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
Shanghai Bronze Award for Outstanding Invention Went in North Carolina
News from this newspaper The results of the 31st Shanghai Excellent Invention Trial jointly organized by the Shanghai Federation of Trade Unions, Shanghai Intellectual Property Office, Shanghai Municipal Committee of the Communist Youth League, Shanghai Science and Technology Association, and Shanghai Invention Association were evaluated a few days ago. The "Quality Improvement and Industrialization Optimization of Erlotinib Hydrochloride and Its Advanced Intermediates" declared by Technology Co., Ltd. won the bronze award. Erlotinib hydrochloride is a targeted therapy drug for the treatment of non-small cell lung cancer, which can prolong the survival time and improve the quality of life of lung cancer patients. It can target and specific sites of action to kill tumor cells, and has little impact on normal tissues. It belongs to the biological and new medical technology in the field of high-tech supported by the state. In this invention, 6,7-dimethoxyquinazoline -4-one, 4-chloro -6,7-di (2-methoxyethoxy) quinazoline and 3-aminophenylacetylene are important intermediates of erlotinib hydrochloride, which is also an important intermediate of icotinib hydrochloride, the first new anti-tumor drug of tinib in China. The invention designs and adopts a new synthesis process route, which can effectively reduce the cost of raw materials, the reactions are mostly aqueous phase reactions, energy consumption and three waste emissions are reduced by about 35%, industrialization conditions are optimized, product quality is improved, and it is applied to Industrialized mass production is conducive to the production of high-quality and low-cost erlotinib hydrochloride drugs and reduces the economic burden of patients. The Shanghai Excellent Invention Trial was founded in 1987. It is an important science and technology award approved by the Shanghai Municipal Government. It not only strongly promoted the majority of employees to carry out invention and creation activities based on their posts, but also improved the order.
2020
07-31
Jiang Xiaomeng was selected as one of the top ten news figures in the building materials industry. "China Building Materials" magazine published an exclusive interview in August. The 8th issue of 2019 "China Building Materials" magazine published a few days ago. In the "Exclusive Perspective" column, it published an exclusive interview with Jiang Xiaomeng, the top ten news figures in the building materials industry in 2018, the party secretary and chairman of the group company. The selection of the top ten news figures in the national building materials industry initiated by "China Building Materials" magazine has established nearly a hundred shining figures in the industry since 1999, which has attracted widespread attention in the industry. The selection of the top ten news figures in the building materials industry in 2018 is described as follows: Jiang Xiaomeng is a scholar and practical outstanding entrepreneur. In 2018, with his strategic thinking of insight into the future, he united and led cadres and employees at all levels of Jianfeng Group to actively adapt to the new economic normal, focusing on deepening supply-side structural reforms, the "Belt and Road" initiative, and vigorously advocating corporate transformation and upgrading and high-quality development. Work, seize opportunities, reform and innovate, and achieve historic new achievements in the development of the peak 60 years. The group's overall economic efficiency and development quality have been significantly improved. In recent years, under the leadership of Jiang Xiaomeng, Jianfeng Group has seized the opportunity to join forces with central enterprises to participate in the establishment of Southern Cement, effectively integrate the cement market in Zhejiang Province, optimize the allocation of cement industry resources, and greatly improve social and economic benefits. It has a positive and far-reaching impact on the supply-side structural reform and healthy development of the cement industry in Zhejiang Province. At the same time, the long-term layout of the peak group, strategically predict the direction of national development.
2020
07-31
Jianfeng Group started from a small cement plant with an annual output of 30000 tons in 1958. Through horizontal alliance with township enterprises, the formation of enterprise groups and the implementation of joint-stock reform, Jianfeng Group took the lead in listing in China's cement industry in 1993 and explored diversified operation. In 2007, Jianfeng joined hands with the central enterprise China Building Materials to participate in the establishment of Southern Cement, which strategically shifted the focus of the cement industry, and at the same time through enterprise mergers and technological innovation, the pharmaceutical industry is growing rapidly ...... Such a long history, in the industry has a good reputation of enterprises, Zhejiang Province, the earliest existing listed companies, its head is Jiang Xiaomeng. Focus on Industry Jiang Xiaomeng has spent nearly 40 years in Jinhua Cement Factory, the predecessor of Jianfeng Group. As a witness and promoter of the development and growth of the peak, Jiang Xiaomeng said that the sustained and steady development of the peak group benefits from the long-term focus on industry, which is the value orientation of the peak and the responsibility of the enterprise. Whether there was only a single cement industry in the early stage or the diversified development after listing, all the investment projects of the peak have not left the industry. With the continuous emergence of new economic formats, many people once suggested that the peak should be transferred to the "fashionable" and rewarding industries such as the Internet, but they were all rejected. Jiang Xiaomeng explained that it is necessary to use professional people to do professional things. Peak's years of experience, talents, and resource accumulation are all in industry. Although the new format is good, it is not necessarily suitable for peak development. Take cement as an example, even in the case of peak pharmaceutical has occupied the group.
2020
07-31
Jiang Xiaomeng was selected as one of the top ten news figures in the building materials industry. "China Building Materials" magazine published an exclusive interview in August. The 8th issue of 2019 "China Building Materials" magazine published a few days ago. In the "Exclusive Perspective" column, it published an exclusive interview with Jiang Xiaomeng, the top ten news figures in the building materials industry in 2018, the party secretary and chairman of the group company. The selection of the top ten news figures in the national building materials industry initiated by "China Building Materials" magazine has established nearly a hundred shining figures in the industry since 1999, which has attracted widespread attention in the industry. The selection of the top ten news figures in the building materials industry in 2018 is described as follows: Jiang Xiaomeng is a scholar and practical outstanding entrepreneur. In 2018, with his strategic thinking of insight into the future, he united and led cadres and employees at all levels of Jianfeng Group to actively adapt to the new economic normal, focusing on deepening supply-side structural reforms, the "Belt and Road" initiative, and vigorously advocating corporate transformation and upgrading and high-quality development. Work, seize opportunities, reform and innovate, and achieve historic new achievements in the development of the peak 60 years. The group's overall economic efficiency and development quality have been significantly improved. In recent years, under the leadership of Jiang Xiaomeng, Jianfeng Group has seized the opportunity to join forces with central enterprises to participate in the establishment of Southern Cement, effectively integrate the cement market in Zhejiang Province, optimize the allocation of cement industry resources, and greatly improve social and economic benefits. It has a positive and far-reaching impact on the supply-side structural reform and healthy development of the cement industry in Zhejiang Province. At the same time, the long-term layout of the peak group, strategically predict the direction of national development.
2020
07-31
Jiang Xiaomeng was selected as one of the top ten news figures in the building materials industry. "China Building Materials" magazine published an exclusive interview in August. The 8th issue of 2019 "China Building Materials" magazine published a few days ago. In the "Exclusive Perspective" column, it published an exclusive interview with Jiang Xiaomeng, the top ten news figures in the building materials industry in 2018, the party secretary and chairman of the group company. The selection of the top ten news figures in the national building materials industry initiated by "China Building Materials" magazine has established nearly a hundred shining figures in the industry since 1999, which has attracted widespread attention in the industry. The selection of the top ten news figures in the building materials industry in 2018 is described as follows: Jiang Xiaomeng is a scholar and practical outstanding entrepreneur. In 2018, with his strategic thinking of insight into the future, he united and led cadres and employees at all levels of Jianfeng Group to actively adapt to the new economic normal, focusing on deepening supply-side structural reforms, the "Belt and Road" initiative, and vigorously advocating corporate transformation and upgrading and high-quality development. Work, seize opportunities, reform and innovate, and achieve historic new achievements in the development of the peak 60 years. The group's overall economic efficiency and development quality have been significantly improved. In recent years, under the leadership of Jiang Xiaomeng, Jianfeng Group has seized the opportunity to join forces with central enterprises to participate in the establishment of Southern Cement, effectively integrate the cement market in Zhejiang Province, optimize the allocation of cement industry resources, and greatly improve social and economic benefits. It has a positive and far-reaching impact on the supply-side structural reform and healthy development of the cement industry in Zhejiang Province. At the same time, the long-term layout of the peak group, strategically predict the direction of national development.
2020
07-30
On August 29, the group company held the 11th meeting of the 10th board of directors of the company by means of communication, and deliberated and passed the semi annual report of Jianfeng group in 2019 and the amendment of internal control system of the company. In the first half of the year, the company focused on the general work policy of "innovation and reform, integration and improvement, scientific layout, and steady development", grasping the opportunities brought by economic structure optimization and industrial upgrading externally, continuously integrating resources internally, and improving the internal management system. Improve the efficiency of enterprise operation. In the first half of 2019, the company achieved total operating income of 1.686 billion billion yuan, an increase of 12.17 percent over the same period last year, and the net profit attributable to the owners of the parent company was 0.476 billion billion yuan, an increase of 57.55 percent over the same period last year. At the end of June 2019, the Company's total assets were $5.383 billion, up 9.82 from the beginning of the year, and its net assets were $3.817 billion, up 10.64 from the beginning of the year. In the first half of the year, the company made a new breakthrough in the expansion of cement business. The group company has completed the acquisition of 100 equity of Guizhou huangpinggu longmingchuan cement co., ltd. and continues to invest in the construction of its new dry cement production line with a daily output of 4500 tons of cement clinker (with waste heat power generation). Yunnan Jianfeng invested 5 million yuan to participate in the establishment of Yunnan Jianfeng Da Zhan Cement Co., Ltd., which plans to build a cement clinker production line in lameng county, Xishuangxian Dai autonomous prefecture by capacity replacement according to relevant national policies. The company's cement subsidiaries continue to carry out in-depth "three down three improve" activities, stable.
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