Product Overview
[Drug name]
Generic name: Finasteride Tablets
Trade name: Puli'an
English name: Finasteride Tablets
Chinese Pinyin: Feinaxiongan Pian
[Ingredients]
The main ingredient of this product is finasteride, its chemical name: 17-(N-tert-butylcarbamoyl)-4-aza-5-androst-1-ene-3-one
[Properties]
This product is a 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%. 2 Other adverse reactions reported after the product was launched include: itching, urticaria, allergic reactions such as swelling of the face and lips, and testicular pain. 3 Laboratory 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. Those who are allergic to any component of this product. 2. Pregnant and potentially pregnant women.
[Precautions]
General Precautions 1Before 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. 2Finasteride is mainly metabolized in the liver, so it should be used with caution in patients with impaired liver function. 3Patients with renal insufficiency do not need to adjust the dosage. II. Effects on prostate specific antigen (PSA) and prostate cancer examination 1Finasteride 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. 2It is recommended to perform regular prostate examinations before and after finasteride treatment, such as rectal examinations and other prostate cancer-related examinations (including PSA). 3Finasteride 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 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. For 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.
[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]
Clinically important drug interactions have not yet been determined. 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 specific drug interaction studies have not been performed, no clinically significant adverse interactions were found when finasteride was used concomitantly with angiotensin-converting enzyme inhibitors, acetaminophen, acetylsalicylic acid, alpha-blockers, beta-blockers, calcium channel blockers, nitrates for cardiac disease, diuretics, H2 antagonists, HMG-CoA reductase inhibitors, nonsteroidal anti-inflammatory drugs (NSAIDs), quinolones, and benzodiazepines in clinical studies.
[Pharmacological action]
This product belongs to the 4-nitrogen steroid hormone compound, which 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 clinical symptoms related to benign prostatic hyperplasia by reducing the level of dihydrotestosterone in the blood and prostate tissue. Toxicological study Genetic toxicity: In vitro bacterial and mammalian cell mutagenicity tests and in vitro alkaline elution tests did not show mutagenic effects. In the in vitro CHO cell chromosome aberration study, finasteride slightly increased the chromosome aberration rate of CHO cells at a concentration of 450-550μmol, which is equivalent to 4000-5000 times the peak plasma concentration of 5mg of this product after oral administration. In the in vivo chromosomal aberration test, mice were given finasteride 250 mg/kg/day (based on AUC, equivalent to 228 times the recommended daily dose of 5 mg in humans, and the calculation method for all toxicology study doses below is the same), and the chromosomal aberration rate did not increase.
[Storage] Sealed, store in a cool place.
[Specification] 5mg
[Packaging specification] Aluminum plastic packaging, 10 tablets per plate/box
[Validity period] 24 months
[Approval number] National Medicine Standard H20050550
[Manufacturer] Company name: Shanghai Modern Pharmaceutical Co., Ltd.
