Ostivea

Ostivea Dosage/Direction for Use

ibandronic acid

Manufacturer:

UNAM Pharmaceutical

Distributor:

Zuellig Pharma
Full Prescribing Info
Dosage/Direction for Use
Posology: The recommended dose of Ibandronic acid is 3 mg, administered as an intravenous injection over 15-30 seconds, every three months.
Patients must receive supplemental calcium and vitamin D (see Precautions and Interactions).
If a dose is missed, the injection should be administered as soon as convenient. Thereafter, injections should be scheduled every 3 months from the date of the last injection.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be reevaluated periodically based on the benefits and potential risks of Ostivea on an individual patient basis, particularly after 5 or more years of use.
Special populations: Patients with renal impairment: OSTIVEA injection is not recommended for use in patients who have a serum creatinine above 200 μmol/l (2.3 mg/dl) or who have a creatinine clearance (measured or estimated) below 30 ml/min, because of limited clinical data available from studies including such patients (see Precautions and Interactions).
No dose adjustment is necessary for patients with mild or moderate renal impairment where serum creatinine is equal or below 200 μmol/l (2.3 mg/dl) or where creatinine clearance (measured or estimated) is equal or greater than 30 ml/min.
Patients with hepatic impairment: No dose adjustment is required (see Pharmacology: Pharmacokinetics under Actions).
Elderly population (>65 years): No dose adjustment is required.
Paediatric population: There is no relevant use of Ostivea in children below 18 years, and Ostivea was not studied in this population.
Method of administration: For intravenous use over 15-30 seconds, every three months.
Strict adherence to the intravenous administration route is required (see Precautions).
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