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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2020
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On December 16, Jiang Xiaomeng, Secretary of the Party committee and chairman of the group company, went to Yunnan Jianfeng cement company to investigate and guide the work. On the morning of the same day, accompanied by the Yunnan peak management team, Jiang Xiaomeng went deep into the front line and successively went to the central control room of the production and manufacturing department, the raw material clay yard, the lignite yard and other areas for field investigation and investigation to understand the problems existing in the production and operation process. Subsequently, a business analysis meeting was held to make a comparative analysis of the various business indicators of Yunnan Jianfeng from January to November this year, and put forward two requirements to the management team: further strengthen internal management and improve execution; strengthen the coordination of external relations, and improve The ability and level of enterprise resource acquisition. At the Yunnan Jianfeng middle-level cadre meeting held on the afternoon of the 16th, Jiang Xiaomeng first fully affirmed Yunnan Jianfeng's highest output and best benefits since it was put into production in 2018, and expressed his gratitude to all cadres and employees of Yunnan Jianfeng for their hard work. After that, Jiang Xiaomeng made a detailed analysis of the cement industry and the regional market environment in Yunnan, and combined with the current production and operation situation of Yunnan Jianfeng, put forward the focus of the next step: 1. should fully attach importance to and mobilize the initiative and responsibility of employees at all levels to improve the overall execution of the team; 2. raw material mines are an important factor restricting the future development of cement enterprises, which should be paid full attention to and formulate clear strategies and methods, set out a timetable to obtain future production resources as much as possible; 3. continuously advocate and promote technological innovation, keep pace with the times, continuously improve production management, equipment management, production technology level, and maintain the competitive advantage of the industry; 4. further strengthen production
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