Instructions for Amlodipine Aspartate Tablets
Release time:
2020-07-31
Approval Date: October 23, 2006
First Amendment Date: June 20, 2010
Second Amendment Date: May 05, 2015
Amlodipine Aspartate Tablets Instruction
Aspartic acid Amlodipine Tablets
Please read the instruction carefully and use
[Drug Name]
generic name under the guidance of a doctor: amlodipine aspartate tablets
trade name: liside
English name: Aspartic acid Amlodipine Tablets
Chinese pinyin: Men dong an suan an lu di ping plan-
[ingredients] the main ingredient of this product is L-amlodipine aspartate
chemical name: 2-1 [2-aminoethoxy] methyl] -4-1 (2-chlorophenyl) -1,4-dihydrogen -6-methyl pyridine -3,5-3-ethyl -5-methyl ester L-a-aspartic acid salt.
Chemical Structural Formula:
Molecular Formula: C20H25CIN205 C4H7N04
Molecular Weight: 541.99
[Character] This product is white or white-like sheet
[Indications] It can be used alone or in combination with other antihypertensive drugs to treat hypertension
[Specification] 5mg (based on amlodipine)
[Usage and Dosage] Usually the initial dose is 5mg (one sheet) once a day, but the elderly, frail, liver damage patients and patients with other antihypertensive drugs, the initial dose can be 2.5mg (half a tablet), once a day. Dosage adjustment should be based on the clinical response of the individual patient, the maximum dose can be increased to 10mg (two tablets), once a day. This product is combined with thiazide diuretics, beta blockers and angiotensin converting enzyme inhibitors without dose adjustment.
[Adverse Reactions] The more common adverse reactions are headache, edema, fatigue, insomnia, nausea, abdominal pain, flushing, palpitations and dizziness. Less common adverse reactions are angina, hypotension, bradycardia, orthostatic hypotension, pruritus, rash, dyspnea, weakness, muscle cramps, and dyspepsia. This product is similar to other calcium antagonists, there are few reports of adverse reactions of myocardial infarction and chest pain, and these adverse reactions can not be clearly distinguished from the patient's own underlying disease; no abnormal laboratory parameters related to this product have been found.
[Contraindications] Patients allergic to dihydropyridine calcium antagonists are contraindicated.
[Precautions]
L. Patients with impaired liver function: As with all other calcium blockers, the half-life of this product is prolonged when liver function is impaired, but the corresponding recommended dose has not yet been determined. Therefore, this product should be used with great care in this case.
2. Patients with renal failure: This product is widely metabolized into inactive metabolites, and only 10% of the drugs are excreted in the original form through urine. Therefore, the change of blood drug concentration is not related to the degree of renal damage. Patients with renal damage can use normal doses. This product is not dialysis.
3. This product, such as other calcium ion blockers, can rarely have gingival hyperplasia, which mostly occurs during 1-9 months of treatment, but symptoms and hyperplasia can be improved l-21 weeks after drug withdrawal.
4. There is no need to stop the drug before surgery, but the anesthesiologist must know to use this drug for treatment.
. The following conditions are prohibited:
① Severe hypotension:
② Aortic stenosis.
[Use for pregnant and lactating women] The safety of this product for pregnant and lactating women has not been established. In animal experiments, rats were given 10 mg/kg of this product. In addition to delayed delivery and prolonged labor, intrauterine death increased 5 times and the number of littermates decreased by 50%. Therefore, this product can only be used when there is no other safer alternative drug and the disease itself is more dangerous to mother and child. There are no reports on whether this product is discharged into milk.
[Children's medication] There is no information on this product for children.
[Elderly Medication] The peak time of blood drug concentration of this product is similar in elderly and young patients. The area under the curve (AUC) of elderly patients is increased, the elimination half-life is prolonged, and the clearance rate is decreased. It has been reported that older patients were as well tolerated as younger patients when receiving similar doses of amlodipine. Therefore, the elderly patients can use the normal dose, but it is advisable to start with a smaller dose, and then gradually increase the appropriate.
[Drug Interactions]
(1) Narcotics: Inhalation of hydrocarbon drugs with this product can cause hypotension.
(2) non-steroidal anti-inflammatory drugs, especially indomethacin: with this product can weaken the hypotensive effect, may be related to the inhibition of prostaglandin synthesis and (or) cause water, sodium retention.
(3) beta blockers: well tolerated with this product, but can cause excessive hypotension, rare cases can increase the possibility of congestive heart failure.
(4) Estrogen: Use with this product can increase fluid retention and increase blood pressure.
(5) Sulfopyrone (sulfinpyrazone): combined with this product can increase the protein binding rate of amlodipine and change the blood drug concentration.
(6) Lithium preparations: When used with this product, it can cause neurotoxicity, such as nausea, vomiting, diarrhea, ataxia, tremor and (or) numbness, and should be used with caution.
(7) Sympathomimetic amines may attenuate the antihypertensive effect of this product.
[Drug Overdose] Existing data suggest that severe overdose can lead to excessive dilatation of peripheral blood vessels, followed by significant and lasting systemic hypotension, bradycardia, rare II or III degree atrioventricular block, and cardiac arrest in a few patients. The former should be given intravenous dopamine, norepinephrine treatment. The latter should be given atropine, isopropyl kidney, calcium chloride treatment, if there are indications should be placed pacemaker.
[Pharmacological Toxicology]
Pharmacological Effects
This product is a calcium ion influx blocker (I. e. calcium channel blocker or calcium ion antagonist), which can selectively inhibit calcium ion from flowing into vascular smooth muscle and myocardial cells across the membrane, especially for vascular smooth muscle. This product directly dilates vascular smooth muscle, dilates peripheral arterioles, reduces peripheral resistance (afterload), and significantly dilates coronary arteries. This product has a negative inotropic effect in vivo, but has no effect on the sinoatrial node and atrioventricular node.
Toxicological Study
Acute Toxicity in Mice: The LD 50 of L-aspartate amlodipine bulk drug administered by gavage is 80.2 mg/kg(95% confidence limit is 71.3-90.2 mg/kg); The LD 50 for intraperitoneal injection is 62.1 mg/kg(95% confidence limit is 55.0-70.1 mg/kg).
Genotoxicity: Mutagenicity test results indicate no drug-related gene or chromosome level mutagenicity.
Reproductive toxicity: General reproductive toxicity test, oral administration of amlodipine 10 mg/kg/day (based on body surface area, about 8 times the maximum recommended human dose of lOmg) to rats has no damage to fertility. Oral administration of 10 mg/kg of amlodipine (about 8 times and 23 times the maximum recommended human dose of 10mg in terms of body surface area, respectively) to pregnant rats and rabbits during organogenesis had no teratogenic effect on embryos. However, oral administration of amlodipine 10 mg/kg 14 days before mating and pregnancy in rats significantly reduced the number of littermates (about 50%), increased intrauterine mortality (about 5 times), and prolonged pregnancy and labor. Adequate and well-controlled trials have not been conducted in pregnant women, so pregnant women should only take this product during pregnancy when their potential benefits are large and potentially dangerous to the fetus.
It is not clear whether this product is excreted in human milk. In view of the lack of information in this regard, it is recommended to stop using it during lactation.
Carcinogenicity: Amlodipine is carcinogenic in rats and mice for two years. Mixed food doses of 0.5,1.25, and 2.5 mg/kg/day are non-carcinogenic. The highest dose (calculated by body surface area, the mouse dose is equivalent to the maximum recommended clinical dose of 10mg, while the rat dose is twice) is close to the maximum tolerance of mice.
[Pharmacokinetics] It is reported in the literature that this product is well absorbed orally and is not affected by food intake. The plasma protein binding rate is about 97.5, the blood drug concentration reaches the peak value 6-12 hours after single administration, the absolute bioavailability is about 64-80%, the apparent distribution volume is about 21L/kg, the final elimination half-life is about 35-50 hours, once a day, after 7-8 days of continuous administration, blood drug concentration reached steady state. This product is widely metabolized by the liver into inactive metabolites, 10% of which are excreted as original drugs and 60% as metabolites through urine.
【Storage】 Shaded, sealed and stored in a dry place..
【Packing】 Aluminum-plastic plate packaging, each small carton containing seven or fourteen pieces.
[Validity] 24 months.
[Implementation Standard] WS-(X-101)-2005Z
[Approval Document No.] Guoyao Zhun Zi H20020487
[Production Enterprise]
Enterprise Name: Zhejiang Jianfeng Pharmaceutical Co., Ltd.
Address: No. 58 Gaofan Section, Baitang Downline, Wucheng District, Jinhua City, Zhejiang Province
Tel: 0579-82661998 (Consultation) 0579-82131973 (Sales)
Fax
:
More information
The company's "three" cultivation through the stage of acceptance
Since November 2015 was included in the second batch of "three" cultivation pilot enterprises in Zhejiang Province, the company has carried out a series of related work in depth. On October 19, the implementation of the company's "three" cultivation project from January 2016 to September 2017 passed the phased acceptance organized by Jinhua Economic and Information Commission and Jinhua Finance Bureau. According to the requirements of the "three" cultivation pilot enterprise responsibility letter signed with Zhejiang Province, Jinhua City and Wucheng District, as of the end of September 2017, the company has invested 16.0772 million yuan in related projects, and has achieved remarkable results in improving management, improving automation and informatization level. For example, after the digital system of quality and cost control in the plant extraction workshop of Jianfeng Health Technology Company is put into use, the whole production process can be controlled and traceable, the product quality is more stable, the production safety is effectively guaranteed, the "three wastes" emission is greatly reduced, and the product cost is reduced by 20%. The electronic label system of the pharmaceutical company automatically addresses and accurately locates the drugs in and out of the warehouse, which reduces the error rate of the out and into the warehouse, and the location management can automatically display the information such as the location and quantity of the drugs, which improves the work efficiency of the warehouse logistics and effectively reduces the management cost. The pharmaceutical company's sales management information system integrates sales management, warehouse management, customer management, statistical analysis and other modules, realizes drug sales management and control functions according to the requirements of GMP and GSP specifications, and analyzes drug regions and sales volume through big data, which will judge drug consumption trends faster and more accurately and improve the accuracy of the company's drug sales decisions. Health
2020
07-31
The company's "three" cultivation through the stage of acceptance
Since November 2015 was included in the second batch of "three" cultivation pilot enterprises in Zhejiang Province, the company has carried out a series of related work in depth. On October 19, the implementation of the company's "three" cultivation project from January 2016 to September 2017 passed the phased acceptance organized by Jinhua Economic and Information Commission and Jinhua Finance Bureau. According to the requirements of the "three" cultivation pilot enterprise responsibility letter signed with Zhejiang Province, Jinhua City and Wucheng District, as of the end of September 2017, the company has invested 16.0772 million yuan in related projects, and has achieved remarkable results in improving management, improving automation and informatization level. For example, after the digital system of quality and cost control in the plant extraction workshop of Jianfeng Health Technology Company is put into use, the whole production process can be controlled and traceable, the product quality is more stable, the production safety is effectively guaranteed, the "three wastes" emission is greatly reduced, and the product cost is reduced by 20%. The electronic label system of the pharmaceutical company automatically addresses and accurately locates the drugs in and out of the warehouse, which reduces the error rate of the out and into the warehouse, and the location management can automatically display the information such as the location and quantity of the drugs, which improves the work efficiency of the warehouse logistics and effectively reduces the management cost. The pharmaceutical company's sales management information system integrates sales management, warehouse management, customer management, statistical analysis and other modules, realizes drug sales management and control functions according to the requirements of GMP and GSP specifications, and analyzes drug regions and sales volume through big data, which will judge drug consumption trends faster and more accurately and improve the accuracy of the company's drug sales decisions. Health
2020
07-30
Yunnan Jianfeng supplies cement directly to Wa State of Myanmar
Yunnan Jianfeng Cement Company not only consolidates the original domestic market, but also gives full play to the location advantages of the three counties (Lancang, Menglian and Ximeng) close to the border to continuously expand the foreign market. Recently, the marketing department took the initiative to step out of the country from the Mangxin port in Menglian County and successfully sold "Jianfeng" brand cement to the newly planned Jinhua Xiaozunhe Island Development Zone in the Wa State of Myanmar. With the rapid development of China's economy in recent years, Myanmar has also increased the development of the China-Myanmar border area year by year. In order to attract more Chinese tourists to spend in transit, the Wa State Government of Myanmar has planned the Jinhua Xiaozunhe Island Development Zone near China's Menglian Mangxin Port. After the development zone is completed, it will mainly focus on gambling, business hotels, and border trade. There is an estimated demand for about 80000 tons of cement. When Yunnan Jianfeng marketing personnel learned of the news, they went deep into the development zone many times to understand the situation and had extensive contact with customers. With the good reputation of Jianfeng Cement in southwest Yunnan in recent years, they successfully signed a supply contract with a commercial mixing station in the development zone. At present, Yunnan Jianfeng has directly supplied 1200 tons of cement through Mangxin Port, and is expected to win 80% of the cement supply business of the development project. The initiative of "Belt and Road Initiative" to open up the international channels of South Asia and Southeast Asia has brought new development opportunities to many enterprises. This time, Yunnan Jianfeng Marketing Department went abroad to seize the opportunity, breaking the previous practice that the company mainly relied on agents for cement export, and achieved a new breakthrough in directly connecting users, which not only increased revenue, but also further expanded the radiation scope of its own marketing network, so as to further expand the scope of going abroad in the future.
2020
07-31
The company's "three" cultivation through the stage of acceptance
Since November 2015 was included in the second batch of "three" cultivation pilot enterprises in Zhejiang Province, the company has carried out a series of related work in depth. On October 19, the implementation of the company's "three" cultivation project from January 2016 to September 2017 passed the phased acceptance organized by Jinhua Economic and Information Commission and Jinhua Finance Bureau. According to the requirements of the "three" cultivation pilot enterprise responsibility letter signed with Zhejiang Province, Jinhua City and Wucheng District, as of the end of September 2017, the company has invested 16.0772 million yuan in related projects, and has achieved remarkable results in improving management, improving automation and informatization level. For example, after the digital system of quality and cost control in the plant extraction workshop of Jianfeng Health Technology Company is put into use, the whole production process can be controlled and traceable, the product quality is more stable, the production safety is effectively guaranteed, the "three wastes" emission is greatly reduced, and the product cost is reduced by 20%. The electronic label system of the pharmaceutical company automatically addresses and accurately locates the drugs in and out of the warehouse, which reduces the error rate of the out and into the warehouse, and the location management can automatically display the information such as the location and quantity of the drugs, which improves the work efficiency of the warehouse logistics and effectively reduces the management cost. The pharmaceutical company's sales management information system integrates sales management, warehouse management, customer management, statistical analysis and other modules, realizes drug sales management and control functions according to the requirements of GMP and GSP specifications, and analyzes drug regions and sales volume through big data, which will judge drug consumption trends faster and more accurately and improve the accuracy of the company's drug sales decisions. Health
2020
07-31
"We were also praised by the traffic police." On September 26, when talking about the civilized travel volunteer activities a few days ago, Li Xuegen of the big pharmacy smiled and was very happy that his work was recognized. Starting from May this year, during the rush hour on the 5th and 20th of each month (weekends and holidays are postponed), there will be a group of volunteers wearing red vests and hats, holding signs with the words "courtesy of zebra crossing, civilized crossing of the road" to divert traffic at many intersections in the city. This is a civilized travel volunteer service activity carried out by Jinhua City to further promote civilized travel and persuade uncivilized behavior. As a civilized unit at the municipal level in Jinhua, Jianfeng Group's duty junction is at the intersection of Bayi North Street and Zhongshan West Road. Before the activity was carried out, as the organizer of the group company, the group office had deep concerns. The activity took a long time and required a lot of manpower. As an enterprise, under the condition of ensuring normal production, it was completed by employees in their spare time. Can it be continued? To this end, Xiang Chongping, the leader in charge of the group company, specially organized a meeting of the directors of the subordinate enterprise offices to mobilize and deploy the matter. The group office also specially established the QQ group of "Peak Civilized Travel Volunteer Service" to release the contents and arrangements of the activities, update the duty situation, and praise the small partners on duty. At the beginning of the activity, colleagues in the headquarters building took the lead in taking up their posts. The first class was Li Hong, Li Xia, Yang Liu and Lei Yuan of the finance department of the group company. Employees of the group office, the peak health experience hall, Qiubin Factory and the international trading company also took up their posts one after another. Other enterprises also took part in an orderly manner according to the duty schedule.
2020
07-31
Daye peak again won the national inspection big contrast "all-excellent award"
A few days ago, daye peak cement co., ltd won the "all-excellent award" in the 16th national cement quality index inspection comparison of "hongchao science and technology cup" organized by the national cement quality supervision and inspection center in 2017 ". The national cement quality index inspection is held every two years. It is the highest level competition in the cement industry. It aims to understand the current quality inspection level of China's cement industry through large-scale comparison, promote various cement inspection departments to improve the inspection quality, and provide accurate data for cement production and use. The results truly reflect the overall inspection level of national cement production enterprises and provincial building materials (cement) inspection stations, it represents the highest level of inspection technology in the cement industry. Over the years, Daye Peak has firmly established the concept of "quality is the life of an enterprise", always puts product quality control in the first place, and conducts daily inspections in strict accordance with the testing items and frequency specified by national standards. actively carry out inspection comparison with provincial and municipal cement quality inspection centers, improve the professional level of inspectors through skill training, and spot check the internal passwords of inspectors every month to strictly ensure the accuracy and reliability of data, to ensure that the quality of the factory cement to meet the market and customer demand, and further enhance the core competitiveness of enterprises. Since it was officially put into production in 2008, Daye Peak has participated in the national cement quality index inspection five times, and has achieved good results. Among them, it won the "All-Excellent Award" in 2009 and the "All-Qualified" in 2011, 2013 and 2015. Unit Award ". (Yang Huiping)
2020
07-31
Contact Us
No. 88 Wujiang East Road, Jinhua City, Zhejiang Province, China
Tel: +86-579-82326868
Fax : +86-579-82324666
©2023 Zhejiang Jianfeng Group Co., Ltd. Powered by: www.300.cn SEO Business License
SAF Coolest v1.2 设置面板 SHJSS-AHDB-FSSQE-ZSW
无数据提示
Sorry, the current column has no content !
You can view other columns or return to Home Page