Product Overview
[Drug Name]
Generic Name: Amlodipine Besylate Tablets
Trade Name: Yabang Beidi
English Name: Amlodipine Besylate Tablets
Chinese Pinyin: Benhuangsuan Anlüdiping Pian
[Ingredients]
3-Ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1,4-dihydro-6-methyl-3,5-pyridinedicarboxylate benzenesulfonate
[Properties]
This product is white or off-white tablets.
[Indications]
1. Hypertension. This product can be used alone or in combination with other antihypertensive drugs. 2. Chronic stable angina and variant angina. This product can be used alone or in combination with other antianginal drugs.
[Dosage and Administration]
1. The initial dose for the treatment of hypertension is 5 mg once daily, and the maximum dose is 10 mg once daily. The initial dose for frail or elderly patients, or those with hepatic impairment, is 2.5 mg once daily; this dose may also be the dose that is added to other antihypertensive medications.Dose adjustments should be made based on individual patient response. Generally, dose adjustments should be initiated after 7 to 14 days. If clinically necessary, dose adjustments may be initiated sooner, with close observation of the patient.
2. The initial dose for the treatment of angina pectoris is 5 to 10 mg once daily. Lower doses are recommended for elderly patients and those with hepatic impairment; the effective dose for most patients is 10 mg/day.
[Adverse Reactions]
This product is well tolerated within the 10 mg/day dose range, with most adverse reactions being mild to moderate. Discontinuation rates due to adverse reactions were only 1.5%, not significantly different from placebo (approximately 1%). The most common adverse reactions were headache and edema. Dose-related adverse reactions occurring in >1% of patients were as follows: edema, dizziness, flushing, and palpitations. Adverse reactions with an incidence greater than 1.0% but with an unclear dose relationship are as follows: headache, fatigue, nausea, abdominal pain, and somnolence. Among these adverse reactions, edema, flushing, palpitations, and somnolence are more common in women than in men. The following adverse events have an incidence of less than 1% but > 0.1%, and a causal relationship to the drug is 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, orthostatic hypotension, and vasculitis; Central and Peripheral Nervous System: hypoesthesia, peripheral neuropathy, paresthesia, tremor, and vertigo; Gastrointestinal: anorexia, constipation, dyspepsia, dysphagia, diarrhea, flatulence, pancreatitis, and 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, pruritus, 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 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 disturbances, visual accommodation disturbances, and xerophthalmia. Other rare reactions, such as myocardial infarction and angina, cannot be distinguished as drug effects or disease states. 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. In some cases, jaundice and elevated liver enzymes (often associated with cholestasis and hepatitis) have been severe, requiring hospitalization.
[Contraindications]
This product is contraindicated in patients who are allergic to dihydropyridines or any of its ingredients.
[Precautions]
1. Warning: A very small number of patients, especially those with severe coronary artery obstructive disease, may experience increased frequency, prolonged duration, and/or worsening of angina pectoris, or acute myocardial infarction, when starting calcium channel blocker therapy or increasing the dose. The mechanism of action is currently unknown. 2. Because amlodipine's vasodilatory effect develops gradually, there have been rare reports of acute hypotension following administration of amlodipine. However, caution should be exercised when used in combination with other peripheral vasodilators in patients with severe aortic stenosis. 3. Use in Patients with Heart Failure: Calcium channel blockers 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 the incidence of worsening heart failure was not significantly different from placebo, there was an increase in reports of pulmonary edema associated with amlodipine. 4. Use in Patients with Impaired Hepatic Function: As with all other calcium channel blockers, the half-life of amlodipine is prolonged in patients with impaired hepatic function, but a recommended dose has not yet been established. Therefore, caution should be exercised when using this drug. 5. Use in Patients with Renal Failure: Changes in amlodipine plasma concentrations are not correlated with the degree of renal impairment; therefore, a normal dose can be used. This drug cannot be dialyzed. Please read the package insert carefully and use as directed by your doctor.
[Use in Special Populations]
Precautions for Children:
Safety and efficacy in children have not been established.
Precautions for Pregnancy and Lactation:
There is a lack of research data on the use of this drug in pregnant women, but based on animal studies, this drug should only be used in pregnant women when absolutely necessary. It is not known whether this drug is excreted in breast milk; lactating women taking this drug should discontinue breastfeeding.
Precautions for the Elderly:
Clinical studies have not demonstrated that elderly individuals respond differently to this drug than younger individuals. However, given that elderly individuals often have impaired liver, kidney, and heart function, as well as other medical conditions and medications, the lower end of the initial dose range is generally used. Elderly individuals have decreased clearance of this drug, with an approximately 40% to 60% increase in the area under the curve (AUC), necessitating a lower initial dose.
[Drug Interactions]
Cimetidine, grapefruit juice, and acidogens: Coadministration does not alter the pharmacokinetics of this drug. Atorvastatin, digoxin, and ethanol: This drug does not affect their pharmacokinetics. Sildenafil: A single dose of sildenafil (Viagra) has no effect on the pharmacokinetics of this drug in patients with essential hypertension. The two drugs produce an independent antihypertensive effect when coadministered. Warfarin: This drug does not alter the prothrombin action time of warfarin. Digoxin, phenytoin, and warfarin: Coadministration with this drug has no effect on plasma protein binding. Anesthetics: Concomitant use of inhaled hydrocarbons with this drug may cause hypotension. Nonsteroidal anti-inflammatory drugs: Indomethacin, in particular, may attenuate the antihypertensive effect of this drug. Beta-blockers: Coadministration with this drug is well tolerated but may cause excessive hypotension and, rarely, worsen heart failure. Estrogen: Concomitant use may cause fluid retention and increase blood pressure. Sulfinpyrazone: Concomitant use may increase the protein binding rate of this drug, resulting in changes in blood drug concentrations. Lithium: Concomitant use may cause neurotoxicity, resulting in nausea, vomiting, diarrhea, ataxia, tremor, and/or numbness; caution is advised. Sympathomimetic amines: May weaken the antihypertensive effect of this drug. Sublingual nitroglycerin and long-acting nitrate preparations: Concomitant use with this drug may enhance the antianginal effect. Although rebound effects have not been reported, the dose should be gradually reduced under the guidance of a physician when discontinuing this drug. Thiazide diuretics, ACE inhibitors, digoxin, warfarin, antibiotics, and oral hypoglycemic agents: These can be safely used with this drug.
[Pharmacological Actions]
Amlodipine is a calcium blocker (also known as a slow-channel blocker or calcium antagonist) that blocks the transmembrane entry of calcium ions into myocardial and vascular smooth muscle cells.
[Storage] Store in a cool, dark place (not exceeding 20°C), sealed.
[Specification] 5mg x 14 tablets
[Packaging] Box
[Expiry Date] 24 months
[Approval Number] National Medicine Standard H20040818
[Manufacturer] Jiangsu Yabang Epson Pharmaceutical Co., Ltd.
