Finasteride Tablets

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 the 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 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 450-550 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 chromosomal aberration test, mice were given finasteride 250 mg/kg/day (based on AUC, equivalent to 228 times the recommended daily dose of 5 mg in humans, and the calculation method for all toxicology study doses below is the same), and the chromosomal aberration rate did not increase.

The main ingredient of this product is finasteride, its chemical name: 17-(N-tert-butylcarbamoyl)-4-aza-5-androst-1-ene-3-one

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

This product is used to treat 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 has good tolerance, 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, loss of 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%). Loss of 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 decrease in prostate-specific antigen (PSA) levels in patients taking finasteride should be taken into account. There were no differences 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 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. Precautions for pregnancy and lactation: This product is contraindicated for women who are pregnant or may become pregnant. 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 tightly closed in a cool place.

5mg

24 months

Shanghai Shyndec Pharmaceutical Co., Ltd.

• Founded in:

  1996-11-27

• Address:

  No. 378, Jianlu Road, Pudong New Area, Shanghai

• Tax NO.:

  91310000630459924R

• Registered Funds:

  1,341,172,692 yuan

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