Finasteride Dispersible Tablets

Pharmacological action: This product belongs to the 4-nitrogen steroid hormone compound, which is a specific type II 5α-reductase competitive inhibitor. It inhibits the conversion of peripheral testosterone into dihydrotestosterone and reduces the level of dihydrotestosterone in blood, prostate, skin and other tissues. The growth, development and benign hyperplasia of the prostate depend on dihydrotestosterone. Finasteride inhibits prostate hyperplasia and improves the clinical symptoms related to benign prostatic hyperplasia by reducing the level of dihydrotestosterone in blood and prostate tissue. Toxicological study: Genetic toxicity: The results of in vitro bacterial and mammalian cell mutagenicity tests and in vitro alkaline elution tests did not show mutagenicity. In the in vitro CHO cell chromosome aberration study, finasteride slightly increased the chromosome aberration rate of CHO cells at a concentration of 450-550 μmol, which is equivalent to 4000-5000 times the peak plasma concentration of 5 mg of this product after oral administration. In the in vivo chromosome aberration test, mice were given finasteride 250 mg/kg/day (calculated by AUC, equivalent to 228 times the recommended daily dose of 5 mg in human clinics, and the calculation method for all toxicological study doses below is the same), and the chromosome aberration rate did not increase. Reproductive toxicity: Finasteride 80 mg/kg/day (calculated as above, equivalent to 543 times the human dose), continuous administration for 12 weeks had no effect on the fertility of sexually mature male rabbits and male rats. When rats were given finasteride 80 mg/kg/day for more than 24 weeks, the weight of their seminal vesicles and prostate was significantly reduced, and sperm plug formation failed during mating, resulting in a decrease in the fertility of the rats; but it had no effect on the testicles and mating behavior of rats and rabbits; the above toxic effects recovered within 6 weeks after discontinuation of the drug. Finasteride given to rats during the teratogenic sensitive period has a significant teratogenic effect on male offspring. At 100μg~100mg/kg/day (same as above, equivalent to 1~1000 times the clinical daily dose of 5mg), dose-dependent hypospadias occurs with an incidence of 3.6~100%. At a dose of ≥30μg/kg/day (same as above, equivalent to 30% of the daily dose in humans), male offspring experience a decrease in prostate and seminal vesicle weight, delayed foreskin separation, and transient breast development. At a dose of 3μg/kg/day (same as above, equivalent to 3% of the daily dose in humans), male offspring experience a shortening of the urogenital tract distance. Studies have shown that the critical time for the above toxicity in male offspring of rats is the 16th to 17th day of pregnancy. The above toxicity caused by finasteride given to pregnant rats is the result of the pharmacological action of this type of drug (5α-reductase inhibitor), which is similar to the malformations reported in male infants with congenital 5α-reductase deficiency. Rhesus monkeys took finasteride 2 mg/kg/day orally during pregnancy (same as above, equivalent to 20 times the daily dose for humans), and male fetuses had external genital malformations. In all teratogenic studies, this product had no teratogenic effects on female offspring. No drug-related effects were observed in the offspring of male rats given 80 mg/kg/day of finasteride and mated with untreated female rats. The administration of finasteride 3 mg/kg/day (same as above, equivalent to 30 times the daily dose for humans) to rats in late pregnancy and lactation resulted in a slight decrease in the fertility of the first generation of male offspring, but had no effect on female offspring. Carcinogenicity: SD female and male rats were given finasteride 320 and 160 mg/kg/day (same as above, equivalent to 274 and 111 times the clinically recommended dose, respectively) for 24 consecutive months, and no tumorigenic effects were observed. In a 19-month carcinogenicity study, administration of finasteride at 250 mg/kg/day (same as above, equivalent to 228 times the recommended daily dose for humans) significantly increased the incidence of testicular Leydig cell adenomas in CD-1 male mice. When mice were given finasteride at 25 mg/kg/day or rats were given at doses exceeding 40 mg/kg/day, the incidence of testicular Leydig cell hyperplasia in both animals was significantly increased; the incidence of testicular Leydig cell hyperplasia was positively correlated with serum LH levels. Rats and dogs were given this product at 20 and 45 mg/kg/day (same as above, equivalent to 30 and 350 times the recommended daily dose for humans) for 1 year or 2.5 mg/kg/day (same as above, equivalent to 2.3 times the recommended daily dose for humans) for 19 months, and no testicular Leydig cell hyperplasia related to administration occurred.

The main ingredient of this product is finasteride. Chemical name: 17β-(N-tert-butylcarbamoyl)-4-aza-5a-androst-1-ene-3-one. Chemical structure: Molecular formula: C23H36N202 Molecular weight: 372.55

This product is white or off-white tablets.

This product is suitable for the treatment of symptomatic benign prostatic hyperplasia (BPH): - Improve symptoms. - Reduce the risk of acute urinary retention. - Reduce the risk of transurethral resection of the prostate (TURP) and prostatectomy.

Oral. Recommended dose: 5 mg (1 tablet) once a day, either on an empty stomach or with food.

Finasteride has good tolerance, and adverse reactions are mostly mild and short-lived. Literature reports: 1. Adverse reactions with an incidence rate ≥ 1% are mainly sexual dysfunction (impotence, decreased libido, ejaculation disorder), breast discomfort (breast enlargement, breast pain) and rash. The incidence of adverse events after one year of use of this product is as follows (the brackets are the placebo control group), and the cumulative incidence of using this product for two to four years shows a downward trend. Impotence: 8.1% (3.7%). Decreased libido: 6.4% (3.4%). Decreased semen volume: 3.7% (0.8%). Ejaculation disorder: 0.8% (0.1%). Breast enlargement: 0.5% (0.1%). Breast pain: 0.4% (0.1%). Rash: 0.5%. 2. Product launch

This product is not suitable for women and children. This product is contraindicated in the following situations: 1. People who are allergic to any of the ingredients in this product. 2. Pregnant women or women who may become pregnant.

Precautions for children: This product is not suitable for children. The safety and effectiveness data for children have not been determined. Precautions for pregnancy and lactation: This product is contraindicated for women who are pregnant or may become pregnant. Since type II 5α-reductase inhibitors, including finasteride, have the effect of inhibiting the conversion of testosterone into dihydrotestosterone, when taken by pregnant women, it may cause abnormalities in the external genitalia of male fetuses. Women who are pregnant or may become pregnant should not touch the fragments and splinters of this product. This product is not suitable for breastfeeding women. It is not known whether finasteride is excreted in human milk. Precautions for the elderly: Elderly patients do not need to adjust the dosage.

No clinically significant drug interactions have been identified. 1. Finasteride has no significant effect on the cytochrome P450-related drug metabolizing enzyme system. Compounds that have been tested in men include propranolol, digoxin, glibenclamide, warfarin, theophylline, and antipyrine, none of which have been found to have clinically significant interactions with finasteride. 2. Other combined therapies. Although no specific drug interaction studies have been conducted, in clinical studies, no significant clinical adverse interactions were found when finasteride was used simultaneously with angiotensin-converting enzyme inhibitors, acetaminophen, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium channel blockers, nitrates for heart disease, diuretics, H2 receptor antagonists, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), quinolones, and benzodiazepines.

Keep in a dark place and sealed (10-30℃).

5mg

Tentative 18 months