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Tablets: alendronovy acid, microcrystallic cellulose, magnesium stearate, croscarmellose sodium.
Capsules: alfakaltsidol, citric acid, α-tocopherol, propyl gallate, peanut butter, ethanol, titan dioxide, glitserol, gelatin.
Set of tablets and capsules:
- tablets of a round form of white color, flat;
- capsules are gelatinous, an oval form of white color.
In the blister from aluminum foil on 1 tablets and 7 capsules in a cardboard pack No. 2, 4, 12 of blisters.
Regulating calcium - a phosphorus exchange, inhibiting a resorption of bones.
Pharmacodynamics and pharmacokinetics
Effect of drug is defined by active agents, being its part.
Treats bisfosfonata, does not exert a direct impact on formation of a new bone tissue, inhibits the process of a resorption of a bone tissue caused by osteoclasts. Alendronovy acid possesses a tropnost to a bone hydroxyapatite, and, respectively, collects in zones of its active resorption. Action is caused by stimulation of process of apoptosis of osteoclasts. At reception of alendronovy acid the mineralization of a bone raises and its qualitative characteristics are normalized.
The predecessor pharmacological of an active metabolite of D3 vitamin, takes part in regulation of a calcium-phosphorus exchange. Increases absorption of calcium and phosphorus in intestines, raises their reabsorption in kidneys, reduces concentration of parathyroid hormone in blood, normalizes calcic balance at a syndrome of calcic malabsorption.
Influencing processes of a resorption and synthesis of a bone, alfakaltsidol increases the maintenance of minerals in a bone tissue and its elasticity due to strengthening of process of protein synthesis of a matrix of a bone, growth factors and bone morphogenetic proteins. At reception of an alfakaltsidol durability of bones of a skeleton increases, physiologically normal histologic structure of bones forms.
Both actively active ingredients mutually increase effects of each other that provides forming and growth of physiologically normal bone structure. Thanks to synergy effect of these substances it is possible to reduce risk of development of a hypercalcuria, hypocalcemia and hypercalcemia that allows to reduce risk of changes, to increase an animal force and speed of muscular reaction.
Bioavailability at the level of 0,6%. After intake in a therapeutic dose concentration of alendronovy acid in blood below the existing definition limit. Linkng with blood proteins — about 78%. It is distributed originally in soft tissues, and then redistributed in a bone where it also is fixed. Biotransformations it is not exposed, removed through kidneys in not changed look.
Alfakaltsidol is quickly soaked up from a gastrointestinal tract. After a single dose of Cmax it is reached in 10 hours. Bioavailability about 100%. In an organism by a hydroxylation turns into calcitriol. The elimination half-life is removed about 35 hours approximately in equal ratios by kidneys and a liver.
Indications to use
Osteoporosis in the period of a postmenopause. The osteoporosis which developed as a result of reception of GKS.
High sensitivity to active ingredients of drug, a state, gullet stricture, a hypocalcemia/hypercalcemia, pregnancy, diseases of kidneys, a hemodialysis, a hypervitaminosis of D, children's age, the lactation period.
It is necessary to take with caution at an exacerbation of diseases gastrointestinal tract diseases, atherosclerosis, at a hypoparathyrosis, an active form of a pulmonary tuberculosis, calcium malabsorption, a leukosis, a hypovitaminosis of D, a nephrolithiasis, HSN.
At reception of alendronovy acid: a febricula, nausea, vomiting, gastritis, an esophagitis, lock/diarrhea, an erosion mucous a gullet, dyspepsia, abdominal pain, a dysphagy, a meteorism, stomach ulcer, an ostealgia, a mialgiya, spasms in muscles, the hypocalcemia which is usually connected with the contributing states, a hypophosphatemia, a headache, a sclerite, local allergic reactions, fever.
Tevabon, application instruction (Way and dosage)
Two dosage forms are a part of drug: capsules of an alfakaltsidol and tablet of alendronovy acid.
Alendronovy acid — to accept inside on 1 tablet in 30 minutes prior to a breakfast or reception of other HP once a week.
Not to chew a tablet. Wash down with usual water. Before morning rise from a bed or before going to bed it is impossible to take a pill. The patient after reception of a tablet has to be in vertical position not less than 30 minutes.
Alfakaltsidol — to accept on 1 capsule swallowing entirely and washing down with water 1 times/days daily in the evening.
At reception of Alendronovy acid in the doses exceeding recommended diarrhea, heartburn, a hypophosphatemia, a hypocalcemia, ulcerations mucous a gastrointestinal tract, an esophagitis are possible.
At Alfakaltsidol's overdose emergence of nausea, metal smack in a mouth, fatigue, a headache, an ostealgia, a mialgiya, increase of the ABP, weight reduction of a body, dryness in a mouth, a lock, diarrhea, anorexia, a skin itch, drowsiness, dizziness, the general weakness, confusion of consciousness is possible.
At joint administration of drug with food additives, drinks (including mineral water) and food, calciferous there is a risk of disturbance of process of absorption of alendronovy acid.
Drugs GKS strengthen side effect of alendronovy acid on mucous a gastrointestinal tract. The concomitant use of an alfakaltsidol with cardiac glycosides increases risk of development of arrhythmia. Absorption of an alfakaltsidol decreases at its joint reception with mineral oil, antacids, kolestipoly, Colestyraminum, sukralfaty, HP, on the basis of albumine.
The concomitant use of an alfakaltsidol with thiazide diuretics, drugs of calcium can cause a hypercalcemia. Joint reception of an alfakaltsidol with other HP containing vitamin D because of risk of development of a hypercalcemia is not recommended. At women in a postmenopause efficiency of an alfakaltsidol can amplify reception of estrogen.
Terms of sale
In the dry place at a temperature not above 25 °C.
Period of validity
There are no structural analogs of drug.
About drug among patients favorable. "… I have osteoporosis. Appointed medicine Tevabon nearly half a year ago. The state improved, pains in chest department of a backbone and a hip decreased". According to doctors administration of drug promotes increase in MPKT in places of the raised loading, to reduction of pains and frequencies of fractures of bones at osteoporosis.
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