Product Overview
[Trade Name]
Tianzhen
[Generic Name]
Amlodipine Besylate Dispersible Tablets
[English Name]
Amlodipine Besylate Dispersible Tablets
[Main Ingredients]
Amlodipine Besylate
[Properties and Dosage Form]
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.
[Specifications]
5mg*14 tablets
[Usage and Dosage]
Oral or swallow after dispersing in water. 1. Treatment of hypertension: The initial dose is 5mg, once a day, and the maximum dose is 10mg, once a day. The initial dose for weak or elderly patients and patients with liver dysfunction is 2.5mg, once a day: This dose can also be the dose for the treatment of other antihypertensive drugs. Dose adjustments should be made based on individual patient response. Generally, dose adjustments should be initiated after 7-14 days. If clinically necessary, dose adjustments may be initiated sooner under close patient monitoring. 2. Treatment of angina pectoris: The initial dose is 5-10 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.
[Contraindications]
This product is contraindicated in patients with allergies to dihydropyridines or any of its ingredients.
[Precautions]
1. Maintain a light diet. 2. Avoid taking tonic Chinese patent medicines while taking this product. 3. Patients with severe chronic conditions such as hypertension, heart disease, liver disease, diabetes, and kidney disease, pregnant women, or those receiving other medical treatments should use this product under the guidance of a physician. 4. If symptoms do not improve after three days of treatment, or if significant vomiting and diarrhea occur, along with other serious symptoms, seek medical attention. 5. Follow the directions and dosage for use. Children and the elderly and frail should use this product under the guidance of a physician. 6. Consult a physician for long-term use. 7. Contraindicated if allergic to this product; use with caution if allergic. 8. Do not use if this product changes properties. 9. Children must be supervised during use. 10. Keep this product out of reach of children. 11. If you are taking other medications, consult a physician or pharmacist before using this product.
[Use in Pregnant and Breastfeeding Women]
There is a lack of research data on its use in pregnant women. However, based on animal studies, this product should only be used in pregnant women when absolutely necessary. It is unknown whether this product is excreted in breast milk; breastfeeding women taking this product should discontinue breastfeeding.
[Pediatric Use]
No data are available for the use of this product in pediatric patients.
[Pharmacokinetics]
This product is well absorbed orally and is not affected by food. Peak plasma concentrations are reached 6-12 hours after administration, with an absolute bioavailability of approximately 64-80% and an apparent volume of distribution of approximately 21 L/kg. In vitro studies indicate that 97.5% of amlodipine circulating in the blood is bound to plasma proteins. This drug has a terminal elimination half-life of approximately 35-50 hours. Steady-state plasma concentrations are achieved after 7-8 days of once-daily dosing. This drug is extensively metabolized in the liver to inactive metabolites, with 10% parent drug and 60% metabolites excreted in the urine.
Storage: Store in a sealed, light-proof container.
Packaging: 5mg x 14 tablets/box.
Expiry Period: 24 months.
Approval Number: National Medicine Standard H20080733
Manufacturer: Ningbo Tianzhen Pharmaceutical Co., Ltd.
