Vardenafil Hydrochloride Tablets

Pharmacological action: Penile erection is a hemodynamic process involving relaxation of the corpus cavernosum and its associated arteriolar smooth muscle. During sexual stimulation, neuronal endings in the corpus cavernosum release nitric oxide (NO), which activates guanylate cyclase in smooth muscle cells, increases intracellular cyclic guanosine monophosphate (cGMP) levels, and ultimately leads to smooth muscle relaxation and increased blood flow in the penis. Vardenafil inhibits phosphodiesterase type 5 (PDE5) that degrades cGMP in the human corpus cavernosum, increases the release of local endogenous nitric oxide in the corpus cavernosum under sexual stimulation, and thus enhances the natural response to sexual stimulation. Toxicological studies: Acute toxicity: The LD50 of rats is 190 mg/kg, and no effects of the drug on visual perception were found in light microscopy, electron microscopy, and visual examinations. Long-term toxicity: The maximum non-toxic dose (NOEL) of rats and dogs is 3 mg/kg. In addition, animals all show cardiovascular toxicity related to PDE5, and rats also show pancreatic, exocrine, and thyroid toxicity related to PDE. Genotoxicity: In vitro Salmonella typhimurium reverse mutation test, mammalian cell HPRT mutation test, chromosome aberration test, and in vivo mouse micronucleus test, vardenafil was not found to be genotoxic and mutagenic. Reproductive toxicity: Rats and rabbits were orally administered with vardenafil, and no effect on animal fertility and embryonic development was observed. Carcinogenicity: Rats and mice were orally administered with vardenafil for 24 consecutive months, and the dosage was 225 times and 450 times the maximum clinically recommended dosage of 20 mg, respectively, based on body surface area, and 360 times and 25 times the maximum clinically recommended dosage of 20 mg, respectively, based on the area under the drug-time curve (AUC). At this time, vardenafil was not found to be carcinogenic.

The main ingredient of this product is vardenafil hydrochloride.

This product is a light orange to dark orange film-coated tablet, which appears white after removing the film coating.

Treating male erectile dysfunction (ED).

Oral. 1. Recommended dose: The recommended starting dose is 10 mg, taken approximately 25-60 minutes before sexual intercourse. In clinical trials, it was still effective when taken 4-5 hours before sexual intercourse. The maximum recommended dose frequency is once a day. Vardenafil can be taken with or without food. Sexual stimulation is required as an instinctive response for treatment. 2. Dose range: Depending on the efficacy and tolerability, the dose can be increased to 20 mg or reduced to 5 mg. The maximum recommended dose is 20 mg per day. 3. Hepatic impairment: No dose adjustment is required for patients with mild hepatic impairment (child-pughA); for patients with moderate hepatic impairment (child-pughB), due to the reduced clearance of vardenafil, the recommended starting dose is 5 mg, which is then gradually increased to 10 mg based on tolerance and efficacy; the pharmacokinetic study of vardenafil in patients with severe hepatic impairment (child-pughC) has not yet been conducted. 4. Renal impairment: No dose adjustment is required for patients with mild, moderate or severe renal impairment. Pharmacokinetic studies of vardenafil in dialysis patients have not been conducted. 5. Concomitant medication: Some patients taking vardenafil and alpha-blockers at the same time may cause symptomatic hypotension. Concomitant medication can only be used when the patient is receiving alpha-blocker treatment and the condition is stable. For patients receiving alpha-blocker treatment and the condition is stable, the dose of vardenafil should be the minimum recommended starting dose of 5 mg and can be taken at any time.

In global clinical trials, more than 7,800 patients took vardenafil and it was well tolerated. Adverse events that occurred were usually transient and mild to moderate.

1. Patients with allergic symptoms to any component of the drug (active or inactive) are prohibited from using this drug. 2. PDE5 inhibitors may enhance the antihypertensive effect of nitrates, similar to the mechanism of action of PDE inhibitors in the NO/cE and GMP pathways. Therefore, patients taking nitrates or nitric oxide donors should avoid using vardenafil at the same time. 3. Avoid using HIV protein kinase inhibitors indinavir or ritonavir and vardenafil at the same time, as they are strong CYP3A4 inhibitors.

Precautions for children: Children (birth to 16 years): Vardenafil is not suitable for children. Precautions for pregnancy and lactation: Not applicable. Precautions for the elderly: The clearance of vardenafil is reduced in elderly patients (ge; 65 years old), and the starting dose is considered to be 5 mg.

CYP inhibitors: Vardenafil is primarily metabolized by the liver enzyme system via cytochrome P450 (CYP) isoenzyme 3A4, with CYP3A5 and CYP2C isoenzymes playing a role in its metabolism. Therefore, inhibitors of these enzymes may reduce the clearance of vardenafil.

Store in sealed container below 25℃.

20 mg

36 months