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Ibandren

Ibandren

ibandronic acid

Manufacturer:

Theragen Etex

Distributor:

Oxford Distributions

Marketer:

Bandwell Pharma
Concise Prescribing Info
Contents
Ibandronic acid
Indications/Uses
Treatment & prevention of postmenopausal osteoporosis.
Dosage/Direction for Use
1 tab once a mth on the same date each mth.
Administration
Should be taken on an empty stomach: Take w/ sufficient water (180-240 mL) in the morning, 1 hr before the 1st food/drink/medication/supplement (including Ca antacids or vit) of the day, while standing or sitting in upright position for least 1 hr. Avoid lying down for 1 hr after taking tab.
Contraindications
Hypersensitivity. Incurable hypocalcemia. Patients who are unable to stand or sit upright for at least 1 hr; w/ abnormalities of esophagus which delay esophageal emptying eg, stricture or achalasia. Galactose intolerance, Lapp lactase deficiency & glucose-galactose malabsorption.
Special Precautions
May cause local irritation on the upper GI mucosa; possible irritant effects & potential worsening of the underlying disease. Patients w/ active upper GI problems. Discontinue if dysphagia, odynophagia, retrosternal pain or new or worsening heartburn developed. Treat hypocalcemia & other disturbances of bone & mineral metabolism before starting therapy. Instruct patients to take supplemental Ca & vit D if dietary intake is inadequate. Severe & occasionally incapacitating bone, joint &/or muscle pain; consider discontinuing use if severe symptoms develop. Osteonecrosis of the jaw. Atypical subtrochanteric & diaphyseal femoral fractures. Not recommended in severe renal impairment (CrCl <30 mL/min). Do not take during pregnancy & lactation. Childn <18 yr.
Adverse Reactions
Irritation, inflammation, or ulcers of the esophagus. Hypocalcemia, spasms, twitches or muscle cramps, numbness or tingling in fingers, toes or around the mouth. Severe bone, joint or muscle pain. Osteonecrosis. Unusual thigh bone fractures. Back pain, heartburn, abdominal pain, pain in arms & legs, diarrhea, headache, muscle pain, flu-like symptoms. Allergic reactions eg, hives, difficulty of breathing, swelling of face, lips, tongue or throat, or feeling faint.
Drug Interactions
Interference of absorption w/ products containing Ca including milk & other multivalent cations (eg, Al, Mg, Fe). May cause GI irritation w/ ASA & NSAIDs. Increased gastric pH w/ H2 blockers or PPIs.
MIMS Class
Agents Affecting Bone Metabolism
ATC Classification
M05BA06 - ibandronic acid ; Belongs to the class of bisphosphonates. Used in the treatment of bone diseases.
Presentation/Packing
Form
Ibandren FC tab 150 mg
Packing/Price
1's
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