Bonviva

Bonviva

ibandronic acid

Manufacturer:

Atnahs Pharma

Distributor:

Zuellig
Concise Prescribing Info
Contents
Ibandronic acid
Indications/Uses
Postmenopausal osteoporosis, to reduce the risk of fractures.
Dosage/Direction for Use
1 tab once a mth, preferably taken on the same date each mth.
Administration
Should be taken on an empty stomach: Take upon arising for the day, at least 1 hr before the 1st food, drink or medication w/ a full glass of plain water only & remain in sitting/upright position for at least 1 hr. Swallow whole, do not chew/crush/suck.
Contraindications
Hypersensitivity. Patients w/ uncorrected hypocalcemia; abnormalities of the esophagus which delay esophageal emptying eg, stricture or achalasia; who are unable to stand or sit upright for at least 60 min.
Special Precautions
Treat hypocalcemia & other disturbances of bone & mineral metabolism before starting therapy. Maintain adequate intake of Ca & vit D. Patients w/ active upper GI problems (eg, known Barrett's esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). Greater risk of severe esophageal adverse experiences in patients who do not comply w/ the dosing instruction &/or those who continue treatment after developing symptoms suggestive of esophageal irritation. Discontinue use if patient develops dysphagia, odynophagia, retrosternal pain or new or worsening heartburn. Risk factors for osteonecrosis of the jaw (ONJ) including cancer diagnosis, concomitant therapies (eg, chemotherapy including angiogenesis inhibitors, RT, corticosteroids), & co-morbid disorders (eg, anemia, coagulopathy, infection, preexisting dental disease). Dental surgery may exacerbate condition for patients who develop ONJ while on therapy. Osteonecrosis of other oro-facial sites including the external auditory canal (possible in patients who present w/ ear symptoms including chronic ear infections). Atypical subtrochanteric & diaphyseal femoral fractures, primarily in patients receiving long-term treatment for osteoporosis. Consider discontinuation of therapy in patients suspected to have an atypical femur fracture. Galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. Concomitant use w/ NSAIDs. Not recommended for patients w/ CrCl <30 mL/min. Not to be used during pregnancy. Lactation. Childn <18 yr.
Adverse Reactions
Gastritis, GERD, oesophagitis, diarrhoea, abdominal pain, dyspepsia, nausea, flatulence; headache, flu-like illness, fatigue; muscle cramp, musculoskeletal pain/stiffness, myalgia, arthralgia; rash.
Drug Interactions
Interfered absorption w/ products containing Ca & other multivalent cations (eg, Al, Mg, Fe), including milk & food. Increased bioavailability w/ ranitidine IV. Upper GI events w/ histamine blockers or PPIs; aspirin or NSAIDs in postmenopausal women w/ osteoporosis.
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
Bonviva FC tab 150 mg
Packing/Price
1's
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