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Ibandrocare 150mg 2 Tablets

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Catalog:
Bisphosphonates
Tab
2
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Ibandrocare 150mg 2 Tablets

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Catalog: Bisphosphonates Tab 2 tab

 

Ibandrocare
Generic Name
Ibandronate sodium
Category
Musculoskeletal System
Form
Tablets
Composition
Ibandronic acid...........150 mg
Description
Properties/Actions
Pharmacodynamics
The action of ibandronate on bone tissue is based on its affinity for hydroxyapeptite which is part of the mineral matrix of bone. Ibandronate inhibits osotelcast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

Pharmacokinetics
Absorption
The absorption of oral ibandronate occurs in the upper gastrointestinal tract plasma concentrations increase in a dose-linear manner up to 50 mg oral intake and increases nonlinearly above this dose.
Following oral dosing, the time to maximum observed plasma ibandronate concentrations ranged from 0.5-2 hours (median 1 hour) in fasted healthy postmenopausal women, the mean oral bioavailability of 2.5 mg ibandronate was about 0.6% compared to intravenous dosing. 
The extent of absorption is impaired by food or beverages (other than plain water). The oral bioavailability of ibandronate is reduced by about 90% when administered concomitantly with a standard breakfast in comparison with bioavailability observed in fasted subjects. 
There is no meaningful reduction in bioavailability when ibandronate is taken at least 60 minutes before a meal. However, both bioavailability and the effect on bone mineral density (BMD) are reduced when food or beverages are taken less than 60 minutes following ibandronate dose.
Distribution
After absorption, ibandronate either rapidly bidngs to bone or is excreted into urine. In humans, the apparent terminal volume of distirbution is at least 90 litres, and the amount of dose removed from the circulation via the bone is estimated to be 40% to 50% of the circulating dose. In vitro protein binding in human serum was 99.5% to 90.9% over an ibandronate concentration range of 2-10 ng/ml in one study and approximately 85.7% over a concentration range of 0.5-0 ng/ml in another study.
Metabolism
Ibandronate does not undergo hepatic metabolism and does not inhibit the hepatic cytochrome P450 system. Ibandronate is eliminated by renal excretion based on a rat study. The ibandronate secretory pathway does not appear to include known acidic or basic transport systems involved in the excretion of other drugs. There is no evidence that ibandronate is metabolised in humans.
Elimination
The portion of ibandronate that is not removed from the circulation via the bone absorption is eliminated unchanged by the kidneys (approximately 50-60% of the absorbed dose). Unabsorbed ibandronate is eliminated unchanged in the feces.
The plasma eliminatin of ibandronate is mutliphasic. Its renal clearance and distribution ino bone accounts for a rapid and early decline in plasma concentrations, reaching 0% of the Cmax within 3-8 hours after intravenous or oral administration, respectively. This is followed by a slower clearance phase as ibandronate redistributes back into the blood from bone. The observed apparent terminal half-life for ibandronate is generally dependent on the dose studied an on assay sensitivity. The observed apparent terminal half-life for the 150 mg ibandronate tablet upon oral administration to healthy postmenopausal women ranges from 37-157 hours.
Total clearance of ibandronate is low, with average values in the range of 84-160 ml/min. Renal clearance (about 60 ml/min in healthy postmenopausal females) accounts for 50-60% of total clearance and is related to creatinine clearance. The difference between the apparent total and renal clearances likely reflects bone uptake of the drug.
Indications
Ibandrocare is indicated in the treatment and prevention of postmenopausal osteoperosis. Ibandrocare increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
Contraindications
Ibandrocare is contraindicated in:
  • Hypersensitivity to any of the product ingredients.
  • Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia inability to stand or sit upirght for at least 60 minutes.
  • Hypocalcemia

Additional Information

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