Product Overview
[Drug name]
Generic name: Finasteride Tablets
Trade name: Yishusheng
English name: Finasteride Tablets
Chinese pinyin: Feinaxiongan Pian
[Ingredients]
The main ingredient of this product is finasteride. Chemical name: 17-(N-tert-butylcarbamoyl)-4-aza-5-androst-1-ene-3-one.
[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 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.
[Usage and Dosage]
Oral. Recommended dose: 5 mg (1 tablet) each time, once a day, can be taken on an empty stomach or with food.
[Adverse Reactions]
Finasteride has good tolerance, and most of the 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 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%). Breast enlargement: 0.5% (0.1%). Breast pain: 0.4% (0.1%). Rash: 0.5%.
[Contraindications]
This product is not suitable for women and children. This product is contraindicated in the following situations: 1 People who are allergic to any ingredient of this product. 2 Pregnant and potentially pregnant women.
[Precautions]
General Precautions 1 Before using this product, other diseases similar to benign prostatic hyperplasia (BPH) should be excluded, such as infection, prostate cancer, urethral stenosis, bladder hypotonia, neurogenic disorders, etc. 2 Finasteride is mainly metabolized in the liver, so it should be used with caution in patients with impaired liver function. 3 No dosage adjustment is required for patients with renal insufficiency. II. Effects on prostate specific antigen (PSA) and prostate cancer examination 1 Finasteride has no clinical efficacy in the treatment of prostate cancer. Finasteride does not affect the incidence of prostate cancer, nor does it affect the detection rate of prostate cancer. 2 It is recommended to perform regular prostate examinations before and after finasteride treatment, such as rectal examinations and other prostate cancer-related examinations (including PSA). 3 Finasteride can reduce the serum PSA concentration of patients with prostate hyperplasia (or with prostate cancer) by approximately 50%. When evaluating PSA data and not excluding the possibility of prostate cancer, it should be considered that finasteride can reduce the serum PSA level of patients with prostate hyperplasia. 4 Patients treated with finasteride should be carefully evaluated for persistently elevated PSA levels, including consideration of non-compliance with finasteride treatment. 3. Drug/laboratory test interactions. Effect on PSA levels. Serum PSA concentrations are related to patient age and prostate volume, which in turn is related to patient age. When evaluating PSA laboratory test results, the fact that PSA levels are reduced in patients treated with finasteride should be considered. In most patients, PSA decreases rapidly within the first month of treatment, and then PSA levels stabilize at a new baseline, with the post-treatment baseline value being approximately half of the pre-treatment baseline value. Therefore, a typical patient treated with finasteride for six months or longer should have a doubled PSA value when compared to the normal PSA value of an untreated male.
[Use in special populations]
Children's precautions: This product is not suitable for children.
Precautions during 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.
[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, α-blockers, β-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]
This product belongs to the 4-nitrogen steroid hormone compound, which is a specific type II 5α-reductase competitive inhibitor, 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 of benign prostatic hyperplasia by reducing the level of dihydrotestosterone in blood and prostate tissue.
[Storage] Store in a dark, airtight, cool and dry place.
[Specification] 5mg
[Packing specification] 5mgX10 tablets/box
[Validity period] 24 months
[Approval number] National Medicine Standard H20051699
[Manufacturer] Enterprise name: Guangdong Yishu Pharmaceutical Co., Ltd.
