Alendronic acid (as alendronate sodium).
Each uncoated tablet contains: Alendronic Acid (as alendronate sodium) 70 mg.
Pharmacology: Pharmacokinetics: Absorption: The oral mean bioavailability of alendronic acid in women was 0.64% for doses ranging from 5 to 70 mg when administered after an overnight fast and two hours before a standardised breakfast. Bioavailability was decreased similarly to an estimated 0.46% and 0.39% when alendronate was administered one hour or half an hour before a standardised breakfast. In osteoporosis studies, alendronate was effective when administered at least 30 minutes before the first food or beverage of the day.
Distribution: Alendronic acid transiently distributes to soft tissues but is then rapidly redistributed to bone or excreted in the urine.
Biotransformation: There is no evidence that alendronate is metabolised in humans.
Elimination: Alendronic acid, approximately 50% was excreted in the urine within 72 hours and recovered in the faeces.
Treatment of postmenopausal osteoporosis and osteoporosis in men.
The Recommended Dosage: one 70 mg tablet once weekly.
Or as prescribed by the physician.
Hypersensitivity to alendronate or to any of the excipients.
Alendronic Acid can cause local irritation of the upper gastro-intestinal mucosa. Because there is a potential for worsening of the underlying disease, caution should be used when alendronate is given to patients with active upper gastro-intestinal problems, such as dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or with a recent history (within the previous year) of major gastro-intestinal disease such as peptic ulcer, or active gastro-intestinal bleeding, or surgery of the upper gastrointestinal tract other than pyloroplasty. In patients with known Barrett's oesophagus, prescribers should consider the benefits and potential risks of alendronate on an individual patient basis.
Use in Pregnancy: Alendronic Acid should not be used during pregnancy.
Use in Lactation: It is not known whether alendronic acid is excreted into human breast milk. Alendronic Acid should not be used by breast-feeding women.
Use in Pregnancy: Alendronic Acid should not be used during pregnancy.
Use in Lactation: It is not known whether alendronic acid is excreted into human breast milk. Alendronic Acid should not be used by breast-feeding women.
Hypersensitivity reactions including urticaria and angioedema, headache, abdominal pain, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, abdominal distension, acid regurgitation.
If taken at the same time, it is likely that food and beverages (including mineral water), calcium supplements, antacids, and some oral medicinal products will interfere with absorption of alendronic acid. Therefore, patients must wait at least 30 minutes after taking alendronate before taking any other oral medicinal product. No other interactions with medicinal products of clinical significance are anticipated. A number of patients in the clinical trials received oestrogen (intravaginal, transdermal, or oral) while taking alendronic acid. No adverse experiences attributable to their concomitant use were identified.
Since NSAID use is associated with gastrointestinal irritation, caution should be used during concomitant use with alendronate.
Store at temperatures not exceeding 30°C.
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
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