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
Two Cement Enterprises Prosperous Production and Sales in May
With the gradual easing of the new crown epidemic, all over the project has started, Hubei, Yunnan two provinces cement market continued to improve, Daye peak cement company, Yunnan peak cement company two enterprises have recently shown a good momentum of production and sales. In May, the sales volume of Yunnan Jianfeng cement continued to rise. As of the time of publication, the average daily shipment volume reached more than 7400 tons, and the highest daily shipment volume reached more than 8700 tons, and the production capacity was fully released. Over the past few days, Yunnan Peak Packaging System has made great efforts to overcome the impact of narrow distribution sites and many cement varieties to ensure the completion of delivery tasks with good quality and quantity every day. In order to further balance production and sales and create conditions for the homogenization of cement delivered from the factory, Yunnan peak packaging system puts forward work requirements for relevant posts, emphasizes equipment inspection and process inspection during production, strictly implements safety operation procedures, and maintains safe and efficient operation of the system. Due to the impact of the new crown epidemic, Hubei cement market started late, Wuhan market is the hardest hit area, the current project construction is still not fully started, the volume pressure is greater. For this reason, daye peak departments cooperate closely, increase market development efforts, develop new mixing stations, focus on increasing the bulk share of Xianning, Huanggang and Wuhan markets, seize the opportunity of fine weather, and achieve the goal of rapid output. Internally, on the basis of equipment technical renovation and production capacity improvement, the delivery is effectively guaranteed, and the daily delivery capacity can basically be maintained at 10,000 tons. In May, Daye Peak sold more than 300000 tons of cement, an increase of 20% over the same period last year, with an average daily sales volume of more than 9900 tons, the highest in the current period since Daye Peak was put into production.
2020
07-31
The company's "safe production month" activities are about to start
June 2020 is the 19th national "safe production month", the theme of the activity is "eliminating hidden dangers of accidents and building a strong line of defense". A few days ago, the group company issued a notice to arrange the activities related to the organization of "safe production month" and put forward requirements. According to the group's "safe production month" activity plan, different key thematic activities will be held in the four weeks of June. The first week is the "Publicity and Safety Education Week", which focuses on the use of WeChat groups, electronic screens, publicity boards, banners, slogans and other forms for safety publicity, and organizes the study of national safety regulations, company safety system specifications and accident-free factory creation standards, Organize to watch safety warning education films, learn accident cases, etc., and improve employees' safety awareness by creating a safety atmosphere and organizing learning activities. The focus of the activities in the second week is "looking for potential sources of danger around you". Each unit takes departments and teams as units to investigate and analyze the potential risk factors in the process of daily production, maintenance and operation, find out the hazard sources that have not been included in the scope of risk point control, and report to the safety management department of the unit to form a risk assessment report, put forward solutions or suggestions, and supervise the implementation of rectification and timely eliminate potential safety hazards. The third week is the "on-site safety innovation achievements exhibition week", which focuses on the achievements of each unit in on-site safety management and on-site safety facilities in the past year, which are displayed in the form of pictures and texts through beautiful articles and wechat, so as to learn from each other and promote common progress. The fourth week is the "safety training and drill week", and the group company organizes the standardization of safety production and the elimination of hidden dangers.
2020
07-31
Jianfeng Pharmaceuticals ranks among the top 50 creative enterprises in Jinhua
News from our newspaper April 26 is World Intellectual Property Day. Jinhua City released the list of "Top 50 Creative Enterprises" for the first time. Jianfeng Pharmaceutical Company entered the list and ranked second among the enterprises in Jinhua Development Zone. The selection of creative enterprises, the enterprise holds the effective invention patent as the main indicator. Over the years, Jianfeng Pharmaceutical Co., Ltd. has taken "intellectual property rights help enterprise development, and scientific and technological innovation creates a century-old peak" as the company's intellectual property policy. It has actively cooperated with China Pharmaceutical University, Sichuan Institute of Antibiotic Industry, Zhejiang University of Technology, Xiamen University and other units to build a scientific research and innovation platform integrating production, learning and research, and flexibly introduced Academician Wang Guangji and Academician Shan Weiguang with the chief scientist system, according to the direction of enterprise development strategy to carry out scientific research work, and achieved fruitful results. In 2019, Spike Pharmaceuticals applied for 2 invention patents and obtained 5 patent authorizations, including 1 invention. By the end of 2019, Spike Pharmaceuticals had obtained a total of 37 patents (including 2 PCT patents), of which 28 were inventions. In recent years, in order to better integrate with the international market, Jianfeng Pharmaceutical has made a complete patent layout for the new drug DPT under development, and has applied for patent protection in multiple countries through the PCT application channel for core patents, and finally in the high-level United States. And Japan was authorized to lay a solid foundation for the product to enter these two overseas high-end markets. At the same time, around the core patent, applied for the preparation, crystal type patent and obtained the invention patent authorization 5. In addition, pharmaceutical companies have also developed patents for other varieties under research.
2020
07-31
Jianfeng Pharmaceuticals ranks among the top 50 creative enterprises in Jinhua
News from our newspaper April 26 is World Intellectual Property Day. Jinhua City released the list of "Top 50 Creative Enterprises" for the first time. Jianfeng Pharmaceutical Company entered the list and ranked second among the enterprises in Jinhua Development Zone. The selection of creative enterprises, the enterprise holds the effective invention patent as the main indicator. Over the years, Jianfeng Pharmaceutical Co., Ltd. has taken "intellectual property rights help enterprise development, and scientific and technological innovation creates a century-old peak" as the company's intellectual property policy. It has actively cooperated with China Pharmaceutical University, Sichuan Institute of Antibiotic Industry, Zhejiang University of Technology, Xiamen University and other units to build a scientific research and innovation platform integrating production, learning and research, and flexibly introduced Academician Wang Guangji and Academician Shan Weiguang with the chief scientist system, according to the direction of enterprise development strategy to carry out scientific research work, and achieved fruitful results. In 2019, Spike Pharmaceuticals applied for 2 invention patents and obtained 5 patent authorizations, including 1 invention. By the end of 2019, Spike Pharmaceuticals had obtained a total of 37 patents (including 2 PCT patents), of which 28 were inventions. In recent years, in order to better integrate with the international market, Jianfeng Pharmaceutical has made a complete patent layout for the new drug DPT under development, and has applied for patent protection in multiple countries through the PCT application channel for core patents, and finally in the high-level United States. And Japan was authorized to lay a solid foundation for the product to enter these two overseas high-end markets. At the same time, around the core patent, applied for the preparation, crystal type patent and obtained the invention patent authorization 5. In addition, pharmaceutical companies have also developed patents for other varieties under research.
2020
07-30
Jianfeng Pharmaceuticals ranks among the top 50 creative enterprises in Jinhua
News from our newspaper April 26 is World Intellectual Property Day. Jinhua City released the list of "Top 50 Creative Enterprises" for the first time. Jianfeng Pharmaceutical Company entered the list and ranked second among the enterprises in Jinhua Development Zone. The selection of creative enterprises, the enterprise holds the effective invention patent as the main indicator. Over the years, Jianfeng Pharmaceutical Co., Ltd. has taken "intellectual property rights help enterprise development, and scientific and technological innovation creates a century-old peak" as the company's intellectual property policy. It has actively cooperated with China Pharmaceutical University, Sichuan Institute of Antibiotic Industry, Zhejiang University of Technology, Xiamen University and other units to build a scientific research and innovation platform integrating production, learning and research, and flexibly introduced Academician Wang Guangji and Academician Shan Weiguang with the chief scientist system, according to the direction of enterprise development strategy to carry out scientific research work, and achieved fruitful results. In 2019, Spike Pharmaceuticals applied for 2 invention patents and obtained 5 patent authorizations, including 1 invention. By the end of 2019, Spike Pharmaceuticals had obtained a total of 37 patents (including 2 PCT patents), of which 28 were inventions. In recent years, in order to better integrate with the international market, Jianfeng Pharmaceutical has made a complete patent layout for the new drug DPT under development, and has applied for patent protection in multiple countries through the PCT application channel for core patents, and finally in the high-level United States. And Japan was authorized to lay a solid foundation for the product to enter these two overseas high-end markets. At the same time, around the core patent, applied for the preparation, crystal type patent and obtained the invention patent authorization 5. In addition, pharmaceutical companies have also developed patents for other varieties under research.
2020
07-22
On April 24, Jiang Xiaomeng, chairman of the group company, presided over the 14th meeting of the 10th board of directors of the company, and deliberated and passed 14 related reports and motions such as the 2019 annual board of directors report, the 2019 general manager business report and the 2019 annual report. The general manager's report pointed out that 2019 is the first year of the implementation of the group's new five-year strategic development plan (2019-2023) and the new three-year business plan (2019-2021) for each business sector. the management team has carried out various operation and management work in an orderly manner around the general policy of "innovation and reform, integration and promotion, scientific layout and steady development", and has better completed the business objectives set by the board of directors at the beginning of the year. In the whole year, the company achieved a total operating income of 3.548 billion billion yuan, an increase of 5.51 percent over the same period last year; net profit attributable to shareholders was 0.725 billion billion yuan, with earnings per share reaching 2.11 billion yuan, an increase of 23.14 percent over the same period last year, a record high; total assets at the end of the year were 5.475 billion billion yuan, an increase of 11.71 percent over the same period last year; and net assets attributable to shareholders were 3.789 billion billion yuan, an increase of 19.81 percent. During the reporting period, the company's two main businesses have achieved great development, benefiting from the further promotion of supply-side structural reform, the overall operation of the cement industry in 2019 is stable, and the industry benefits are further improved. During the reporting period, the company made new progress in the construction of cement projects, completed the acquisition, capital increase and name change of Guizhou Mingchuan (Guizhou Huangping Jianfeng Cement Co., Ltd.), and continued to invest in the construction of its new dry cement production line with a daily output of 4500 tons of clinker.
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