WARNINGS AND PRECAUTIONS

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

What is erectile dysfunction (ED)?

Vardenafil AUC and Cmax in elderly males 65 years or older taking vardenafil hydrochloride orally disintegrating tablets were increased by 39% and 21%, respectively, in comparison to patients aged 45 years and below. No overall differences in safety or effectiveness were observed between patients ≥65 years old and those < 65 years old in placebo-controlled clinical trials [see Clinical Pharmacology (12.3)]. Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate or severe hepatic impairment. In volunteers with mild hepatic impairment (Child-Pugh A), the Cmax and AUC following a 10 mg vardenafil (film-coated tablets) dose were increased by 22% and 17%, respectively, compared to healthy control subjects. Do not use vardenafil hydrochloride orally disintegrating tablets in patients with moderate to severe hepatic impairment [see Warnings and Precautions (5.8) and Dosage and Administration (2).] Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis.

Other Interactions

In volunteers with mild renal impairment (CLcr = 50 to 80 mL/min), the pharmacokinetics of vardenafil 20 mg film-coated tablets were similar to those observed in a control group with normal renal function. 10 OVERDOSAGE The maximum dose of vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets 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. No muscle or neurological toxicity was identified.In cases of overdose, standard supportive measures should be taken as required. Renal dialysis is not expected to accelerate clearance because vardenafil is highly bound to plasma proteins and is not significantly eliminated in the urine.

Dosage for people with liver disease

The maximum dose of medicine for erectile dysfunction vardenafil for which human data are available is a single 120 mg dose of the film–coated tablets 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. No muscle or neurological toxicity was identified. In cases of overdose, standard supportive measures should be taken as required. The blood pressure effects were observed when vardenafil 20 mg was dosed 1 or 4 hours before NTG

Brand Name	Price per Pack	Dosage Options	Over-the-counter (OTC)	Prescription Required
Levitra	$40-$60	5, 10, 20 mg	No	Yes
Vardenafil Generic	$10-$25	5, 10, 20 mg	No	Yes
Other Brands	Varies	5-20 mg	No	Yes

and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG.

Product	Dosage	Quantity + Bonus	Price
Cialis Generic	5mg	90 + 6 Pills	115.91€ 110.39€	Buy
Cialis Generic	60mg	180 + 10 Pills	313.11€ 298.20€	Buy
Levitra Professional	20mg	30 Pills	119.12€ 113.45€	Buy
Cialis Professional	40mg	90 + 2 Pills	348.59€ 331.99€	Buy
Cialis Professional	20mg	360 + 6 Pills	807.03€ 768.60€	Buy
Viagra Professional	100mg	360 + 6 Pills	527.09€ 501.99€	Buy
Cialis Generic	10mg	20 Pills	48.23€ 45.93€	Buy
Viagra Generic	50mg	270 + 8 Pills	198.48€ 189.03€	Buy
Viagra Original	100mg	12 Pills	72.54€ 69.09€	Buy
Levitra Generic	60mg	30 + 2 Pills	109.43€ 104.22€	Buy
Levitra Soft Tabs	20mg	270 + 10 Pills	521.78€ 496.93€	Buy

Additional blood pressure and heart rate changes were not detected when vardenafil 20 mg film-coated tablet was dosed 24 hours before

Vardenafil contraindications

Vardenafil hydrochloride orally disintegrating tablets can be used in patients with mild, moderate or severe renal impairment. Do not use vardenafil hydrochloride orally disintegrating tablets in patients on renal dialysis as vardenafil has not been evaluated in such patients [see Dosage and Administration (2.3) and Warnings and Precautions (5.9)]. Vardenafil hydrochloride orally disintegrating tablets are not indicated for use in females. There are no data with the use of vardenafil hydrochloride orally disintegrating tablets in pregnant women to inform any drug-associated risks. In animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of vardenafil during organogenesis at exposures for unbound vardenafil and its major metabolite at approximately 100 and 29 times, respectively, the maximum recommended human dose (MRHD) of 20 mg based on AUC(see Data).

Related treatment guides

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. 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. There is no information on the presence of vardenafil and its major metabolite in human milk, the effects on the breastfed infant, or the effects on milk production.

Last Reviewed Date

Vardenafil is present in rat milk of lactating rats (see Data). 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. Vardenafil hydrochloride orally disintegrating tablets are not indicated for use in pediatric patients. Safety and efficacy in children has not been established. NTG (see Figure 1).Figure 1: Placebo-subtracted point estimates (with 90% CI) of mean maximal blood pressure and heart rate effects of pre-dosing

• Vardenafil can cause temporary vision disturbances.
• Do not use if you have a recent history of heart attack.
• It should be used with caution in those with kidney issues.
• Men with liver problems should seek medical advice.

with vardenafil 20 mg at 24, 8, 4, and 1 hour before 0.4 mg NTG sublinguallyBecause the disease state of patients

Drug Category	Potential Interaction	Effect
Nitrates	Dangerous hypotension	Severe decrease in blood pressure
CYP3A4 Inhibitors	Increased vardenafil levels	Increased side effects
Alpha-blockers	Risk of hypotension	Dizziness, fainting
Pesticides (e.g., erythromycin)	Possible increased plasma levels	Enhanced side effects

requiring nitrate therapy is anticipated to increase the likelihood of hypotension, the use of vardenafil by patients on nitrate therapy or on nitric oxide donors is contraindicated [see Contraindications (4.1)].Blood Pressure Effects

Related Products

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 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).12.2 PharmacodynamicsThe pharmacodynamic studies described below were conducted using vardenafil film-coated tablets.Effects on Blood PressureIn a clinical pharmacology study of patients with erectile dysfunction, single doses of vardenafil 20 mg film-coated tablets 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. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents [see Drug Interactions (7)].Effects on Blood Pressure and Heart Rate when Vardenafil is Combined with NitratesA 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 vardenafil 20 mg film-coated tablets at various times before NTG administration. in Patients on Stable Alpha-Blocker TreatmentThree clinical pharmacology studies were conducted

What should I know about storage and disposal of this medication?

11 DESCRIPTION Vardenafil hydrochloride orally disintegrating tablets, USP are an oral therapy for the treatment of erectile dysfunction. This monohydrochloride salt of vardenafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific PDE5.Vardenafil HCl, USP is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula:Vardenafil HCl, USP is a white or slightly brown or yellow powder with a molecular weight of 579.1. It is slightly soluble in water, freely soluble in anhydrous Ethanol. Practically insoluble in heptane.Vardenafil hydrochloride orally disintegrating tablets, USP are formulated as white to off white, round, orally disintegrating tablets. Vardenafil hydrochloride orally disintegrating tablets, USP are an oral therapy for the treatment of erectile dysfunction.

What are the serious side effects of vardenafil?

Vardenafil HCl, USP is designated chemically as piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-, monohydrochloride and has the following structural formula: Vardenafil hydrochloride orally disintegrating tablets, USP are formulated as white to off white, round, orally disintegrating tablets. 12 CLINICAL PHARMACOLOGY 12.1 Mechanism of ActionPenile 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. in patients with benign prostatic hyperplasia (BPH) on stable-dose alpha-blocker treatment

Parameter	Value	Notes
Absorption Time	30-60 minutes	Peak plasma concentration reached during this time
Half-life	4-5 hours	Duration of drug activity
Bioavailability	Approximately 15%	Oral absorption efficiency
Metabolism	Via CYP3A4 enzyme	Liver processing of drug

, consisting of alfuzosin, tamsulosin or terazosin.Study 1: This study was

• Vardenafil’s patent protection has expired, leading to generic options.
• Side effects can diminish over time with continued use.
• Do not share medication with others.
• Always check for interactions with other medications.

designed to evaluate the effect of 5 mg vardenafil film-coated tablets compared to placebo when administered to BPH patients on chronic alpha-blocker

• Vardenafil is sometimes prescribed off-label for pulmonary hypertension.
• It is not suitable for women or children.
• Patients should report any unexplained vision loss.
• Avoid using grapefruit juice with vardenafil.

therapy in two separate cohorts: tamsulosin 0.4 mg daily (cohort 1, n=21) and terazosin 5 or 10 mg daily (cohort 2, n=21).

• Vardenafil efficacy depends on proper dosage and timing.
• It is generally safe when used as directed.
• Patients should avoid heavy meals before intake.
• Follow-up with your healthcare provider regularly.