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Alendronate Sodium Tablets

Function and Efficacy

This product is a bone metabolism regulator, an aminobisphosphonate, which has a strong affinity with hydroxyapatite in the bone. It can enter the hydroxyapatite crystals in the bone matrix. When osteoclasts dissolve the crystals, the drug is released, which can inhibit the activity of osteoclasts and indirectly inhibit bone resorption through osteoblasts. It is characterized by strong anti-bone resorption activity and no bone mineralization inhibition.

Ingredients

The main ingredients of this product are: Alendronate sodium Chemical name: (4-amino-1-hydroxybutylene) diphosphonic acid monosodium salt trihydrate.

Name Description Content CAS NO. Manufacturer
Alendronate sodiumIngredients

This product is a bone metabolism regulator, an aminobisphosphonate, which has a strong affinity with hydroxyapatite in the bone. It can enter the hydroxyapatite crystals in the bone matrix. When osteoclasts dissolve the crystals, the drug is released, which can inhibit the activity of osteoclasts and indirectly inhibit bone resorption through osteoblasts. It is characterized by strong anti-bone resorption activity and no bone mineralization inhibition.

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121268-17-5 38

Appearance

This product is white or off-white tablets.

Indication

1. For the treatment of osteoporosis in postmenopausal women. 2. For the prevention of hip and spinal fractures (vertebral compression fractures).

Usage and Dosage

This product must be taken with plain water at least half an hour before the first meal, drink or other medication of the day, because other beverages (including mineral water), food and some medicines may reduce the absorption of this product (see [Drug Interactions]). In order to deliver the drug to the stomach as quickly as possible and reduce irritation to the esophagus, this product should be taken with a full glass of plain water in the early morning, and the patient should avoid lying down for at least 30 minutes after taking the medicine and before the first meal of the day. This product should not be taken at bedtime or before getting up in the morning, otherwise it will increase the risk of esophageal adverse reactions (see [Precautions]). If the intake from food is insufficient, all osteoporosis patients should supplement calcium and vitamin D (see [Precautions]). Elderly patients or those with mild to

Adverse Reactions

The drug is well tolerated after taking it. A small number of patients may experience gastrointestinal reactions, such as nausea, abdominal distension, abdominal pain, etc., occasionally headache, skeletal muscle spasm, etc., and rarely rash or erythema.

Precautions

*Esophageal abnormalities that delay esophageal emptying, such as stenosis or atonia *Inability to stand or sit upright for at least 30 minutes *Allergy to any component of this product *Hypocalcemia (see [Precautions])

Special Population Medication

Precautions for children: This product has not been studied in children and should not be used by children. Precautions for pregnancy and lactation: This product has not been studied in pregnant women and should not be used by pregnant women. This product has not been studied in breastfeeding women and should not be used by such patients. Precautions for the elderly: In clinical studies, no age-related differences in treatment and safety were found for this product, or follow the doctor's advice.

Drug Interactions

If calcium supplements, antacids and other oral medications are taken at the same time, the absorption of this product may be interfered with. Therefore, patients must wait at least half an hour after taking this product 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 plus mn; progesterone) (intravenous and transdermal administration or oral administration) and this product in postmenopausal women with osteoporosis. Compared with single application, the combined use of hormone replacement therapy and this product can increase bone mass more and reduce bone turnover more. In these studies, combined treatment and single treatment are consistent in safety and tolerability. Specific interaction studies have not yet been conducted.

Storage

Store in a sealed container. Valid for 24 months.

Packaging Specification

10mg (calculated as alendronic acid)

Validity Period

24 months

Manufacturer

Beijing Foyou Pharma Co., Ltd.

  • Founded in:

    1999-02-03
  • Address:

    No. 8 Guangyuan East Street, Tongzhou Industrial Development Zone, Tongzhou District, Beijing
  • Tax NO.:

    91110112700216160K
  • Registered Funds:

    480 million yuan
  • Website:

  • Email:

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