Finasteride Tablets

Finasteride is a synthetic steroidal compound that is a specific inhibitor of the intracellular enzyme type II 5α-reductase in the process of metabolism of the androgen testosterone to dihydrotestosterone. Finasteride has no affinity for androgen receptors and has no androgenic, anti-androgenic, estrogenic, anti-estrogenic or progestational effects. Inhibition of this enzyme can hinder the conversion of testosterone to the androgen dihydrotestosterone in peripheral tissues, resulting in a significant decrease in dihydrotestosterone concentrations in serum and tissues. Compared with placebo, it can increase the level of testosterone in the blood circulation by about 10-15%, but it is still within the physiological range. Finasteride can rapidly reduce the concentration of dihydrotestosterone in serum, significantly reducing it within 24 hours after administration. Hair follicles contain type II 5α-reductase. In the bald area of the scalp of patients with male pattern baldness, the hair follicles become smaller and dihydrotestosterone increases. Administration of finasteride can reduce the concentration of dihydrotestosterone in the scalp and serum of these patients. Men who are congenitally deficient in type II 5α-reductase do not suffer from male pattern baldness. These data and the results of clinical studies confirm that finasteride can inhibit the shrinkage of scalp hair follicles and reverse the process of hair loss.

The main ingredient of this product is finasteride.

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 male baldness (androgenic alopecia), which can promote hair growth and prevent further hair loss. This product is not suitable for women and children.

1. Oral administration. The recommended dose is one tablet (1 mg) once a day. It can be taken on an empty stomach or with food. 2. Generally, the effects of increased hair growth, increased hair growth in a few days, and/or prevention of further hair loss can only be observed after continuous use for three months or more. It is recommended to continue using the drug to achieve the maximum therapeutic effect. The therapeutic effect can be reversed within 12 months after stopping the drug.

This product is generally well tolerated, and adverse reactions are usually mild, and treatment does not generally need to be discontinued. The safety of finasteride in the treatment of alopecia has been evaluated in a series of clinical studies involving more than 3,200 male patients. In three 12-month, placebo-controlled, double-blind studies involving multiple research centers, the safety of this product was similar to that of placebo. 1.7% of the 945 male patients treated with this product discontinued treatment due to adverse reactions, while 2.1% of the 934 male patients treated with placebo discontinued treatment due to adverse reactions. In these studies, ≥1% of male patients treated with this product experienced the following medication-related adverse reactions: decreased libido (1.8% for this product, 1.3% for placebo) and impotence (1.3% for this product, 0.7% for placebo). In addition, 0.8% of male patients treated with this product experienced a decrease in ejaculation volume, compared with 0.4% in the placebo control group. These adverse reactions disappeared after discontinuation of treatment with this product, and many patients also had these adverse reactions disappear on their own during continued medication. In another study, the effect of this product on ejaculation volume was tested and found to be no different from placebo. In patients who used this product for 5 years, the incidence of the above adverse reactions was reduced to ≤0.3%. The adverse events reported after marketing are as follows: abnormal ejaculation, breast tenderness and swelling, allergic reactions (including rash, itching, urticaria and swelling of the lips) and testicular pain.

This product is contraindicated in the following situations: 1. Pregnant women or women who may become pregnant. 2. People who are allergic to any of the ingredients in this product. 3. This product is not suitable for women and children.

Precautions for children: This product is not suitable for children. Safety and efficacy studies in pediatric patients have not been established. Precautions for pregnancy and lactation: 1. This product is not suitable for women. 2. This product is contraindicated for pregnant or pregnant women. Because type II 5α-reductase inhibitors inhibit the conversion of testosterone to dihydrotestosterone in certain tissues, such inhibitors (including finasteride) can cause malformation of the external genitalia of male fetuses if used in pregnant women. 3. Pregnant or pregnant women should not touch broken finasteride tablets. Because the drug may be absorbed and then cause harm to the male fetus. The intact tablets have an outer coating to prevent contact with the active ingredients of the drug during normal operation. 4. This product is not suitable for breastfeeding women. It is not clear whether finasteride is secreted in human milk. Precautions for the elderly: Clinical studies have not been established in male patients over 65 years old. According to the results of the pharmacokinetic study of finasteride 5mg, the elderly do not need to adjust the dose. However, the effectiveness of finasteride 1mg in the treatment of hair loss in elderly patients has not been determined.

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 in a dark place, tightly sealed and store below 30℃.

1 mg

24 months

Zhejiang Xianju Pharmaceutical Co., Ltd.

• Founded in:

  2000-06-26

• Address:

  No. 1, Xianyao Road, Xianju County, Taizhou City, Zhejiang Province

• Tax NO.:

  913300007047892221

• Registered Funds:

  989.204866 million yuan

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