Finasteride 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: In vitro bacterial and mammalian cell mutagenicity tests and in vitro alkaline elution tests did not show mutagenic effects. In the in vitro CHO cell chromosome aberration study, finasteride slightly increased the chromosome aberration rate of CHO cells at a concentration of 450~550μmol, which is equivalent to 4000~5000 times the plasma concentration of 5mg of this product after oral administration. In the in vivo chromosome aberration test, mice were given finasteride 250mg/kg/day (calculated by AUC, equivalent to 228 times the recommended daily dose of 5mg in human clinics, and the calculation method for all toxicological studies below is the same), and the chromosome aberration rate did not increase. Reproductive toxicity: Finasteride 80mg/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 80mg/kg/day for more than 24 weeks, the weight of their seminal vesicles and prostates was significantly reduced, and sperm plug formation failed during mating, resulting in a decrease in the fertility of 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 about 3.6~100%. When the dose is ≥30μg/kg/day (same as above, equivalent to 30% of the daily dose for humans), male offspring experience reduced prostate and seminal vesicle weight, delayed foreskin separation, and transient breast development. When the dose is 3μg/kg/day (same as above, equivalent to 3% of the daily dose for humans), male offspring experience shortened urogenital tract distance. Studies have shown that the critical time for the above toxicity in male offspring of rats is the 16th-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 human dose), and male fetuses showed external genital malformations. In all teratogenic studies, this product had no effect 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 human dose) 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 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 20 and 45 mg/kg/day (same as above, equivalent to 30 and 350 times the daily dose for humans) for 1 year or mice were given 2.5 mg/kg/day (same as above, equivalent to 2.3 times the 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-5α-androst-1-ene-3-one

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

This product is suitable for the treatment of symptomatic benign prostatic hyperplasia (BPH): 1. Improve symptoms. 2. Reduce the risk of acute urinary retention. 3. 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 is well tolerated, and most adverse reactions are mild and short-lived. • Literature reports: 1. Adverse reactions with an incidence rate of ≥ 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 for 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%). Enlarged breasts: 0.5% (0.1%). Breast pain: 0.4% (0.1%). Rash: 0.5%. 2. Other adverse reactions reported after the product was launched include: allergic reactions such as itching, urticaria and swelling of the face and lips, and testicular pain. 3. Laboratory test results: When evaluating laboratory test results, the reduction in prostate-specific antigen (PSA) levels in patients taking finasteride should be taken into account. There was no difference in other standard laboratory parameters between patients taking finasteride or placebo.

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

Precautions for children: This product is not suitable for children. The safety and efficacy 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 can cause abnormalities in the external genitalia of male fetuses. Pregnant or potentially pregnant women should not come into contact with 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 antagonists, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), quinolones, and benzodiazepines.

Keep away from light, sealed and stored in a dry place.

5mg/tablet

24 months

Beijing Hanmi Pharmaceutical Co., Ltd.

• Founded in:

  1996-03-27

• Address:

  No. 10, Tianzhu West Road, Area A, Tianzhu Airport Industrial Zone, Shunyi District, Beijing

• Tax NO.:

  91110113600048921K

• Registered Funds:

  630 million yuan

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