Vardenafil 5 mg Oral Tablet RxNorm 349478

You may report side effects to the FDA at 1-800-FDA-1088.

Before Using

These side effects may go away during treatment as your body adjusts to the medicine. 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. LEVITRA- vardenafil hydrochloride tablet, film coated APHENA PHARMA SOLUTIONS - TENNESSEE, INC.

• Vardenafil 5 mg may be less effective if taken with high-fat meals.
• Side effects like indigestion or muscle aches are possible.
• Inform your doctor about any allergic reactions experienced.
• Be cautious if you have low blood pressure or heart disease.
• It is recommended to avoid taking other ED medications concurrently.
• Regular check-ups help assess medication effectiveness.
• Discontinue use and seek help if adverse reactions occur.
• The medication can improve intimacy confidence and quality.
• Use the lowest effective dose to minimize side effects.
• Vardenafil 5 mg is generally safe when used responsibly.
• Keep out of reach of children and pets.
• Consult your healthcare provider for personalized advice.

LEVITRA® is an oral therapy for the treatment of erectile dysfunction.

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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.

Warnings & Precautions

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. 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.

Full form of descriptor (FN): Product containing precisely vardenafil (as vardenafil hydrochloride) 5 mg/1 each conventional release oral tablet (clinical drug) (Atom ID: 11440906)

Peel back the foil and take the tablet out. 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. 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. Nitric oxide activates the enzyme guanylate cyclase resulting in increased synthesis erectile dysfunction treatment 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.

Vardenafil dosing information

Do not eat grapefruit or drink grapefruit juice while you are using this medicine. 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.

What is vardenafil, and what is it used for?

The amount of medicine that you take depends on the strength of the medicine. 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 buy super p force jelly day, approximately 1 hour before sexual activity. The tissue concentration of cGMP is regulated by both the rates of synthesis and degradation via phosphodiesterases (PDEs).

• Vardenafil 5 mg is effective in treating primary and secondary ED.
• It is marketed under various brand names worldwide.
• Generic Vardenafil 5 mg is usually more affordable.
• It is not suitable for individuals with certain eye conditions.
• Possible side effects include nasal congestion or dizziness.
• Use with caution if you have kidney or liver issues.
• Consultation with a healthcare provider is essential before use.
• Vardenafil 5 mg does not provide protection from sexually transmitted infections.
• Keep medical records updated when taking this medication.
• Never share your medication with others.
• It is important to have realistic expectations about treatment.
• Follow-up appointments help monitor efficacy and safety.

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.

Upcoming Events

Ask your healthcare professional how you should dispose of any medicine you do not use. 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 lovegra 100 mg 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®.

What are the most common side effects of vardenafil?

Some illegal ("street") drugs called "poppers" also contain nitrates such as amyl nitrate and butyl nitrate. 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. 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).

Storage Condition	Recommended Temperature	Light & Moisture Protection	Shelf Life
In a cool, dry place	15-30°C (59-86°F)	Keep in tightly sealed container	2-3 years from manufacture date
Keep out of reach of children	Yes	Yes
Avoid exposure to humidity	No	Store away from sunlight

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.

• Vardenafil 5 mg is a PDE5 inhibitor for erectile dysfunction.
• It helps men achieve and maintain an erection suitable for intercourse.
• Vardenafil 5 mg is often prescribed when other treatments fail.
• This medication can be taken with or without food.
• The effects of Vardenafil 5 mg last about 4-6 hours.
• It is important to follow your healthcare provider’s instructions.
• Avoid high-fat meals close to taking Vardenafil for faster effect.
• Combining Vardenafil 5 mg with recreational drugs is dangerous.
• It may interact with blood pressure medications.
• Do not exceed the prescribed dose to prevent risks.
• Vardenafil 5 mg is generally well-tolerated.
• Always check for contraindications before use.

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). 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.

Usual Adult Dose for Erectile Dysfunction

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. 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.

Dosage Modifications

Do not take other medicines unless they have been discussed with your doctor. 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. 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%.

What are the differences between vardenafil and tadalafil?

However, the dose is usually not more than 20 mg once per day.Children—Use is not recommended. 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.

Who should not take vardenafil?

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. 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. 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 208 L, indicating extensive tissue distribution.

• Vardenafil 5 mg is not suitable for individuals taking certain heart medications.
• The medication may cause dizziness or lightheadedness in some users.
• Proper storage extends shelf life and maintains potency.
• Lifestyle factors like stress can impact treatment success.
• Avoid heavy meals before taking Vardenafil 5 mg to speed absorption.
• The medication does not work without sexual stimulation.
• Be aware of potential interactions with other prescribed drugs.
• Patients should avoid driving if feeling dizzy after taking it.
• Consult your doctor if you experience prolonged or painful erections.
• Vardenafil 5 mg has a rapid onset but variable duration.
• It is important to review medical history before starting therapy.
• Combination therapy with other ED treatments should only be under medical supervision.

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.