Alendronate Sandoz

Alendronate Sandoz

alendronic acid

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Alendronate Na trihydrate
Indications/Uses
Treatment & prevention of osteoporosis in postmenopausal woman to prevent fractures, including those of the hip & spine (vertegral compression fractures). Treatment of osteoporosis in men to prevent fractures.
Dosage/Direction for Use
Administration
Should be taken on an empty stomach: Take at least 30 min before the 1st food/drink/medication of the day w/ a full glass of plain water & remain in sitting/upright position for at least 30 min. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity. Abnormalities of the esophagus & other factors delaying esophageal emptying eg, stricture or achalasia. Inability to stand or sit upright for 30 min. Hypocalcemia.
Special Precautions
Discontinue use if signs or symptoms of possible oesophageal reaction occurs; in patients suspected w/ atypical femur fracture. Severe skin reactions including SJS & TEN. Patients w/ active upper GI problems, eg, dysphagia, oesophageal disease, gastritis, duodenitis, ulcers, or w/ recent history (w/in previous year) of major GI disease eg, peptic ulcer, or active GI bleeding, or upper GI tract surgery other than pyloroplasty; known Barrett's oesophagus. Bone, joint, &/or muscle pain; atypical subtrochanteric & diaphyseal femoral fractures; symptomatic hypocalcaemia in patients w/ predisposing conditions (eg, hypoparathyroidism, vit D deficiency & Ca malabsorption). Osteonecrosis of the jaw & external auditory canal. Perform dental exam w/ appropriate preventive dentistry prior to treatment in patients w/ poor dental status. Maintain good oral hygiene, receive routine dental check-ups, & any oral symptoms eg, dental mobility, pain, or swelling. Examine contralateral femur in bisphosphonate-treated patients who have sustained a femoral shaft fracture. Correct hypocalcaemia before initiating therapy. Monitor serum Ca & symptoms of hypocalcaemia during therapy. Ensure adequate Ca & vit D intake. Avoid invasive dental procedures. May affect ability to drive & operate machinery. Not recommended for patients w/ renal impairment CrCl <35 mL/min. Not to be used during pregnancy & lactation. Not recommended in childn <18 yr.
Adverse Reactions
Musculoskeletal (bone, muscle or joint) pain. Headache, dizziness; vertigo; abdominal pain & distension, dyspepsia, constipation, diarrhoea, flatulence, oesophageal ulcer, dysphagia, acid regurgitation; alopecia, pruritus; joint swelling; asthenia, peripheral oedema.
Drug Interactions
Interfered absorption w/ Ca supplements, antacids, food & beverages, some oral medicinal products if taken at the same time. NSAIDs.
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 FC tab 70 mg
Packing/Price
4's
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