blood pressure, do not take CIALIS. Such combinations could cause a sudden, unsafe drop in blood pressure. Don't drink alcohol in excess (to a level of intoxication) with CIALIS. This combination may increase your chances of getting dizzy or lowering your blood pressure. CIALIS does not protect a man or his partner from sexually transmitted diseases, including HIV.

The most common side effects with CIALIS were headache and upset stomach. Backache and muscle ache were also reported, sometimes with delayed onset. Most men weren't bothered by the side effects enough to stop taking CIALIS. Although a rare occurrence, men who experience an erection for more than 4 hours (priapism) should seek immediate medical attention. Discuss your medical conditions and medications with your doctor to ensure CIALIS is right for you and that you are healthy enough for sexual activity. Individual results may vary. In clinical trials, CIALIS was shown to improve, up to 36 hours after dosing, the ability of men with ED to have a single successful intercourse attempt. CIALIS has not been studied for multiple sexual attempts per dose. After taking a single tablet, some of the active ingredient of Cialis remains in your body for more than 2 days. The active ingredient can remain longer if you have problems with your kidneys or liver, or you are taking certain other medications.

Flomax® (tamsulosin HCl) is a registered trademark of Boehringer Ingelheim.



VIAGRA® PRECAUTIONS

General

The evaluation of erectile dysfunction should include a determination of potential underlying causes and the identification of appropriate treatment following a complete medical assessment.

Before prescribing sildenafil citrate, it is important to note the following:

Patients on multiple antihypertensive medications were included in the pivotal clinical trials for sildenafil citrate. In a separate drug interaction study, when amlodipine, 5 mg or 10 mg, and sildenafil citrate, 100 mg were orally administered concomitantly to hypertensive patients mean additional blood pressure reduction of 8 mmHg systolic and 7 mmHg diastolic were noted. Controlled studies of drug interactions between sildenafil citrate and other antihypertensive medications have not been performed.

The safety of sildenafil citrate is unknown in patients with bleeding disorders and patients with active peptic ulceration.

Sildenafil citrate 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).

The safety and efficacy of combinations of sildenafil citrate with other treatments for erectile dysfunction have not been studied. Therefore, the use of such combinations is not recommended.

In humans, sildenafil citrate has no effect on bleeding time when taken alone or with aspirin. In vitro studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside (a nitric oxide donor). The combination of heparin and sildenafil citrate had an additive effect on bleeding time in the anesthetized rabbit, but this interaction has not been studied in humans.

Information for the Patient

Physicians should discuss with patients the contraindication of sildenafil citrate with regular and/or intermittent use of organic nitrates. Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patients who experience symptoms (e.g., angina pectoris, dizziness, nausea) upon initiation of sexual activity should be advised to refrain from further activity and should discuss the episode with their physician. 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 sildenafil citrate. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result. The use of sildenafil citrate offers no protection against sexually transmitted diseases. Counseling of patients about the protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), may be considered.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Sildenafil was not carcinogenic when administered to rats for 24 months at a dose resulting in total systemic drug exposure (AUCs) for unbound sildenafil and its major metabolite of 29- and 42-times, for male and female rats, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 100 mg. 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 0.6 times the MRHD on a mg/m2 basis.

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.

There was no impairment of fertility in rats given sildenafil up to 60 mg/kg/day for 36 days to females and 102 days to males, a dose producing an AUC value of more than 25 times the human male AUC.

There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil citrate in healthy volunteers.

Pregnancy, Nursing Mothers, and Pediatric Use

Sildenafil citrate is not indicated for use in newborns, children, or women.

Pregnancy Category B: No evidence of teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits which received up to 200 mg/kg/day during organogenesis. These doses represent, respectively, about 20 and 40 times the MRHD on a mg/m2 basis in a 50 kg subject. In the rat pre- and postnatal development study, the no observed adverse effect dose was 30 mg/kg/day given for 36 days. In nonpregnant rat the AUC at this dose was about 20 times human AUC. There are no adequate and well-controlled studies of sildenafil in pregnant women.


 
 
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