Universal reference book for medicines
Product name: OSTEOGENON ®

Active substance: nonappropriate

Type: A drug regulating bone metabolism

Manufacturer: PIERRE FABRE MEDICAMENT PRODUCTION (France)
Composition, form of production and packaging
The tablets covered with a cover of
light yellow color, oblong, biconcave.

1 tab.

ossein-hydroxyapatite compound 830 mg

Excipients: microcrystalline cellulose, silicon dioxide colloid, magnesium stearate, potato starch.

Sheath composition: hypromellose, titanium dioxide, macrogol, talc, iron oxide yellow .

10 pieces.
- blisters (4) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

A drug that affects the mineralization of bones (the calcium-phosphorus metabolism regulator).

Osteogenone contains the components necessary for the synthesis of bone tissue and has a dual effect on the metabolism of bone tissue: it stimulates osteoblasts and inhibits osteoclasts.

Calcium is contained in the preparation in the form of hydroxyapatite (in relation to phosphorus 2: 1), which contributes to its full absorption from the digestive tract.Inhibits the production of parathyroid hormone and prevents hormone-induced bone resorption.
Delayed release of calcium from hydroxyapatite causes the absence of a peak of hypercalcemia.
Phosphorus, involved in the crystallization of hydroxyapatite, promotes the fixation of calcium in the bone and inhibits its excretion by the kidneys.

Ossein is an organic component of the preparation containing local regulators of bone tissue remodeling (? -transforming growth factor, insulin-like growth factors I and II, osteocalcin, collagen type 1), which activate the process of bone formation and inhibit the resorption of bone tissue.

? -transforming growth factor stimulates the activity of osteoblasts, increases their number, promotes the production of collagen, and also inhibits the formation of osteoclastic progenitors.

Insulin-like growth factors I and II stimulate the synthesis of collagen and osteocalcin.

Osteocalcin promotes the crystallization of bone tissue by binding calcium.

Collagen type 1 provides the formation of bone matrix.

PHARMACOKINETICS

Data on the pharmacokinetics of the drug are not available.

INDICATIONS

- prevention and treatment of primary osteoporosis of various etiologies (premenopausal, menopausal, senile);

- prevention and treatment of secondary osteoporosis of various etiologies (due to rheumatoid arthritis, liver and kidney diseases, hyperthyroidism, hyperparathyroidism, imperfect bone formation, application of GCS, heparin, immobilization);

- correction of osteopenia and violations of phosphoric-calcium metabolism (including during pregnancy and during breastfeeding);

- acceleration of healing of bone fractures.

DOSING MODE

Adults with osteoporosis are advised to take inside 2-4 tab.
2 times / day; for other indications - 1-2 tablets / day.
The duration of treatment is determined by the patient's condition.

SIDE EFFECT

In very rare cases (<1/1 000 000), allergic reactions are possible ;
with prolonged use - hypercalcemia, hypercalciuria.
CONTRAINDICATIONS

- severe renal insufficiency;

- hemodialysis;

- pronounced hypercalciuria;

- childhood;

- Hypersensitivity to the components of the drug.

PREGNANCY AND LACTATION

Osteogenon can be used during pregnancy and during breastfeeding after indications after a doctor's consultation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindicated use of the drug in severe hypercalciuria.

SPECIAL INSTRUCTIONS

Patients who are predisposed to urolithiasis may need to adjust the dosage regimen depending on laboratory parameters.

Patients with impaired renal function should avoid prolonged use of high doses of the drug.

The composition of the drug includes only trace amounts of sodium chloride, so the use of osteogenone in patients with hypertension is acceptable.

OVERDOSE

At present, there have been no reports of overdose of Osteogenon.

DRUG INTERACTION

Osteogenon slows down the absorption of iron preparations, bisphosphonates and antibiotics of the tetracycline group, so when used simultaneously with these drugs, the interval between their intake should be at least 4 hours.

When Osteogenon is simultaneously used with vitamin D or thiazide diuretics, the doctor should assess the risk of developing hypercalcemia due to increased calcium resorption.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children at a temperature of no higher than 30 ° C.
Shelf life - 4 years.
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