for medical use
of OSTALON® medicine
the Trade name
the International unlicensed
name Alendronovaya acid
the Dosage form
of the Tablet, film coated, 70 mg
One tablet contains
active agent – sodium of the alendronat of 91.35 mg (70 mg of acid alendronovy are equivalent),
excipients: sodium of a kroskarmelloz, magnesium stearate, silicon dioxide colloidal anhydrous, cellulose microcrystalline,
structure of a cover: To a chandelier Klear of HP 103 consisting of cellulose microcrystalline, a macrogoal 8000, a karadzhenin.
of the Tablet of round shape, with a biconvex surface, film coated white color, with an engraving of M14 on one party.
Drugs, for treatment of diseases of bones. The drugs affecting structure and a mineralization of bones. Bisfosfonata. Alendronovy acid.
ATX M05BA04 code.
Pharmacokinetics Later properties of single dose of drug in a dose of 35 mg or 70 mg in the morning on an empty stomach, for 2 h till a breakfast, the bioavailability is 0.64%. At an interval of 1 h or 30 min. between intake of drug and food the absorbability of alendronovy acid decreases and the bioavailability is it 0.46-0.39%. However decrease in absorbability has no significant effect on efficiency of drug. The concomitant use of coffee or orange juice reduces biocomprehensibility by 60%.
Communication with proteins of plasma makes about 78%.
After intake, alendronovy acid is temporarily distributed in soft tissues, then quickly built in a bone tissue and removed with urine.
At oral introduction in 6 h the plasma concentration of alendronovy acid decreases more, than by 95%. Elimination half-life makes about 10 years that indicates long removal of alendronovy acid from a bone tissue. The alendronovy acid absorbed, but not built in a bone tissue quickly is removed with urine. Alendronovy acid is not removed by either the acid, nor alkaline transport systems of kidneys: possibly, alendronat does not influence removal of medicinal substances above the specified systems.
Despite the absence of proofs, in diseases of kidneys the decrease in excretion of the alendronat with the subsequent increase in adjournment in a bone tissue is possible. In stool active agent does not come to light. The data confirming metabolism of the alendronat in a human body no.
Active agent of the drug Ostalon® – sodium alendronat is bisfosfonaty. Interferes with a resorption of bones osteoclasts, does not influence processes of forming of a bone tissue. Blocking activity of osteoclasts, does not influence their local reproduction and the introduction in communication with a bone surface. Progressively increases the mineral density of bones (regulates phosphorus-calcium exchange), promotes forming of a bone tissue of normal structure and structure.
– treatment of osteoporosis in a postmenopause (reduction of risk of development of fractures of vertebras and a femur)
the Route of administration and doses
the Recommended dose: 70 mg once a week.
For ensuring optimum absorbability the drug should be taken in the morning on an empty stomach, for half an hour before meal, liquid or other medicines, washing down with simple drinking water. Other drinks, including mineral waters (both with gas, and without it), food, a number of medicines can worsen absorbability of the alendronat.
In order to avoid local irritation of a mucous oral cavity and a gullet it is necessary to observe the following measures:
– Осталон® it has to be accepted at once after rise from a bed and it is washed down not less than 200 ml of water.
– the Patient has to take a pill entirely, without chewing and without allowing it to be dissolved in a mouth. After reception it is impossible to take a pill horizontal position of a body, at least, within half an hour.
– It is impossible to take a pill before morning rise from a bed or before going to bed.
Treatment of Ostalonom® should be added with intake of calcium and vitamin D if with food the insufficient amount of these substances arrives.
It is not required from elderly people of dose adjustment of drug.
Renal failure: at the glomerular filtration rate (GFR) & gt, 35 ml/min. dose adjustment is not required, in heavier stages of a renal failure (SKF & lt, 35 ml/min.) the prescribing of drug is not recommended, due to the lack of clinical experience.
Often (1/100, & lt, 1/10)
– a headache
– abdominal pain, dyspepsia, a constipation, diarrhea, a meteorism, gastritis, a gullet ulcer, stomach ulcer, a dysphagy, an esophagitis, a melena, an abdominal distension, an eructation acid, nausea
– an ossalgiya, an arthralgia, myalgia, spasms
Infrequently (1/1000, & lt, 1/100)
– an itching, rash, a dermahemia
– vomiting, a gullet erosion
Seldom (1/10000, & lt, 1/1000)
– allergic reactions (including a small tortoiseshell, angioedy)
– weakness, feeling sick, high temperature of a body
– an esophageal stenosis, an oropharyngeal ulcer, perforation, ulcers, bleedings from upper parts of digestive tract
– a uveitis, a sclerite, conjunctivitis, chiolite, an episcleritis
– Stephens-Johnson’s syndrome, a toxic epidermal necrolysis
– a symptomatic hypocalcemia and a fosfatemiya of moderate severity
– an asthenia, peripheral swell
– a jaw osteonecrosis, an atypical subtrokhanterny and diaphyseal fracture of a femur
of the Contraindication
– hypersensitivity to any of drug ingredients
– anomalies of a gullet and other factors complicating passability of a gullet (achalasia, a stricture)
– inability of the patient to remain in vertical position, at least sitting, within 30 minutes
– a hypocalcemia
– a renal failure with the glomerular filtration rate & lt, 35 ml/min.
– pregnancy and the period of a lactation
– children’s and teenage age up to 18 years
Calcium, antacids, some oral drugs, food, drinks, including mineral waters, affect absorbability of the alendronat. Patients after reception of the alendronat have to wait at least 30 minutes before accepting any other medicines.
Special researches on medicinal interactions were not conducted, however in researches with alendronaty, the patients who were at the same time accepting other oral medicines participated. The side effects connected with a concomitant use of other drugs were not observed.
Ranitidine increases bioavailability of the alendronat (the clinical value is unknown).
NPVS enhance adverse effects of Ostalona®.
The local irritation of a mucous membrane of upper parts of a digestive tract can cause the special instructions Ostalon®. The course of diseases of upper parts of a digestive tract can worsen during treatment of Ostalonom®. It is necessary to observe extra care when prescribing drug to patients with active diseases of an upper part of digestive tract, such as, a dysphagy, gullet diseases, gastritis, a duodenitis, ulcers or in the serious diseases of digestive tract postponed to the previous 12 months (for example, a round ulcer, gastrointestinal bleeding, surgical intervention on upper parts of digestive tract, except for pyloroplasty).
Cases of the side reactions from a gullet (esophagitis, an ulcer or an erosion of a gullet) sometimes proceeding in a severe form both demanding hospital treatment, and which were complicated by forming of a stricture are known. It is necessary to draw the attention of patients that at emergence of signs of irritation of a gullet (a dysphagy, retrosternal pain when swallowing, emergence or deterioration in a course of heartburn), administration of drug it is necessary to stop and see a doctor.
The risk of damage of a gullet is higher at the patients who are not following Regulations of Admission of drug, or continuing treatment contrary to emergence of signs of irritation of a gullet. It is extremely important to inform in due time patients on value of observance of rules on administration of drug and to be convinced that the patient understood it.
There are rare (post-marketing) messages about development of a peptic ulcer of a stomach and a duodenum, some of them were heavy and proceeded with complications though in expanded clinical trials of increase in risk of these diseases it was not noted.
During treatment of a bisfosfonatama the patients have to observe strictly hygiene of an oral cavity, regularly undergo dental inspection, report to the doctor about such symptoms as mobility of teeth, a toothache, swelled gums. Atypical subtrokhanterny and diaphyseal fractures of a femur were registered at therapy of a bisfosfonatama, first of all at the patients receiving long-term treatment from osteoporosis. These cross or slanting short changes can come in any place along a hip from the lower trochantin to epicondylic hollows. Changes can arise after the minimum injury or without it, and some patients can feel meralgias or a groin within several weeks or months before a change. Changes often are bilateral therefore those patients who have a femur fracture it is necessary to perform examination of an opposite hip. Bad healing of these changes is noted. The termination of therapy of a bisfosfonatama at patients who have a risk of developing of atypical fractures of femur has to be considered on the basis of individual assessment of risk and advantage. Patients during treatment of a bisfosfonatama have to report to the doctor about any meralgias or a groin, patients with such symptoms have to be estimated on an incomplete fracture of a femur.
It is necessary to warn patients that in case of the admission of the next dose of medicine, the passed pill should be taken the next morning, it is not necessary to take two pill in one day at all.
Prescribing of drug in the osteoporosis which is not connected with a postmenopause and not having age character, perhaps only individually.
Treatment can be begun only after elimination of a hypocalcemia, disturbances of mineral and vitamin exchanges (for example, insufficiency of vitamin D). Reception of the alendronat leads to increase in content of mineral salts in a bone tissue, process can be followed by asymptomatic change of levels of calcium and phosphorus. Ensuring the corresponding intake of calcium and vitamin D especially important in case of treatment of the patient with glucocorticosteroid hormonal drugs.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
Drug does not affect ability to drive the car and to perform the works connected with high risk of traumatism, however at development
of side effects from an organ of sight (conjunctivitis, chiolite) driving and working mechanisms contraindicated until total disappearance of side reactions.
Symptoms: a hypocalcemia, a hypophosphatemia, side reactions from upper parts of a digestive tract (heartburn, an esophagitis, gastritis, an ulcer).
Treatment: there is no specific antidote. Intake of milk, antacids is recommended. In order to avoid irritation of a gullet it is impossible to cause vomiting, the patient should accept vertical position (standing or sitting).
The form of release and packing
On 4 tablets place in blister strip packaging from aluminum foil. On 1 planimetric packing together with the instruction for medical use in the state and Russian languages put in a cardboard pack.
To Store storage conditions in original packing at a temperature from 15 °C to 30 °C.
To store out of children’s reach!
Not to use a period of storage of 5 years after expiry date!
According to the prescription
the Name and the country of the manufacturing organization and the packer
of LLC Gideon Richter Polsha, Poland
the Name and the country of the owner of the registration certificate
of JSC Gideon Richter, Hungary
the Address of the organization accepting in the territory of the Republic of Kazakhstan claims from consumers on quality of products: Representative office of JSC Gideon Richter in RK E-mail: Phone number: 8-(7272)-58-26-22, 8-(7272)-58-26-23
To develop firstname.lastname@example.org