Product Overview
[Drug name]
Generic name: Amlodipine besylate tablets
Trade name: PuZuo BenHuangSuanAnLvDiPingPian 5mg*14 tablets
Pinyin full code: PuZuo BenHuangSuanAnLvDiPingPian 5mg*14Pian
[Main ingredient]
Amlodipine besylate.
[Properties]
This product is a white tablet.
[Indications/Main functions]
Amlodipine besylate tablets 1. Suitable for the treatment of hypertension. It can be used alone or in combination with other antihypertensive drugs. 2. Coronary heart disease (CAD) chronic stable angina This product is suitable for the symptomatic treatment of chronic stable angina. It can be used alone or in combination with other anti-anginal drugs. Vasospastic angina (Prinzmeta's or variant angina) This product is suitable for the treatment of confirmed or suspected vasospastic angina. It can be used alone or in combination with other anti-anginal drugs. For patients with coronary heart disease confirmed by angiography, but with an ejection fraction ≥ 40% and no heart failure, amlodipine besylate tablets can reduce the risk of hospitalization for angina pectoris and the risk of coronary artery reconstruction.
[Specification]
5mg*14 tablets
[Usage and Dosage]
Adults: The starting dose of this product for the treatment of hypertension is usually 5mg, once a day, and the maximum dose is 10mg, once a day. For patients with small stature, weakness, elderly, or liver dysfunction, the starting dose is 2.5mg, once a day; this dose can also be the dose of this product combined with other antihypertensive drugs. Dose adjustment should be based on individual patient response. General dose adjustment should be started after 7-14 days. If clinically necessary, dose adjustment can be made more quickly under close monitoring of the patient. The recommended dose for the treatment of chronic stable or vasospastic angina is 5-10mg, once a day. A lower dose is recommended for elderly and liver dysfunction patients. The effective dose for most patients is 10mg, once a day. The recommended dose for the treatment of coronary heart disease is 5-10 mg, once a day.
[Adverse Reactions]
Cardiovascular system: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, hypotension, peripheral ischemia, syncope, tachycardia, postural dizziness, postural hypotension, vasculitis. Central and peripheral nervous systems: hypoesthesia, peripheral neuropathy, paresthesia, tremor, dizziness. Gastrointestinal system: anorexia, constipation, dyspepsia, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. Systemic: allergic reaction, fatigue**, back pain, hot flashes, general malaise, pain, stiffness, weight gain, weight loss. Musculoskeletal system: arthralgia, arthritis, muscle cramps**, myalgia. Psychiatry: sexual dysfunction, insomnia, nervousness, depression, abnormal dreams, anxiety, personality disorder. Respiratory system: dyspnea, epistaxis. Skin and appendages; angioedema, erythema multiforme, pruritus, rash, erythematous rash, maculopapular rash. In placebo-controlled studies, the incidence of these events was less than 1%, but in all multiple-dose studies, the incidence of these adverse reactions was between 1% and 2%. Paresthesia: visual abnormalities, conjunctivitis, diplopia, eye pain, tinnitus. Urinary system: frequent urination, urination disorder, nocturia. Autonomic nervous system: dry mouth, sweating. Nutritional metabolism: hyperglycemia, thirst. Hematopoietic system: leukopenia, purpura, thrombocytopenia.
[Contraindications]
Contraindicated in patients allergic to dihydropyridine calcium antagonists.
[Drug interactions]
1. In vitro data In vitro study data show that amlodipine besylate tablets do not affect the binding of digoxin, phenytoin sodium, warfarin or indomethacin to plasma proteins. 2. The combined use of cimetidine and cimetidine does not change the pharmacokinetics of amlodipine. 3. Grapefruit juice 20 healthy volunteers took 240ml grapefruit juice and a single dose of 10mg amlodipine at the same time, and no significant effect was found on the pharmacokinetics of amlodipine. 4. Magnesium-aluminum hydroxide antacids Taking magnesium-aluminum hydroxide antacids and a single dose of amlodipine besylate at the same time did not have a significant effect on the pharmacokinetics of amlodipine. 5. Sildenafil A single dose of 100mg sildenafil does not affect the pharmacokinetic parameters of amlodipine in patients with essential hypertension. When the two drugs are used together, each drug can independently exert its antihypertensive effect. 6. Atorvastatin 10mg amlodipine besylate tablets were given multiple times and combined with 80mg atorvastatin, and the steady-state pharmacokinetic parameters of atorvastatin did not change significantly. 7. Simvastatin 10mg amlodipine was given multiple times and combined with 80mg simvastatin, and the exposure of simvastatin increased by 77% compared with simvastatin alone. Patients taking amlodipine should limit the dose of simvastatin to less than 20 mg/day. 8. Digoxin Co-administration of this product with digoxin does not change the plasma digoxin level or renal digoxin clearance rate of normal volunteers. 9. Single or multiple administrations of 10 mg of ethanol (alcohol) of this product have no significant effect on the pharmacokinetics of ethanol. 10. Warfarin Co-administration of this product with warfarin does not change the prothrombin reaction time of warfarin. 11. CYP3A4 inhibitors In elderly hypertensive patients, the daily dose of 180 mg of diltiazem and 5 mg of this product increased the systemic exposure of amlodipine by 60%. Co-administration of this product with erythromycin in healthy volunteers did not significantly affect the systemic exposure of amlodipine. However, strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir) may increase the plasma concentration of amlodipine more than diltiazem. Symptoms of hypotension and edema should be monitored when amlodipine is taken with CYP3A4 inhibitors. 12.CYP3A4 inducers There is currently no data on the effects of CYP3A4 inducers on amlodipine. Blood pressure levels should be closely monitored when amlodipine is taken with CYP3A4 inducers. 13. Interactions with drugs/laboratory tests are unclear.
[Precautions]
1. Hypotension Symptomatic hypotension may occur, especially in patients with severe aortic stenosis. Because the vasodilator effect of amlodipine besylate tablets is gradually produced, there are rare reports of acute hypotension after taking this product. 2. Aggravation of angina pectoris or myocardial infarction A very small number of patients, especially those with severe coronary artery obstructive disease, may experience worsening angina pectoris or acute myocardial infarction when starting treatment with amlodipine besylate or increasing the dose. 3. Discontinuation of beta-blockers Sudden discontinuation of beta-blockers may be dangerous. Since amlodipine is not a beta-blocker, it cannot provide effective protection against the dangers caused by discontinuation of beta-blockers; any beta-blocker should be discontinued gradually. 4. Use in patients with impaired liver function: Amlodipine besylate tablets are extensively metabolized by the liver, and the plasma elimination half-life (t1/2) in patients with impaired liver function is 56 hours. Therefore, this product should be slowly increased in doses when used in patients with severe impaired liver function.
