Date of approval.
Date of revision.
Tamsulosin hydrochloride extended release capsule instructions
Please read the instructions carefully and use under the guidance of a physician
Drug Name]
Generic name: Tamsulosin Hydrochloride Sustained-release Capsules
English name: Tamsulosin Hydrochloride Sustained-release Capsules
Hanyu Pinyin: Yansuan Tansuoluoxin Huanshi Jiaonang
Ingredients
The main ingredient of this product is tamsulosin hydrochloride.
Chemical name: (-)-(R)-5-[2-[[2-(o-ethoxyphenoxy)ethyl]amido]propyl]-2-methoxyphenyl sulfonamide hydrochloride.
Chemical structure formula.
Molecular formula: C20H28N2O5S-HCl
Molecular weight: 444.97
Properties】This product is a capsule, the contents of which are off-white to light yellow micro-pills.
Indications】Disorders of urination caused by prostatic hyperplasia.
Specification】0.2mg
Dosage】Adults take one capsule (0.2mg) once daily by mouth after meals. It can be increased or decreased according to age and symptoms.
Adverse reactions
1. Serious adverse reactions: Loss of consciousness, loss of consciousness (frequency unknown): Because of the possibility of transient loss of consciousness accompanied by a drop in blood pressure, adequate observation should be made during the use of the drug, and when abnormalities occur, the drug should be discontinued and appropriate treatment measures should be taken.
2. Other adverse reactions: ①Psychoneurological system: occasional dizziness, headache, hobbling sensation and other symptoms. ②Circulatory system: Occasionally, decrease in blood pressure, postural hypotension, accelerated heart rate, palpitations, etc. ③Allergic reactions: itching, rash, and hives may occasionally occur; stop taking the drug when such symptoms occur. ④Digestive system: occasional nausea, vomiting, stomach discomfort, abdominal pain, loss of appetite, diarrhea, constipation, difficulty in swallowing, etc. ⑤ Liver function: occasional elevation of GOT, GPT, LDH. (6) Intraoperative iris relaxation syndrome: Intraoperative Floppy Iris Syndrome (Iris) due to alpha1 receptor antagonism has been reported in patients who are taking or have taken alpha1 receptor antagonists. Ophthalmologists should be aware of the occurrence of Intraoperative Floppy Iris Syndrome when performing ophthalmic surgery. (7) Other: Occasional nasal congestion, epistaxis, swelling, lethargy, abnormal penile erectile disorder, ejaculation disorder, blurred vision, visual impairment, erythema multiforme, exfoliative dermatitis, etc.
Contraindications
It is prohibited for those who are allergic to this product.
Precautions
1. This product can be used after the diagnosis of prostate cancer has been excluded. It is recommended that patients be screened for other diseases that can cause the same symptoms as prostate enlargement, such as prostate cancer, before treatment with tamsulosin, and regularly after tamsulosin treatment. 2. Blood pressure changes should be closely monitored when combining antihypertensive drugs. 3. Be careful not to chew the granules inside the capsule. 4. Use with caution in patients with postural hypotension and severe hepatic dysfunction. 5. No need to reduce the dose in patients with renal insufficiency. Caution should be exercised in patients with severe renal dysfunction (creatinine clearance <10ml/min) as it has not been studied in such patients. 6. When administered, it is possible that tamsulosin exposure may be significantly increased. When co-administered with ketoconazole (CYP3A4 inhibitor), it leads to a 2.2 and 2.8-fold increase in Cmax and AUC of tamsulosin, respectively. When co-administered with paroxetine (CYP2D6 inhibitor), it resulted in a 1.3- and 1.6-fold increase in Cmax and AUC of tamsulosin, respectively.8. Cases of allergic reactions when tamsulosin was administered to patients with a history of sulfonamide allergy have been reported. Tamsulosin hydrochloride should be taken with caution in patients with a history of sulfonamide allergy.
For pregnant and lactating women
Not yet available
For Children
Not for use in children.
Geriatric use]
Since the elderly are often associated with low renal function, due attention should be paid to the condition of the patient after taking the drug. If the desired effect is not achieved, the dosage should not be increased, but other appropriate disposal methods should be used.
Drug Interactions
1. The combination of this product with other adrenergic blocking agents may affect their pharmacokinetics and pharmacokinetics, and it is recommended not to combine them. 2. Cimetidine increases the absorption and reduces the clearance of this product. Use with caution, especially when the dose exceeds 0.4 mg.
Overdose]
Overdose of this product may cause a drop in blood pressure, so be careful with the dosage.
Pharmacology and Toxicology
The main mechanism of action is to selectively block the α1A adrenergic receptors in the prostate gland and relax the smooth muscle of the prostate gland, thus improving the symptoms of BPH such as difficulty in urination.
Pharmacokinetics]
Absorption, distribution and elimination: When adults take 0.2mg orally at one time, the blood concentration reaches the peak after 6.8 hours, and the half-life is 10.0 hours, and its AUC0~∞ is almost equal to the common preparation, so it is a slow-release preparation with no decrease in bioavailability. The blood concentration can reach steady state on the 4th day after continuous oral administration.
Storage】Sealed and stored.
Package】Double aluminum package, 10 capsules/plate/box.
Expiration date】24 months
Execution Standard
Approval number
Drug marketing license holder
Name: Shanghai Anbisen Pharmaceutical Technology Co.
Registered Address: Unit E, 7/F, Building 4, No. 889 Yishan Road, Xuhui District, Shanghai
Postal Code: 200233
Tel: 4000075658
Fax number: 021-54973497
Web address: http://www.anbison.com
Manufacturer
Company name: Hangzhou Minsheng Binjiang Pharmaceutical Co.
Address: Building 2, No. 658, Binan Road, Binjiang District, Hangzhou, Zhejiang Province
Postal code: 310051
Tel: 0571-89976059
Fax number: 0571-89976050
Web address: www.msbinjiangpharma.com