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
Daye Jianfeng Jinshan limestone mine is included in the national green mine list.
On January 11, the Ministry of Natural Resources issued an announcement announcing the list of mines that were included in the national list of green mines in 2020, with the Jinshan limestone mine of Daye Peak Cement Company among them. The final result of the green mine selection is in accordance with the requirements of the notice of the general office of the Ministry of natural resources on doing a good job in the selection of green mines in 2020 (natural resources office letter [2020] No. 839), on the basis of enterprise self-evaluation, third-party evaluation, provincial verification and recommendation, after examination and social publicity. In 2020, a total of 301 mines were selected and included in the national green mine list, subject to social supervision. Green mine refers to the implementation of scientific and orderly mining in the whole process of mineral resources development, the control of the disturbance of the mining area and the surrounding ecological environment within a controllable range, and the realization of environmental ecology, scientific mining methods, efficient resource utilization, and management Information digitization and mining area community harmony of the mine. In order to meet the selection criteria of national green mines, we must carry out the work from two categories and nine aspects, namely, the comprehensive utilization of resources, technological innovation, energy conservation and emission reduction led by the technical strength of mining enterprises, and the operation of mines according to law, standardized management, environmental protection, land reclamation, community harmony, corporate culture and so on. These requirements fully reflect the development concepts advocated by the current state, such as people-oriented, harmonious development of society and environment, and sustainable development. Jinshan limestone mine is a limestone raw material mine supporting Daye peak production line, about 1km away from the plant. Since it was put into operation, Jinshan limestone mine has been carrying out ore mining according to law. With the deepening of the establishment of green mines, Daye Peak, based on the principle of "mining while managing", has made orderly progress in the work of mine greening, dust control and information-based intelligent mine construction. It has successively built a centralized management and control platform for mine automation, integrating automatic control system, remote monitoring system, reserve management system and various monitoring systems, basically realizing the automation of fixed facilities and unattended operation. Harden the roads in mining areas; tens of millions of yuan have been invested in the restoration and management of the geological environment, planting more than 20000 camphor trees, Luan Shu and other seedlings, more than 2000 square meters of Parthenocissus creeper, laying more than 26000 square meters of lawns, and spraying more than 60000 square meters of guest soil. The forest land in some areas that will not be mined within 5 years has been restored, and the overall look of the mining area is new, which fully embodies the green mine development concept of "innovation, green, green. (this newspaper reporter)
2021
01-21
A few days ago, daye peak cement company donated 100000 yuan to daye city charity association as a poverty alleviation fund. A group of agents in Hubei province of peak cement visited left-behind children and families of poor students in Gulin town, where Huang ping peak cement company is located, and formed a helping pair with 8 poor students. Spike poverty alleviation and aid to write a new page. Jianfeng has always had a tradition of helping the poor and helping students. In addition to donating eight hope primary schools in Jinhua, Tibet, Xinjiang, Gansu, Yunnan and other places, individual or collective employees also subsidize poor students to complete their studies through fixed-point pairing and participation in the hope project. From the beginning of its establishment, Daye Jianfeng's employees have spontaneously contributed personal funds to pair with local poor students to provide help to students in need; in recent years, they have also helped children from poor employees' families complete their studies through "Golden Autumn Aid" and other channels. At the simple donation ceremony of the student aid fund held by Daye Peak, Zhang Fengliang, deputy general manager of the group company and general manager of Daye Peak, said that helping poor students realize their dreams of studying and dedicating a love to Daye's education is Daye The unshirkable responsibility of the peak people is the responsibility of the enterprise. As a key enterprise in Daye City, Daye Peak has been fulfilling its social responsibilities with practical actions while developing, and will continue to support and participate in this meaningful work that benefits the country and the people in the future. Ke Lingxiao, deputy secretary-general of the Daye Chu Chamber of Commerce and director of the Party Committee Office, attended the donation ceremony. Yang Jianxiong, the relevant person in charge of the Daye Charity Federation, accepted donations on behalf of the Charity Federation. In mid-December 2020, a group of agents from Peak Cement Hubei went to Gulin Town, Huangping County, Guizhou Province, to have a discussion with the leaders in charge of education in Gulin Town and the principals of some schools in the area to learn about the local education work. In order to have a closer understanding of the life and study of poor students, they also went deep into the local mountainous areas to visit left-behind children and poor students. An agent said: "The peak has given us this platform, our career development today is closely related to the peak, in a way, we are also 'peak man'. It is a very meaningful thing to go to Guizhou to experience the new factory style of Huangping Peak, to send warmth to the local poor children and to show the love of Peak agents." After on-the-spot visits, eight children were finally identified as the objects of assistance, some of which were orphans, some were single-parent families, and some of the parents suffered from major diseases that led to family poverty. In the future, peak agents will help these children in their lives and studies, so that they can complete their studies in peace of mind. (Zhu Yong and Lu Meiyan)
2021
01-11
Peak Metro Special Communication Cable Patented
On December 11, the cable company's subway special communication cable utility model patent authorization announcement, this is the cable company's fourth new utility model patent this year. Metro special communication cable is a kind of special cable which is optimized and improved on the basis of traditional urban communication cable. In order to meet the requirements of the subway environment and users, the cable company studies the longitudinal waterproof, radial waterproof and high flame retardant performance of the cable. In terms of longitudinal waterproofing, the traditional use of hot oil paste is changed to cold oil paste, and an automatic oil filling device is made, which not only simplifies the structure of the filling equipment, reduces the investment cost and floor area of the equipment, but also has simple filling process, easy operation and control, stable product quality, energy consumption saving, production cost reduction, no paste dripping during filling, and clean and pollution-free production site. The ointment filling process is not affected by temperature changes, and there is no insulation layer scald, paste dripping and cracking. Radial waterproofing adopts special hot melt adhesive technology that can bond metals, so that the joints of aluminum strips are tightly bonded and the radial waterproofing is more thorough, thus solving the problems of unround appearance of sheath, depression or flounces, poor sealing performance, affecting the waterproof performance of cables, etc. caused by the original heating technology of hot air gun. At the same time, in terms of high flame retardancy, the material of the outer sheath is improved, and the environmentally friendly flame retardant low-smoke halogen-free material is adopted, so that the product meets the environmental protection and fire safety requirements of the current key projects. With the increase of domestic subway projects, the use of subway special communication cables is also increasing. The acquisition of this patent has a certain effect on cable companies to expand their market influence and increase sales. (lu chao-fang)
2021
01-04
Huang Ping Peak "Try" to "Quasi"
On December 23, Guizhou Huangping Jianfeng Cement Company obtained the national industrial product production license. According to the relevant policies and regulations, the products produced by the enterprise meet the national standards, have applied for the national industrial product production license procedures, and have been accepted and filed by the relevant competent departments. During the period of waiting for the license to be issued, the trial production products can be sold, but the words "trial products" must be printed on the packaging bag. Due to the outbreak of the new coronary pneumonia epidemic at the beginning of the year, the construction of the Huangping peak project and the handling of production licenses and other related work have been affected to some extent. After the initial relief of the epidemic in May, Huang Ping peak in the intensified construction at the same time, but also began to carry out the production license processing. Due to the differences in the understanding of the relevant requirements and standards by the local competent departments, the relevant departments of Huang Ping Jianfeng worked together to deeply understand the local policy requirements and actively communicate with the administrative departments, and finally completed the work. Although trial products and formal products are subject to the same quality management standards, in actual marketing, user acceptance is often "discounted". The relevant person in charge of Huang Ping Jianfeng said that with this "birth permit", it means that the product has been officially affirmed and licensed by the state. As a new force in Southeast Guizhou, Jianfeng cement can truly participate in the market competition at the same level as the original local similar products, which will play a positive role in promoting the follow-up production and sales work. (Zhu Yong)
2021
01-04
On the afternoon of December 19, Wu Jin, deputy secretary of Huangshi municipal Party committee and mayor, Wang Gang, Secretary of Daye municipal Party committee, and Wang Ding, mayor of Daye City, visited Daye Jianfeng cement company for investigation. Wu Jin proposed that Daye Peak, as a key industrial enterprise in Daye City, should strengthen its advantages and make up for its shortcomings under the leadership of the Daye City Government, and strive to be the main engine and pioneer demonstration of the city's transformation and upgrading and high-quality development. Accompanied by Yuan Xianming, executive deputy general manager of Daye Peak, and Tao Yesheng, deputy general manager, Wu Jin and his entourage visited the production site of Daye Peak, spoke highly of the site management level of Daye Peak, and carefully inquired about the production and operation situation in 2020 and the future medium-and long-term development plan. Prior to this, the Huangshi Municipal CPC Committee held the second Plenary session of the 13th CPC Central Committee, planning to formulate the 14th five-year Plan and build a regional development layout system of "one heart, two belts, multi-point support, and global development." Wu Jin stressed in his investigation that he hoped Daye would seize the favorable opportunity of the "14th five-year Plan" building materials industry, actively respond to the government's industrial construction transformation plan, and make positive contributions to the reconstruction of Huangshi industry. (Xu Ying, Wang Yiyan)
2021
01-04
Another batch of old employees retired
On the morning of December 25, the group company held a farewell party for retired employees in 2020. Jiang Xiaomeng, secretary of the party committee and chairman of the group company, Qin Xuping, chairman of the trade union of the group company, and more than 20 retired old employees gathered together to share their work feelings and talk about their future life. Qin Xuping briefly reviewed the development history of Jianfeng Group over the past 60 years, thanked the retired employees and wished them good health and a happy life. He said that Jianfeng Group's achievements embody the wisdom, strength and painstaking efforts of the old comrades, and Jianfeng Group will not forget their contributions. I also hope that the old employees will not retreat and continue to pay attention to supporting peak development. Old employees are also actively speaking, talk about life planning after retirement. Jiang Xiaomeng introduced to the retired employees the company's current overall operation, the latest progress of the cement and pharmaceutical sector, and the industrial layout in various places. I hope the trade union will strengthen the service awareness of retired employees and do a good job in logistics services. I hope that the old employees will keep in touch with the company, communicate more, make more suggestions and suggestions, and thank the retired employees for their hard work over the years and their dedication and support to Jianfeng Group. (Reporter Chen Shengmu)
2021
01-04