Sildenafil Citrate Tablets

The main ingredient of this product is sildenafil citrate. Molecular weight: C22H30N6O4S·C6H8O7

This product is a blue diamond-shaped film-coated tablet, which appears white or off-white after removing the film coating.

For most patients, the recommended dose is 50 mg, taken as needed approximately 1 hour before sexual activity; however, it can be taken at any time within 0.5-4 hours before sexual activity. Based on efficacy and tolerability, the dose can be increased to 100 mg (maximum recommended dose) or reduced to 25 mg. Take up to once daily. In the absence of sexual stimulation, the recommended dose of sildenafil is ineffective. The following factors are associated with increased plasma sildenafil levels (AUC): age over 65 years (increase of 40%), liver damage (such as cirrhosis, increase of 80%), severe renal impairment (creatinine clearance [30 ml/min, increase of 100%), and concomitant use of potent cytochrome P4503A4 inhibitors [ketoconazole, itraconazole (increase of 200%), erythromycin (increase of 182%).

Pre-marketing experience: In clinical trials worldwide, more than 3,700 patients (aged 19-87 years) took sildenafil. More than 550 of these patients were treated for more than one year. In placebo-controlled clinical trials, there was no significant difference in the discontinuation rate due to adverse events in the trial group (2.5%) compared with the placebo group (2.3%). Adverse events are generally transient and mostly mild to moderate in nature. In various forms of clinical trials, adverse events reported by patients in the trial group are usually similar. In fixed-dose trials, the incidence of certain adverse events increased with increasing doses. Generally, flexible-dose trials better reflect the recommended dosage of the drug, and the nature of adverse events seen in the trials is similar to those in fixed-dose trials. In flexible-dose, placebo-controlled clinical trials

Due to the known effects of this product on the nitric oxide/cGMP pathway (see "Pharmacology and Toxicology"), sildenafil can enhance the antihypertensive effect of nitrates. Therefore, patients taking any dosage form of nitrates, whether regularly or intermittently, are contraindicated. It is not clear when patients can safely take nitrates (if needed) after taking sildenafil. According to the pharmacokinetic data of healthy volunteers, after a single oral dose of 100 mg, the plasma sildenafil concentration is about 2ng/ml (peak blood concentration is about 440ng/ml) 24 hours later (see "Pharmacology"). The following patients have plasma sildenafil concentrations 3-8 times higher than healthy volunteers 24 hours after taking the drug: patients over 65 years old, liver damage (such as cirrhosis), severe renal damage (creatinine clearance

Precautions for children: Sildenafil is not suitable for newborns, children or women. Precautions for pregnancy and lactation: Sildenafil is not suitable for newborns, children or women. Precautions for the elderly: The clearance of sildenafil is reduced in healthy elderly volunteers (>65 years old) (see "Pharmacokinetics: Pharmacokinetics in special populations"). Given that higher blood drug concentrations may increase both efficacy and the occurrence of adverse events, the starting dose is preferably 25 mg (see "Usage and Dosage").

Effects of other drugs on sildenafil In vitro experiments: This product is metabolized mainly through cytochrome P4503A4 (major pathway) and 2C9 (minor pathway). Therefore, inhibitors of these isozymes will reduce the clearance of sildenafil. In vivo experiments: Healthy volunteers took 50 mg of this product and 800 mg of cimetidine (a non-specific cytochrome P450 inhibitor) at the same time, resulting in a 56% increase in plasma sildenafil concentrations. When a single dose of sildenafil 100 mg was combined with erythromycin, a specific inhibitor of cytochrome P4503A4 (500 mg twice a day for 5 days to reach steady state), the area under the concentration-time curve (AUC) of sildenafil increased by 182%. In addition, in a study conducted on healthy male volunteers, when HIV protease inhibitors

seal.

50mg*4s

24 months

Changshan Biochem PHARM(Jiangsu) Co., Ltd.

• Founded in:

  1994-09-10

• Address:

  No. 18, Guoxiang Road, Wujin Economic Development Zone, Jiangsu

• Tax NO.:

  913204122509309646

• Registered Funds:

  66 million yuan

• Website:

  Log in to view

• Email:

  Log in to view