Pharmacological action
Inhibitor of bone resorption. Aminobisfosfonat, is an analogue of pyrophosphate. The mechanism of action is associated with suppression of osteoclastic activity.
Pharmacokinetics
Alendronate sodium immediately before, during or after a meal reduces the bioavailability. When taken with coffee or orange juice reduced bioavailability of alendronate sodium by about 60%.
After oral administration in therapeutic doses, the concentration of alendronate sodium in the blood plasma are usually below the lowest concentration, identifiable (less than 5 ng / ml).
Temporarily distributed in soft tissues, then rapidly redistributed to bone or excreted in urine. Plasma protein binding is approximately 78%. Not metabolized. Primarily excreted by the kidneys. T1 / 2 in the final phase can be more than 10 years, due to the release of the active substance from the bones.
Statement
Treatment and prevention of osteoporosis in postmenopausal women. Treatment of osteoporosis in men to increase bone mass. Treatment of osteoporosis caused by the use of corticosteroids in men and women. Paget’s disease (bone disease) in men and women.
Dosing regimen
Individual, depending on the evidence.
Side effect
From the digestive system: pain in the epigastric region, rarely – constipation, diarrhea, flatulence, dysphagia.
From a metabolism: asymptomatic hypocalcemia.
Dermatological reactions: skin rash, erythema.
Other: headache, myalgia.
Contraindications
Stricture of the esophagus, achalasia, the failure of the patient to stand or sit upright for at least 30 minutes after ingestion, hypocalcemia, increased sensitivity to alendronate sodium.
Application of pregnancy and breastfeeding
Adequate and well-controlled clinical trials the safety of alendronate sodium in pregnancy and lactation is not carried out. If necessary, use during lactation breastfeeding should be discontinued.
In experimental studies on rats showed that alendronate sodium at doses of 2 mg / kg / day and above caused discoordination labor due to hypocalcaemia, at doses above 5 mg / kg / day marked reduction in the weight of the fetus.
Cautions
Not recommended for use in severe renal impairment, as well as children.
With careful use in diseases of the digestive tract in acute phase.
Before starting treatment for patients with disorders of mineral metabolism should be their full correction.
Between alendronate sodium and other drugs in the interval should be at least 1 hour
Drug Interactions
With the simultaneous ingestion of other drugs and products containing calcium, disturbed absorption of alendronate sodium.
In postmenopausal women treated with estrogen, there were no side effects associated with alendronate sodium.
In clinical trials, there was increased frequency of adverse reactions on the part of the digestive system in the application of alendronate sodium in a dose of 10 mg / day during therapy with acetylsalicylic acid.
