BYS Jin Ge Sildenafil Citrate Tablets Viagra For Erectile Dysfunction 50mg*10 Tablets

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SKU:
BA092
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Origin:
China
Form:
Tablets
Packaging:
Box

Common Name : Sildenafil Citrate Tablets

Product name : Jin Ge

Ingredients: Sildenafil Citrate

Traits: This product is a film-coated tablet, which is white to almost white after removing the coating.

Indications: Sildenafil is suitable for the treatment of erectile dysfunction.

Specifications : 50mg*10 tablets/box

Dosage : For most patients, the recommended dose is 50 mg, taken about 1 hour before sexual activity; however, it can be taken at any time within 0.5 to 4 hours before sexual activity. Based on efficacy and tolerance, the dose can be increased to 100 mg (maximum recommended dose) or reduced to 25 mg, taken up to once a day.

Adverse reactions : 1. In clinical trials worldwide, more than 3,700 patients (aged 19-87 years old) took sildenafil. More than 550 patients have been treated for more than one year. 2. In placebo-controlled clinical trials, the discontinuation rate (2.5%) in the trial group was not significantly different from the placebo group (2.3%). Adverse events are generally transient and mostly mild to moderate in nature. 3. In various forms of clinical trials, adverse events reported by patients in the trial group are usually similar. In fixed-dose trials, certain adverse events increased with increasing doses. In general, the flexible dose test better reflects the use of the drug's recommended dose. The nature of the adverse events seen in the trial is similar to that of the fixed dose test.

Taboo : Patients taking any form of nitrate drug, whether regularly or intermittently, are contraindications. Patients who are allergic to any component of sildenafil are contraindicated.

Precautions : The sildenafil-nitrate interactions that affect blood pressure can persist from the beginning of dosing to the entire 6-hour observation period. Therefore, in all cases, the combined administration of sildenafil and organic nitrates or the provision of NO drugs (such as sodium nitroprusside) is contraindicated. Sildenafil is used with caution in the following patients: Anatomical malformations of the penis (such as degenerative penis, cavernous fibrosis, Peyronie's disease), diseases that are likely to cause abnormal penile erections (eg sickle cell anemia, multiple myeloma, leukemia) . The safety and efficacy of other methods of treating erectile dysfunction combined with this product have not been studied and are not recommended for joint use. In the presence of cardiovascular risk factors, there is a risk of non-fatal/fatal cardiac events after sexual activity. If angina, dizziness, nausea and other symptoms occur at the beginning of sexual activity, sexual activity must be terminated. After the approval of this product on the market overseas, there are reports of a small amount of erection (more than 4 hours) and abnormal erection (more than 6 hours of painful erections). If the erection lasts for more than 4 hours, the patient should seek medical attention immediately. If abnormal erections are not treated immediately, the penis tissue will likely be damaged and may result in permanent loss of erectile function. Sildenafil has no protective effect on sexually transmitted diseases.

Medicine interactions : Effects of other drugs on sildenafil: In vitro: Metabolism of this product is mainly through cytochrome P450 3A4 (primary pathway) and 2C9 (secondary pathway), so inhibitors of these isoenzymes will reduce the clearance of sildenafil. In vivo experiments: Healthy volunteers were treated with 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 concentration. The area under the curve (AUC) of sildenafil when treated with a single dose of sildenafil 100 mg and a specific inhibitor of cytochrome P450 3A4 erythromycin (500 mg twice daily for 5 days to reach steady state) Increased by 182%; a single dose of sildenafil 100 mg was combined with another CYP4503A4 inhibitor HIV protease inhibitor saquinavir, reaching a steady state (1200 mg, three times a day), the latter's Cmax increased by 140%, and the AUC increased by 210 %, sildenafil does not affect the pharmacokinetics of the latter; ketoconazole, itraconazole and other more potent CYP4503A4 inhibitors, these effects may be greater; when with CYP4503A4 inhibitors (such as ketoconazole, When erythromycin and cimetidine were combined, the clearance rate of sildenafil decreased. It can be predicted that simultaneous induction of CYP4503A4 inducer (such as rifampicin) will reduce plasma sildenafil levels. Single dose antacids (aluminum hydroxide/magnesium hydroxide) have no effect on the bioavailability of the product; CYP4502C9 inhibitors (eg tolbutamide, warfarin), CYP4502D6 inhibitors (eg selective serotonin reuptake inhibition Agents, tricyclic antidepressants, thiazides and thiazide diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, etc., have no effect on the pharmacokinetics of sildenafil. The loop diuretics and potassium-sparing diuretics increase the AUC of sildenafil-active metabolites (N-desmethyl sildenafil) by 62%, while the non-selective beta-blockers increase it by 102%. . These effects on sildenafil metabolites do not cause clinical changes. Effect of sildenafil on other drugs: in vitro: This product is a weak inhibitor of cytochrome P450 1A2, 2C9, 2C19, 2D6, 2E1, and 3A4 (IC50 > 150 μM). Since the peak plasma concentration of the recommended dose of sildenafil is approximately 1 μM, sildenafil does not alter the clearance of these isozyme-action substrates. In vivo: Patients with hypertension were treated with sildenafil (100 mg) and amlodipine 5 mg or 10 mg simultaneously. The supine systolic blood pressure was further reduced by an average of 8 mmHg, and the diastolic pressure was further reduced by an average of 7 mmHg. No significant interactions were observed between sildenamol (250 mg) and warfarin (40 mg) metabolized by CYP4502C9 with sildenafil. Sildenafil (50 mg) did not increase the bleeding time caused by aspirin (150 mg). When the average maximum plasma alcohol concentration of healthy volunteers was 0.08%, sildenafil (50 mg) did not enhance the antihypertensive effect of alcohol. Sildenafil (100 mg) did not affect the pharmacokinetics of HIV protease inhibitors saquinavir or ritonavir at steady state, both of which were substrates for CYP4503A4.

Storage: Shading, sealed and stored.

Validity period: 36 Months.

Executive Standard: 20 tablets per box.

Approval Number : State quasi-word H20143255

Company Name : Guangzhou Baiyunshan Pharmaceutical Co., Ltd. Guangzhou Baiyunshan Pharmaceutical Factory

Company address : No. 88, Yunxiang Road, Tonghe Street, Baiyun District, Guangzhou City, Guangdong Province, China