Product Overview
[Drug name]
Generic name: Finasteride Tablets
Trade name: Proscar
English name: Finasteride Tablets
Chinese Pinyin: QianLieXianZengShengQiangXiaoTaoZhuang
[Ingredients]
Each tablet contains 5mg of finasteride.
[Properties]
Finasteride Tablets: This product is a special-shaped film-coated tablet, which is white or off-white after removing the coating. Tamsulosin Hydrochloride Sustained Release Capsules: This product is a capsule, and the contents are off-white spherical particles.
[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]
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.
[Contraindications]
This product is contraindicated for use in pregnant women or women who may become pregnant (see [Use in 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. General precautions 1. Other diseases similar to benign prostatic hyperplasia (BPH) should be ruled out before using this product, 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 liver dysfunction. 3. No dosage adjustment is required for patients with renal insufficiency. 2. Effects on prostate-specific antigen and prostate cancer examinations 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 have regular prostate examinations before and after a period of treatment with finasteride, such as rectal digital examination 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 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. The post-treatment baseline value is 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: See the specific description in [Usage and 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 obvious 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]
This drug belongs to the 4-nitrogen steroid hormone compound, which is a specific type II 5-alpha-reductase competitive inhibitor, inhibits the conversion of peripheral testosterone into dihydrotestosterone, reduces the level of dihydrotestosterone in blood and prostate, skin and other tissues. The growth, development and benign hyperplasia of the prostate depend on dihydrotestosterone. Finasteride inhibits prostate hyperplasia by reducing the level of dihydrotestosterone in blood and prostate tissue, and improves the clinical symptoms related to benign prostatic hyperplasia.
[Storage] Keep in a dark, airtight, cool and dry place.
[Validity period] 36 months
[Approval number] National Medicine Standard H20070112
[Manufacturer] Company name: Merck Sharp & Dohme Limited
