Ibandronate sodium is a bisphosphonate that inhibits osteoclast-mediated bone resorption and turnover leading to a net gain in bone mass. The mechanism of action is based on the affinity of ibandronate for hydroxyapatite, which is part of the mineral matrix of bone .
藥動學
Absorption:
Bioavailability: (Oral), 0.6%
Distribution:
Vd: 90 L
Metabolism:
No evidence of drug metabolism
Excretion:
Renal: about 50% to 60% of absorbed dose
Dialyzable: yes (hemodialysis)
Elimination Half Life:
Intravenous: 4.6 to 25.5 hours, dose dependent .
禁忌症
Hypersensitivity to ibandronate or to any of its excipients
Hypocalcemia; correct prior to initiation of therapy
懷孕分類
C (FDA)
哺乳分類
Infant risk cannot be ruled out.(MDX)
副作用
Common:
Cardiovascular: Hypertension (6.3% to 7.3% )
Gastrointestinal: Abdominal pain (5% to 7.8% ), Diarrhea (2% to 7% ), Indigestion (4% to 12% ), Nausea (2% to 5.1% )
Musculoskeletal: Backache (4.3% to 14% ), Pain in limb (1.3% to 8% )
Neurologic: Headache (3% to 7% )
Respiratory: Bronchitis (2% to 10% ), Upper respiratory infection (1% to 34% )
Serious:
Gastrointestinal: Duodenal ulcer disease, Esophageal erosions, Esophageal perforation, Esophageal stricture, Esophagitis, Gastric ulcer, Ulcer of esophagus
Musculoskeletal: Arthralgia (3.5% to 14% ), Aseptic necrosis of bone of jaw, Bone pain, Musculoskeletal pain, Myalgia (0.8% to 6% ).
劑量和給藥方法
Postmenopausal osteoporosis:
3 mg IV infused over 15 to 30 seconds every 3 months.
小兒調整劑量
腎功能調整劑量
renal impairment, mild to moderate (CrCl 30 mL/min or greater): no dosage adjustment needed
renal impairment, severe (CrCl less than 30 mL/min): use not recommended .