Osteogenon (Osteogenon)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsp
coated tablets

Composition:

Each tablet, coated with a shell, contains:

The core of the tablet

Active ingredient: the compound ossein-hydroxyapatite (OCS) - 830 mg (refers to the dry substance), corresponding to: ossein - about 291 mg, consisting of:

non-collagen peptides / proteins - 75 mg, collagen - 216 mg;

calcium hydroxyphosphate (hydroxyapatite) - about 444 mg,

including: calcium - 178 mg, phosphorus - 82 mg;

the inactive organic fraction of OGS is about 95 mg,

consisting of lipids, citric acid, glycosoaminoglycan, carbonates in various proportions, depending on the particular batch of animal raw materials.

Excipients: microcrystalline cellulose - 69 mg; silicon dioxide colloid - 10 mg; magnesium stearate - 3 mg; potato starch - 15 mg (water content in OCS - about 58 mg).

Sheath:

hypromellose - 9.0 mg; macrogol - 1,5 mg; iron oxide yellow - 0.5 mg; titanium dioxide 3.0 mg; talc - 1.0 mg

Description:Biconvex, oblong-shaped tablets, coated, light yellow in color.
Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
ATX: & nbsp
  • Other drugs affecting the mineralization of bones
    • Pharmacodynamics:
    Osteogenon contains a complex of organic components of bone matrix and microcrystals of hydroxyapatite, in which calcium and phosphorus are present in physiologically balanced proportions.Ossein contains non-collagen peptides, proteins, collagen, organic components of non-protein nature, which have a positive effect on the formation of bone tissue.
    Clinical studies in healthy volunteers have shown that the absorption of calcium required for bone synthesis with the application of the ossein-hydroxyapatite compound is higher than when using other preparations containing calcium salts.
    Pharmacokinetics:
    Absorption of the drug occurs in the intestine. Slow dissolution of the ossein-hydroxyapatite compound ensures a gradual absorption of calcium throughout the intestine, including in the distal parts. Slow dissolution of the compound provides a long suction.
    Pre-clinical safety data
    Preclinical data obtained during toxicity, genotoxicity and reproductive toxicity studies with repeated use of the drug did not reveal potential risks to human health.
    Indications:
    Osteoporosis of various etiologies (postmenopausal, senile, caused by the use of glucocorticosteroids).
    To regulate the calcium-phosphorus balance during pregnancy and during breastfeeding.
    As an additional therapy for fractures of bones.
    Contraindications:
    Hypersensitivity to the drug components, severe renal failure, hemodialysis, hypercalcaemia, hypercalciuria, calcium nephrolithiasis or calcification of tissues, children's age.
    Pregnancy and lactation:
    Pregnancy
    The available data on the use of ossein-hydroxyapatite compounds during pregnancy indicate the absence of malformative or feto / neonatal toxicity. Pre-clinical studies in animals showed no reproductive toxicity. The drug Osteogenon can be used during pregnancy in the presence of clinical indications.
    Breast-feeding
    The ossein-hydroxyapatite compound and, in particular, calcium can potentially penetrate into breast milk. According to available data, when applying Osteogenon in the recommended dose range, no adverse effect on the breastfed infant is expected.
    The drug Osteogenon can be used during breastfeeding.
    Dosing and Administration:

    The drug is taken orally, with food, with a small amount of water. Tablets can not be chewed.

    With osteoporosis: 2-4 tablets 2 times a day.

    To regulate the calcemic-phosphorus balance during pregnancy and during breastfeeding: 1-2 tablets per day.

    As an additional therapy for bone fractures in patients without bone pathology: 1-2 tablets per day. In patients with bone disease, the dose is determined by the doctor, based on a specific clinical situation.

    The duration of the course of treatment is determined by the doctor.

    Side effects:

    Undesirable reactions are systematized according to the system-organ classes in accordance with MedDRAnd according to the frequency of development in accordance with the WHO Classification:

    Often (≥1/10), often (≥ 1/100, but <1/10), infrequently (≥1/1000, but <1/100), rarely (≥ 1/10000, but <1/1000), very rarely (<1/10000), frequency is unknown - the frequency can not be determined from the available data.

    Disorders from the metabolism and nutrition:

    frequency unknown - hypercalcemia (elevated concentration of calcium in the blood plasma).

    Disorders from the gastrointestinal tract:

    frequency unknown - nausea, abdominal pain, constipation.

    Disturbances from the skin and subcutaneous tissues:

    frequency unknown rash, itching.

    Disorders from the kidneys and urinary tract:

    frequency unknown - hypercalciuria (increased concentration of calcium in the urine).

    If any undesirable reactions occur, inform your doctor.

    Overdose:
    Overdose is possible with the intake of calcium in a dose of over 2000 mg / day (more than 11 tablets of the drug Osteogenone per day).
    Clinical symptoms are mainly associated with hypercalcemia: thirst, polyuria (increased urine formation), nausea, vomiting, dehydration, increased blood pressure, vasomotor disorders, constipation, loss of appetite, arrhythmia, general weakness, nephrocalcinosis, nephrolithiasis, bone pain, alteration of mental status.
    Treatment: stop taking the drug; standard treatment includes rehydration, correction of abnormalities in the level of electrolytes in the blood plasma; if necessary, use diuretics, glucocorticosteroids, bisphosphonates, calcitonin. In some cases, peritoneal dialysis or hemodialysis may be required.
    Interaction:

    Joint use is not recommended

    Thiazide diuretics: there is a risk of hypercalcemia as a result of reduced excretion of calcium in the urine.

    Joint use with caution

    Cardiac glycosides: there is a risk of heart rhythm disturbances. Medical supervision is recommended, if necessary - electrocardiography, control of calcium concentration in blood plasma. Tetracyclines: decrease in absorption of tetracyclines in the gastrointestinal tract. Between the medications of the drugs, you need to take a break for at least two hours.

    Medicinal preparations and biologically active additives containing iron and zinc: risk of reducing intestinal absorption of iron and zinc in connection with the formation of chelate compounds. Between the medications of the drugs, you need to take a break for at least two hours.

    Bisphosphonates: the risk of reducing the intestinal absorption of bisphosphonates in connection with the formation of chelate compounds. Between the medications of the drugs, you need to take a break for at least two hours.

    Quinolones: risk of reducing the intestinal absorption of quinolones in connection with the formation of chelating compounds. Between the medications of the drugs, you need to take a break for at least two hours.

    Glucocorticosteroids: risk of reducing intestinal calcium absorption.Between the medications of the drugs, you need to take a break for at least two hours.

    Strontium preparations: risk of reducing intestinal absorption of strontium. Between the medications of the drugs, you need to take a break for at least two hours.

    Thyroid hormones: risk of reducing intestinal absorption of levothyroxine. Between the medications of the drugs, you need to take a break for at least two hours.

    Estramustine: risk of decreased estramustine absorption. Between the medications of the drugs, you need to take a break for at least two hours.

    Special instructions:
    Calcium
    When combined with vitamin O, regular monitoring of calcium concentration in blood plasma and urine is necessary. In the case of an increase in the concentration of calcium in the blood or urine above the limit values, dosage adjustment is necessary. Patients with renal insufficiency are recommended regular monitoring of calcium concentration in blood plasma and urine. Avoid application of the drug in large doses and (or) long-term treatment. It is necessary to reduce the dose or temporarily stop taking the drug if the concentration of calcium in the urine reaches 7.5 mmol / 24 hours (300 mg / 24 hours).

    Patients with history of calcium history of nephrolithiasis the following is recommended: adhere to a standard preventive diet; Limit the dose of calcium obtained with the drug Osteogenone to 500 mg per day (no more than three tablets per day); to adjust the intake of calcium with food in order not to exceed the daily dose of calcium of 1.5 g; avoid concomitant medication containing vitamin D.

    Phosphorus

    Patients with moderate renal insufficiency it is recommended to regularly monitor the concentration of phosphorus in the blood plasma.

    Effect on the ability to drive transp. cf. and fur:Special studies have not been conducted. The cases of the effect of the drug on the ability to perform potentially dangerous activities requiring an increased concentration of attention and speed of psychomotor reactions (vehicle management, work with moving mechanisms) have not been revealed.
    Form release / dosage:
    Tablets coated with a coating, 830 mg.
    Packaging:For 10 tablets in a blister of PVC / PVDC and aluminum foil. 4 blisters with instructions for use in a pack of cardboard.
    Storage conditions:At a temperature of no higher than 30 ° C. Keep out of the reach of children.
    Shelf life:
    4 years. Do not use after expiry date.
    Terms of leave from pharmacies:On prescription
    Registration number:П N013182 / 01
    Date of registration:30.07.2007
    Expiration Date:Unlimited
    The owner of the registration certificate:Pierre Fabre Medication ProductionPierre Fabre Medication Production France
    Manufacturer: & nbsp
    Representation: & nbspPIER FABR PIER FABR France
    Information update date: & nbsp14.06.2017
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