Product Overview
[Drug name]
Generic name: Finasteride Tablets
Trade name: Lanle
English name: Finasteride Tablets
Chinese Pinyin: Feinaxiong’an Pian
[Ingredients]
Each tablet contains 5 mg of finasteride.
[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]
This product is generally well tolerated, and adverse reactions are usually mild, and generally do not need to be discontinued. 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, multi-center, placebo-controlled, double-blind studies, 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 and 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 of the ingredients in this product This product is not suitable for women and children.
[Precautions]
I. 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, so it 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 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 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 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. III. Drug/Laboratory Test Interactions Effects 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. The baseline value after treatment is approximately half of the baseline value before treatment. 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 for pregnancy and lactation: This product is contraindicated for pregnant or potentially pregnant women.
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 drug 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, 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 by reducing the level of dihydrotestosterone in blood and prostate tissue, and improves the clinical symptoms related to benign prostatic hyperplasia.
[Storage] Store in a light-proof, airtight, cool and dry place.
[Specification] 5mg
[Packaging specification] 5mg*30/box
[Validity period] 24 months
[Approval number] National Medicine Standard H20030951
[Manufacturer] Enterprise name: Tianfang Pharmaceutical Co., Ltd.
