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
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2020
07-31
"We were also praised by the traffic police." On September 26, when talking about the civilized travel volunteer activities a few days ago, Li Xuegen of the big pharmacy smiled and was very happy that his work was recognized. Starting from May this year, during the rush hour on the 5th and 20th of each month (weekends and holidays are postponed), there will be a group of volunteers wearing red vests and hats, holding signs with the words "courtesy of zebra crossing, civilized crossing of the road" to divert traffic at many intersections in the city. This is a civilized travel volunteer service activity carried out by Jinhua City to further promote civilized travel and persuade uncivilized behavior. As a civilized unit at the municipal level in Jinhua, Jianfeng Group's duty junction is at the intersection of Bayi North Street and Zhongshan West Road. Before the activity was carried out, as the organizer of the group company, the group office had deep concerns. The activity took a long time and required a lot of manpower. As an enterprise, under the condition of ensuring normal production, it was completed by employees in their spare time. Can it be continued? To this end, Xiang Chongping, the leader in charge of the group company, specially organized a meeting of the directors of the subordinate enterprise offices to mobilize and deploy the matter. The group office also specially established the QQ group of "Peak Civilized Travel Volunteer Service" to release the contents and arrangements of the activities, update the duty situation, and praise the small partners on duty. At the beginning of the activity, colleagues in the headquarters building took the lead in taking up their posts. The first class was Li Hong, Li Xia, Yang Liu and Lei Yuan of the finance department of the group company. Employees of the group office, the peak health experience hall, Qiubin Factory and the international trading company also took up their posts one after another. Other enterprises also took part in an orderly manner according to the duty schedule.
2020
07-30
The company's two projects received financial subsidies for the integration of the two.
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2020
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Daye peak won the title of "best integrity enterprise"
On September 4, daye city held a grand commendation meeting, daye peak cement company as the "best integrity enterprise" was commended. This is also the first time that Daye City has selected and commended the "Best Integrity Enterprise". In order to commend the advanced, promote righteousness, establish models, give full play to the role of demonstration and leadership, further encourage and stimulate the enthusiasm of enterprises and employees, unswervingly strengthen the construction of spiritual civilization and credit system in Daye City, and promote the economy of local enterprises. Good and fast development. The Daye City Federation of Trade Unions and the Office of the Spiritual Civilization Construction Committee initiated the selection and recognition of the best honest enterprises, the best honest teams, and the most beautiful honest employees throughout the city. After recommendation, review, evaluation, and publicity procedures, a total of 10 "best integrity enterprises", 10 "best integrity teams", and 20 "most beautiful integrity employees" in Daye City were selected. At the commendation meeting on September 4, Xu Yilong, member of the standing Committee of the Daye Municipal CPC Committee, minister of the United Front work, and chairman of the Municipal Federation of Trade unions, spoke highly of the scientific management and honest operation of Daye Jianfeng cement Company in recent years. I hope Daye Jianfeng can cherish the honor, give full play to its exemplary and leading role, forge ahead, and achieve better results. Xu Yilong also asked the city's enterprises, teams and employees to follow the example of award-winning units and individuals, further emancipate their minds, change their production and management concepts, establish a career with integrity, be honest, and make new contributions to serving the economic development of Daye City. (Zhu Yong)
2020
07-30
Daye peak won the title of "best integrity enterprise"
On September 4, daye city held a grand commendation meeting, daye peak cement company as the "best integrity enterprise" was commended. This is also the first time that Daye City has selected and commended the "Best Integrity Enterprise". In order to commend the advanced, promote righteousness, establish models, give full play to the role of demonstration and leadership, further encourage and stimulate the enthusiasm of enterprises and employees, unswervingly strengthen the construction of spiritual civilization and credit system in Daye City, and promote the economy of local enterprises. Good and fast development. The Daye City Federation of Trade Unions and the Office of the Spiritual Civilization Construction Committee initiated the selection and recognition of the best honest enterprises, the best honest teams, and the most beautiful honest employees throughout the city. After recommendation, review, evaluation, and publicity procedures, a total of 10 "best integrity enterprises", 10 "best integrity teams", and 20 "most beautiful integrity employees" in Daye City were selected. At the commendation meeting on September 4, Xu Yilong, member of the standing Committee of the Daye Municipal CPC Committee, minister of the United Front work, and chairman of the Municipal Federation of Trade unions, spoke highly of the scientific management and honest operation of Daye Jianfeng cement Company in recent years. I hope Daye Jianfeng can cherish the honor, give full play to its exemplary and leading role, forge ahead, and achieve better results. Xu Yilong also asked the city's enterprises, teams and employees to follow the example of award-winning units and individuals, further emancipate their minds, change their production and management concepts, establish a career with integrity, be honest, and make new contributions to serving the economic development of Daye City. (Zhu Yong)
2020
07-31
Daye peak won the title of "best integrity enterprise"
On September 4, daye city held a grand commendation meeting, daye peak cement company as the "best integrity enterprise" was commended. This is also the first time that Daye City has selected and commended the "Best Integrity Enterprise". In order to commend the advanced, promote righteousness, establish models, give full play to the role of demonstration and leadership, further encourage and stimulate the enthusiasm of enterprises and employees, unswervingly strengthen the construction of spiritual civilization and credit system in Daye City, and promote the economy of local enterprises. Good and fast development. The Daye City Federation of Trade Unions and the Office of the Spiritual Civilization Construction Committee initiated the selection and recognition of the best honest enterprises, the best honest teams, and the most beautiful honest employees throughout the city. After recommendation, review, evaluation, and publicity procedures, a total of 10 "best integrity enterprises", 10 "best integrity teams", and 20 "most beautiful integrity employees" in Daye City were selected. At the commendation meeting on September 4, Xu Yilong, member of the standing Committee of the Daye Municipal CPC Committee, minister of the United Front work, and chairman of the Municipal Federation of Trade unions, spoke highly of the scientific management and honest operation of Daye Jianfeng cement Company in recent years. I hope Daye Jianfeng can cherish the honor, give full play to its exemplary and leading role, forge ahead, and achieve better results. Xu Yilong also asked the city's enterprises, teams and employees to follow the example of award-winning units and individuals, further emancipate their minds, change their production and management concepts, establish a career with integrity, be honest, and make new contributions to serving the economic development of Daye City. (Zhu Yong)
2020
07-31
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