Amlodipine Besylate Tablets

Pharmacological action: Amlodipine besylate is a dihydropyridine calcium antagonist (calcium ion antagonist or slow channel blocker). The contraction of myocardial and smooth muscle depends on the entry of extracellular calcium ions into cells through specific ion channels. This product selectively inhibits the transmembrane entry of calcium ions into smooth muscle cells and myocardial cells, and has a greater effect on smooth muscle than on myocardium. Its interaction with calcium channels is determined by the progressive rate of binding and dissociation between it and receptor sites, so the pharmacological effect is gradually produced. This product is a peripheral artery dilator that acts directly on vascular smooth muscle, reduces peripheral vascular resistance, and thus lowers blood pressure. At therapeutic doses, negative inotropic effects can be observed in in vitro experiments, but not in whole animal experiments. This product does not affect plasma calcium concentrations. 15 randomized, double-blind, placebo-controlled trials

The main ingredient of this product is amlodipine.

This product is white tablets.

1. Hypertension (used alone or in combination with other drugs); 2. Angina pectoris: especially spontaneous angina pectoris (used alone or in combination with other drugs).

The usual starting oral dose is 5 mg, once a day, and the maximum dose is no more than 10 mg, once a day. Thin people, weak people, elderly patients or those with impaired liver function start taking the drug from 2.5 mg, once a day; those who take other antihypertensive drugs in combination also start taking the drug from this dose. The dosage is adjusted according to individual needs, and the adjustment period should be no less than 7 to 14 days so that the doctor can fully evaluate the patient's response to the dose. However, under the premise of clinical guarantee, the adjustment speed can be accelerated. The recommended dose for the treatment of angina pectoris is 5 to 10 mg, and the elderly patients or those with impaired liver function need to reduce the dose.

This product is well tolerated within the dose range of 10 mg/day, and most adverse reactions are mild to moderate. Only 1.5% of patients discontinued this product due to adverse reactions, which was not significantly different from placebo (about 1%). The most common adverse reactions were headache and edema. The dose-related adverse reactions with an incidence of 1% are as follows: edema, dizziness, hot flashes, and palpitations. The relationship with the dose is unclear, but the adverse reactions with an incidence of more than 1.0% are as follows: headache, fatigue, nausea, abdominal pain, and drowsiness. Among the above adverse reactions, the incidence of edema, hot flashes, palpitations, and drowsiness in women is higher than that in men. The following adverse events occurred at a rate of 1% but 0.1% and the causal relationship to the drug was unclear: General: allergic reaction, asthenia, back pain, hot flashes, malaise, pain, stiffness, weight gain; Cardiovascular: arrhythmia (including tachycardia, bradycardia, or atrial fibrillation), chest pain, hypotension, peripheral ischemia, syncope, postural dizziness, postural hypotension, and vasculitis; Central and peripheral nervous system: hypoesthesia, peripheral neuropathy, paresthesia, tremor, vertigo; Gastrointestinal: anorexia, constipation, dyspepsia, dysphagia, diarrhea, flatulence , pancreatitis, vomiting, gingival hyperplasia; musculoskeletal system: joint pain, arthritis, muscle cramps, myalgia; mental: sexual dysfunction, insomnia, tension, depression, nightmares, anxiety, depersonalization; skin and appendages: angioedema, erythema, itching, rash, maculopapular rash; special senses: visual abnormalities, conjunctivitis, diplopia, eye pain, tinnitus; urinary system: frequent urination, urination disorder, nocturia; autonomic nervous system: dry mouth, night sweats; metabolism and nutrition: hyperglycemia, thirst; hematopoietic system: leukopenia, purpura, thrombocytopenia. The incidence of the following adverse events was le;0.1%: asthenia, irregular pulse, extrasystoles, skin discoloration, urticaria, dry skin, dermatitis, alopecia, muscle weakness, twitches, ataxia, hypertonia, migraine, cold and wet skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, cough, rhinitis, dysuria, polyuria, parosmia, taste reversal, visual accommodation disorders, dry eyes. Other occasional reactions such as myocardial infarction and angina pectoris cannot be distinguished as drug effects or disease states. Routine laboratory test items did not change significantly, and no significant changes were found in blood potassium, blood sugar, triglycerides, total cholesterol, high-density lipoprotein (HDL), uric acid, blood urea nitrogen or creatinine. After the drug was launched, there were occasional reports of male breast development in the drug population, but the causal relationship with the drug was unclear; in some cases, jaundice and elevated liver enzymes (often accompanied by cholestasis and hepatitis) were more severe and required hospitalization.

Allergic to dihydropyridine calcium antagonists.

Precautions for children: The safety and effectiveness for children have not been determined. Precautions for pregnancy and lactation: There is a lack of research data on the use of this drug in pregnant women, but according to the results of animal tests, this product can only be used in pregnant women when it is absolutely necessary. It is not yet known whether this product can be secreted through breast milk. Lactating women who take this drug should stop breastfeeding. Precautions for the elderly: Clinical studies have not confirmed that the elderly react to this drug differently from young people, but considering that the elderly often have decreased liver, kidney and heart function, and are accompanied by other diseases and corresponding drug treatments, the lower limit of the dosage range is generally used for initial medication. The clearance rate of this product is reduced in the elderly, and the drug-time curve (AUC) increases by about 40% to 60%, so a lower initial dose is also required.

Cimetidine, grapefruit juice, acidogens: The pharmacokinetics of this product are not changed when used together. Atorvastatin, digoxin, ethanol: This product does not affect their pharmacokinetics. Sildenafil: A single dose of sildenafil (Viagra) in patients with essential hypertension has no effect on the pharmacokinetics of this product. The two drugs produce an independent antihypertensive effect when used together. Warfarin: This product does not change the prothrombin action time of warfarin. Digoxin, phenytoin and warfarin: The combination with this product has no effect on the plasma protein binding rate. Anesthetics: Inhaled hydrocarbons combined with this product can cause hypotension. Nonsteroidal anti-inflammatory drugs: Indomethacin in particular can weaken the antihypertensive effect of this product. -Blockers: The combination with this product is well tolerated, but it can cause excessive hypotension and rarely aggravate heart failure. Estrogen: The combination can cause fluid retention and increase blood pressure. Sulfinpyrazone: The combination can increase the protein binding rate of this product and produce changes in blood drug concentration. Lithium: Co-administration may cause neurotoxicity, nausea, vomiting, diarrhea, ataxia, tremor and/or numbness, so be cautious. Sympathomimetic amines: May weaken the antihypertensive effect of this product. Sublingual nitroglycerin and long-acting nitrate preparations: Co-administration with this product may enhance the anti-anginal effect. Although rebound effects have not been reported, the dosage should be gradually reduced under the guidance of a doctor when the drug is discontinued. Thiazide diuretics, ACEI, digoxin, warfarin, antibiotics and oral hypoglycemic drugs: Can be safely used with this product.

Keep in a light-proof and airtight container.

5mg

24 months.

Anhui Changjiang Pharmaceutical Co., Ltd.

• Founded in:

  2001-12-25

• Address:

  No. 152, Changjiang South Road, High-tech Industrial Development Zone, Wuhu City, Anhui Province (declaration commitment)

• Tax NO.:

  91340200733036887Q

• Registered Funds:

  82.35294118 million yuan

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