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Amlodipine besylate tablets

Product description
Approved date: January 29, 2007
 
Modified date: November 30, 2015
 
Amlodipine besylate tablet instructions
 
 Please read the instructions carefully and use them under the guidance of a physician.
 
【Drug Name】
 
Common name: amlodipine besylate tablets
 
English name: Amlodipine Besilate Tablets
 
Pinyin: Benhuangsuan Anlüdiping Pian
 
[Ingredients] The main component of this product is: amlodipine besylate, its chemical name is: (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)- 1,4-Dihydro-6-methyl-3,5-pyridinedicarboxylic acid-5-methyl ester, 3-ethyl ester benzene sulfonate.
 
 
 
Molecular formula: C20H25ClN2O5·C6H6O3S
 
Molecular weight: 567.05
 
【Properties】 This product is white or off-white.
 
[indications]
 
1. Hypertension. It can be used alone or in combination with other antihypertensive drugs.
 
2. Chronic stable angina and variant angina. It can be used alone or in combination with other anti-angina drugs.
 
[Specification] 5mg according to C20H25ClN2O5
 
【Dosage】
 
1. The initial dose for the treatment of hypertension is 5mg (1 tablet), once a day, the maximum dose is 10mg (2 tablets), once a day. The initial dose of patients with weak or elderly patients with hepatic insufficiency is 2.5 mg (1/2 tablet) once daily. This dose can also be used for the treatment of other antihypertensive drugs. The dose adjustment should be based on the patient's individual response. General dose adjustment should begin after 7 to 14 days. As required by the clinic, dose adjustments can be initiated more quickly after careful observation of the patient.
 
2. The initial dose for the treatment of angina pectoris is 5 ~ 10mg (1 ~ 2 tablets), once a day, elderly patients with hepatic insufficiency is recommended to use a lower dose of treatment. The effective dose for most people is 10 mg (2 tablets) per day.
 
【Adverse reactions】
 
· Amlodipine is well tolerated. In a placebo-controlled clinical trial of hypertension or angina, the most common adverse events were:
 
· Autonomic nervous system: flushing
 
· Body: fatigue
 
· Cardiovascular, general: edema
 
· Central and peripheral nervous system: dizziness, headache
 
· Gastrointestinal tract: abdominal pain, nausea
 
·Heart rate / heart rate: heart palpitations
 
·Psychological: sleepiness
 
No significant clinical laboratory abnormalities associated with this product were found in these clinical trials.
 
The fewer adverse events observed after the listing were:
 
· Autonomic nervous system: dry mouth, increased sweating
 
· Whole body: weakness, back pain, general malaise, pain, weight gain/decrease
 
· Cardiovascular, general: hypotension, syncope
 
· Central and peripheral nervous system: high muscle tone, hypoesthesia / paresthesia, peripheral neuropathy, tremor
 
·Endocrine: breast hyperplasia
 
· Gastrointestinal tract: changes in bowel habits, indigestion (including gastritis), gingival hyperplasia, pancreatitis, vomiting
 
· Metabolic / nutritional: high blood sugar
 
· Musculoskeletal: joint pain, muscle spasm, muscle pain
 
· platelet / hemorrhage / coagulation: purpura, thrombocytopenic purpura
 
·Psychological: impotence, insomnia, attitude change
 
·Respiratory system: cough, difficulty breathing
 
· Skin / Accessories: hair loss, skin discoloration
 
·Special feeling: taste disorder, tinnitus
 
· Urology: frequent urination
 
·Vascular (extracardiac): vasculitis
 
· Vision: visual impairment
 
· White blood cell / reticuloendothelial system: leukopenia
 
Allergic reactions are rare, including pruritus, rash, vasogenic edema, and polymorphous erythema.
 
There have been very rare reports of elevated hepatitis, jaundice, and transaminases (usually associated with cholestasis). Some serious cases requiring hospitalization have been reported to be associated with the use of amlodipine. But in most cases, the causal relationship has not been determined.
 
Similar to other calcium antagonists, the following adverse events have been reported in a few cases, but the events are difficult to distinguish from the natural course of the underlying disease, such as: myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia and atrial fibrillation) And chest pain.
 
[Contraindications] It is contraindicated in patients who are allergic to dihydropyridines or any of the ingredients in this product.
 
【Precautions】
 
1. Warning: Very few patients, especially those with severe coronary artery disease, have increased angina frequency, prolonged and/or increased severity, or acute myocardial infarction when starting treatment with calcium antagonists or increasing doses. The mechanism of action is still unclear.
 
2. Because the vasodilator effect of this product is gradually produced, the occurrence of acute hypotension after taking this product is rarely reported. However, in patients with severe aortic stenosis, attention should be paid when used in combination with other peripheral vasodilators.
 
3. Use of heart failure patients: Calcium antagonists should be used with caution in patients with congestive heart failure. In a long-term, placebo-controlled study (PRAISE-2) of patients with non-ischemic heart failure (NYHA class III-IV), although there was no significant difference in the incidence of heart failure compared with placebo, with ammonia There has been an increase in reported reports of pulmonary edema associated with clondipine.
 
4. Use of patients with impaired liver function: Like all other calcium antagonists, the half-life of this product is prolonged when liver function is impaired. However, the corresponding recommended dose has not been determined, so use this product should be cautious.
 
5. Use of patients with renal failure: There is no correlation between changes in plasma concentration of amlodipine and the extent of renal impairment. Therefore, a normal dose can be used. This product cannot be removed by dialysis.
 
[Pregnant women and lactating women] There is no corresponding research data for pregnant women. However, animal test results show that 10mg / kg of this product can cause a decrease in litter size, increased stillbirth, delayed delivery and delayed labor, so this product can only be used in pregnant women when it is necessary. It is not known whether this product can be secreted through milk, and lactating women who take the drug should stop breastfeeding.
 
[Child medication] There is no information on this product for children.
 
[Geriatric Use]
 
The peak time of blood concentration of this product is similar in elderly and young patients. The increase in area under the curve-time curve (AUC) and the extension of elimination half-life in elderly patients have a tendency to decrease. It has been reported that elderly patients have the same good tolerance as younger patients when receiving similar doses of amlodipine. Therefore, elderly patients can use normal doses. However, it is advisable to use a smaller dose at the beginning, and then gradually increase it.
 
【medicine interactions】
 
   This product is safe to use with the following drugs: thiazide diuretics, α-adrenergic receptor blockers, β-adrenergic receptor blockers, angiotensin converting enzyme inhibitors, long-acting nitric acid Ester drugs, sublingual nitroglycerin, non-steroidal anti-inflammatory drugs, antibiotics and oral hypoglycemic agents.
 
In vitro studies using human plasma have shown that this product does not affect the plasma protein binding rate of digoxin, phenytoin, warfarin or indomethacin.
 
The effect of other drugs on amlodipine:
 
Cimetidine: The combination with cimetidine does not alter the pharmacokinetics of amlodipine.
 
Grapefruit juice: 20 healthy volunteers took 240ml grapefruit juice and 10mg amlodipine at the same time. No obvious effect on the pharmacokinetics of amlodipine.
 
Aluminum/magnesium (antacid): Simultaneous administration of aluminum/magnesium antacids and single-dose amlodipine showed no significant effect on the pharmacokinetics of amlodipine.
 
Sildenafil (SILDENAFIL): Single dose of 100 mg of sildenafil does not affect the pharmacokinetics of amlodipine in patients with essential hypertension. The two drugs are combined, and each drug independently exerts its antihypertensive effect.
 
The effect of amlodipine on other drugs:
 
ATORVASTATIN: There was no significant change in the steady-state pharmacokinetic parameters of atorvastatin with 10 mg of amlodipine and 80 mg of atorvastatin.
 
Digoxin: Amlodipine and digoxin were used in combination, and there was no change in plasma digoxin concentration or renal clearance rate in normal volunteers.
 
Ethanol (alcohol): Single or multiple doses of 10 mg of amlodipine have no effect on the pharmacokinetics of ethanol.
 
Warfarin: Amlodipine in combination with warfarin does not change the prothrombin reaction time of warfarin.
 
Cyclosporin: Pharmacokinetic studies indicate that amlodipine does not significantly alter the pharmacokinetics of cyclosporin.
 
Drug/Laboratory Interaction: Unknown.
 
【Drug overdose】
 
Available data suggest that severe overdose can lead to excessive expansion of peripheral blood vessels, followed by significant and persistent systemic hypotension.
 
Use this product to wash the stomach in excess. When causing significant hypotension, active cardiovascular support is required, including cardiopulmonary monitoring, raising the limbs, paying attention to circulating blood volume and urine output. In order to restore vascular tone and blood pressure, vasoconstrictors can also be used in the absence of contraindications. Intravenous calcium gluconate is also beneficial in reversing the effects of calcium antagonists. Because of the high rate of binding of this product to plasma proteins, dialysis treatment is not beneficial.
 
[Pharmacology and Toxicology] Amlodipine is a calcium channel blocker (also known as a slow channel blocker or a calcium antagonist) that blocks calcium ions from entering the myocardium and vascular smooth muscle cells.
 
The mechanism of amlodipine against hypertension is to directly relax vascular smooth muscle. The exact mechanism for relieving angina is not fully affirmed, but it can reduce peripheral vascular resistance, reduce coronary vasospasm, reduce cardiac afterload, reduce cardiac energy expenditure and oxygen demand by expanding peripheral arterioles and coronary arteries. Relieve angina.
 
[Pharmacokinetics] Amlodipine is well absorbed orally and is not affected by food intake. The plasma concentration reaches a peak 6 to 12 hours after administration, the absolute bioavailability is about 64-80%, the apparent volume of distribution is about 21L/kg, and the terminal elimination half-life is about 35-50 hours, once a day. After 7-8 days of continuous administration, the plasma concentration reached steady state. Amlodipine was metabolized by the liver to inactive metabolites, and 10% of the original drug and 60% of metabolites were excreted from the urine. Plasma protein binding rate It is about 97.5%.
 
[Storage] shading, sealed (10 ~ 30 ° C) preservation.
 
[Packing] Aluminum-plastic packaging, 6 pieces per box; 7 pieces per box; 10 pieces per box; 12 pieces per box; 14 pieces per box; 21 pieces per box; 30 pieces per box.
 
[Validity Period] 24 months
 
[Executive Standards] "Chinese Pharmacopoeia" 2015 Edition 2
 
[Approval No.] National Drug Standard H20057316
 
【manufacturer】
 
    Company Name: Guangdong Pi Di Pharmaceutical Co., Ltd.
 
    Production address: No. 66, Pidi Avenue, Yueshan Town, Kaiping City, Guangdong Province
 
    Postal code: 529331
 
    Phone number: (0750) 2789348 2787017
 
              400-8899-328 (National Service Phone)
 
Fax number: (0750) 2789348
 
Website: http://www.pdpharm.com
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