Alendronate Sandoz

Alendronate Sandoz

alendronic acid

Manufacturer:

Sandoz

Distributor:

Zuellig
/
Four Star
Concise Prescribing Info
Contents
Alendronic acid
Indications/Uses
Postmenopausal osteoporosis. Reduces on the risk of vertebral & hip fractures.
Dosage/Direction for Use
1 tab once wkly.
Administration
Should be taken on an empty stomach: Take w/ a full glass of plain water at least 30 min before the 1st food/drink/medication of the day & remain in upright position for at least 30 min. Swallow whole, do not chew/suck.
Contraindications
Hypersensitivity to alendronate or to any of the excipients of Alendronate Sandoz. Oesophageal abnormalities & other factors that delay oesophageal emptying eg, stricture or achalasia. Hypocalcemia. Inability to stand or sit upright for 30 min.
Special Precautions
Local irritation to the upper GI mucosa. Patient w/ active upper GI problems eg, dysphagia, oesophageal disease, gastritis, duodenitis or ulcers, or in cases of recent (during the last yr) severe GI disease eg, gastric ulcer, active GI bleeding or surgery in the upper GIT other than pyloroplasty; patient w/ known Barrett's esophagus. Discontinue if symptoms of oesophageal irritation develop eg, dysphagia, pain on swallowing, retrosternal pain or new/worsening heartburn. Osteonecrosis of the jaw associated w/ tooth extr &/or local infection (osteomyelitis). Perform dental exam w/ appropriate preventive dentistry prior to treatment. Avoid invasive dental procedures. Hypocalcaemia in patients w/ predisposing conditions eg, hypoparathyroidism, vit D deficiency & Ca malabsorption). Ensure adequate Ca & vit D intake. Atypical subtrochanteric & diaphyseal femoral fractures in patient under long-term treatment for osteoporosis. Pregnancy & lactation. Childn <18 yr w/ osteogenesis imperfecta.
Adverse Reactions
Headache; abdominal pain & distention, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcers, dysphagia, acid regurgitation; musculoskeletal pain.
Drug Interactions
Ca supplement, antacids.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA04 - alendronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Alendronate Sandoz tab 70 mg
Packing/Price
4's
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