Vardenafil Hydrochloride Tablets

Ensure you read and understand the patient information leaflet provided with vardenafil hydrochloride tablets before starting and each time you refill your prescription. This leaflet is a valuable source of new information and can be shared with your partner. However, it does not replace professional consultations with your doctor, with whom you should discuss your use of vardenafil hydrochloride tablets at the commencement and during routine appointments. If any information is unclear or if you have further questions, consult with your healthcare provider or pharmacist.

CRUCIAL INFORMATION REGARDING VARDENAFIL HYDROCHLORIDE TABLETS

When combined with certain medications, vardenafil hydrochloride tablets can lead to a significant and unsafe drop in blood pressure, potentially causing dizziness, fainting, or even a heart attack or stroke.

Avoid vardenafil hydrochloride tablets if you:

• Use medicines known as "nitrates" commonly prescribed for chest pain or angina.
• Consume "poppers," recreational substances like amyl nitrate or butyl nitrate.
• Take riociguat (Adempas®), a medication for treating specific types of pulmonary hypertension.

Inform all your healthcare providers about your use of vardenafil hydrochloride tablets, especially in emergencies involving heart conditions, to ensure they are aware of your last dosage.

UNDERSTANDING VARDENAFIL HYDROCHLORIDE TABLETS

Vardenafil hydrochloride is a prescription medication for treating erectile dysfunction (ED) in men, designed to be taken orally.

ED is when the penis does not become firm or stay firm during sexual arousal, causing distress. Men facing such issues should consult their doctor. Vardenafil hydrochloride tablets can aid in achieving and maintaining an erection when sexually aroused.

However, vardenafil hydrochloride tablets do not:

• Cure ED
• Boost sexual desire
• Prevent sexually transmitted infections (STIs), including HIV. Discuss STI prevention with your doctor.
• Act as a contraceptive for men.

Vardenafil hydrochloride tablets are specifically for men with ED and should not be used by women or children, only under medical supervision.

HOW VARDENAFIL HYDROCHLORIDE TABLETS FUNCTION

Vardenafil hydrochloride tablets work by enhancing blood flow to the penis during sexual stimulation, facilitating an erection. After sexual activity, the increased blood flow will subside, and the erection will diminish.

ELIGIBILITY FOR VARDENAFIL HYDROCHLORIDE TABLETS USE

Consult your doctor to determine if vardenafil hydrochloride tablets are suitable for you. They are proven effective for men over 18 years old with ED, including those with diabetes or who have had a prostatectomy.

WHO SHOULD AVOID VARDENAFIL HYDROCHLORIDE TABLETS?

Avoid vardenafil hydrochloride tablets if you:

• Take nitrates for chest pain or angina.
• Use riociguat for pulmonary hypertension.
• Have been advised against sexual activity due to health concerns, as it may strain the heart.

BEFORE TAKING VARDENAFIL HYDROCHLORIDE TABLETS

Discuss your health history with your doctor, including any heart, blood pressure, stroke, seizure, liver, kidney, eye diseases, ulcers, bleeding disorders, penis deformities, prolonged erections, blood cell issues, or hearing problems.

INTERACTIONS WITH OTHER MEDICATIONS

Inform your doctor about all medications, vitamins, and supplements you're taking, as vardenafil hydrochloride tablets can interact with other drugs, especially nitrates, certain antifungals, HIV protease inhibitors, antibiotics, alpha-blockers, and medications for irregular heartbeat.

TAKING VARDENAFIL HYDROCHLORIDE TABLETS

Follow your doctor's instructions closely. Do not exceed one tablet per day, and allow at least 24 hours between doses. Your doctor will determine the appropriate dose based on your health and other medications. Vardenafil hydrochloride tablets can be taken with or without food and require sexual stimulation to work effectively.

Consult your doctor for any dose adjustments and seek immediate medical help if you overdose.

POSSIBLE SIDE EFFECTS

Common side effects include headaches, flushing, nasal congestion, indigestion, dizziness, and back pain, which typically resolve within a few hours. Seek medical attention for prolonged erections, vision or hearing changes, or any bothersome side effects.

STORAGE INSTRUCTIONS

Store the tablets at room temperature, away from children.

GENERAL VARDENAFIL GUIDANCE

Vardenafil hydrochloride tablets should not be shared or used for conditions not prescribed. For more detailed information, consult healthcare professionals.

Active Ingredient: Vardenafil hydrochloride. Inactive ingredients include microcrystalline cellulose, hydroxypropyl cellulose, and others, with specific colorants listed.

This information is FDA-approved for your safety and awareness.

For further details, contact 1-866-210-9797.

This summary reflects key points about vardenafil hydrochloride tablets and is not exhaustive. Always consult healthcare providers for medical advice and information tailored to your health needs.

More complete information may be found here.

General Vardenafil Dosage Guidelines

General Dosage Guidelines For the majority of individuals, it is advised to begin with a 10 mg dose of vardenafil hydrochloride, taken orally when needed, about an hour prior to sexual activity. Depending on the effectiveness and any side effects experienced, this dosage can be adjusted up to a maximum of 20 mg or reduced to 5 mg. It is recommended not to exceed one dose per day. For the medication to work, sexual arousal is necessary.

Consumption with Food The intake of vardenafil hydrochloride tablets is not affected by food, meaning they can be consumed either with or without eating.

Recommendations for Specific Groups Elderly Patients: For those aged 65 and over, a reduced starting dose of 5 mg vardenafil hydrochloride tablets is advised.

Patients with Moderate Liver Problems: A starting dose of 5 mg is recommended for individuals with moderate liver issues (Child-Pugh B), and the dose should not exceed 10 mg.

Patients with Severe Liver Problems: Vardenafil hydrochloride tablets are not recommended for those with severe liver conditions (Child-Pugh C).

Patients with Kidney Issues: These tablets should not be used by individuals undergoing kidney dialysis.

Interactions with Other Medications Nitrates and Nitric Oxide Donors: The simultaneous use of these substances with vardenafil is strictly prohibited.

GC Stimulators like Riociguat: Such concurrent use is also prohibited.

CYP3A4 Inhibitors: Adjustments to the vardenafil dosage may be necessary for individuals taking potent inhibitors like ketoconazole, itraconazole, and others, as well as those on moderate inhibitors like erythromycin.

Specific Dosage Adjustments for CYP3A4 Inhibitors include:

• Ritonavir: No more than 2.5 mg within 72 hours
• Indinavir, saquinavir, atazanavir, clarithromycin, and certain doses of ketoconazole and itraconazole: Maximum of 2.5 mg in 24 hours
• Lower doses of ketoconazole, itraconazole, erythromycin: Up to 5 mg in 24 hours
• Cobicistat: No more than 2.5 mg in a 72-hour period

Alpha-Blockers: Patients already on stable alpha-blocker treatment should start PDE5 inhibitors like vardenafil at the lowest possible dose. Vardenafil's initiation and any increase in alpha-blocker dosage should be carefully managed to avoid blood pressure reductions. For patients stable on alpha-blocker therapy, a starting dose of 5 mg vardenafil (or 2.5 mg when also taking certain CYP3A4 inhibitors) is recommended.

A consideration for the timing between doses is needed when prescribing vardenafil alongside alpha-blocker therapy.

Assessing erectile dysfunction involves a medical evaluation

Assessing erectile dysfunction involves a medical evaluation, identifying any underlying causes, and determining the right treatment.

Before prescribing vardenafil hydrochloride, consider the following:

Cardiovascular Concerns General

The cardiovascular health of patients should be assessed, as sexual activity carries a certain level of cardiac risk. Therefore, men who are advised against sexual activity due to cardiovascular issues should not use treatments for erectile dysfunction, including vardenafil hydrochloride.

Vardenafil should not be used in patients with certain conditions due to lack of controlled clinical safety or efficacy data: unstable angina, low blood pressure (systolic <90 mmHg), high blood pressure (>170/110 mmHg), recent stroke, severe arrhythmia, recent heart attack (within 6 months), or severe heart failure.

Left Ventricular Outflow Obstruction

Individuals with conditions like aortic stenosis or hypertrophic subaortic stenosis may be particularly sensitive to vasodilators, including PDE5 inhibitors.

Effects on Blood Pressure

Vardenafil has been shown to lower blood pressure temporarily in healthy individuals. Doctors should thus carefully consider prescribing vardenafil to patients with cardiovascular diseases due to the potential adverse effects of these vasodilatory properties.

Interactions with CYP3A4 Inhibitors Vardenafil levels can increase significantly when taken with strong (e.g., ritonavir, indinavir, ketoconazole) or moderate (e.g., erythromycin) CYP3A4 inhibitors, necessitating dosage adjustments.

There is no long-term data on the safety of vardenafil when taken with HIV protease inhibitors.

Priapism Risk Rare instances of prolonged erections over 4 hours and priapism (painful erections over 6 hours) have been reported. Immediate medical help should be sought if an erection lasts over 4 hours to prevent permanent damage.

Patients with penis deformities or conditions increasing priapism risk should use vardenafil cautiously.

Vision Effects Patients should be instructed to seek immediate medical attention if they experience sudden vision loss. This could indicate a condition called NAION, which has been associated rarely with PDE5 inhibitor use. While there's no proven cause-and-effect relationship, patients with certain risk factors for NAION should use PDE5 inhibitors, including vardenafil, with caution.

Vardenafil is not recommended for patients with certain hereditary eye diseases due to lack of safety information.

Sudden Hearing Loss Patients should be advised to stop PDE5 inhibitors, including vardenafil, if they experience sudden hearing loss. These incidents have been noted after PDE5 inhibitor use but a direct cause has not been established.

Alpha-Blockers Co-administration with alpha-blockers can cause significant blood pressure drops. Patients should be stable on alpha-blocker therapy before starting PDE5 inhibitors, and vice versa, with careful monitoring of blood pressure.

QT Prolongation Vardenafil can prolong the QT interval. It should be prescribed cautiously to patients with a history of QT prolongation or those taking medications that could prolong the QT interval.

Patients with certain antiarrhythmic medications or congenital QT prolongation should avoid vardenafil.

Liver Impairment Patients with moderate liver impairment require dosage adjustments, while those with severe impairment should not take vardenafil.

Kidney Impairment Vardenafil is not recommended for patients on dialysis.

Use with Other Erectile Dysfunction Treatments The combined use of vardenafil with other erectile dysfunction treatments has not been studied and is not advised.

Bleeding Effects Vardenafil does not increase bleeding time but has not been studied in patients with bleeding disorders or significant peptic ulceration, necessitating careful assessment before prescription.

Prevention of Sexually Transmitted Diseases Vardenafil does not protect against sexually transmitted infections. Patients should be counseled on protective measures against STDs, including HIV.

Vardenafil tablets may contain tartrazine, which can cause allergic reactions in susceptible individuals, particularly those with aspirin hypersensitivity.

In Summary

In summary, the comprehensive approach to managing erectile dysfunction includes careful consideration of the patient's overall health, particularly their cardiovascular status, due to the inherent risks associated with sexual activity. Before prescribing vardenafil hydrochloride, healthcare providers must evaluate potential interactions with other medications, especially those affecting the CYP3A4 system, and the risk factors that could increase the likelihood of adverse effects such as priapism, sudden loss of vision or hearing, and significant interactions with alpha-blockers. Additionally, awareness of the patient's hepatic and renal function is crucial for dosing adjustments or determining the appropriateness of vardenafil hydrochloride use. Lastly, it's important to discuss the potential risk of sexually transmitted diseases with patients and to consider the presence of ingredients like tartrazine that may trigger allergic reactions in susceptible individuals.

The highlights above do not include all or the complete information needed to use Vardenafil safely and effectively. See full prescribing information for Vardenafil.

Additional information at https://dailymed.nlm.nih.gov