Levitra (vardenafil) Info

Cardiovascular Disease

There is some element of cardiac risk involved in sexual activity, therefore physicians must take a look their patients cardiovascular condition before prescribing erectile dysfunction treatment.

Other Pre-existing Medical Conditions

Patients with anatomically deforming penis conditions (like cavernosal fibrosis, angulation, or Peyronie’s disease) or with condition that might induce priapism (like leukemia, sickle cell anemia, or multiple myeloma) must use agents for treating erectile dysfunction carefully.

Using a combination of vardenafil drugs with other erectile dysfunction treatments (this includes other PDE5 inhibitors) has yet to be studied and is therefore ill-advised.

Patients with significant active peptic ulceration or other bleeding disorders have not yet been given vardenafil therefore should not be given vardenafil until after a serious benefit-risk assessment. Vardenafil medication has no effect on human bleeding time, alone or with aspirin. Human platelets from in vitro studies showed that platelet aggregation caused by various types of platelet agonists was not inhibited by vardenafil. Studies observed a small concentration-dependent improvement of the antiaggregatory effect fo sodium nitroprusside, a nitric oxide donor, with super-therapeutic concentrations of generic vardenafil. Though combining heparin and vardenafil has yet to be studied in humans, it did not effect the bleeding time in rats.

Use with Alpha-Blockers

Some patients may experience symptomatic hypotension with the conjoined use of alpha-blockers and vardenafil. Conjoining alpha-blockers with vardenafil is ill-advised until more is known about such a combination.

Use with Potent CYP 3A4 Inhibitors

Expect a notable increase in vardenafil plasma levels with the conjoined use of the potent cytochrome P450 3A4 (CYP 3A4) inhibitors, ritovavir, ketoconazole, indinavir, or itraconazole. Not only will higher levels of plasma increase effectiveness but it will also increase the occurance of conflicting events. If being combined with the usage of erythromycin, ketoconazole, and itraconazole, vardenafil’s dose should not exceed a maximum of 5 mg. Do not use vardenafil with the HIV protease inhibitors ritonavir or indinavir. (See INTERACTION WITH DRUGS).

Ability to Drive and Use Machines

Before driving or operating machinery patients should take note of their reactions to vardenafil.

Carcinogenesis/Mutagenesis

Cheap Vardenafil was administers orally in doses up to 75 mg/kg/day to male rates and 25 mg/kg/day to female rats also in drinking water to mice at 150 mg/kg/day to males and 193 mg/kg/day and displayed no carcinogenic activity. Systematic exposure (AUC) to vardenafil was associated with the maximum dose in the studies: 25 (mice) or ~300 (rats) multiplied by that expected in a man taking a daily vardenafil dose of 20mg. When tested for gene mutation (forward mutations in Chinese hamsters V79 cells in vitro and reverse mutations in bacterial cells) or chromosomal damage (mouse micronucleus tested in vivo and Chinese hamsters V79 cells in vitro) vardenafil was found to be non-genotoxic.

Impairment of Fertility

Sperm morphology, motility, nor a variety or parameters that indicate the function of male reproduction were affected, in an individual clinical trial, after a single oral dose of 20 mg of vardenafil. A maximum of 0.0002% of the given dose appeared in patients semen when measurements were taken of vardenafil in the semen of healthy patients 90 mins post dosing.

Male and female rats issued an oral dose of 100 mg/kg/day had no effects on fertility, reproductive performance, or reproductive organ morphology (systematic exposure is greater than 200 times that expected at a dose of 20 mg, the maximum recommended, based on AUC).

Use in Pregnancy (Category B3)

Generic Vardenafil should not be used by women.

Vardenafil (Levitra) and/or its metabolites has seen to cross the placenta and issued to the fetus, according to rat studies. Neither pregnant rats or rabbits, issued vardenafil in oral doses up to 18 mg/kg/day, displayed signs of teratogenicity or embryofetal toxicity. Systematic exposure to vardenafil 7 (rabbit) or 125 (rat) times more than what’s expected at 20 mg, the maximum advised dose, were associated with these doses, based on AUC. Both rats and rabbits experienced increased embryonic resorptions, maternal toxicity, and delayed fetal development when taking higher doses.

Delayed physical development and postnatal pup mortality was a direct result of giving rats a 60 mg/kg/day dose of vardenafil throughout lactation and in late gestation. Systematic exposure ~28 times that expected in a human being 20 mg vardenafil, maximum advised dose, was associated with the “no-effect-dose” of 8 mg/kg/day.

Canadian Vardenafil has not been tested and studied in pregnant women.

Use in Lactation

Vardenafil should not be used by women.

The milk of lactating rats experiences an excretion of vardenafil and/or its metabolites up to 19 times more than the parallel maternal plasma concentration. Rats given an oral vardenafil dose of 60 mg/kg/day during lactation and gestation periods suffered increases in delayed physical development and prenatal and postnatal mortality to offspring.

Human data regarding vardenafil excretion in breast milk or the safty of infants exposed to vardenafil has not been collected.