Product Overview
Generic name: H finasteride tablets
Trade name: QianLieKang QianLie H finasteride tablets 5mg*10 tablets
Pinyin full code: QianLieKang QianLie HFeiNaXiongAnPian 5mg*10Pian
[Main ingredients]
The main ingredient of this product is finasteride, and its chemical name is N-tert-butyl-3-oxo-4-aza-5α-androst-1-ene-17β-carboxamide. Molecular formula: C23H36N2O2. Molecular weight: 372.55
[Properties]
This product is a film-coated tablet, which is white or off-white after removing the coating.
[Indications/Main Functions]
1. This product is suitable for the treatment and control of benign prostatic hyperplasia (BPH) and the prevention of urinary system events: --- Reduce the risk of acute urinary retention. -- Reduce the risk of transurethral resection of the prostate (TURP) and prostatectomy. 2. This product can shrink the enlarged prostate, improve urine flow and improve symptoms related to prostate hyperplasia. This product is suitable for patients with prostate hypertrophy.
[Specifications]
5mg*10 tablets
[Usage and Dosage]
The recommended dose is 1 tablet per day, 5 mg per tablet, taken with or without food. Dosage for patients with renal insufficiency No dosage adjustment is required for patients with various degrees of renal insufficiency (creatinine clearance as low as 9 ml/min), because pharmacokinetic studies have confirmed that there is no change in the in vivo process of finasteride. Dosage for the elderly Although pharmacokinetic studies have shown that the clearance of finasteride is reduced in patients over 70 years old, there is no need to adjust the dosage.
[Adverse Reactions]
This product has good tolerance. In the PLESS study, 1524 patients took 5 mg of this product daily and 1516 patients took placebo for more than 4 years of safety evaluation. 4.9% (74 patients) discontinued treatment due to adverse reactions related to this product, compared with 3.3% (50 patients) in the placebo group. 3.7% (57 patients) of patients taking this product and 2.1% (32 patients) of patients treated with placebo discontinued treatment due to adverse reactions related to sexual function, which was the most reported adverse reaction. In the more than 4 years of research, the clinical adverse reactions that were considered by the researchers to be possible, very likely and certain to be related to this product, with an incidence of 1% and greater than placebo, were mainly affected sexual function, breast discomfort and rash. In the first year of the study, 8.1% of patients taking this product developed impotence, while 3.7% of patients taking placebo developed impotence; 6.4% of those with decreased libido were compared with 3.4%, and 0.8% of those with ejaculation disorders were compared with 0.1%. In the second to fourth years of the study, the incidence of these three adverse reactions did not differ significantly between the two treatment groups. Cumulative incidences from the second to fourth year were: impotence (5.1% for levofloxacin; 5.1% for placebo); decreased libido (2.6%; 2.6%); and ejaculation disorders (0.2%; 0.1%). In the first year, 3.7 and 0.8% of patients with levofloxacin and placebo, respectively, had decreased ejaculation volume; in the second to fourth years, the cumulative incidences were 1.5% for levofloxacin and 0.5% for placebo. In the first year, breast hyperplasia (0.5%; 0.1%), breast tenderness (0.4%; 0.1%), and rash (0.5%; 0.2%) were reported in the levofloxacin and placebo groups.In the one-year, placebo-controlled Phase III clinical study and the five-year extension study (853 patients extended treatment to five to six years), the adverse reactions were similar to those reported in PLESS from two to four years. No adverse reactions were found to increase with the extension of the treatment period of this product. The incidence of new drug-related adverse reactions in sexual function decreased with the extension of treatment time. Other long-term research data In a 7-year, placebo-controlled clinical study, a total of 18,882 healthy men were enrolled. In the data analysis of prostate needle biopsy in 9060 men, the occurrence of prostate cancer was observed in 803 (18.4%) of the patients in the FDA group and 1147 (24.4%) in the placebo group. According to the prostate needle biopsy data, 280 (6.4%) of the patients with prostate cancer in the FDA group with a Gleason score of 7-10 were found in the placebo group, while 237 (5.1%) were found in the placebo group. Further analysis showed that the increase in high-scoring prostate cancer patients in the finasteride group may be caused by detection bias due to the effect of finasteride on prostate volume. Approximately 98% of all cases of prostate cancer diagnosed in this study were classified as intracystic tumors (clinical stage T1 or T2) at diagnosis. The clinical significance of GleaSon scores of 7-10 is unclear. Breast Cancer In the MTOPS study, which enrolled 3047 men for 4-6 years and compared them with placebo and control drugs, there were 4 cases of breast cancer in men treated with finasteride and no cases of breast cancer in men not treated with finasteride.In the 4-year, placebo-controlled PLESS study of 3,040 men, there were 2 cases of breast cancer in men treated with placebo but no cases of breast cancer in men treated with finasteride. In the 7-year, placebo-controlled Prostate Cancer Prevention Trial (PCPT) of 18,882 men, there was 1 case of breast cancer in a man treated with finasteride and 1 case of breast cancer in a man treated with placebo. There have been postmarketing reports of breast cancer in men using finasteride. The relationship between long-term use of finasteride and male breast tumor formation is unknown. Postmarketing Experience The following are adverse reactions reported postmarketing with finasteride 5 mg and/or low-dose finasteride. Because these adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their incidence or establish a causal relationship to drug exposure. Immune system disorders: Hypersensitivity reactions, such as pruritus, urticaria, and angioedema (including swelling of the lips, tongue, throat, and face). Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis, myopathy, myalgia, myasthenia, creatine kinase increased. In some cases, these events were reversible after discontinuation of finasteride treatment. Psychiatric Disorders: Depression, anxiety, decreased libido that persists after discontinuation of treatment. Cardiac Disorders: Palpitations. Hepatobiliary Disorders: Elevated liver enzymes. Reproductive System and Breast Disorders: Sexual dysfunction (erectile dysfunction and ejaculation abnormalities), testicular pain, hematospermia, male infertility and/or poor semen quality that persist after discontinuation of treatment. There have been reports of normalization or improvement in semen quality after discontinuation of finasteride. Male Breast Cancer. Laboratory Test Results When evaluating laboratory test results, the decrease in PSA levels in patients taking finasteride (see PRECAUTIONS) should be taken into account. There were no other differences in 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: those who are allergic to any of the ingredients in this product. Pregnancy - pregnant and potentially pregnant women (see Pregnant and lactating women).
[Precautions]
General Precautions Before starting treatment with this product, other urinary system diseases that may cause similar symptoms should be considered. In addition, prostate cancer and BPH may coexist. Patients with large amounts of residual urine and/or severe urinary flow reduction should be closely monitored for obstructive urinary tract diseases. Effects on PSA and prostate cancer tests So far, no clinical efficacy has been shown in patients with prostate cancer treated with this product. In controlled clinical studies, patients with prostate hyperplasia and elevated prostate-specific antigen (PSA) were monitored by serial PSAs and prostate biopsies. In these studies of prostate hyperplasia, this product did not change the detection rate of prostate cancer, and there was no significant difference in the overall incidence of prostate cancer between patients using this product and those using placebo. It is recommended to perform regular rectal examinations before and after treatment with this product, as well as other prostate cancer tests. Serum PSA is also used for prostate cancer testing. Generally speaking, a baseline PSA>10 ng/mL (Hybritech) indicates that further examination and consideration of biopsy are required; further examination is recommended for PSA levels between 4 and 10 ng/mL. There is some overlap in PSA levels in men with and without prostate cancer. Therefore, in men with prostate hyperplasia, whether or not they take this product, if the PSA value is within the normal reference range, the possibility of prostate cancer cannot be ruled out. Prostate cancer cannot be ruled out if the baseline PSA is <4 ng/ml. Even with prostate cancer, this product can reduce the serum PSA concentration of patients with prostate hyperplasia by about 50%. When evaluating PSA data and not ruling out prostate cancer, it should be considered that this product will reduce the serum PSA level of patients with prostate hyperplasia.Although there are individual differences among patients, the extent of the reduction in PSA values is predictable within the data. Analysis of PSA data from the double-blind, placebo-controlled, 4-year PLESS Long-term Efficacy and Safety Study (PLESS) of more than 3,000 patients demonstrated that the typical patient treated with finasteride for 6 months or longer should have a PSA value doubled compared to the normal PSA value of untreated men. This adjustment not only preserves the sensitivity and specificity of the PSA test, but also maintains its effectiveness in detecting prostate cancer. Patients treated with finasteride should be evaluated with caution if their PSA levels continue to rise, including consideration of non-compliance with finasteride treatment. Finasteride does not cause a significant decrease in the free PSA percentage (free PSA/total PSA), and the free PSA/total PSA value remains constant under the influence of finasteride. When the free PSA percentage is used to detect prostate cancer, its value does not need to be adjusted. Increased risk of high-grade prostate cancer In the 7-year Prostate Cancer Prevention Trial (PCPT), men aged 55 years and older with normal rectal examination and baseline PSA ≤3.0 ng/mL who took finasteride 5 mg/day had an increased risk of Gleason score 8-10 prostate cancer (finasteride 1.8% vs placebo 1.1%). Similar results were observed in another 4-year controlled clinical trial of a 5α-reductase inhibitor (dutasteride) versus placebo (1% dutasteride vs 0.5% placebo). 5α-reductase inhibitors may increase the risk of high-grade prostate cancer. It has not been determined whether the effect of 5α-reductase inhibitors on reducing prostate volume or the effects of study-related factors influenced the results of these studies. Mood changes and depression Mood changes, including low mood, depression, and less frequently suicidal ideation, have been reported in patients treated with finasteride 5 mg. Patients should be monitored for psychiatric symptoms and advised to consult a physician if these symptoms occur.Effects on Semen Characteristics Semen parameters were assessed in healthy male volunteers taking finasteride 5 mg for 24 weeks and no clinically significant effects of finasteride on sperm concentration, motility, morphology or pH were found. A decrease in median ejaculate volume of 0.6 ml (22.1%) was observed, as was a decrease in total sperm count per ejaculate. These parameters remained within normal ranges and recovered after discontinuation of the drug, with a mean return to baseline of 84 weeks. Effects of Drug/Laboratory Test Interactions on PSA Levels Serum PSA concentrations are related to patient age and prostate volume, which in turn is related to patient age. The fact that PSA levels decrease in patients treated with finasteride should be considered when evaluating PSA laboratory test results. In most patients, PSA decreases rapidly within the first month of treatment, followed by stabilization of PSA levels to a new baseline. Post-treatment baseline values are approximately half of pre-treatment baseline values. 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 in untreated men. For clinical interpretation, see Precautions - Effects on PSA and Prostate Cancer Testing. Lactose tablets contain lactose. Patients with any of the following genetic defects should not take this product: galactose intolerance, total lactase deficiency or glucose-galactose malabsorption.
