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
On December 30, the group company held a special study meeting. Members of the group's party committee and management team concentrated on learning the spirit of the central economic work conference and the Zhejiang provincial party committee economic work conference. From December 16 to 18, the annual Central Economic Work Conference was held in Beijing, which made it clear that in 2021, "we should continue to implement a proactive fiscal policy and a prudent monetary policy, maintain the necessary support for economic recovery, be more accurate and effective in policy operation, do not make sharp turns, and grasp the effectiveness of the policy. It is necessary to make good use of the precious time window, concentrate on promoting reform and innovation, and take high-quality development as the general tone of the 14th five-year Plan. It is proposed to strengthen the national strategic scientific and technological strength, enhance the independent and controllable ability of the industrial chain supply chain, adhere to the strategic basis of expanding domestic demand, and comprehensively promote reform and opening up. On the 25th, the Zhejiang Provincial Party Committee Economic Work Conference was held in Hangzhou to make specific arrangements for the economic development of Zhejiang Province in 2021. At the study meeting, Jiang Xiaomeng, secretary of the party committee and chairman of the group company, together with the leaders attending the meeting, analyzed and studied the key issues raised at the economic work conference of the central and Zhejiang provincial party committees one by one. In his study and discussion, Jiang Xiaomeng stressed that the current neo-coronary pneumonia epidemic is still spreading around the world, the world economy is in a deep recession, the risk of strong stimulus policies in developed countries has spilled over, the global industrial chain supply chain cycle has been blocked, and international trade and investment have shrunk; major strategic achievements have been made in the prevention and control of the domestic epidemic, and the economy has recovered steadily, but there is still greater uncertainty of instability. China has turned to the stage of high-quality development, the economy has been improving for a long time, the development resilience is strong, and the overall social situation is stable. At the same time, the problem of unbalanced and inadequate development in China is still prominent, the reform task of key links in key areas is still arduous, and the innovation ability is not suitable; at present and in the future, China's development is still in an important period of strategic opportunities, but there are new development and changes in opportunities and challenges, we are accelerating the construction of a new development pattern with the domestic cycle as the main body and the domestic and international double cycle promoting each other. The economic work conference of the Central Committee and the Zhejiang provincial Party committee has set the tone and pointed the way for the future development of enterprises. Party organizations at all levels and enterprise management teams should seriously organize and study, deeply understand the spirit of the conference, correctly understand and judge the future policy direction and industry trend, scientifically plan the work of the new year in combination with the actual work of the enterprise, and promote the better development of the enterprise. (this newspaper reporter)
2021
01-04
A few days ago, Tianjin Jianfeng Flanders Company successfully passed the national high-tech enterprise re-identification review work, and once again joined the ranks of high-tech enterprises after the transformation of the enterprise. The original development orientation of Flanders is pharmaceutical excipients, which belongs to the biomedical industry supported by the state. Its products are mainly aimed at major pharmaceutical factories, with clear product standards and strong technical pertinence, so it has been recognized as a national high-tech enterprise for a long time. Starting from 2019, Flanders has embarked on an industrial transformation in the direction of healthy functional foods. The food industry has a variety of products and serves a wide range of people. Enterprises need to come up with products with unique value in order to be accepted and recognized by the market. The difficulty of identifying high-tech enterprises has also increased accordingly. In order to do a good job in the application evaluation of high-tech enterprises, Flanders, in addition to further combing the achievements of previous technological innovation, has also adjusted and established a high-level R & D team on the basis of establishing postdoctoral workstations in cooperation with Shenyang Pharmaceutical University and Tianjin University of traditional Chinese Medicine, and strengthened technological innovation and intellectual property protection in the direction of new industries. For more than a year, Flanders has successfully transformed, produced and put on the market a number of small molecule functional foods and special dietary products such as Huizhi Gold Drink. In order to further accelerate the pace of development in the health food industry, Flanders has successively joined the Tianjin Health Association, Tianjin Food Safety Association and other food industry organizations; and with the strong support of the Tianjin Association for Science and Technology, it began to prepare for the establishment of the Tianjin Medical and Health Society Health Industry Professional Committee. National high-tech enterprises identified once every three years. The person in charge of Flanders said that the company is currently in a critical period of development and transformation. The identification of high-tech enterprises is not only the recognition of the work of Flanders in the past two years by the competent authorities and the industry, but also will provide assistance to the future development of the company. In the future, Flanders will further increase its scientific research efforts, continue to develop and create new products with high-tech content, and make more contributions to public health. (Liu Hairong)
2020
12-22
On the afternoon of December 2, Sang Weiliang, secretary of the Qiandongnan Prefecture Party Committee of Guizhou Province, Wu Ming, deputy director of the Standing Committee of the State People's Congress, Long Zaichong, deputy secretary-general of the State Party Committee, and the main party and government leaders of Huangping County visited Huangping Jianfeng Cement Co., Ltd. to investigate and investigate, and preach the spirit of the Fifth Plenary Session of the 19th Central Committee of the Party. After visiting and understanding the company's production process, Sang Weiliang said happily: "I am very satisfied with the construction of a modern, clean and standardized cement production line in such a short period of time!" At the peak of Huang Ping, Sang Weiliang conveyed and preached the main contents of the spirit of the Fifth Plenary session of the 19th CPC Central Committee. He pointed out that governments at all levels in Qiandongnan Prefecture should thoroughly study and implement the spirit of the Fifth Plenary session of the 19th CPC Central Committee, earnestly implement the decisions and arrangements of the plenary session, focus on the main line of high-quality development, firmly grasp industrial projects, pay close attention to industrial economy, fully promote high-quality economic and social development, and strive to start a new journey of socialist modernization. We should persist in promoting the "four wheels" of new industrialization, we should pay close attention to the industrial economy, accelerate the transformation and upgrading of industrial industries, improve quality and efficiency, and strive to promote high-quality development and achieve stability and long-term development. During the investigation, Hu Hongwei, general manager of Huang Ping Jianfeng, introduced the basic situation of Jianfeng Group and Huang Ping Jianfeng to the state and county leaders, and focused on the equipment and process advantages of the production line, production process, production process, product quality control indicators, as well as various consumption indicators and emission indicators at the leading level in China. He also reported some problems and difficulties encountered after the formal operation of the enterprise. In view of the deficiencies in road traffic construction in Huangping County, Sang Weiliang asked the transportation department to strengthen communication, report and docking, strive for relevant support, do a solid job in the "14th Five-Year Plan" transportation development plan, further improve the road network connection and improve the transportation system, and provide strong support for the development of advantageous enterprises in Huangping Jianfeng and other regions. Sang Weiliang and his party also conducted in-depth research in the production workshop, checked the operation of the production line, and talked with the line staff. At the end of the investigation, he highly affirmed the construction and production work of Huang Ping Jianfeng for more than a year. The development of enterprises must take the road of sustainable development. It is necessary to ensure product quality and take into account the local ecology in order to develop in a long-term and sustainable manner. Sang Weiliang hopes that the Huangping County Government will do its best to ensure service, firmly establish a sense of service, and actively serve the enterprise. Serve, sincerely solve practical difficulties for the enterprise, create a good business environment, and help the enterprise achieve better development; also hope that Huang Ping Jianfeng will continue to play a pioneering role, jointly promote the high-quality economic and social development of Huangping County. (Pan Yi)
2020
12-22
Beirunning won the "13th Five-Year Chinese Medical Science and Technology Iconic Achievement" Award
From December 8 to 11, under the guidance of China Pharmacists Association, China over the counter drug Association and China Medical Education Association, the "2020 national pharmaceutical economic information conference and rice room annual meeting" sponsored by punctuation information (Group) was held in Guangzhou. During the event, the authoritative professional media of Chinese medicine, "Pharmaceutical Economics", released the list of "13th Five-Year China Pharmaceutical Science and Technology Iconic Achievements" and awarded the honorary certificate. The peak pharmaceutical product Berunning (Olopatadine Hydrochloride Eye Drops) is among them. Great changes have taken place in China's pharmaceutical industry during the 13th Five-Year Plan period. Drug review reform, consistency evaluation, volume procurement and other heavy policies in-depth promotion, driving the pharmaceutical industry innovation and upgrading. Chinese pharmaceutical leading enterprises take advantage of the trend, devote themselves to the development of new drugs, actively promote international registration, expand the international market, carry out international mergers and acquisitions, in the world life science stage blooming Chinese style. Lin Jianning, director of the Southern Institute of Pharmaceutical Economics of the State Drug Administration, combed the current operation of the pharmaceutical economy in detail and led the delegates to think deeply about the new changes in the pharmaceutical market in 2021. The industry authoritative media "Pharmaceutical Economic News" sponsored by the Southern Institute of Pharmaceutical Economics released the "13th Five-Year China Pharmaceutical Science and Technology Iconic Achievements" list during the event. The selection of this award aims to explore the scientific and technological achievements of China's pharmaceutical industry during the 13th five-year Plan period from the dimensions of scientific and technological innovation, clinical efficacy, market share and industry influence, so as to help transform pharmaceutical scientific and technological achievements. to help China move from a big pharmaceutical country to a pharmaceutical power. Pinnacle Pharmaceuticals' product, Berunning, is on the list. Berunning is the first eye drops to pass the consistency evaluation in China, and by virtue of its antagonistic histamine H1-receptor, stable mast cell two-way anti-allergy unique efficacy has been widely concerned. Beirunning in the treatment of children with allergic conjunctivitis has good effect, fast curative effect, will not cause significant mast cell degranulation, so the use of more safe, and almost no adverse reactions to the eye tissue, is the current treatment of allergic conjunctivitis an ideal drug. Since its launch in 2019, Berunning has received unanimous recognition and praise from domestic ophthalmologists. (Xu Yuting)
2020
12-22
On December 15, Xing Zhihong, deputy secretary of the Jinhua Municipal CPC Committee and acting mayor, accompanied by Cai Yan, secretary of the Wucheng District CPC Committee, Huang Guojun, and other leaders, visited the company for research, discussed and exchanged views with the company's management team, and put forward hope for the future development of Jianfeng as a leading enterprise in Jinhua City. Jiang Xiaomeng, chairman of the group company, introduced to Xing Zhihong and his party the development strategy, industrial layout, business performance in recent years, scientific and technological innovation, management innovation, as well as the work in charity, poverty alleviation and so on, which was fully affirmed by Xing Zhihong. Xing Zhihong said in the exchange that the peak is Jinhua's landmark enterprise and Jinhua's pride. It is not easy to stick to the industry for many years. Peak has a clear strategic direction and policy, and its good business performance in recent years has fully proved the courage and foresight of the management team. In view of the current situation that the pattern of economic competition at home and abroad is undergoing tremendous changes and the country's increasing requirements for environmental and ecological development, Xing Zhihong hopes that in the future work, Jianfeng will unswervingly follow the path of innovation and development, further increase investment in innovation and research and development, and further promote Green environmental protection production sets an example for Jinhua enterprises. He also hopes that the peak can "lay out the golden industry in the golden area", not only the enterprise itself through technological innovation to achieve high-quality development, but also further lead the upstream and downstream industries, attract potential and competitive enterprises to invest in Jinhua, forming a cluster effect. The municipal party committee and municipal government will also actively study and introduce better support policies to further optimize the business environment, so that enterprises can do a good job in production and operation without distractions, so that Jinhua can form a better industrial ecology. (this newspaper reporter)
2020
12-22
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