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Amlodipine Besylate Tablets

Drug Name:
Amlodipine besylate tablets
Product Category:
tablet
common name:
Amlodipine besylate tablets
English name:
Amlodipine Besylate Tablets
Chinese Pinyin:
Benhuangsuan Anlüdiping Pian
Ingredients:
The main ingredient of this product is amlodipine besylate, its chemical name is: 3-ethyl-5-methyl-2-(2-aminoethoxymethyl)-4-(2-chlorophenyl)-1 , 4-Dihydro-6-methyl-3, 5-pyridinedicarboxylate benzenesulfonate.
Structural formula:
Molecular formula:
20 H 25 N 2 O 5 Cl, C 6 H 6 O 3 S
Molecular weight:
567.1
Traits:
This product is white or almost white film.
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) and
chronic stable angina pectoris
This product is suitable for the symptomatic treatment of chronic stable angina pectoris. It can be used alone or in combination with other anti-angina drugs.
Vasospasm angina (Prinzmetal's or variant angina)
This product is suitable for the treatment of confirmed or suspected vasospasm angina. It can be used alone or in combination with other anti-angina drugs.
Coronary heart disease confirmed
by angiography is confirmed to be coronary heart disease by angiography, but for patients with ejection fraction ≥40% and no heart failure, this product can reduce the risk of hospitalization for angina pectoris and the risk of coronary artery reconstruction.
specification:
5mg
Dosage:

Adults: Usually, the initial dose of this product for the treatment of hypertension is 5 mg once a day, and the maximum dose is 10 mg once a day. For patients who are small, weak, elderly, or with liver insufficiency, the starting dose is 2.5 mg once a day; this dose can also be used in combination with other antihypertensive drugs.
Dose adjustment should be based on the individual response of the patient. The general dose adjustment should start after 7-14 days. If clinically required, the dosage can be adjusted more quickly when the patient is closely monitored.
The recommended dose for the treatment of chronic stable or vasospasm angina pectoris is 5-10 mg once a day. Older patients and patients with liver insufficiency are recommended to use lower dose treatment. The effective dose for most patients is 10 mg once a day.
The recommended dose for the treatment of coronary heart disease is 5-10 mg once a day. In clinical studies, most patients need a dose of 10mg/day (see [Clinical Trials]).
Combined with other antihypertensive drugs and/or antiangina drugs: Amlodipine is safe to use in combination with thiazide diuretics, ACEIs, β-blockers, long-acting nitrates and/or sublingual nitroglycerin .

Adverse reactions:

The safety of this product has been confirmed in clinical studies in the United States and other foreign countries, involving more than 11,000 patients. In general, patients have a good tolerance for the daily dose of this product up to 10mg. The adverse reactions reported during the treatment of this product were mostly mild to moderate. In a clinical study of 10 mg of this product (N=1730) directly compared with placebo (N=1250), only 1.5% of the amlodipine group discontinued due to adverse reactions, which was not significant compared to the placebo group (about 1%) The difference in sex. The most common side effects are headache and edema. The incidence of dose-related side effects (%) is as follows:

Adverse events

2.5 mg N=275

5.0 mg N=296

10.0 mg N=268

Placebo N=520

Edema

1.8

3.0

10.8

0.6

dizziness

0.7

 3.4

 3.4

1.5

Flushing

0.7

 1.4

 2.6

0.0

Palpitations

0.7

 1.4

 4.5

0.6

The correlation between other adverse reactions and dose is uncertain, but the incidence of more than 1% in
placebo-controlled studies includes: placebo-controlled studies:


Amlodipine (%) (N=1730)

Placebo (%) (N=1250)

headache

7.3

 7.8

fatigue

4.5

 2.8

nausea

2.9

 1.9

stomach ache

1.6

 0.3

Lethargy

1.4

 0.6

Some adverse reactions that have been shown to be related to drugs and doses and occur more frequently in women than men are shown below:

Next: End

Amlodipine


Placebo


Adverse events

Male% (N=1218)

Female% (N=512)

Male% (N=914)

Female% (N=336)

Edema

5.6

 14.6

1.4

 5.1

Flushing

1.5

 4.5

0.3

 0.9

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