Bioavailability when administered orally alendroiata morning fasting two hours before a standard breakfast at a dose of 5-70 mg was 0.64% for women and 0.6% for men. When receiving alendroiata empty stomach one hour or half an hour before a standardized breakfast oiodostunnost decreased to 0.46% and 0.39% respectively. In studies of osteoporosis, alendronate was effective when administered at least 30 minutes before the first ingestion of food or drink during the day.
Bioavailability was negligible when alendronate in a standard breakfast and for two hours afterwards. When simultaneous administration of alendronate with coffee IPT orange juice bioavailability was reduced by approximately 60%.
In healthy subjects with oral prednizoia tren ace half life no clinically significant changes in bioavailability alendroiata when administered orally (average increase in the range from 20% to 44%).
Average equilibrium distribution volume, excluding the bone in humans is at least 28 liters. Concentrations of drug in plasma following oral administration of therapeutic doses are too low for analytical detection (<5 ng / ml). Plasma protein binding in humans is approximately 78%.
no supporting evidence that alendronate is metabolized in humans or animals.
After a single intravenous alendronate approximately 50% of the radioactivity was excreted in the urine within 72 hours and little or no excreted in the feces. Alendroiata Renal clearance was 71 ml / min, and systemic clearance did not exceed 200 ml / min. The plasma concentrations decreased by more than 95% within six hours after intravenous administration.
The half-life in the terminal phase in humans is estimated to exceed ten years, reflecting release of alendronate from the skeleton. Alendronate is not output through the acidic and basic transport system of kidneys in rats; thus it can be expected that it does not disturb the removal of other drugs through these systems in humans.
Preclinical studies have tren ace half life shown that a drug that does not accumulate in the bone is rapidly excreted in urine. Evidence of saturation of bone accumulation after repeated intravenous administration of cumulative doses of 35 mg / kg was found in animals. Although no clinical data are available, it is likely that, as in animals, elimination of alendronata through kidney will be reduced in patients with impaired renal function.
Thus, in patients with impaired renal function, you can expect a few more alsndronata accumulation in the bone .
Indications for use:
- Treatment of osteoporosis in postmenopausal women for the prevention of fracture, including hip fracture and vertebral compression fractures.
- Treatment of osteoporosis in men tren ace half life for the prevention of fracture.
- Diseases of the esophagus and other factors that slow emptying, such as stricture or achalasia.
- The inability to sit or stand upright for 30 minutes.
- Giperchuvstvntelyyust to alendronate or to any excipient product.
- Hereditary lactase deficiency, glucose-galactose malabsorption.
- Severe disturbances of mineral metabolism.
- Chronic renal failure.
- Deficiency of vitamin D.
- In acute diseases of the upper gastrointestinal tract, such as dysphagia, esophageal disease gastritis, duodenitis or gastric ulcer.
- In severe gastrointestinal disease, carried in the preceding 12 months, for example, peptic ulcer, gastrointestinal bleeding, surgery on the upper gastrointestinal tract, except pyloroplasty.
- When susceptibility to giiokaltsiemii (hypothyroidism, calcium malabsorption).
Application of pregnancy and during breastfeeding
Application of pregnancy
Alendronate should not be tren ace half life used during pregnancy. Data on the use of alendronate in pregnant women is not enough.
Animal studies do not indicate a direct adverse effects during pregnancy, embryo-fetal development, or postnatalyyugo development. Alendronate, administered to rats during pregnancy, caused dystocia due to hypocalcemia.
Use during breast-feeding
data on the allocation of alendronate in breast milk are not available. Alendronate should not be administered to women during breast-feeding.
The ® should not be used in children under the age of 18 years due to insufficient data on safety and efficacy in diseases associated with childhood osteoporosis.
Dosage and administration:
The recommended dose – 70 mg one tablet once per week. The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued bisphosphonate therapy should be evaluated on a regular basis based on the benefit / risk of the use for each patient, particularly after 5 or more years of use.
To ensure sufficient absorption of alendronate:
Tren ace half life must be taken at least 30 minutes prior to the first dose write. beverage or drug daily intake, drinking just plain water. Other beverages (including mineral water), food and certain drugs may decrease the absorption of alendronate.