Product Overview
[Drug name]
Generic name: Finasteride Tablets
Trade name: Xianju
English name: FINASTERIDE TABLETS
Chinese Pinyin: Feinaxiongan Pian
[Ingredients]
The main ingredient of this product is finasteride.
[Properties]
This product is a blue film-coated tablet, which is white or off-white after removing the film coating.
[Indications]
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.
[Usage and Dosage]
1. Oral, the recommended dose is once a day, one tablet (1 mg) at a time, taken on an empty stomach or with food. 2. Generally, the effect of increased hair growth, increased hair growth in a few days and/or prevention of further hair loss can be observed after continuous use of the drug for three months or more. It is recommended to continue to use the drug to achieve the maximum therapeutic effect. The therapeutic effect can be reversed within 12 months after stopping the drug.
[Adverse Reactions]
This product is generally well tolerated, and adverse reactions are usually mild, and generally do not require discontinuation of treatment. The safety of finasteride in the treatment of alopecia was 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 decreased ejaculation volume, compared with 0.4% in the placebo control group. These adverse reactions disappeared after discontinuation of 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%. Adverse events reported after marketing are as follows: abnormal ejaculation, breast tenderness and swelling, allergic reactions (including rash, itching, urticaria and lip swelling) and testicular pain.
[Contraindications]
This product is contraindicated in the following situations: 1. Pregnant women or women who may become pregnant. 2. People who are allergic to any ingredient of this product. 3. This product is not suitable for women and children.
[Precautions]
1. Direct contact with women - Risk to male fetuses This product is not suitable for use by women. Pregnant or potentially pregnant women must not come into contact with broken finasteride tablets to avoid absorption of finasteride and potential harm to the male fetus in the abdomen. Finasteride tablets have an outer film coating to prevent contact with the active ingredients of the drug during normal operation when the tablets are not broken. 2. Effect on PSA (serum prostate-specific antigen) In clinical studies of men aged 18 to 41, serum prostate-specific antigen (PSA) dropped from a baseline level of 0.7ng/ml to 0.5ng/ml after taking finasteride 1mg for 12 months. In addition, when finasteride 5mg was used to treat elderly male hair loss patients with benign prostatic hyperplasia (BPH), serum prostate-specific antigen levels dropped by nearly 50%. Other studies have shown that finasteride 5mg can also reduce serum prostate-specific antigen in patients with prostate cancer. These findings can be used to explain the serum prostate-specific antigen levels in men treated with finasteride. Any confirmed increase in serum prostate-specific antigen during the use of finasteride 1 mg, even if the value is within a reasonable range for men not taking 5α-reductase inhibitors, needs to be evaluated because it indicates the possibility of prostate cancer. Failure to comply with the finasteride 1 mg treatment regimen will also affect the results of serum prostate-specific antigen tests. 3. 5α-reductase inhibitors increase the risk of high-grade prostate cancer. In a 7-year prostate cancer prevention trial (PCPT), men over 55 years old who passed routine rectal examinations and had PSA ≤ 3.0 ng/ml were given finasteride 5 mg/day (5 times the dose of finasteride tablets 1 mg). When the Gleason score reached 8-10, the incidence of prostate cancer in the finasteride group was 1.8%, higher than 1.1% in the placebo group. In a 4-year clinical trial of another 5α-reductase inhibitor (dutasteride, AVODART) and placebo, the incidence of prostate cancer was similar, 1% in the dutasteride group and 0.5% in the placebo group. The clinical significance of these findings for men using finasteride 1 mg is unknown. 5α-reductase inhibitors may increase the risk of high-grade prostate cancer. The effect of 5α-reductase inhibitors in reducing prostate volume or whether research-related factors affect these research results has not yet been determined. 4. Mood changes and depression: There are reports of mood changes, including low mood, depression, and uncommon suicidal thoughts, in patients taking finasteride tablets 1 mg. The patient's mental state should be monitored. If the above reactions occur, finasteride should be discontinued and a doctor's advice should be sought. 5. There is no data showing that finasteride has an effect on the ability to drive and use machines. 6. During the use of this product, if any adverse events and/or adverse reactions occur, please consult a doctor. 7. Please inform your doctor if you use other medicines at the same time. 8. Please keep out of the reach of children. 9. Use with caution in patients with abnormal liver function. 10. No dosage adjustment is required for patients with renal impairment.
[Special population use]
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.
【Drug Interactions】
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.
[Pharmacological Action]
Finasteride is a synthetic steroid compound that is a specific inhibitor of the intracellular enzyme type II 5α-reductase in the process of metabolizing the androgen testosterone into dihydrotestosterone. Finasteride has no affinity for androgen receptors, and has no androgen-like, anti-androgen-like, estrogen-like, anti-estrogen-like or progestational effects. Inhibition of this enzyme can hinder the conversion of testosterone to androgen dihydrotestosterone in peripheral tissues, significantly reducing the concentration of dihydrotestosterone in serum and tissues. Compared with placebo, the level of testosterone in the blood circulation can be increased by about 10-15%, but it is still within the physiological range. Finasteride can rapidly reduce the concentration of dihydrotestosterone in serum and significantly reduce it within 24 hours after administration. Hair follicles contain type II 5α-reductase. In the bald area of male baldness patients, the hair follicles in the scalp 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 will 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.
[Storage] Shade, seal, and store below 30°C.
[Validity period] 24 months
[Approval number] National Medicine Standard H20070112
[Manufacturer] Company name: Zhejiang Xianju Pharmaceutical Co., Ltd.
