Ibandronic acid coated tablets 50 mg. №30blis

$435.00

Manufacturer: Spain

Treatment of osteoporosis in postmenopausal women with an increased risk of fractures. A reduction in the risk of vertebral fractures has been demonstrated, and the effectiveness of preventing hip fractures has not been established.

Category:

Description

Ibandronic №30blis Storage
active substance: ibandronic acid;

1 film-coated tablet contains ibandronic acid 150 mg in the form of sodium ibandronate monohydrate 168.75 mg;

excipients: lactose monohydrate; microcrystalline cellulose; crospovidone (type A); colloidal anhydrous silica, sodium stearyl fumarate;

film shell (Opadry II white): polyvinyl alcohol, titanium dioxide (E 171), talc, macrogol 3350.

Ibandronic №30blis Dosage form
Film-coated tablets.

Main physical and chemical properties: oblong tablets, from white to almost white, on the one hand engraving tablets “I9VE”, on the other hand – “150”.

Ibandronic №30blis Pharmacotherapeutic group
Agents that affect the structure and mineralization of bones. Bisphosphonates. Ibandronic acid.

ATX code M05B A06.

Pharmacological properties

Pharmacodynamics.

Ibandronic acid is a highly active nitrogen-containing bisphosphonate that selectively acts on bone tissue and specifically inhibits osteoclast activity and has no direct effect on bone formation. The drug does not affect the process of replenishing the pool of osteoclasts. In menopausal women, it reduces the increased rate of bone renewal to the level of premenopause, which leads to a progressive increase in bone mass and a decrease in the frequency of fractures.

Ibandronic acid inhibits bone resorption. In vivo, ibandronic acid prevents bone destruction caused experimentally by gonadal blockade, retinoids, tumors, and tumor extracts. Bone resorption was also observed in young (fast-growing) rats, leading to an increase in normal bone mass compared to untreated animals.

Animal models confirm that ibandronic acid is a high-potency inhibitor of osteoclast activity. In growing rats, no signs of mineralization were observed, even when used in doses greater than 5,000 times the dose required for the treatment of osteoporosis.

Daily long-term use and periodic use (at long intervals) for a long time in rats, dogs and monkeys was associated with the formation of new bone of normal quality with preservation or increased mechanical strength, even when used in the toxic range.

In animal models, ibandronic acid results in biochemical changes that indicate dose-dependent inhibition of bone resorption, including decreased levels of biochemical markers of urinary bone collagen degradation (such as deoxypyridinoline and cross-linked type I collagen N-telopeptide).

Indication
Treatment of osteoporosis in postmenopausal women with an increased risk of fractures. The reduction of the risk of vertebral fractures has been demonstrated, the effectiveness of prevention of fractures of the femoral neck has not been established.

Contraindication
Hypersensitivity to ibandronic acid or to any other component of the drug (see section “Composition”).

Hypocalcemia.

Diseases of the esophagus with slow esophageal emptying, such as stricture, achalasia.

Failure to stand upright (standing or sitting) for at least 60 minutes.