Sildenafil Citrate Tablets

This product is an oral medication for the treatment of erectile dysfunction. It is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). The physiological mechanism of penile erection involves the release of nitric oxide (NO) in the corpus cavernosum of the penis during sexual stimulation. NO activates guanylate cyclase, resulting in increased levels of cyclic guanosine monophosphate (cGMP), which relaxes the smooth muscles in the corpus cavernosum and allows blood to flow in. Sildenafil has no direct relaxant effect on isolated human corpus cavernosum, but it can enhance the effect of nitric oxide (NO) by inhibiting phosphodiesterase type 5 (PDE5) that breaks down cGMP in the corpus cavernosum. When sexual stimulation causes local NO release, sildenafil's inhibition of PDE5 can increase cGMP levels in the corpus cavernosum, relax smooth muscles, and allow blood to flow into the corpus cavernosum. In the absence of sexual stimulation, sildenafil at the recommended dose is ineffective.

Sildenafil citrate. Molecular weight: C22H30N6O4S·C6H8O7

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

Indicated for the treatment of erectile dysfunction.

1. 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 to 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 a day. In the absence of sexual stimulation, the recommended dose of sildenafil is ineffective. 2. 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%), concurrent use of potent cytochrome P450 3A4 inhibitors [ketoconazole, itraconazole (increase of 200%), erythromycin

The following are adverse events with an incidence of 2% in controlled clinical trials. It is not certain whether their occurrence is caused by sildenafil. 1 Events that may be related to medication are included here, but minor events and inaccurate reports are omitted. 1. Systemic reactions: facial edema, photosensitivity reaction, shock, fatigue, pain, chills, accidental falls, abdominal pain, allergic reaction, chest pain, accidental injury. 2. Cardiovascular system: angina pectoris, atrioventricular block, migraine, syncope, tachycardia, palpitations, hypotension, postural hypotension, myocardial ischemia, cerebral thrombosis, cardiac arrest, heart failure, electrocardiogram abnormalities, cardiomyopathy. 3. Digestive system: vomiting, glossitis, colitis, dysphagia, gastritis, gastroenteritis, esophagitis, stomatitis, dry mouth, abnormal liver function, rectal bleeding, gingivitis. 4. Blood and lymphatic system: anemia and leukopenia. 5. Metabolism and nutrition: thirst, edema, gout, unstable diabetes, hyperglycemia, peripheral edema, hyperuricemia, hypoglycemic reaction, hypernatremia. 6. Musculoskeletal system: arthritis, arthrosis, myalgia, tendon rupture, tenosynovitis, bone pain, myasthenia, synovitis. 7. Nervous system: ataxia, hypertonia, neuralgia, neuropathy, paresthesia, tremor, vertigo, depression, insomnia, drowsiness, abnormal dreams, weakened reflexes, and dysesthesia. 8. Respiratory system: asthma, dyspnea, laryngitis, pharyngitis, sinusitis, bronchitis, sputum, and cough. 9. Skin and its appendages: urticaria.

Currently, there is no clinical controlled trial data on the safety and efficacy of sildenafil in the following populations. Prescriptions should be used with caution in such patients: 1. Patients with myocardial infarction, shock, or life-threatening arrhythmias within the last 6 months. 2. Patients with resting hypotension (blood pressure below 90/50 mmHg) or hypertension (blood pressure above 170/110 mmHg). 3. Patients with heart failure or unstable angina due to coronary heart disease. 4. Patients with pigmentary retinitis (a small number of patients with this disease have inherited abnormalities of retinal phosphodiesterase). 5. Patients with sickle cell anemia or related anemia.

Precautions for children: Not suitable for newborns and children. Precautions for pregnancy and lactation: Not suitable for women. Precautions for the elderly: The clearance of sildenafil in healthy elderly volunteers (65 years old) is reduced (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.

Effects of other drugs on sildenafil: In vitro experiments: This product is metabolized mainly through cytochrome P4503A4 (main pathway) and 2C9 (minor pathway), so 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 the plasma concentration of sildenafil. When a single dose of sildenafil 100 mg was co-administered 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%; a single dose of sildenafil 100 mg combined with another CYP4503A4 inhibitor HIV protein

Keep away from light and store in sealed container.

0.1g x 1 tablet

24 months

Jiangsu Yabang Translation Love Posen Pharmaceutical Co., Ltd.

• Founded in:

  2001-01-17

• Address:

  Yancheng Xiangshui County Economic Development Zone

• Tax NO.:

  91320921703859698E

• Registered Funds:

  40 million yuan

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