Product Overview
Drug name
Trade name: Qiannuolin
Generic name: Finasteride tablets
English name: Finasteride Tablets
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 (see pregnant women and clinical research sections) and children.
Main ingredients
The main ingredients of this product and their chemical names, chemical structures, molecular formulas, and molecular weights are: Main ingredient: Finasteride Its chemical name is: N-tert-butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide Chemical structure: Molecular formula: C23H36N2O2 Molecular weight: 372.55
Properties
This product is a film-coated tablet, which is white or off-white after removing the film coating.
Specifications
1mg*20 tablets
Drug interactions
No important drug interactions have been found clinically. Finasteride does not affect the drug metabolism enzyme system related to cytochrome P450. Drugs that have been studied in men include antipyrine, digoxin, glyburide, propranolol, theophylline, and warfarin, and no interactions have been found. Although no specific interaction studies have been conducted, in clinical studies, no important adverse interactions were observed when finasteride at a dose of 1 mg or more was used in combination with angiotensin-converting enzyme inhibitors, acetaminophen, alpha blockers, benzodiazepines, beta blockers, calcium channel blockers, nitrates, diuretics, H2 receptor antagonists, beta-hydroxy-beta-methylglutaryl coenzyme A reductase inhibitors, prostaglandin synthetase inhibitors, and quinolones.
Adverse reactions
This product is generally well tolerated, and adverse reactions are usually mild, and generally do not require discontinuation of treatment.
Contraindications
This product is contraindicated for: Pregnant women or women who may become pregnant (see [Pregnant and lactating women]) Those who are allergic to any component of this product This product is not suitable for women and children.
Precautions
1. Direct contact with women - risks to male fetuses This product is not suitable for use by women. Pregnant or potentially pregnant women should not come into contact with broken finasteride tablets to prevent absorption of finasteride and potential harm to the male fetus in the womb. Finasteride tablets have an outer film coating that prevents contact with the active ingredients of the drug during normal handling when the tablets are not broken. 2. Effect on PSA (serum prostate-specific antigen) In a clinical study of men aged 18 to 41 years, serum prostate-specific antigen (PSA) decreased 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 decreased 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 of men treated with finasteride. Any confirmed increase in serum prostate-specific antigen during finasteride 1 mg therapy, even if the value is within a reasonable range for men not taking 5α-reductase inhibitors, requires evaluation because it indicates the possibility of prostate cancer. Failure to adhere to the finasteride 1 mg treatment regimen can also affect serum prostate-specific antigen test results. 3.5α-reductase inhibitors increase the risk of high-grade prostate cancer In a 7-year Prostate Cancer Prevention Trial (PCPT), men aged 55 years and older with a PSA ≤ 3.0 ng/ml on routine rectal examination were given finasteride 5 mg/day (five times the dose of finasteride 1 mg tablets) and a Gleason score of 8-10. The incidence of prostate cancer was 1.8% in the finasteride group, which was higher than 1.1% in the placebo group. In a 4-year clinical trial of another 5α-reductase inhibitor (dutasteride, AVODART) versus 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 on reducing prostate volume or whether study-related factors affect these study results has not been determined. 4. Mood changes and depression: There have been 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 affects 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 drugs 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.
Storage
Shade, seal, and store below 30°C.
Approval number
National Medicine Standard H20237067
Manufacturer
Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.
