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)
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More information
Editor's note: During the National Day, the "Jinhua New Observation" column of Jinhua TV Station launched a series of reports on "National Day New Observation: New Development of Old Enterprises" to understand the new developments of those old enterprises that have grown up with New China in the new era. October 3 broadcast of the "peak of the 'centennial 'ideal", about the development of the peak group and the future direction of development. The "century" ideal of the peak Jinhua TV reporter Wang Dujuan Jiang Qian host: speaking of Zhejiang Jianfeng Group Co., Ltd., Jinhua people are no stranger. The older generation of Jinhua people are more familiar with, may be the predecessor of Jianfeng Group-Jinhua Cement Factory. Open the first old photo 58 years ago, surrounded by mountains and a rice field in the middle. Old Jinhua can see at a glance that this is the Wise Temple, 8 kilometers north of Jinhua City and east of the former Zhuangtou of Luodian Town. In August 1958, the first group of pioneers came here and built Jinhua's first cement factory on a desolate hillside of 16.94 mu with a pair of hands and warm blood. From the earliest cattle-drawn ball forming machine to the electric ball forming machine, from pure manual labor to machine substitution, it took 26 years of hard work. By 1983, the annual output of peak cement reached 120000 tons, the output value was 6.75 million yuan, and the profit was 2.4 million yuan. In these 26 years, the cement plant has experienced a difficult period of the country, and the ten-year catastrophe of the "Cultural Revolution" has finally ushered in a good time of reform and opening up with tenacious vitality, laying the foundation for steady development in the future. Looking at these old pictures,
2020
07-31
Peak Cement Successfully Enters Lancang Airport Project
News from our newspaper On September 26, the first batch of airport runway cement produced by Yunnan Jianfeng Cement Company was successfully delivered to the Lancang Airport site, which marked another important step in the expansion of Jianfeng Cement in the southwest Yunnan market. Lancang Airport is located in Donghi Town, Lancang Lahu Autonomous County, Pu'er City. It is the center of the "three counties" and "Pu'er Green Triangle" tourist areas of Lancang, Menglian and Ximeng, with a wide range of radiation and obvious location advantages. The project is a national "Twelfth Five-Year Plan" construction project and a key construction project in Yunnan Province. It was approved by the State Council and the Central Military Commission in January 2013. It started construction at the end of November 2014 and is expected to be completed in April 2017. The current project of Lancang Airport is designed to meet the target of 250000 passenger throughput and 750 tons of cargo throughput by 2020, including the construction of a 2600-meter-long and 45-meter-wide runway, the construction of a new 3000-square-meter terminal building and 4 apron parking spaces, including communication, navigation, lighting, meteorology and other supporting projects. The total investment of the project is 1.533 billion yuan. Upon completion, it can be used for Boeing 737 series, Airbus A319 and A320 series, MA-60 and other passenger aircraft take off and land. Since the start of the Lancang Airport project, Yunnan Peak has listed it as an important goal to strive. Compared with ordinary cement, special cement for airport runways has the characteristics of small shrinkage, strong wear resistance, good frost resistance and low alkali content in addition to the requirements of ordinary 42.5 Portland cement. To this end, Yunnan peak in the project to strive for at the same time, the collection of technical forces to tackle the problem, in the clinker composition to determine, cooked.
2020
07-31
Jianfeng won the Zhejiang Industrial Award
A few days ago, we learned from the relevant departments of Zhejiang Province that the company won the 2016 "Zhejiang Industrial Award Silver Award". Zhejiang Industrial Award was established in 2014 and is selected every two years. The purpose of carrying out the selection and commendation of the Zhejiang Industrial Awards is to thoroughly implement the "August 8 Strategy", comprehensively implement the innovation-driven development strategy, speed up the industrial transformation and upgrading with the "four for three" as the starting point, and commend the adherence to the scientific concept of development. adhere to industry, conscientiously fulfill social responsibilities, establish a modern enterprise system, and take a new road of industrialization with characteristics. The evaluation work is jointly organized and implemented by Zhejiang Industrial Economic Federation, Enterprise Federation, Entrepreneur Association, relevant provincial industry associations, municipal industrial economic federations, enterprise federations, entrepreneur associations, and relevant units. The award review committee is composed of relevant government departments, provincial "three committees", relevant provincial industry associations, and experts in industrial economy, management, finance, taxation, quality, environmental protection, safety, technology, and law, the participating enterprises are comprehensively evaluated from the aspects of industry demonstration role, scientific and technological innovation, economic benefits, resource utilization, environmental protection, brand strategy, product quality, production safety, social responsibility, enterprise management, human resources and so on. "The enterprises that have won the Zhejiang Industrial Award this time are all outstanding enterprises that have made significant contributions to the promotion of Zhejiang's economic development; they are all leading enterprises, backbone enterprises, and high-growth enterprises from different industries, representing the scale of Zhejiang's industrial development. The direction and leading spirit represent the highest level of Zhejiang's industrial development." According to the organizers related negative
2020
07-31
Peak Cement Successfully Enters Lancang Airport Project
News from our newspaper On September 26, the first batch of airport runway cement produced by Yunnan Jianfeng Cement Company was successfully delivered to the Lancang Airport site, which marked another important step in the expansion of Jianfeng Cement in the southwest Yunnan market. Lancang Airport is located in Donghi Town, Lancang Lahu Autonomous County, Pu'er City. It is the center of the "three counties" and "Pu'er Green Triangle" tourist areas of Lancang, Menglian and Ximeng, with a wide range of radiation and obvious location advantages. The project is a national "Twelfth Five-Year Plan" construction project and a key construction project in Yunnan Province. It was approved by the State Council and the Central Military Commission in January 2013. It started construction at the end of November 2014 and is expected to be completed in April 2017. The current project of Lancang Airport is designed to meet the target of 250000 passenger throughput and 750 tons of cargo throughput by 2020, including the construction of a 2600-meter-long and 45-meter-wide runway, the construction of a new 3000-square-meter terminal building and 4 apron parking spaces, including communication, navigation, lighting, meteorology and other supporting projects. The total investment of the project is 1.533 billion yuan. Upon completion, it can be used for Boeing 737 series, Airbus A319 and A320 series, MA-60 and other passenger aircraft take off and land. Since the start of the Lancang Airport project, Yunnan Peak has listed it as an important goal to strive. Compared with ordinary cement, special cement for airport runways has the characteristics of small shrinkage, strong wear resistance, good frost resistance and low alkali content in addition to the requirements of ordinary 42.5 Portland cement. To this end, Yunnan peak in the project to strive for at the same time, the collection of technical forces to tackle the problem, in the clinker composition to determine, cooked.
2020
07-31
Peak Cement Successfully Enters Lancang Airport Project
News from our newspaper On September 26, the first batch of airport runway cement produced by Yunnan Jianfeng Cement Company was successfully delivered to the Lancang Airport site, which marked another important step in the expansion of Jianfeng Cement in the southwest Yunnan market. Lancang Airport is located in Donghi Town, Lancang Lahu Autonomous County, Pu'er City. It is the center of the "three counties" and "Pu'er Green Triangle" tourist areas of Lancang, Menglian and Ximeng, with a wide range of radiation and obvious location advantages. The project is a national "Twelfth Five-Year Plan" construction project and a key construction project in Yunnan Province. It was approved by the State Council and the Central Military Commission in January 2013. It started construction at the end of November 2014 and is expected to be completed in April 2017. The current project of Lancang Airport is designed to meet the target of 250000 passenger throughput and 750 tons of cargo throughput by 2020, including the construction of a 2600-meter-long and 45-meter-wide runway, the construction of a new 3000-square-meter terminal building and 4 apron parking spaces, including communication, navigation, lighting, meteorology and other supporting projects. The total investment of the project is 1.533 billion yuan. Upon completion, it can be used for Boeing 737 series, Airbus A319 and A320 series, MA-60 and other passenger aircraft take off and land. Since the start of the Lancang Airport project, Yunnan Peak has listed it as an important goal to strive. Compared with ordinary cement, special cement for airport runways has the characteristics of small shrinkage, strong wear resistance, good frost resistance and low alkali content in addition to the requirements of ordinary 42.5 Portland cement. To this end, Yunnan peak in the project to strive for at the same time, the collection of technical forces to tackle the problem, in the clinker composition to determine, cooked.
2020
07-30
Peak two enterprises were commended
On September 23, the launching ceremony of the 2016 Jinhua Zhejiang Shopping Festival and the 2015 Jinhua Honest Enterprise Commendation Conference were held in the urban people's square. Jianfeng Group's Jinhua Jianfeng Pharmacy Chain Co., Ltd. and Zhejiang Jianfeng International Trade Co., Ltd. were commended.
2020
07-31