Product Overview
[Drug Name]
Generic Name: Amlodipine Besylate Tablets
Trade Name: Jinbao Amlodipine Besylate Tablets 5mg*30 Tablets
Pinyin Full Code: JinBao BenHuangSuanAnLvDiPingPian 5mg*30 Tablets
[Main Ingredient]
Amlodipine Besylate
[Indications/Main Functions]
Hypertension: This product is indicated for the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs. Coronary Artery Disease (CAD): This product is indicated for the symptomatic treatment of chronic stable angina. It can be used alone or in combination with other antianginal drugs. Vasospastic angina (Prinzmetal's or variant angina): This product is indicated for the treatment of confirmed or suspected vasospastic angina. It can be used alone or in combination with other antianginal drugs. This drug can reduce the risk of hospitalization for angina and coronary revascularization in patients with angiographically confirmed coronary artery disease (CAD), or an ejection fraction ≥40% and without heart failure.
[Specifications]
5mg*30 tablets
[Dosage and Administration]
The usual starting oral dose is 5mg once daily, with a maximum of 10mg once daily. Patients of small stature, frail constitution, elderly patients, or those with impaired liver function should begin with 2.5mg once daily; patients taking other antihypertensive medications should also begin with this dose. The dose should be adjusted based on individual needs, with a minimum adjustment period of 7-14 days to allow the physician to fully assess the patient's response. However, faster adjustment may be possible if clinically warranted. The recommended dose for the treatment of angina is 5-10mg; elderly patients or those with impaired liver function may require a reduced dose.
[Adverse Reactions]
1. This drug is well tolerated within the 10mg/day dose range, with most adverse reactions being mild to moderate. Only 1.5% of patients discontinued this product due to adverse reactions, which was not significantly different from placebo (approximately 1%). The most common adverse reactions were headache and edema. 2. Dose-related adverse reactions with an incidence rate >1% were as follows: edema, dizziness, flushing, and palpitations. Adverse reactions with unclear dose relationships but an incidence rate of more than 1.0% were as follows: headache, fatigue, nausea, abdominal pain, and drowsiness. Among the above adverse reactions, edema, flushing, palpitations, and drowsiness occurred more frequently in women than in men. 3. The following adverse events had an incidence rate ≤1% but >0.1%, and the causal relationship with the drug was unclear. (1) General: allergic reactions, weakness, back pain, hot flashes, discomfort, pain, stiffness, and weight gain. (2) Cardiovascular: arrhythmias (including tachycardia, bradycardia, or atrial fibrillation), chest pain, hypotension, peripheral ischemia, syncope, postural dizziness, postural hypotension, and vasculitis. (3) Central and peripheral nervous systems: hypoesthesia, peripheral neuropathy, paresthesia, tremor, vertigo. (4) Gastrointestinal: anorexia, constipation, dyspepsia, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. (5) Musculoskeletal system: arthralgia, arthritis, muscle cramps, myalgia. (6) Psychiatric: sexual dysfunction, insomnia, tension, depression, nightmares, anxiety, depersonalization. (7) Skin and appendages: angioedema, erythema, pruritus, rash, maculopapular rash. (8) Special senses: visual disturbances, conjunctivitis, diplopia, eye pain, tinnitus. (9) Urinary system: frequent urination, dysuria, nocturia. (10) Autonomic nervous system: dry mouth, night sweats. (11) Metabolism and nutrition: hyperglycemia, thirst. (12) Hematopoietic system: leukopenia, purpura, thrombocytopenia. 4. The incidence of the following adverse events is ≤ 0.1%: heart failure, irregular pulse, extrasystoles, skin discoloration, urticaria, dry skin, dermatitis, alopecia, muscle weakness, twitching, ataxia, hypertonia, migraine, cold and clammy skin, apathy, agitation, amnesia, gastritis, increased appetite, loose stools, cough, rhinitis, dysuria, polyuria, parosmia, taste perversion, visual accommodation disturbances, and xerophthalmia. 5. Other occasional reactions, such as myocardial infarction and angina, cannot be distinguished as drug effects or disease states. 6. Routine laboratory tests were unremarkable, with no significant changes in serum potassium, blood glucose, triglycerides, total cholesterol, high-density lipoprotein (HDL), uric acid, blood urea nitrogen, or creatinine. Post-marketing, there have been occasional reports of gynecomastia in patients taking the drug, but a causal relationship to the drug is unclear. Jaundice and elevated liver enzymes (often associated with cholestasis and hepatitis) have been severe in some cases, requiring hospitalization.
