Finished product reference
Alendronic Acid / Colecalciferol
Tablet · Oral · 70 mg/140 µg
- List code
- 18452
- Pharmacologic class
- Bisphosphonate with vitamin D3
What it is and how it works
Alendronic acid binds to bone hydroxyapatite and inhibits osteoclast-mediated bone resorption, increasing bone mineral density. Colecalciferol (vitamin D3) ensures adequate vitamin D status to support calcium absorption.
Indications
Treatment of postmenopausal osteoporosis in women at risk of vitamin D insufficiency.
Dosage and administration (summary)
One tablet (alendronic acid 70 mg with colecalciferol 2800 or 5600 IU) orally once weekly, taken with a full glass of plain water at least 30 minutes before the first food, drink or other medicine of the day; remain upright for 30 minutes.
Contraindications
Oesophageal abnormalities delaying emptying (stricture, achalasia); inability to stand or sit upright for 30 minutes; hypocalcaemia; hypersensitivity.
Warnings and precautions
Oesophageal irritation and ulceration may occur if instructions are not followed. Osteonecrosis of the jaw and atypical femoral fractures have been reported with long-term use; dental review is advised before treatment. Correct hypocalcaemia before starting; not recommended if creatinine clearance is below 35 mL/minute.
Pregnancy
Not intended for use in pregnancy.
Storage and supply
Store below 25 °C in the original blister, protected from moisture and light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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