Chemical name: 1-(((3-(3,4-dihydro-5-methyl)-4-oxo-7-propylimidazo(5,1-f)-as-triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethylpiperazine
Formula: C23H32N6O4S
Anabolic activity index: not a steroid
Androgenic activity index: not a steroid
ZHEWITRA-40
Introduction
ZHEWITRA-40 is a pharmaceutical product developed and manufactured by Sunrise Remedies, a well-respected name in the pharmaceutical industry known for its commitment to quality and innovation. Each tablet of ZHEWITRA-40 contains 40 mg of Vardenafil, a potent and selective phosphodiesterase type 5 (PDE5) inhibitor. This medication is primarily used to manage erectile dysfunction (ED) in men, helping to improve sexual performance and satisfaction. By increasing blood flow to the penis during sexual stimulation, ZHEWITRA-40 enables men to achieve and maintain an erection sufficient for satisfactory sexual activity.
Composition
Each ZHEWITRA-40 tablet contains:
- Active Ingredient: Vardenafil Hydrochloride equivalent to Vardenafil 40 mg.
- Inactive Ingredients: The formulation includes various excipients such as microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, and other inactive components. These ingredients help in the tablet’s stability, appearance, and ease of consumption.
Indications
ZHEWITRA-40 is indicated for the treatment of erectile dysfunction (ED) in adult men. Erectile dysfunction is a condition characterized by the inability to achieve or maintain an erection adequate for sexual intercourse. ZHEWITRA-40 helps address this issue by enhancing erectile function through its action on the PDE5 enzyme, which plays a crucial role in regulating blood flow in the penis.
Mechanism of Action
Vardenafil, the active ingredient in ZHEWITRA-40, belongs to a class of drugs known as phosphodiesterase type 5 (PDE5) inhibitors. The primary mechanism of action involves the inhibition of the PDE5 enzyme, which is responsible for breaking down cyclic guanosine monophosphate (cGMP). cGMP is a molecule that promotes smooth muscle relaxation and vasodilation in the penis. By inhibiting PDE5, Vardenafil increases the levels of cGMP, leading to enhanced blood flow to the penile tissues. This mechanism facilitates the achievement and maintenance of an erection when sexually aroused.
Dosage and Administration
- Recommended Dosage: The typical dose of ZHEWITRA-40 is one 40 mg tablet taken orally approximately 1 hour before sexual activity. The onset of action generally occurs within 30 to 60 minutes after ingestion.
- Administration: The tablet should be swallowed whole with a full glass of water. It can be taken with or without food; however, heavy or high-fat meals may delay the absorption and onset of action.
- Dosage Adjustment: Depending on individual response and tolerability, the dosage may be adjusted. The maximum recommended dose is 40 mg per day. ZHEWITRA-40 should not be taken more than once in a 24-hour period.
- Important Note: Patients should consult a healthcare provider to determine the appropriate dosage based on their health status and specific needs.
Contraindications
ZHEWITRA-40 is contraindicated in patients with:
- Hypersensitivity: Known hypersensitivity to Vardenafil or any other components of the tablet.
- Severe Cardiovascular Conditions: Recent history of stroke, myocardial infarction, or life-threatening arrhythmia.
- Severe Liver Impairment: Patients with severe liver dysfunction as Vardenafil is metabolized in the liver.
- Concurrent Use of Nitrates: Concurrent use with nitrates or nitric oxide donors is contraindicated due to the risk of severe hypotension.
- Severe Renal Impairment: Not recommended for patients with severe renal impairment.
Precautions and Warnings
- Cardiovascular Health: Patients with a history of cardiovascular disease should use ZHEWITRA-40 with caution. A thorough cardiovascular assessment is advised before initiating therapy.
- Hypotension: Caution is required in patients with hypotension or those taking medications that may lower blood pressure.
- Visual Disturbances: Rare cases of visual disturbances have been reported. Patients with a history of vision loss or eye conditions should be monitored closely.
- Priapism: Seek immediate medical attention if an erection lasts longer than 4 hours, as this condition (priapism) can lead to serious complications.
Side Effects
ZHEWITRA-40 may cause side effects, some of which may require medical attention:
- Common Side Effects: Headache, flushing, nasal congestion, dyspepsia, and back pain. These side effects are usually mild to moderate and tend to resolve with continued use or discontinuation of the medication.
- Less Common Side Effects: Dizziness, visual disturbances, tinnitus, and muscle pain. If these side effects persist or worsen, it is essential to consult a healthcare provider.
- Severe Side Effects: In rare cases, patients may experience severe reactions such as prolonged erection (priapism), sudden vision loss, or severe allergic reactions. Immediate medical attention is required if any of these severe side effects occur.
Drug Interactions
ZHEWITRA-40 may interact with other medications, potentially altering its effectiveness or increasing the risk of side effects:
- Nitrates: Concurrent use with nitrates or nitroglycerin can lead to severe hypotension and is contraindicated.
- Alpha-Blockers: Caution is advised when used with alpha-blockers as it may increase the risk of symptomatic hypotension.
- CYP3A4 Inhibitors: Strong inhibitors of CYP3A4 (such as ketoconazole, ritonavir, and clarithromycin) can increase Vardenafil levels, potentially leading to an increased risk of adverse effects.
- Other ED Medications: Concurrent use with other erectile
dysfunction medications is not recommended due to the risk of additive effects and potential for severe adverse reactions.
Storage
- Temperature: Store ZHEWITRA-40 at room temperature, between 20°C to 25°C (68°F to 77°F).
- Conditions: Keep the tablets in their original blister packaging to protect from moisture and light. Do not store in a bathroom or other damp environments.
- Keep Out of Reach of Children: Ensure that the medication is stored securely out of reach of children and pets to prevent accidental ingestion.
Packaging
ZHEWITRA-40 is supplied in blister packs containing 10 tablets each. The blister packaging is designed to protect the tablets from environmental factors that could affect their stability and efficacy. Each blister pack is enclosed in a carton that includes the product’s labeling and informational insert.
Manufacturer Information
Sunrise Remedies is a reputable pharmaceutical company known for producing high-quality medications. With a focus on innovation and stringent quality control, Sunrise Remedies ensures that ZHEWITRA-40 meets rigorous standards for safety, efficacy, and reliability. The company is dedicated to providing effective treatments for various health conditions, contributing to the overall well-being of patients worldwide.
Clinical Efficacy
Clinical studies have demonstrated the effectiveness of Vardenafil in treating erectile dysfunction. ZHEWITRA-40 has shown significant improvement in erectile function as measured by various clinical parameters, including the International Index of Erectile Function (IIEF) scores and patient-reported outcomes. The medication enhances the ability to achieve and maintain an erection during sexual activity, thereby improving sexual satisfaction and quality of life for patients.
Patient Counseling Information
Patients should be informed about the following key points when prescribed ZHEWITRA-40:
- Usage: ZHEWITRA-40 should be taken only as directed by a healthcare provider. It is intended for use as needed and should not be used more frequently than once daily.
- Timing: The tablet should be taken approximately 1 hour before anticipated sexual activity to allow for optimal effectiveness.
- Lifestyle Considerations: Patients are advised to avoid excessive alcohol consumption and to be aware that high-fat meals may delay the onset of action.
- Medical History: Inform your healthcare provider of any pre-existing medical conditions, particularly cardiovascular issues, liver or kidney impairment, and any history of vision problems.
- Side Effects: Be aware of potential side effects and seek medical attention if severe reactions occur.
Conclusion
ZHEWITRA-40 (Vardenafil Tablets 40 mg) represents a valuable treatment option for men experiencing erectile dysfunction. Manufactured by Sunrise Remedies, this medication leverages the efficacy of Vardenafil to enhance erectile function and sexual satisfaction. With a well-established mechanism of action, comprehensive clinical support, and a commitment to quality, ZHEWITRA-40 provides a reliable solution for managing ED. As with any medication, it is essential for patients to use ZHEWITRA-40 under the guidance of a healthcare provider to ensure safe and effective treatment. By improving the ability to achieve and maintain an erection, ZHEWITRA-40 helps individuals and their partners enjoy a more fulfilling sexual experience.
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