Vilitra 20 mg- Vardenafil Tablets 20mg – Generic Levitra

Pediatrics: Vardenafil trials were not conducted in the pediatric population.

Proper Use

Seek medical attention if the erection persists for more than 4 hours after sexual intercourse. Skip alcohol or limit it, as too much can reduce the effectiveness of the medicine. If you feel dizzy, lightheaded, or experience chest discomfort after taking Vilitra 20 Tablet, contact your doctor immediately. Do not take Vilitra 20 Tablet if you recently had a stroke, a heart attack or if you have severe liver disease or very low blood pressure. Katzung BG, Chatterjee K.

Understanding the Benefits of Generic Levitra

Vasodilator & the Treatment of Angina Pectoris. New Delhi, India: Tata McGraw Hill Education Private Limited; 2009. p. 197. LEVITRA- vardenafil hydrochloride tablet, film coated APHENA PHARMA SOLUTIONS - TENNESSEE, INC. Geriatrics: In a healthy volunteer study of elderly males (≥65 years) and younger males (18–45 years), mean Cmax and AUC were 34% and 52% higher, respectively, in the elderly males (see PRECAUTIONS, Geriatric Use and DOSAGE AND ADMINISTRATION). Consequently, a lower starting dose of LEVITRA (5 mg) in patients ≥65 years of age should be considered. Renal Insufficiency: In volunteers with mild renal impairment (CLcr = 50-80 ml/min), the pharmacokinetics of vardenafil were similar to those observed in a control group with normal renal function.

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In the moderate (CLcr = 30-50 ml/min) or severe (CLcr<30 ml/min) renal impairment groups, the AUC of vardenafil was 20–30% higher compared to that observed in a control group with normal renal function (CLcr>80 ml/min). Vardenafil pharmacokinetics have not been evaluated in patients requiring renal dialysis (see PRECAUTIONS, Renal Insufficiency, and DOSAGE AND ADMINISTRATION). Hepatic Insufficiency: 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.

How should I use vardenafil?

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). The pharmacokinetics of vardenafil are approximately dose proportional over the recommended dose range. Vardenafil is eliminated predominantly by hepatic metabolism, mainly by CYP3A4 and to a minor extent, CYP2C isoforms. Concomitant use with potent CYP3A4 inhibitors such as ritonavir, indinavir, ketoconazole, as well as moderate CYP3A inhibitors such as erythromycin results in significant increases of plasma levels of vardenafil (see PRECAUTIONS, WARNINGS and DOSAGE AND ADMINISTRATION).

Typical dose

Mean vardenafil plasma concentrations measured after the administration of a single oral dose of 20 mg to healthy male volunteers are depicted in Figure 1. Figure 1: Plasma Vardenafil Concentration (Mean ± SD) Curve for a Single 20 mg LEVITRA Dose Vardenafil is rapidly absorbed with absolute bioavailability of approximately 15%. Maximum observed plasma concentrations after a single 20 mg dose in healthy volunteers are usually reached between 30 minutes and 2 hours (median 60 minutes) after oral dosing in the fasted state. Two food-effect studies were conducted which showed that high-fat meals caused a reduction in Cmax by 18%-50%. The mean steady-state volume of distribution (Vss) for vardenafil is brand levitra price 208 L, indicating extensive tissue distribution. In volunteers with moderate hepatic impairment (Child-Pugh B), the Cmax and AUC following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects. Consequently, a starting dose of 5 mg is recommended for patients with moderate hepatic impairment, and the maximum dose should not exceed 10 mg (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).

What special precautions should I follow?

Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1). This protein binding is reversible and independent of total drug concentrations. Following a single oral dose of 20 mg vardenafil in healthy volunteers, a mean of 0.00018% of the administered dose was obtained in semen 1.5 hours after dosing. Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms. The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil.

Symptoms of overdose may include:

The plasma concentration of M1 is approximately 26% that of the parent compound. This metabolite shows a phosphodiesterase selectivity profile similar to that of vardenafil and an in vitro inhibitory potency for PDE5 28% of that of vardenafil. Therefore, M1 accounts for approximately 7% of total pharmacologic activity. The total body clearance of vardenafil is 56 L/h, and the terminal half-life of vardenafil and its primary metabolite (M1) is approximately 4-5 hours. After oral administration, vardenafil is excreted as metabolites predominantly in the feces (approximately 91-95% of administered oral dose) and to a lesser extent in the urine (approximately 2-6% of administered oral dose). Vardenafil has not been evaluated in patients with severe (Child-Pugh C) hepatic impairment. 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.

What is vardenafil?

Do not take this medicine if you have severe heart or liver problems, if you have recently had a stroke or heart attack or if you have low blood pressure. Let your doctor know if you suffer from these or any other health problems before taking it. You should not drive if this medicine makes you feel dizzy. Avoid drinking alcohol while taking this medicine as it can lead to side effects. Do not take this medicine if you also take medicines called nitrates (often given for chest pain).

When to Seek Medical Attention

Flushing (sense of warmth in the face, ears, neck and trunk) Vilitra 20 Tablet is not indicated for use in women. Vilitra 20 Tablet is not indicated for use in women. Take Vilitra 20 Tablet about 30 to 60 minutes before sexual activity for best results. Avoid high-fat meals around the time you take it, as they can slow down how quickly this medicine works. Do not take more than one dose in a day as it will not improve the effect and may cause side effects. 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.

What other drugs will affect Levitra?

LEVITRA® is an oral therapy for the treatment of erectile dysfunction. Vardenafil HCl 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 is a nearly colorless, solid substance with a molecular weight of 579.1 g/mol and a solubility of 0.11 mg/mL in water. LEVITRA is formulated as orange, round, film-coated tablets with “BAYER” cross debossed on one side and “2.5”, “5”, “10”, and “20” on the other side corresponding to 2.5 mg, 5 mg, 10 mg, and 20 mg of vardenafil, respectively. 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.

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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. Vardenafil may add to the blood pressure lowering effects of antihypertensive agents (see PRECAUTIONS, Drug Interactions). 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. The blood pressure effects were observed when LEVITRA 20 mg was dosed 1 or 4 hours before NTG and the heart rate effects were observed when 20 mg was dosed 1, 4, or 8 hours before NTG. Additional blood pressure and heart rate changes were not detected when LEVITRA 20 mg was dosed 24 hours before NTG.

• Levitra 20 mg is a phosphodiesterase inhibitor used for ED.
• The tablet can be taken with or without food for convenience.
• It is important to have an erection sufficient for sexual activity.
• Do not take Levitra if you are on nitrate medications.
• Alcohol can impair the effectiveness and increase side effects.
• Overuse can increase the risk of serious side effects.
• Follow your doctor's guidelines for safe use and dosage.
• Patients should report any persistent or painful erections.
• Levitra 20 mg may cause flushing, headache, or upset stomach.
• Avoid using with grapefruit or grapefruit juice.
• Tell your doctor if you experience sudden vision loss.
• Store medication out of children's reach and at room temperature.

Figure 2: Placebo-subtracted point estimates (with 90% CI) of mean maximal blood pressure and heart rate effects of pre-dosing with LEVITRA 20 mg at 24, 8, 4, and 1 hour before 0.4 mg NTG sublingually. Because the disease state of patients 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).

• Levitra 20 mg should be used responsibly under medical advice.
• Do not mix with recreational drugs or alcohol.
• The medication requires sexual stimulation to work.
• It is a prescription medication, not over-the-counter.
• Patients with liver or kidney issues should consult a doctor.
• Levitra may cause a drop in blood pressure.
• The medication is designed for adult men only.
• Always read the patient information leaflet carefully.
• Do not use if allergic to vardenafil or any component.
• Be aware of potential drug interactions before use.
• Seek emergency medical help if symptoms of an allergic reaction occur.
• Regular check-ups are recommended for ongoing treatment.

The effect of 10 mg and 80 mg vardenafil on QT interval was evaluated in a single-dose, double-blind, randomized, placebo- and active-controlled (moxifloxacin 400 mg) crossover study in 59 healthy males (81% White, 12% Black, 7% Hispanic) aged 45-60 years. The QT interval was measured at one hour post dose because this time point approximates the average time of peak vardenafil concentration.

Condition	Risk/Consideration	Alternative Recommendation
Nitrate use	Severe hypotension	Do not take Levitra with nitrates
Severe hepatic impairment	Increased drug levels	Consult doctor for adjusted dose
Retinitis Pigmentosa	Potential for vision disturbance	Use under medical supervision
Hypotension (<90/50 mmHg)	Risk of worsening symptoms	Monitor blood pressure
Heart failure (unstable)	Increased cardiovascular risk	Medical evaluation beforehand