|Dosage and administration||
|Warnings and precautions for use||
|Recommendation for pregnancy and breastfeeding||
Ostagi-D3 is indicated for postmenopausal women, contraindicated for pregnant women or breast-feeding women.
|Effects on ability to drive and use machines||
There are no studies on the effects of the drug on the driver and the operator of machines, but caution should be exercised as the rare side effects of unreal hearing, visual disturbances may occur.
|Interactions, incompatibilities of medicine||
|Undesirable effects (ADRs)||
The adverse reactions of the drug are mainly caused by alendronate. These reactions are usually mild, and it is not generally necessary to discontinue Ostagi-D3. The most commonly reported adverse reactions are upper gastrointestinal adverse reactions.
|Overdose and management||
Symptoms of overdose:
Alendronate: Alendronate is a synthetic aminobisphosphonate, an analogue of pyrophosphate, which acts as a specific inhibitor of osteoclastic bone resorption. Unlike pyrophosphates, but like etidronate and pamidronate, alendronate is not hydrolyzed by phosphatase. Preclinical studies have shown that alendronate is localized preferentially to sites of bone resorption where it inhibits osteoclast activity. Alendronate binds to the bone and its terminal half-life in humans is estimated to exceed ten years, however alendronate still has pharmacological activity when binding to the skeleton. Clinical studies have shown that treatment with alendronate can significantly increase bone mass in the spine bone, femoral neck and trochanter.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.
Composition: Each tablet contains:
Alendronic acid . . . . . . . . . . . . . . . . . . . . . . . . 70 mg
(as sodium alendronate trihydrate . . . . . . . . .91.35 mg)
Cholecalciferol . . . . . . . . . . . . . . . . . . . . .. .2,800 IU
(as Cholecalciferol oily solution 1 M.IU/ g . . . . . 2.8 mg)
1 blister of 4 tablets in a carton box.
Ostagi-D3 is indicated for the treatment of osteoporosis in postmenopausal women, the treatment of osteoporosis in men. Ostagi-D3 increases bone mass and prevents fractures, including those of the hip, wrist and spine (vertebral compression fractures) and vitamin D supplementation to the body.
Prevention and treatment of corticosteroid-induced osteoporosis.
Paget’s disease treatment: Paget’s disease where the level of serum alkaline phosphatase is at least twice upper limit of normal, in those who are symptomatic, or who are at risk for future complications of disease.