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
Recently, it was learned from the competent department that the "ERP/MES full-process informatization" project of Jianfeng Pharmaceutical Company has been included in the list of key projects of "integration of industrialization and industrialization" in Jinhua City, and has now entered the publicity period. In order to speed up the in-depth integration of informatization and industrialization, according to the evaluation criteria in Jinhua City's "Several Opinions on Accelerating Informatization Construction" and "Jinhua City Informatization and Industrialization Integration Key Project Management Measures", 148 projects were included in 2017 Jinhua City's "Integration of Industrialization and Industrialization" key projects. The "ERP/MES Full Process Informatization" project of Jianfeng Pharmaceutical Co., Ltd. was finally included in the list after being recommended, material reviewed and expert reviewed by Jinhua Economic and Information Committee. The ERP-level subsystems of ERP/MES full-process informatization project include sales system, procurement system, MRP system, GMPQbD system, connecting UFIDA financial software and HR system. MES-level subsystems include industrial data acquisition and monitoring system, GAMP/MES system, eBPR (electronic batch production record system), cGMP quality assurance system, QC/eBTR(QC process and electronic batch inspection record system), LIMS system, etc. After the construction is completed, the visualization of drug production process and the collection and integration of industrial data will be realized. Realize the electronization of drug production process parameters, electronic batch production and inspection records; the realization of big data integration of industrial data and information will also be in line with the regulatory concept of GMP data integrity and quality traceability to the greatest extent. The establishment of a unified enterprise information platform will eliminate information islands and realize data one.
2020
07-31
The company's first-half profit record high
According to the 15th meeting of the ninth board of directors of the company on August 25, in the first half of 2017, the company achieved a net profit of 240.5357 million yuan, the highest level in half a year's history. In the first half of 2017, the company focused on the general work policy of "grasping trends, precise development, strengthening management, and improving efficiency", grasping the opportunities brought by economic structure optimization and industrial upgrading, strengthening lean production and management improvement internally, and actively exploring externally Develop new opportunities and continue to promote the "three reductions and three improvements" work. Through the joint efforts of all employees of the company, the best semi-annual performance in history has been achieved. As of the end of June 2017, the company's total assets were 4.226 billion yuan and net assets were 2.511 billion yuan; the company achieved total operating income of 1,305.9327 million yuan, an increase of 18.42 percent over the same period last year, and net profit attributable to owners of the parent company was 240.5357 million yuan, an increase of 132.11 percent over the same period last year. Earnings per share are 0.7 yuan. In the second half of the year, the company will continue to focus on the annual business plan, carry out in-depth work of "three reductions and three improvements", further do a good job in internal control, prevent business risks, and further do a good job in safety and environmental protection. we will further develop and improve the complementary relatively diversified main business structure and constantly enhance the company's core competitiveness. The 15th meeting of the 9th board of directors held on August 25 was presided over by Jiang Xiaomeng, chairman of the group company. Four proposals and reports including the 2017 semi annual report and the proposal on the change of the company's accounting policy were deliberated and passed. on the same day, the 12th meeting of the eighth board of supervisors was held,
2020
07-31
General Manager Yu Jianhong to Yunnan Peak to Guide Work
On August 23, Yu Jianhong, general manager of the group company, went to Yunnan Jianfeng cement company for investigation and guidance, and put forward requirements for the key work in the last few months of this year. At the peak of Yunnan Province, Yu Jianhong went deep into the production site to learn more about the current production and operation situation, and convened the middle-level and above management backbones to have in-depth exchanges and discussions with everyone on the problems existing in work efficiency changes, personnel stability, current production and management after the implementation of post optimization and re-organization. Since the beginning of this year, Yunnan's peak production and sales volume, profits and various technological and technical indicators have been relatively ideal. The kiln output in April has also reached the best level since it was put into production. The development and maintenance of the market, the environmental management of the factory area, and the professional quality and mental state of cadres and workers have also been greatly improved. While fully affirming the above achievements, Yu Jianhong pointed out that as the homogenization of the cement market becomes more and more serious, the market changes faster and faster. If we can't recognize the situation and seize the opportunity, enterprises will face more and more problems. In this case, the management backbone should give full play to the role of the backbone, quickly change the management concept, and strive to improve the competitiveness of enterprises. In view of the focus of work in the last four months of this year, Yu Jianhong put forward the following requirements for Yunnan Jianfeng: break the inherent concept of post functions and responsibilities, set up posts and organizational structures around logistics, people flow and capital flow, and cultivate and forge a team that can fight well. To further implement the training of job skills and quality, managers should take the lead in strengthening their own learning and formulate annual, monthly and weekly training plans, through the combination of internal and external training, theory and practice.
2020
07-30
General Manager Yu Jianhong to Yunnan Peak to Guide Work
On August 23, Yu Jianhong, general manager of the group company, went to Yunnan Jianfeng cement company for investigation and guidance, and put forward requirements for the key work in the last few months of this year. At the peak of Yunnan Province, Yu Jianhong went deep into the production site to learn more about the current production and operation situation, and convened the middle-level and above management backbones to have in-depth exchanges and discussions with everyone on the problems existing in work efficiency changes, personnel stability, current production and management after the implementation of post optimization and re-organization. Since the beginning of this year, Yunnan's peak production and sales volume, profits and various technological and technical indicators have been relatively ideal. The kiln output in April has also reached the best level since it was put into production. The development and maintenance of the market, the environmental management of the factory area, and the professional quality and mental state of cadres and workers have also been greatly improved. While fully affirming the above achievements, Yu Jianhong pointed out that as the homogenization of the cement market becomes more and more serious, the market changes faster and faster. If we can't recognize the situation and seize the opportunity, enterprises will face more and more problems. In this case, the management backbone should give full play to the role of the backbone, quickly change the management concept, and strive to improve the competitiveness of enterprises. In view of the focus of work in the last four months of this year, Yu Jianhong put forward the following requirements for Yunnan Jianfeng: break the inherent concept of post functions and responsibilities, set up posts and organizational structures around logistics, people flow and capital flow, and cultivate and forge a team that can fight well. To further implement the training of job skills and quality, managers should take the lead in strengthening their own learning and formulate annual, monthly and weekly training plans, through the combination of internal and external training, theory and practice.
2020
07-31
Spike Pharmaceuticals set out to explore a new sales model
Agency and Terminal Link Production and Chain Cooperation Spike Pharmaceuticals to Explore New Sales Models From August 16 to 21, the 2017 China Pharmaceutical Retail Industry Information Conference (hereinafter referred to as "Xipu Conference") with the theme of "Building a Blueprint-Market Awakening Focusing on Demand" was held in Boao, Hainan. Huang Jinlong, deputy general manager of the group company and general manager of the pharmaceutical company, and relevant leaders of Spike Health, pharmaceutical sales company and Spike Pharma pharmacy were invited to attend the event, to create a new sales model "road". This year coincides with the 10th anniversary of the Western Conference. More than 1200 mainstream chain pharmacies, more than 800 brand pharmaceutical industries, more than 100 cross-border affiliated institutions, more than 130 top domestic and foreign capital institutions, more than 60 representatives of authoritative media, and authoritative experts in the industry, with nearly 4000 people gathered in Boao. The meeting combed the context of the pharmaceutical retail industry in the past ten years, discussed the development of the industry in the new decade, and built a new blueprint for the industry. During the meeting, Huang Jinlong led the peak participants to have in-depth exchanges with the organizers of the conference and industry experts on issues such as the impact of national policies such as the brand strategy of enterprises, the role of brand enterprises in the industry, medical reform, prescription outflow, etc. on the original sales mode of pharmaceutical enterprises. He also had extensive contact with pharmaceutical counterparts and terminal chains, listened to front-line sales experience, collected relevant information on terminal chains, and collected market trends of the top 100 chains. In the past ten years, the scale of drug retail sales in China has increased from 143 billion yuan to 337.7 billion yuan, and the chain rate has increased from 35.3 percent to 49.4 percent.
2020
07-31
General Manager Yu Jianhong to Yunnan Peak to Guide Work
On August 23, Yu Jianhong, general manager of the group company, went to Yunnan Jianfeng cement company for investigation and guidance, and put forward requirements for the key work in the last few months of this year. At the peak of Yunnan Province, Yu Jianhong went deep into the production site to learn more about the current production and operation situation, and convened the middle-level and above management backbones to have in-depth exchanges and discussions with everyone on the problems existing in work efficiency changes, personnel stability, current production and management after the implementation of post optimization and re-organization. Since the beginning of this year, Yunnan's peak production and sales volume, profits and various technological and technical indicators have been relatively ideal. The kiln output in April has also reached the best level since it was put into production. The development and maintenance of the market, the environmental management of the factory area, and the professional quality and mental state of cadres and workers have also been greatly improved. While fully affirming the above achievements, Yu Jianhong pointed out that as the homogenization of the cement market becomes more and more serious, the market changes faster and faster. If we can't recognize the situation and seize the opportunity, enterprises will face more and more problems. In this case, the management backbone should give full play to the role of the backbone, quickly change the management concept, and strive to improve the competitiveness of enterprises. In view of the focus of work in the last four months of this year, Yu Jianhong put forward the following requirements for Yunnan Jianfeng: break the inherent concept of post functions and responsibilities, set up posts and organizational structures around logistics, people flow and capital flow, and cultivate and forge a team that can fight well. To further implement the training of job skills and quality, managers should take the lead in strengthening their own learning and formulate annual, monthly and weekly training plans, through the combination of internal and external training, theory and practice.
2020
07-31