Product Overview
[Drug name]
Generic name: Finasteride Tablets
Trade name: Qiannuolin
English name: Finasteride Tablets
Chinese Pinyin: Feinaxiongan Pian
[Ingredients]
The main ingredient of this product is finasteride. Chemical name: 17β-(N-tert-butylcarbamoyl)-4-aza-5α-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]
Benign prostatic hyperplasia.
[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 adverse reactions are mostly mild and short-lived. Literature reports: 1 Adverse reactions with an incidence rate of ≥1% are mainly sexual dysfunction (impotence, decreased libido, ejaculation disorders), breast discomfort (breast enlargement, breast pain) and rash. The incidence of adverse events after one year of use of this product is as follows (placebo control group in brackets), and the cumulative incidence after two to four years of use of the product 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%. 2Other adverse reactions reported after the product was marketed include: allergic reactions such as itching, urticaria, and swelling of the face and lips, and testicular pain. 3Laboratory 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 was no difference in other standard laboratory parameters between patients taking finasteride or placebo.
[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 women and women who may become pregnant.
[Precautions]
General precautions 1 Other diseases similar to benign prostatic hyperplasia (BPH) should be excluded before using this product, such as infection, prostate cancer, urethral stenosis, bladder hypotonia, neurogenic disorders, etc. 2 Finasteride is mainly metabolized in the liver, and should be used with caution in patients with liver dysfunction. 3 Patients with renal insufficiency do not need to adjust the dosage. 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 about 50%. When evaluating PSA data and not excluding the presence of prostate cancer, it should be considered that finasteride will reduce serum PSA levels in 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 patients treated with finasteride have reduced PSA levels 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 man.
[Special population use]
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 combination therapies. Although no specific drug interaction studies have been conducted, in clinical studies, no obvious 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 and 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 related clinical symptoms of benign prostatic hyperplasia by reducing the level of dihydrotestosterone in the blood and prostate tissue.
[Storage] Store in a dark, airtight, cool and dry place.
[Validity period] 24 months
[Approval number] National Medicine Standard H20040333
[Manufacturer] Company name: Hunan Qianjin Xiangjiang Pharmaceutical Co., Ltd.
