Product Overview
[Drug name]
Generic name: Tamsulosin Hydrochloride Sustained-release Capsules
Trade name: Bitan
English name: Tamsulosin Hydrochloride Sustained-release Capsules
Chinese Pinyin: Yansuan Tanluoxin Huanshi Jiaonang
[Ingredients] The main ingredient of this product is tamsulosin hydrochloride.
[Properties] This product is a hard capsule with off-white spherical pellets.
[Indications] Used to relieve urination disorders caused by benign prostatic hyperplasia (BPH).
[Specifications] 0.2mg.
[Usage and Dosage] Usage: Oral, oral after meals. Dosage: 0.2mg (1 capsule) once a day. It can be increased or decreased appropriately according to age and symptoms.
[Adverse reactions]
1. Neuropsychiatric system: Occasionally dizziness, staggering, etc.
2. Circulatory system: Occasionally, blood pressure drops, heart rate increases, etc.
3. Allergic reactions: Occasionally, rashes may occur. If such symptoms occur, the medication should be stopped.
4. Digestive system: Occasionally nausea, vomiting, stomach discomfort, abdominal pain, loss of appetite, etc.
5. Liver function: Occasionally ALT, AST, and LDH increase, which can return to normal after stopping the drug.
6. Others: Occasionally nasal congestion, edema, dysphagia, fatigue, etc.
[Contraindications] The following patients are prohibited: 1. Those who are allergic to this drug. 2. Patients with renal insufficiency.
[Precautions] 1. Be careful not to chew it and swallow it whole. 2. Patients with orthostatic hypotension and coronary heart disease should use it with caution. 3. Patients with renal insufficiency should use it with caution or prohibit it depending on the Cr situation.
[Pregnant and lactating women] This product is prohibited.
[Children's use] This product is prohibited.
[Elderly use] Because elderly patients often have low renal function, in this case, full attention should be paid to observing the patient's condition after taking the medicine. If the expected effect is not obtained, the increase should not continue, but other appropriate treatment methods should be used instead.
[Drug Interactions] When taking antihypertensive drugs together, pay close attention to changes in blood pressure.
[Drug Overdose] Overdose of this product may cause a drop in blood pressure, so pay attention to the dosage.
[Pharmacology and Toxicology] 1
Pharmacological Action: 1. Blocking effect on sympathetic nerve α1 receptors: This product can selectively block α1 receptors, and its effect is 0.5-22 times stronger than prazosin hydrochloride and 45-140 times stronger than phentolamine mesylate. In addition, the affinity of this product for α1 receptors is 5400-24000 times stronger than that of α2 receptors.
2. Effects on the urethra, bladder and prostate: Because this product is a specific antagonist of the α1 receptor subtype α1A, and the α1 receptors present in the urethra, bladder neck and prostate are mainly α1A receptors, this product has a highly selective blocking effect on the urethra, bladder neck and prostate smooth muscle, relaxes the smooth muscle, reduces urethral compression, and its ability to inhibit the increase in urethral pressure is 13 times that of inhibiting the increase in vasodilation pressure.
3. Effect of improving urination disorder: This product can reduce the prostate pressure in the urethral pressure curve, but has no effect on rhythmic bladder contraction and bladder pressure curve.
Toxicological study: Repeated dose toxicity literature reports that rats and beagles (oral) were found to have reduced uterine and ovarian weight after continuous administration for 3 months. Reproductive toxicity Male rats taking a single or multiple dose of tamsulosin hydrochloride 300mg/kg/d can lead to a significant decrease in fertility, but this effect is reversible. Fertility improves after stopping the single dose for 3 days or the multiple dose for 4 weeks, and returns to normal after stopping the multiple dose for 9 weeks. Male rats given multiple doses of 10mg/kg/d or 100mg/kg/d (AUC is 0.2 and 16 times that of normal people, respectively) will not affect fertility. In the various tests that have been completed, tamsulosin hydrochloride has no teratogenic effect.
Carcinogenic toxicity It is reported that the incidence of mammary fibrosis increased in female rats after the dose of tamsulosin hydrochloride exceeded 5.4 mg/kg (P<0.015). Female mice were given tamsulosin hydrochloride at 45 mg/kg/d and 158 mg/kg/d for two consecutive years, and the incidence of mammary fibroadenoma (P<0.001) and adenocarcinoma (P<0.075) increased. The occurrence of mammary tumors in female rats and mice in the experiment may be related to the increase in prolactin levels caused by tamsulosin hydrochloride.
[Pharmacokinetics] After a single oral dose of 0.2 mg of this product, the blood drug concentration reached the peak time of 5.2±1.0 hours, the peak concentration was 7.37±1.12 ng/ml, the apparent elimination half-life was 7.68±1.40 hours, and the average residence time MRT was 12.31±1.70 hours.
[Storage] Sealed and stored in a greenhouse.
[Packaging] Cold stamping solid medicinal composite hard skin and aluminum foil for drug packaging, 7 tablets/plate, 1 plate/box.
[Validity period] 24 months
[Approval number] National Medicine Standard H2005285
[Manufacturer] Hangzhou Kangenbei Pharmaceutical Co., Ltd.
