Characteristics:
This product is white piece.
Indications:
1. Hypertension
This product is 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 symptomatic treatment of chronic stable angina pectoris. It can be used alone or in combination with other antiangina drugs.
Vasospastic angina (Prinzmetal's or variant angina)
This product is indicated for the treatment of confirmed or suspected angina spasmodic angina. It can be used alone or in combination with other anti-angina drugs.
Coronary heart disease confirmed by angiography
In patients with angiographically confirmed coronary heart disease but with ejection fraction ≥40% and without heart failure, this product reduces the risk of hospitalization for angina and coronary artery reconstruction.
Usage And Dosage:
Adults: the usual starting dose for hypertension is 5mg once daily and the maximum dose is 10mg once daily. For small, frail, elderly, or patients with liver insufficiency, the initial dose should be 2.5mg once daily; This dose can also be used in combination with other antihypertensive drugs.
Dose adjustment should be carried out according to individual patient response. General dose adjustment should be initiated after 7-14 days. If clinically necessary, dose adjustment can be made more quickly under close monitoring of the patient.
The recommended dose for chronic stable or vasospastic angina is 5 to 10mg once daily. The lower dose is recommended for the elderly and patients with liver insufficiency. The effective dose for most patients is 10mg once daily.
The recommended dose for coronary heart disease is 5-10mg once daily. In clinical studies, most patients require a dose of 10mg/ day
Interactions:
1. In vitro data
Data from in vitro studies show that this product does not affect the binding of digoxin, phenytoin, warfarin or indomethacin to plasma proteins.
2. Cimetidine
Combination with cimetidine did not change the pharmacokinetics of amlodipine.
3.Grapefruit juice
No significant effect on the pharmacokinetics of amlodipine was observed in 20 healthy volunteers who received 240ml grapefruit juice and a single dose of 10mg amlodipine.
4. Magnesium aluminum hydroxide antacid
There was no significant effect on the pharmacokinetics of amlodipine after the administration of magnesium aluminum hydroxide antacid and single dose of amlodipine besylate.
5.atorvastatin
The steady-state pharmacokinetic parameters of atorvastatin did not change significantly after multiple administration of 10mg of this product combined with 80mg of atorvastatin.
6.simvastatin
Multiple doses of 10mg amlodipine combined with 80mg simvastatin increased simvastatin exposure by 77% compared with simvastatin alone. Patients taking amlodipine should limit their simvastatin dose to less than 20mg/ day.
7. Digoxin
The combination of this product and digoxin did not alter plasma digoxin levels or renal digoxin clearance in normal volunteers.
8. Ethanol
Single or multiple doses of 10mg had no significant effect on the pharmacokinetics of ethanol.
9. Warfarin
Concomitant use of this product with warfarin does not change the prothrombin reaction time of warfarin.
10. CYP3A4 inhibitor
In elderly hypertensive patients, 180mg diltiazem combined with 5mg of diltiazem resulted in a 60% increase in systemic exposure to amlodipine. Concomitant administration with erythromycin did not significantly affect systemic exposure to amlodipine in healthy volunteers. However, CYP3A4 suppressor agents (e.g. Ketoconazole, itraconazole, ritonavir) may increase amlodipine plasma concentration more than diltiazem. Hypotension and edema symptoms should be monitored when amlodipine is taken with CYP3A4 inhibitor.
11. CYP3A4 inducer
There are no relevant data on the effect of CYP3A4 inducer on amlodipine. Blood pressure should be closely monitored when amlodipine is taken with CYP3A4 inducer.
12. Interactions with medications/laboratory tests
Storage:
Shading, sealed storage.
Production:
Inspection:
Loading:
Certificates:
Audited Supplier 
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