Non-hormonal specific inhibitor of osteoclastic bone resorption.
It stimulates bone formation and restores a positive balance between bone resorption and reducing bone, increases bone mineral density (regulates calcium and phosphorus metabolism), promotes the formation of bone tissue with normal histological structure. Pharmacokinetics Absorption. The bioavailability tren acetate half life of alendronate at a dose of 70 mg ingestion fasting for 2 hours before a standard breakfast was 0.64% in women, in men – 0.59%. When receiving 1 hour or half an hour before breakfast reduced bioavailability of alendronate to 0.46% and 0.39%, respectively. In clinical studies confirmed the effectiveness of alendronic acid in the application of at least 30 minutes before the first ingestion of food or drinks when used together with alendronic acid or a food for 2 hours after a meal the drug absorption dramatically decreases the bioavailability of alendronate becomes negligible. When co-administered with coffee or orange juice reduced bioavailability of the drug by about 60%. The distribution. Alendronic acid after intravenous administration at a dose of 1 mg / kg temporarily distributed into soft tissue and then rapidly redistributed to bone or excreted in urine. The mean volume of distribution at steady state except bone, in humans is about 28 liters. The concentration of drug in blood plasma is negligible (less than 5 ng / ml). Communication with plasma proteins -. About 78% . Metabolism There is no evidence that the alendronic acid is metabolized in the human body. Excretion. After a single intravenous administration of alendronic acid labeled with carbon atoms kidneys stands 50 % and a minor amount of the substance – via the intestine.
Terminal half-life exceeds 10 years, reflecting the release of alendronic acid from the bone. Pharmacokinetics in specific groups of patients Sex: Bioavailability alendronic acid is not significantly different for males and females. Older age: bioavailability and elimination of alendronic acid similar in the older and younger patients.Race : pharmacokinetic differences based on race have not been studied. kidney function impairment: in healthy volunteers, alendronate, do not accumulate in bone is rapidly excreted in the urine. Controlled pharmacokinetic studies on the use of alendronate has not been in renal failure, but in patients with severe renal impairment is likely, elimination of alendronate is decreased. We can therefore expect a somewhat larger accumulation of alendronate in bone in patients with impaired renal function. If creatinine clearance tren acetate half life from 35 to 60 ml / min the dose correction is not required. Apply alendronate in patients with less than 35 ml / min is not recommended due to the lack of such experience. In patients with impaired hepatic function there is no need to adjust the dose of alendronate, as it is not metabolized and excreted in the bile.
• Treatment of osteoporosis in postmenopausal women, including reducing the risk of vertebral compression fractures and hip fractures;
• the treatment of osteoporosis in men to prevent fractures;
• treatment of osteoporosis caused by long-term use of glucocorticoid drugs.
• Hypersensitivity to alendronate or to other components of the tren acetate half life drug;
• stricture of the esophagus, achalasia, and other conditions that lead to dysphagia and slow progress on the esophagus food;
• vitamin deficiency the D;
• the inability of a patient to stand or sit for 30 minutes;
• severe renal insufficiency ( creatinine clearance less than 35 mL / min);
• severe disorders of mineral metabolism (hypocalcemia);
• pregnancy, breast-feeding;
• children’s age (efficacy and safety have not been established).