Product Overview
Generic name: Alendronate Sodium Tablets
English name: Alendronate Sodium Tablets
Chinese Pinyin: Alunlinsuanna Pian
[Ingredients] The main ingredient of this product is alendronate sodium.
[Properties] This product is white or almost white tablets.
[Indications] It is suitable for the treatment of osteoporosis in postmenopausal women to prevent hip and spine fractures (vertebral compression fractures).
It is suitable for the treatment of male osteoporosis to increase bone mass.
[Specifications] 70mg (as alendronate)
[Usage and Dosage] This product must be taken with white water at least half an hour before the first meal, drink or other drug treatment every day, because other drinks (including mineral water), food and some drugs may reduce the cost The absorption of the product (see [Drug Interactions]).
In order to deliver the medicine to the stomach as soon as possible and reduce the irritation to the esophagus, this product should be taken in the morning with a full glass of white water, and the patient should avoid lying down within at least 30 minutes after taking the medicine and before the first meal of the day . This product should not be taken at bedtime and before getting up early in the morning. Otherwise it will increase the risk of adverse esophageal reactions (see [Precautions]).
If the food intake is insufficient, all osteoporosis patients should be supplemented with calcium and vitamin D (see [Precautions]).
Elderly patients or patients with mild to moderate renal insufficiency (creatinine clearance 35-60ml/min) do not need to adjust the dose. Due to lack of relevant medication experience, this product is not recommended for patients with more severe renal insufficiency (creatinine clearance <35ml/min).
Treatment of osteoporosis in postmenopausal women:
The recommended dose is: once a week, 1 tablet 70mg once a time
Treatment of male osteoporosis to increase bone mass:
The recommended dose is 70 mg once a week.
[Adverse reactions] See the instructions for details.
【Taboo】
Esophageal abnormalities that cause delayed emptying of the esophagus, such as stenosis or slack.
Cannot stand or sit upright for at least 30 minutes.
Those who are allergic to any ingredient of this product.
Hypocalcemia (see [Precautions]).
【Notes】Refer to the manual for details.
[Medicine for pregnant and lactating women]
It has not been studied in pregnant women and should not be used by pregnant women.
It has not been studied in breastfeeding women and should not be used in such patients.
【Children's Medication】It has not been studied in children and should not be used by children.
[Geriatric medication] In clinical studies, no age-related differences in efficacy and safety of this product have been found, or follow the doctor's advice.
[Drug interactions] If calcium supplements, antacid drugs and other oral drugs are taken at the same time, it may interfere with the absorption of the product. Therefore, after taking this product, the patient must wait at least half an hour before taking other drugs.
No other clinically significant drug interactions are expected.
Two one- or two-year clinical studies evaluated the simultaneous use of hormone replacement therapy (estrogen ± progesterone) (intravenous transdermal or oral administration) and the product in postmenopausal women with osteoporosis. Compared with the single application, the combined application of hormone replacement therapy and the product can increase bone mass and reduce bone turnover more. In these studies, the combination therapy and single therapy are consistent in terms of safety and tolerability.
Specific interaction studies have not been conducted yet. In the treatment of osteoporosis in men and postmenopausal women, this product has been used simultaneously with various commonly used prescription drugs, and there is no clear clinical adverse interaction.
[Drug overdose] There is no data on overdose of this product. Overdose of oral medications may cause hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events such as stomach upset, heartburn, esophagitis, gastritis, or ulcers. Milk or antacids should be given to combine alendronate. Due to the danger of esophageal irritation, vomiting should not be induced and the patient should remain upright.
【Pharmacology and Toxicology】See the instructions for details.
[Pharmacokinetics] See the instructions for details.
【Storage】Keep tightly closed and in a dry place.
[Packing] Aluminum-plastic packaging. 4 pieces per board, 1 board per box.
【Validity】24 months
[Approval number] National Medicine Standard H20059029
【Manufacturer】Beijing Fuyuan Pharmaceutical Co., Ltd.
