Rekostin
Producer: Biofarm Ltd Biofarm Ltd, Poland
Code of automatic telephone exchange: M05BA04
Release form: Firm dosage forms. Tablets.
General characteristics. Structure:
Active agent: sodium of an alendronat of trihydrate, 10 mg of alendronovy acid are equivalent;
Other components: cellulose microcrystallic, lactoses monohydrate, sodium of a kroskarmeloz, magnesium stearate.
Pharmacological properties:
Pharmacodynamics. Rekostin includes алендронат sodium – to substance from group of aminobiphosphonates – a synthetic analog of a pyrophosphate, powerful specific inhibitor of a resorption of the bone tissue caused by osteoclasts. At the same time алендронат does not break its mineralization. Existence in structure of medicine of communication of P-C-P defines Rekostin's resistance to hydrolysis and limits its penetration through cellular membranes that explains its hypotoxicity. Alendronat of sodium normalizes excessive dynamics of reorganization of a bone which especially expressed at women in the period of a menopause. As processes of construction and a resorption of a bone connected among themselves, a final effect of use of medicine increase in bone weight is. Within several weeks of treatment decrease in concentration of calcium ions in daily is observed wet, and also markers and products of degradation of collagen of a bone that testify about considerable delay of process of its resorption, and this effect is dozozavisimy. At use of an alendronat several months, process of reorganization of a bone are stabilized, providing uniform increase in its mineral density in comparison with an output indicator before an initiation of treatment.
Pharmacokinetics. Absorption. Biological availability makes 0,7% at women and men have 0,6%, at use in a dose from 5 to 40 mg in 2 hours before food. It decreases approximately by 40% if medicine is used less, as in 2 hours before food and to 0% if to apply it during the period or after food. Different drinks, except water, can lower its bioavailability even by 60%.
Distribution. Extent of linkng with proteins of plasma makes about 78%. During the 6th hour after reception concentration of an alendronat in plasma decreases more, as by 95%.
Metabolism. Alendronat does not metabolizut.
Elimination (removal). During 72 hours with urine eliminirut about 50% of a drug dose. The insignificant quantity (traces) is removed with bile. The renal clearance of an alendronat makes 71ml/min. Release of an alendronat from a bone tissue is insignificant, the average period availability of medicine in a bone tissue makes nearly 10 years.
Indications to use:
Treatment and prevention of osteoporosis at women in the period of a postmenopause, at men – for the purpose of increase in bone weight; treatments of the osteoporosis caused by use of glucocorticoid means for men and women; Pedzhet's disease (deforming osteit).
Route of administration and doses:
Pill is taken inside, without chewing and not rassasyvy, on an empty stomach, in 30 - 60 minutes prior to the first reception of food, washing down with a full glass of boiled water.
The recommended dose for adults – 10 mg (1 tablet) a day; at Pedzhet's disease – 40 mg (4 tablets) a day within 6 months.
At osteoporosis a course of treatment drug long – 2 - 3 years and more. After 3 years of treatment Rekostin's dose is reduced to 5 mg a day.
For elderly and sick with an average and moderate renal failure (clearance of creatinine of 35 - 60 ml/minutes) so most doses.
After use of drug of the patient has to there are in vertical position (not to go to bed) not less than 30 minutes.
Features of use:
At Rekostin's reception it is necessary to adhere to the recommendations concerning use strictly. From survey on risk of irritant action on a mucous membrane of a digestive tract, medicine it is necessary to use with care at patients with such diseases as a dysphagy, gastritis, a duodenitis, a round ulcer.
Before Rekostin's use it is necessary to carry out correction of all disturbances of mineral exchange.
During treatment the diet enriched with calcium is necessary.
Influence on ability to manage vehicles and moving mechanisms which need big attention of concentration.
Alendronat of sodium does not influence psychophysical activity and ability to manage difficult mechanisms.
Side effects:
Abdominal pains, dyspepsia, lock, diarrhea, meteorism, dysphagy, esophagitis, ostealgia, muscles or joints, and also a headache can be observed. There are a skin rash, nausea, vomiting less often. Very seldom – allergic reactions (a small tortoiseshell and a Quincke's disease), a photosensitization, perforation, an erosion, gullet ulcer, an inflammation of a mucous membrane of an eye, tranzitorny and insignificant decrease in concentration of calcium and phosphates in blood serum.
Interaction with other medicines:
Rekostin with care apply together with non-steroidal anti-inflammatory drugs. Simultaneous use of medicine in association with non-steroidal anti-inflammatory drugs increases risk of development of side effects from upper parts of digestive tract. Antacids, calcium drugs, food and drinks (except water) slow down absorption of an alendronat therefore the interval between Rekostin's use and food has to make not less than 30 min. And at use of drugs of calcium, Rekostin it is worth taking for 1 hour to or in 3 - 4 hour after their use. Interactions between alendronaty and means of replacement therapy at a menopause are unknown about clinically powerful.
It is proved - administration of ranitidine increases absorption of an alendronat.
Contraindications:
Hypersensitivity to any of medicine components, a gipokaltsiyamiya, gullet diseases (strictures, an achalasia) that complicate evacuation of contents, a renal failure (clearance of creatinine less than 35 ml/minutes), stay in a sitting position or costing impossibility at least 30 min. It is not recommended to use medicine during pregnancy or feeding by a breast. Children's age.
Overdose:
Considerable excesses of the maximum daily dose can entail disturbance of electrolytic balance (a gipokaltsiyamiya, a hypophosphatemia), heartburn, gastritis and a round ulcer of a stomach and duodenum. An antidote is milk and antacids. Considering risk of development of perforation in upper parts of digestive tract you should not cause vomiting. Dialysis is inefficient.
Storage conditions:
To store in unavailable to children, the dry place at a temperature of 15 - 25 °C.
Issue conditions:
According to the recipe
Packaging:
On 2 or 4 tablets in one blister, on 1 blister in a cardboard box.