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Dosage adjustment is necessary in patients with moderate hepatic impairment (Child-Pugh B). Do not use LEVITRA in patients with severe (Child-Pugh C) hepatic impairment.

[See DOSAGE AND ADMINISTRATION and CLINICAL PHARMACOLOGY and Use In Specific Populations .] Renal Impairment.

Do not use LEVITRA in patients on renal dialysis, as vardenafil has not been evaluated in this population [see DOSAGE AND ADMINISTRATION and Use In Specific Populations ]. Combination With Other Erectile Dysfunction Therapies. The safety and efficacy of LEVITRA used in combination with other treatments for erectile dysfunction have not been studied.

Therefore, the use of such combinations is not recommended.

In humans, vardenafil alone in doses up to 20 mg does not prolong the bleeding time.

There is no clinical evidence of any additive prolongation of the bleeding time when vardenafil is administered with aspirin.

LEVITRA has not been administered to patients with bleeding disorders or significant active peptic ulceration.

Therefore LEVITRA should be administered to these patients after careful benefit-risk assessment.

The use of LEVITRA offers no protection against sexually transmitted diseases. Counseling of patients about protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered.

Inform patients that LEVITRA is contraindicated with regular and/or intermittent use of organic nitrates.

Patients should be counseled that concomitant use of LEVITRA with nitrates could cause blood pressure to suddenly drop to an unsafe level, resulting in dizziness, syncope, or even heart attack or stroke. Inform patients that Levitra is contraindicated in patients who use guanylate cyclase stimulators, such as riociguat. Discuss with patients the potential cardiac risk of sexual activity for patients with preexisting cardiovascular risk factors.

Concomitant Use With Drugs Which Lower Blood Pressure.

Inform patients that in some patients concomitant use of PDE5 inhibitors, including LEVITRA, with alpha-blockers can lower blood pressure significantly leading to symptomatic hypotension (for example, fainting).

Patients prescribed LEVITRA who are taking alpha-blockers should be started on the lowest recommended starting dose of

LEVITRA

Patients should be counseled regarding the dosing of LEVITRA especially regarding the maximum daily dose. Patients should be advised to contact their healthcare provider for dose modification if they are not satisfied with the quality of their sexual performance with LEVITRA or in the case of an unwanted effect.

Inform patients that there have been rare reports of prolonged erections greater than 4 hours and priapism (painful erections greater than 6 hours in duration) for LEVITRA and this class of compounds.

In the event that an erection 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. Advise patients to contact the prescribing physician if new medications that may interact with LEVITRA are prescribed by another healthcare provider.

Inform patients to stop use of all PDE5 inhibitors, including LEVITRA, and seek medical attention in the event of sudden loss of vision in one or both eyes. Such an event may be a sign of non-arteritic anterior ischemic optic neuropathy (NAION), a cause of decreased vision, including permanent loss of vision, that has been reported rarely post-marketing in temporal association with the use of all PDE5 inhibitors. Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye. Physicians should also discuss with patients the increased risk of NAION among the general population in patients with a “crowded” optic disc, although evidence is insufficient to support screening of prospective users of PDE5 inhibitor, including LEVITRA, for this uncommon condition [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS ]. Advise patients to stop taking PDE5 inhibitors, including LEVITRA, and seek prompt medical attention in the event of sudden decrease or loss of hearing. These events, which may be accompanied by tinnitus and dizziness, have been reported in temporal

association

Inform patients viagra no prescription usa that LEVITRA offers no protection against sexually transmitted diseases. Counsel patients that protective measures necessary to guard against sexually transmitted diseases, including the Human Immunodeficiency Virus (HIV), should be considered. Inform patients that the recommended starting dose of LEVITRA is 10 mg.

The dose may be increased to a maximum recommended dose of 20 mg or decreased to 5 mg based on efficacy and tolerability. The maximum recommended dosing frequency is one tablet per day. Carcinogenesis, Mutagenesis, Impairment Of Fertility.

Vardenafil was not carcinogenic in rats and mice when administered daily for 24 months. In these studies systemic drug exposures (AUCs) for unbound (free) vardenafil and its major metabolite were approximately 400-and 170-fold for male and female rats, respectively, and 21-and 37-fold for male and female mice, respectively, the exposures observed in human males given the Maximum Recommended Human Dose (MRHD) of 20 mg. Vardenafil was not mutagenic as assessed in either the in vitro bacterial Ames assay or the forward mutation assay in Chinese hamster V 79 cells. Vardenafil was not clastogenic as assessed in either the in vitro chromosomal aberration test or the in vivo mouse micronucleus test. Vardenafil did not impair fertility in male and female rats administered doses up to 100 mg/kg/day for 28 days prior to mating in male, and for 14 days prior to mating and through day 7 of gestation in females.

In a corresponding 1-month rat toxicity study, this dose produced an AUC value for unbound vardenafil 200 fold greater than AUC in humans at the MRHD of 20 mg. Pregnancy Category B LEVITRA is not indicated for use in women. There are no studies of LEVITRA use in pregnant women.

No evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis.

This dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the AUC values for unbound vardenafil and its major metabolite in humans given the maximum recommended human dose (MRHD) of 20 mg.

In the rat pre-and postnatal development study, the NOAEL (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day.

Retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. The number of living pups born to rats exposed pre-and postnatally was reduced at 60 mg/kg/day.

Based on the results of the pre-and postnatal study, the developmental NOAEL is less than 1 mg/kg/day.

Based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total AUC values for unbound vardenafil and its major metabolite comparable to the human AUC at the MRHD of 20 mg. It is not known if vardenafil is excreted in human breast milk.

Vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma.

Following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours.

LEVITRA is not indicated for use in pediatric patients. Safety and efficacy have not been established in this population. Elderly males 65 years of age and older have higher vardenafil plasma concentrations than younger males (18 – 45 years), mean Cmax and AUC were 34% and 52% higher, respectively. Phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of LEVITRA 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients. However, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg LEVITRA should be considered in patients ?65 years of age [see CLINICAL PHARMACOLOGY ].

Dosage adjustment is necessary in patients with moderate hepatic impairment. Do not use LEVITRA in patients with severe hepatic impairment (Child-Pugh C). Vardenafil has not been evaluated in this patient population.

A starting dose of 5 mg is recommended in patients with moderate hepatic impairment (Child-Pugh B) and the maximum dose should not exceed 10 mg. In volunteers with moderate hepatic impairment, the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. [See WARNINGS AND PRECAUTIONS and DOSAGE AND ADMINISTRATION .] In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. No dosage adjustment is necessary in patients with mild hepatic impairment.

Do not use LEVITRA in patients on renal dialysis as vardenafil has not been evaluated in such patients.

No dosage adjustment is necessary in patients with creatinine clearance (CLcr) of 30–80 mL/min. In male volunteers with CLcr = 50-80 ml/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with CLcr >80 mL/min.

In male volunteers with CLcr = 30-50 mL/min or CLcr 80 mL/min.

[See DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS .] OVERDOSE. The maximum dose of LEVITRA for which human data are available is a single 120 mg dose administered to healthy male volunteers. The majority of these subjects experienced reversible back pain/myalgia and/or “abnormal vision.” Single doses up to 80 mg vardenafil and multiple doses up to 40 mg vardenafil administered once daily over 4 weeks were tolerated without producing serious adverse side effects.

When 40 mg of vardenafil was administered twice daily, cases of severe back pain were observed.

In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance as vardenafil is highly bound to plasma proteins and not significantly eliminated in the urine.

Administration of LEVITRA with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see CLINICAL PHARMACOLOGY ]. Consistent with the effects of PDE5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, PDE5 inhibitors, including LEVITRA, may potentiate the hypotensive effects of nitrates. A suitable time interval following dosing of LEVITRA for the safe administration of nitrates or nitric oxide donors has not been determined. Do not use LEVITRA in patients who are using a GC stimulator, such as riociguat. PDE5 inhibitors, including LEVITRA may potentiate the hypotensive effects of GC stimulators. Penile erection is a hemodynamic process initiated by the relaxation of smooth muscle in the corpus cavernosum and its associated arterioles. During sexual stimulation, nitric oxide is released from nerve endings and endothelial cells in the corpus cavernosum. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis of cyclic guanosine monophosphate (cGMP) in the smooth muscle cells of the corpus cavernosum.

The cGMP in turn triggers smooth muscle relaxation, allowing increased blood flow into the penis, resulting in erection. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs).

The most abundant PDE in the human corpus cavernosum is the cGMP-specific phosphodiesterase type 5 (PDE5); therefore, the inhibition of PDE5 enhances erectile function by increasing the amount of cGMP.

Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 has no effect in the absence of sexual stimulation. In vitro studies have shown that vardenafil is a selective inhibitor of PDE5.

The inhibitory effect of vardenafil is more selective on PDE5 than for other known phosphodiesterases (>15-fold relative to PDE6, >130-fold relative to PDE1, >300-fold relative to PDE11, and >1,000-fold relative to PDE2, 3, 4, 7, 8, 9, and 10). In a clinical pharmacology study of patients with erectile dysfunction, single doses of vardenafil 20 mg caused a mean maximum decrease in supine blood pressure of 7 mmHg systolic and 8 mmHg diastolic (compared to placebo), accompanied by a mean maximum increase of heart rate of 4 beats per minute. The maximum decrease in blood pressure occurred between 1 and 4 hours after dosing. Following multiple dosing for 31 days, similar blood pressure responses were observed on Day 31 as on Day 1. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents [see DRUG INTERACTIONS ]. Effects On Blood Pressure And Heart Rate When LEVITRA Is Combined With Nitrates.

A study was conducted in which the blood pressure and heart rate response to 0.4 mg nitroglycerin (NTG) sublingually was evaluated in 18 healthy subjects following pretreatment with LEVITRA 20 mg at various times before NTG administration.

LEVITRA 20 mg caused an additional time-related reduction in blood pressure and increase in heart rate in association with NTG administration.