Label: VARDENAFIL tablet, orally disintegrating

This medicine should come with a patient information leaflet.

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Blood vessel problems creams for erectile dysfunction (eg, aortic stenosis, idiopathic subaortic stenosis) or Heart attack (within the last 6 months) or Retinitis pigmentosa (an inherited eye disorder) or Stroke, history of—Should not be used in patients with these conditions. Stomach ulcers—Chance of problems occurring may be increased. It is not known if the medicine is safe for use in these patients. Fructose intolerance—The Staxyn® disintegrating tablet contains sorbitol, which can make this condition worse. QT prolongation (rare heart condition), or history of—Use with caution. Ask your doctor or pharmacist if you have any questions. You may take this medicine with or without food. This medicine usually begins to work within 60 minutes after taking it and stimulation of the penis is required.

If you have any questions about the use of vardenafil, talk to your doctor.

Dose Adjustments

By blocking PDE5, vardenafil increases cGMP levels, improving blood flow to the penis and improving erectile function. The pharmacodynamics of vardenafil involves its ability to inhibit PDE5, which results in increased levels of cGMP and improved erectile function. vardenafil has more excellent selectivity for PDE5 than other PDE isoforms, reducing the likelihood of side effects. The onset of action is 60 minutes The peak plasma time is 30-120 min The drug is metabolized in the liver by CYP2C9 and CYP3A4 The half-life is 3-6 hours The rate of total body clearance is 56 L/hr The drug is excreted 95% in feces and 5% in urine vardenafil is a medication typically taken orally, about 30 to 60 minutes before sexual activity. The medication is in tablet form and should be taken with a full glass of water.

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The recommended starting dose of vardenafil is 10 mg, although the dose may be adjusted based on individual response and tolerability. The maximum recommended dose is 20 mg per day. vardenafil should not be taken more than once per day, and it should not be taken with grapefruit juice or high-fat meals, as these can affect the absorption and effectiveness of the medication. Individuals taking vardenafil should avoid alcohol and not take the medication with other drugs that can interact with it, such as nitrates or nitric oxide donors. vardenafil is used to treat erectile dysfunction (ED) in adult men.

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Erectile dysfunction is when a man has difficulty achieving or maintaining an erection sufficient for sexual activity. vardenafil works by increasing blood flow to the penis, which helps to improve erectile function. vardenafil belongs to a class of drugs called phosphodiesterase type 5 (PDE5) inhibitors, which also include sildenafil (Viagra) and tadalafil (Cialis). These medications all work by inhibiting the action of the enzyme PDE5, which breaks down cyclic guanosine monophosphate (cGMP), a molecule that plays a role in erectile function. By blocking PDE5, vardenafil increases cGMP levels in the smooth muscle cells of the penis, leading to improved blood flow and better erectile function. If you are using the disintegrating tablet, make sure your hands are dry before you handle the tablet. Do not open the blister pack until you are ready to take the tablet. Peel back the foil and take the tablet out.

• Vardenafil 10 mg tablets treat erectile dysfunction in men.
• The medication works by increasing blood flow to the penis.
• Take vardenafil 10 mg about 30 minutes before activity.
• It can be taken with or without food, but high-fat meals may delay effects.
• Maximum recommended dose is one tablet per 24 hours.
• Vardenafil may cause side effects like headache or flushing.
• Do not use vardenafil if you take nitrates for chest pain.
• Consult a doctor before using vardenafil if you have heart problems.
• Store vardenafil tablets at room temperature, away from moisture.
• Alcohol can increase side effects of vardenafil.

Do not push the tablet through the foil. Place the tablet on your tongue and allow it to melt.

• Some users may experience mild flickering vision episodes.
• The efficacy of vardenafil varies between individuals.
• The medication is available in various dosage forms.
• Always follow the specific instructions provided.
• Avoid taking vardenafil with high-fat meals to speed absorption.
• Do not take vardenafil if allergic to its ingredients.
• The drug may cause a temporary burning sensation.
• Use caution in patients with a history of priapism.
• Avoid combining vardenafil with certain herbal supplements.
• Consult your doctor about any ongoing health treatments.

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.

Usual Geriatric Dose for Erectile Dysfunction

The effects may be increased because of slower removal of the medicine from the body. Phenylketonuria (PKU)—The Staxyn® disintegrating tablet contains aspartame, which can make this condition worse. Use this medicine exactly as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. If you use too much, the chance of having unwanted effects is increased. 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.

• Vardenafil 10 mg enhances natural erectile response.
• The medication is prescription-only in most countries.
• Common brand names include Levitra and Staxyn.
• Do not crush or split the tablet unless instructed.
• Using more than the prescribed dose can increase risk.
• Vardenafil is a phosphodiesterase inhibitor.
• It is not intended for use by women.
• Possible side effects include nasal congestion and dizziness.
• Seek medical advice if you experience priapism.
• Keep out of reach of children.

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.

Do erectile dysfunction medicines increase sexual desire?

Without physical action to the penis, such as that occurring during sexual intercourse, avanafil will not work to cause an erection. This medicine is available only with your doctor's prescription. This product is available in the following dosage forms: In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines.

Consumer Information Use and Disclaimer

Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully. Vardenafil is not indicated for use in children. Safety and efficacy have not been established. Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vardenafil in the elderly.

What should I tell my healthcare provider before taking vardenafil?

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding. Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. 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.

12.2 Pharmacodynamics

The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive. Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take. Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Usual Adult Dose for:

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially: Abnormally shaped penis, including a curved penis and birth defects or Crowded disc or low cup to disc ratio in the eye (an eye disorder) or Hyperlipidemia (high fats in the blood) or Multiple myeloma (cancer of the blood) or Non-arteritic anterior ischemic optic neuropathy (NAION; serious eye condition), history of or Smoking—May increase the chance for a serious side effect in the eye called NAION. Your doctor may adjust your dose if needed.

5.12 Phenylketonurics

Bayer healthcare pharmaceuticals inc • Vardenafil is indicated for the treatment of erectile dysfunction. Vardenafil is a phosphodiesterase 5 inhibitor used to treat erectile dysfunction. Vardenafil inhibits cyclic guanosine monophosphate (GMP) specific phosphodiesterase type 5 (PDE5), which is responsible for the degradation of cyclic GMP in the corpus cavernosum located around the penis. Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cyclic GMP in smooth muscle cells.

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Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum. Therefore, the inhibition of PDE5 by vardenafil enhances erectile function by increasing the amount of vigora 200 mg cyclic GMP. Vardenafil is indicated for the treatment of erectile dysfunction. Vardenafil is used to treat men with erectile dysfunction (sexual impotence). It belongs to a group of medicines called phosphodiesterase 5 (PDE5) inhibitors.

Who should not take vardenafil?

These medicines prevent an enzyme called phosphodiesterase type-5 from working too quickly. The penis is one of the areas where this enzyme works. Erectile dysfunction is a condition where the penis does not harden and expand when a man is sexually excited, or when he cannot keep an erection. When a man is sexually stimulated, his body's normal response is to increase blood flow to his penis to produce an erection. By controlling the enzyme, avanafil helps to maintain an erection after the penis is stroked by increasing blood flow to the penis. 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.

• Side effects can include headache, flushing, or stomach upset.
• Serious side effects are rare but require immediate medical attention.
• Vardenafil may cause changes in color vision.
• Use caution if using other medication for blood pressure.
• The medication helps improve erectile function temporarily.
• Do not share tablets with others.
• Follow storage instructions to maintain efficacy.
• Report any allergic reactions promptly.
• The drug should be used only under medical supervision.
• Used responsibly, vardenafil can improve quality of life.