Instructions for Osteogenon film-coated tablets blister pack No. 40
Composition
active ingredient: 1 tablet contains 830 mg of ossein-hydroxyapatite compound, which includes: ossein 291 mg, which includes non-collagen peptides and proteins (75 mg) and collagens (216 mg);
hydroxyapatite 444 mg, which includes calcium (178 mg) and phosphorus (82 mg);
Excipients: microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate, potato starch, hypromellose, titanium dioxide (E171), polyethylene glycol, talc, yellow iron oxide (E172).
Dosage form
Film-coated tablets.
Main physicochemical properties: oblong biconvex tablets, film-coated, uniformly colored in light yellow.
Pharmacotherapeutic group
Agents that affect bone structure and mineralization.
ATX code M05V X.
Pharmacological properties
Pharmacodynamics.
Calcium-phosphorus metabolism regulator used in systemic osteoporosis. The drug has a dual effect on bone metabolism: stimulating osteoblasts and inhibiting osteoclasts. These different actions physiologically complement each other and regulate the balance between bone resorption and bone tissue regeneration. Calcium, which is part of the drug, is contained in the form of hydroxyapatite, which contributes to a more complete absorption of calcium from the gastrointestinal tract. Phosphorus, which participates in the crystallization of hydroxyapatite, contributes to the fixation of calcium in the bones and inhibits its excretion by the kidneys.
Animal studies have shown that when administered orally, the organic component of the drug (ossein, which contains type I collagen, osteocalcin, growth factors, and other proteins) provides a more pronounced osteogenic effect than a single mineral component (hydroxyapatite).
Clinical studies have confirmed that the ossein-hydroxyapatite complex causes an anabolic effect on bone metabolism that exceeds that observed with the use of calcium alone.
Pharmacokinetics.
Studies using the isotope-labeled (47Сa) drug have demonstrated that absorption occurs in the intestinal tract.
The slow release of calcium from the ossein-hydroxyapatite compound ensures prolonged absorption in the gastrointestinal tract and results in the absence of a peak of hypercalcemia (unlike preparations containing only calcium salts).
Indication
Osteoporosis prevention.
Osteoporosis treatment.
Prevention or treatment of calcium deficiency in the body.
Adjunctive therapy to improve bone growth in fractures.
Contraindication
Hypersensitivity to the active substance or to other components of the drug.
Severe renal impairment; patients on hemodialysis.
Hypercalcemia, hypercalciuria, urolithiasis, tissue calcification.
Prolonged immobilization accompanied by hypercalciuria and/or hypercalcemia.
Children's age (see the "Children" section).
Interaction with other medicinal products and other types of interactions
Undesirable combinations.
Thiazide diuretics: may reduce urinary calcium excretion and cause hypercalcemia.
Combinations requiring special precautions
Vitamin D: Caution is required when using Osteogenon in combination with vitamin D, as vitamin D increases calcium absorption and may cause hypercalcemia.
Cardiac glycosides: risk of arrhythmias. Such patients should be closely monitored and regular monitoring of ECG and serum calcium levels is recommended.
Cyclins: risk of reduced absorption of cyclins in the intestinal tract with simultaneous use of calcium preparations due to the formation of insoluble chelates, therefore it is recommended to take Osteogenon and cyclins with an interval of at least 2 hours.
Preparations containing iron and zinc salts: risk of reduced absorption of iron and zinc in the intestinal tract with simultaneous use of calcium preparations due to the formation of insoluble chelates, therefore Osteogenon and these preparations are recommended to be taken with an interval of at least 2 hours.
Bisphosphonates: risk of reduced absorption of bisphosphonates in the intestinal tract with simultaneous use of calcium preparations due to the formation of insoluble chelates, therefore it is recommended to take Osteogenon and bisphosphonates with an interval of at least 2 hours.
Quinolones: risk of reduced absorption of quinolones in the intestinal tract with simultaneous use of calcium preparations due to the formation of insoluble chelates, therefore it is recommended to take Osteogenon and quinolones with an interval of at least 2 hours.
Glucocorticosteroids: when used concomitantly, glucocorticosteroids may reduce calcium absorption in the intestinal tract.
Strontium preparations: there is a risk of reduced absorption of strontium in the intestinal tract with simultaneous use of calcium preparations, therefore it is recommended to take Osteogenon and strontium preparations with an interval of at least 2 hours.
Thyroid hormones: risk of reduced absorption of levothyroxine in the intestinal tract.
Estramustine: risk of reduced absorption of estramustine with concomitant use of calcium preparations.
Application features
Calcium.
When used in combination with vitamin D, it is necessary to systematically monitor serum and urine calcium levels, and in case of their increase, adjust the doses accordingly.
With prolonged use of the drug and/or in the presence of impaired renal function, it is necessary to regularly monitor calcium levels in the urine and reduce doses or temporarily suspend treatment if levels exceed 7.5 mmol per 24 hours (300 mg per 24 hours) in adults and 0.12-0.15 mmol/kg body weight per 24 hours (5-6 mg/kg body weight per 24 hours) in children.
Before starting treatment in patients with a history of urolithiasis, the benefit-risk ratio of therapy should be carefully assessed.
In patients with moderate renal impairment, it is recommended to systematically monitor serum and urine calcium levels, and to avoid prescribing high doses of the drug and/or prolonged use.
Phosphorus.
In patients with moderate renal impairment, periodic monitoring of serum phosphorus levels is recommended.
Use during pregnancy or breastfeeding
Available data on the use of the drug in pregnant women (from 300 to 1000 patients) indicate the absence of malformations or feto/neonatal toxicity of Osteogenon.
Animal studies have not revealed reproductive toxicity of the drug.
If necessary, Osteogenon can be used during pregnancy.
The excretion of ossein-hydroxyapatite compound into animal milk has not been studied.
Studies of bioactive dietary supplements have demonstrated that calcium excretion into breast milk does not change with increasing calcium intake during lactation, even in women who previously had low calcium intake.
The ossein-hydroxyapatite compound, in particular calcium, is potentially excreted into breast milk in small amounts, however, when the drug is used in therapeutic doses, its effect on the child is not expected.
Osteogenon can be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Method of administration and doses
Tablets should be taken orally with a small amount of water, preferably during meals.
Adults and elderly patients should be prescribed 2-4 tablets per day (in divided doses in 2 doses). In case of severe osteoporosis, the dose may be increased at the doctor's discretion.
The course of treatment is determined by the doctor individually depending on the nature and course of the disease.
Children.
Because experience with ossein-hydroxyapatite compound in children is limited, recommendations for doses and treatment regimens in children have not yet been developed.
Overdose
An overdose of Osteogenon is unlikely.
The data below relate to an overdose of calcium salts (2000-2500 mg of calcium per day).
Symptoms of overdose: clinical symptoms are mainly associated with hypercalcemia and are non-specific, including thirst, polyuria, polydipsia, nausea, vomiting, dehydration, increased blood pressure, vasomotor disorders, constipation, loss of appetite, arrhythmias, weakness, nephrocalcinosis, nephrolithiasis, bone pain, mental changes.
In children, failure to gain weight/failure to thrive may precede all of these symptoms.
Treatment of overdose: drug withdrawal and restoration of water and electrolyte balance; depending on the severity of hypercalcemia, diuretics and/or corticosteroids, bisphosphonates, calcitonin should be used. Some patients may require peritoneal dialysis or hemodialysis.
Adverse reactions
Depending on the frequency, adverse reactions are divided into the following categories: very common (≥ 1/10), common (≥ 1/100, < 1/10), uncommon (≥ 1/1000, < 1/100), rare (≥ 1/10,000, < 1/1000), isolated (< 1/10,000), with an unknown frequency (available data do not allow to estimate the frequency of these reactions).
Metabolism and nutrition
Frequency not known: hypercalcemia (with prolonged use in high doses).
Gastrointestinal tract
Not known: gastrointestinal disorders, including nausea, abdominal pain, constipation.
Skin and subcutaneous tissue disorders
With unknown frequency: hypersensitivity reactions, including itching, rash.
Renal and urinary disorders
Frequency not known: hypercalciuria (with prolonged use in high doses).
Expiration date
4 years.
Storage conditions
Store in the original packaging out of the reach of children at a temperature not exceeding 25 ºС.
Packaging
10 tablets in a blister, 4 blisters in a cardboard box.
Vacation category
According to the recipe.
Producer
Pierre Fabre Medicament Production/Pierre Fabre Medicament Production.
Location of the manufacturer and its business address
Progipharm production site, Rue du Lycee, 45500 Gien, France/ site Progipharm, Rue du Lycee, 45500 Gien, France.
