Vardenafil Hydrochloride Tablets
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The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
Product Description
Approval Number:
Calculated as C23H32N6O4S 10mg: H20254129
Calculated as C23H32N6O4S 20mg: H20254130
Indications:
Treatment of Male Erectile Dysfunction (ED)
Administration:
Oral administration
Recommended Dosage:
The recommended starting dose is 10 mg, to be taken approximately 25 to 60 minutes before sexual activity. Clinical trials have shown that the drug remains effective when taken 4-5 hours prior to intercourse. The maximum recommended dosing frequency is once daily. Vardenafil may be taken with or without food. Sexual stimulation is required to elicit the therapeutic response.
Dosage Range:
Depending on efficacy and tolerability, the dose may be increased to 20 mg or decreased to 5 mg. The maximum recommended dose is 20 mg per day.
Hepatic Impairment:
Patients with mild hepatic impairment (Child-Pugh A) require no dose adjustment. For patients with moderate hepatic impairment (Child-Pugh B), due to reduced clearance of vardenafil, the recommended starting dose is 5 mg, which may be gradually increased to 10 mg based on tolerability and efficacy. Pharmacokinetic studies have not been conducted in patients with severe hepatic impairment (Child-Pugh C).
Renal Impairment:
No dose adjustment is necessary for patients with mild, moderate, or severe renal impairment. Pharmacokinetic studies have not been conducted in patients undergoing dialysis.
Concomitant Medication:
Concomitant administration of vardenafil and alpha-blockers may lead to symptomatic hypotension in some patients. Combination therapy should only be considered in patients who are hemodynamically stable on alpha-blocker treatment.
For patients stabilized on alpha-blocker therapy, vardenafil should be initiated at the lowest recommended starting dose of 5 mg. Tamsulosin may be taken at any time. When vardenafil is coadministered with other alpha-blockers, an appropriate dosing interval should be maintained. For patients already taking the optimal dose of vardenafil, alpha-blocker therapy should be initiated at the lowest dose. Dose escalation of alpha-blockers in patients taking PDE5 inhibitors (including vardenafil) may cause additional lowering of blood pressure.
Dose adjustment of vardenafil may be required in patients taking certain CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, indinavir, and erythromycin).
When coadministered with erythromycin, the maximum dose of vardenafil should not exceed 5 mg.
When coadministered with ketoconazole or itraconazole, the maximum dose of vardenafil should not exceed 5 mg. Vardenafil is contraindicated when the daily dose of ketoconazole or itraconazole exceeds 200 mg.
Concomitant use with potent CYP3A4 inhibitors (indinavir and ritonavir) should be avoided.
Specifications:
10mg/20mg
The company has production licenses for tablets, capsules, granules, suppositories, powders, injections, oral solutions, dry suspensions, and eye drops.
The main products cover cardiovascular diseases, diabetic complications, anti-tumor, calcium supplementation, digestive system, respiratory system, and orthopedics.
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