Clinical Benefits of Low-Dose Vardenafil Treatment

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).

Related/similar drugs

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them: Feeling of warmth and redness of the face, neck, arms, and occasionally, upper chest burning feeling in the chest or stomach burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings feeling of constant movement of self or surroundings increased sensitivity of the eyes to sunlight sores, ulcers, or white spots on the lips or tongue or inside the mouth Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

What are the side effects of vardenafil?

LEVITRA- vardenafil hydrochloride tablet, film coated APHENA PHARMA SOLUTIONS - TENNESSEE, INC. 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. 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%.

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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%.

Warnings & Precautions

Do not use this medicine if you also use riociguat (Adempas®). If you experience a prolonged or painful erection for 4 hours or more, contact your doctor right away. This condition may require prompt medical treatment to prevent serious and permanent damage to your penis. If you have a sudden loss of vision in one or both eyes, contact your doctor right away. Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing with dizziness or ringing in the ears.

Medications & Supplements

If you already use medicine for high blood pressure (hypertension), vardenafil could make your blood pressure go too low. Call your doctor right away if you have blurred vision, confusion, dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position, sweating, or unusual tiredness or weakness. This medicine does not protect you against sexually transmitted diseases (including HIV or AIDS). Use protective measures and ask your doctor if you have any questions about this. Do not take other medicines unless they have been discussed with your doctor.

Erectile Dysfunction

This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements. Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention. Check with your doctor immediately if any of the following side effects occur: dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position fast, irregular, pounding, or racing heartbeat or pulse pain or discomfort in the arms, jaw, back, or neck puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. The mean steady-state volume of distribution (Vss) for vardenafil is 208 L, indicating extensive tissue distribution.

Related Products

Do not push the tablet through the foil. Place the tablet on your tongue and allow it to melt. Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way. Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Are vardenafil and tadalafil available over the counter?

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so. The amount of medicine that you take depends on the strength of the medicine.

What are the most common side effects of vardenafil?

Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine. For treatment of erectile dysfunction:For oral dosage form (disintegrating tablets):Adults—10 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity.Children—Use is not recommended.For oral dosage form (tablets):Adults 65 years and older—5 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. Your doctor may adjust your dose if needed. However, the dose is usually not more than 20 mg once per day.Adults up to 65 years—10 mg as a single dose, no more than once per day, approximately 1 hour before sexual activity. However, the dose is usually not more than 20 mg once per day.Children—Use is not recommended. Vardenafil and its major circulating metabolite, M1, are highly bound to plasma proteins (about 95% for parent drug and M1).

• Vardenafil 5 mg offers a discreet treatment for erectile issues.
• Its onset of action is approximately 30 minutes after ingestion.
• It should be taken about an hour before intimacy.
• Do not crush or break the tablets; swallow whole.
• Patients should discuss health conditions with their doctor first.
• Vardenafil 5 mg is not a cure but manages symptoms.
• Regular use can improve confidence in sexual activity.
• Use caution if you have heart problems or low blood pressure.
• The medication should not be used by women.
• Safety during activities requiring alertness should be assessed.
• Overdose symptoms may include dizziness or chest pain.
• Always adhere to medical advice when using Vardenafil.

This protein binding is reversible and independent of total drug concentrations.

Generic vs Brand

During sexual stimulation, nitric oxide is fildena purple pill 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. 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.

How to Order

For oral dosage form (disintegrating tablets):Adults—10 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity.Children—Use is not recommended. Adults—10 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. For oral dosage form (tablets):Adults 65 years and older—5 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. Adults 65 years and older—5 milligrams (mg) as a single dose, no more than once per day, approximately 1 hour before sexual activity. However, the dose is libido booster women usually not more than 20 mg once per day.

ED Prescriptions for $1-2 Per Pill

Adults up to 65 years—10 mg as a single dose, no more than once per day, approximately 1 hour before sexual activity. Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.

Are you currently using Vardenafil (Levitra, Staxyn)?

It is important that you tell all of your doctors that you take vardenafil. If you need emergency medical care for a heart problem, it is important that your doctor knows when you last took vardenafil. Do not use this medicine if you are also using a nitrate medicine for angina or high blood pressure. Some examples of nitrate medicines include nitroglycerin, isosorbide, Imdur®, Nitro-Bid®, Nitro-Dur®, Nitrol® ointment, Nitrolingual® spray, Nitrostat®, and Transderm Nitro®. Some illegal ("street") drugs called "poppers" also contain nitrates such as amyl nitrate and butyl nitrate. Vardenafil is metabolized predominantly by the hepatic enzyme CYP3A4, with contribution from the CYP3A5 and CYP2C isoforms.

Contraindication	Explanation	Alternative suggestions
Use with nitrates	Can cause dangerous drop in blood pressure	Seek medical advice for ED treatments
Severe cardiovascular disease	Increased risk during sexual activity	Assess cardiovascular health beforehand
Liver impairment	Altered drug metabolism	Dose adjustment or alternative therapy
Retinitis pigmentosa	Potential risk linked to PDE inhibitors	Consult eye specialist

The major circulating metabolite, M1, results from desethylation at the piperazine moiety of vardenafil.

• Vardenafil 5 mg is used to treat erectile dysfunction in men.
• It works by increasing blood flow to the penis.
• Vardenafil 5 mg usually starts working within 30-60 minutes.
• The typical dosage for Vardenafil 5 mg is once daily.
• It is available by prescription only.
• Vardenafil 5 mg may cause side effects like headache or flushing.
• It is more effective when taken on an empty stomach.
• Alcohol can increase the risk of side effects with Vardenafil.
• Do not take Vardenafil 5 mg with nitrates or certain medications.
• Store Vardenafil 5 mg in a cool, dry place away from children.
• Consult your doctor before starting Vardenafil 5 mg.
• Report any persistent or severe side effects to your doctor.

The plasma concentration of M1 is approximately 26% that of the parent compound.

Patient Education

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). 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.

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