Ostalon® Calcium-D (Ostalon® Calcium-D)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspfilm coated tablets in a set of 2 types: colcalceferol + calcium carbonate and alendronic acid
Composition:

Each tablet of colcalciferol + calcium carbonate contains:

Active substances:

colcalciferol powder 4,00 mg (in terms of colcalciferol 0.01 mg, which corresponds to vitamin D 400 IU): colcalciferol 0.01 mg; d,l-α-Tocopherol 0.008 mg; soybean oil hydrogenated 0.3 mg; gelatin 1.52 mg; sucrose 1.52 mg; corn starch 0.642 mg.

calcium carbonate 1500 mg (equivalent to 1578 mg calcium carbonate powder, in terms of calcium 600.00 mg): maltodextrin 76 mg, polysorbate 80 2 mg.

Excipients: cellulose crystalline 39 mg, copovidone 17 mg, crospovidone 8 mg, magnesium stearate 4 mg.

Film coating: septiphilm 4202 yellow 50 mg: hypromellose (55-65%), macrogol (10-16%), talc (10-20%); titanium dioxide (E171) (5-15%), iron dye oxide yellow (E172) (5%).

Each alendronic acid tablet contains:

Active substance: alendronic acid 70.00 mg (in the form of alendronate sodium trihydrate 91.35 mg).

Auxiliary substances of the core: cellulose microcrystalline 261.25 mg, silicon dioxide colloid 3.5 mg, croscarmellose sodium 1.28 mg, magnesium stearate 2.62 mg.

Shell accessories: Luster Klear LS 103 1 mg: microcrystalline cellulose ≈ 44%, carrageenan ≈ 18%, macrogol 8000 ≈ 38 %.

Description:

Tablets of colcalciferol + calcium carbonate: oblong, covered with a film coating of pale brownish-yellow color, tablets with a risk on one side; on the cross section the core of the tablet is white.

Tablets of alendronic acid: round biconvex tablets covered with a film shell of white color, with engraving "M14" on one side.

Pharmacotherapeutic group:Osteoporosis remedy combined (bone resorption inhibitor bisphosphonate + calcium-phosphorus metabolism regulator + calcium drug)
ATX: & nbsp
  • Alendronic acid and colcalciferol
    • Pharmacodynamics:

    Combined drug. Alendronic acid, being a bisphosphonate, penetrates into areas of active bone resorption, inhibits the process of resorption, without directly affecting the formation of new bone tissue, which leads to an increase in bone mass. During treatment, normal bone tissue is formed (at therapeutic doses alendronic acid does not cause osteomalacia).

    Calcium carbonate contains calcium, which is an important element that plays a key role in the electrolyte balance.It is necessary for muscle contraction, nerve impulses and blood coagulation. It plays a crucial role in the transmission of intracellular signal and in the control of various metabolic processes. Calcium is the main inorganic component of bone tissue. 99% of the total calcium content in the body is present in the bone tissue.

    Kolekaltsiferol increases the intestinal absorption of calcium and phosphate, regulates their excretion by the kidneys, and also regulates the concentration of calcium in the blood plasma.

    Pharmacokinetics:

    Alendronic acid: bioavailability when administered on an empty stomach 2 hours before meals - 0.64% (in women) and 0.6% (in men); at reception for 1-1.5 ч up to meal decreases on 40%. Coffee and orange juice reduces bioavailability by 60%. The volume of distribution is 28 liters (excluding bone tissue). When taken in therapeutic doses, the concentration of the drug in the plasma is less than 5 ng / ml. The connection with proteins is 78%. Kidney clearance - 71 ml / min (with a dose of 10 mg IV). After 6 hours after IV introduction, the concentration in the blood plasma is reduced by more than 95%. Half-life (T1/2) - 72 hours, final T1/2 more than 10 years (reflects excretion from bone tissue). It is excreted mainly by the kidneys, a small amount is removed through the intestine.

    Colocalciferol: The bioavailability of colcalciferol in combination with alendronic acid is similar to the bioavailability of colcalciferol in isolated administration.

    Calcium carbonate: approximately 1/5 - 1/3 part of the orally administered drug is absorbed in the small intestine; this process depends on the presence of vitamin D, pH, the characteristics of the diet and the presence of factors affecting the ability to bind calcium. The absorption of calcium increases with its deficiency and the use of a diet with a reduced content of calcium. In blood plasma, about 45% is in combination with proteins. About 20% is excreted by the kidneys, the rest amount (80%) is removed through the intestine.

    Indications:

    The combination of alendronic acid with colcalciferol + calcium carbonate is recommended in the treatment of:

    osteoporosis in postmenopausal women (reducing the risk of fractures, including hip fractures and compression fractures of the spine);

    - osteoporosis in men (reduced risk of fractures);

    - Osteoporosis, caused by long-term use of glucocorticosteroid drugs (GCS).

    Contraindications:

    For alendronic acid: individual intolerance to the drug; hypocalcemia; period of pregnancy; lactation period; childhood.Anomalies of the esophagus and other factors that complicate the passage of the esophagus (achalasia, stricture, etc.); inability of the patient to remain in an upright position (stand or sit upright) for 30 minutes; chronic renal failure (creatinine clearance <35 mL / min).

    For a combination of colcalciferol + calcium carbonate: increased individual sensitivity to the components of the drug; hypercalcemia (including as a result of hyperparathyroidism primary or secondary); hypercalciuria; calcium nephrolithiasis; hypervitaminosis D; sarcoidosis; osteoporosis due to immobilization; pulmonary tuberculosis (active form).

    Carefully:Diseases of the gastrointestinal tract in the phase of exacerbation: dysphagia, esophagitis, gastritis, peptic ulcer and duodenal ulcer.
    Pregnancy and lactation:Ostalon® Calcium-D is contraindicated in pregnancy and lactation.
    Dosing and Administration:

    Alendronic acid: Inside, 1 tablet 1 time per week. A tablet taken as a whole, in the morning on an empty stomach, drinking a glass of water, not less than 30 minutes before the first meal, drink or use of other drugs.

    The drug is recommended to be taken on the same day of the week.

    Drink only with normal water, as other beverages (including mineral water, coffee, tea, orange juice) reduce absorption.

    After taking the drug, the patient should maintain the vertical position of the body (standing or sitting) for at least 30 minutes. Do not take the drug before going to bed or before going to bed early.

    It is necessary to warn the patient that in case of missing the next dose of alendronic acid, the missed tablet should be taken the next day. In no case should you take two tablets on the same day.

    Tablets can not be chewed or rassasyvat.

    Kolekaltsiferol + calcium carbonate: Inside, 1 tablet daily, after dinner or dinner, with a glass of water. Do not chew the tablet. On the day of alendronic acid, the drug should be taken no earlier than 3 hours after taking alendronic acid.

    Side effects:

    Side effects associated with the reception of alendronic acid

    Often (1/100, <1/10)

    From the gastrointestinal tract: abdominal pain; dyspepsia; constipation; diarrhea; flatulence; ulcer of the esophagus; dysphagia; bloating; heartburn.

    From the side of the musculoskeletal system: ossalgia; arthralgia; myalgia.

    From the nervous system: headache; irritability.

    Infrequently (1/1000, <1/100)

    From the skin: itching; rash; hyperemia of the skin.

    From the gastrointestinal tract: nausea; vomiting; gastritis; esophagitis; erosion of the esophagus; melena.

    Rarely (1/10000, <1/1000)

    Are common: allergic reactions (hives, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis); transient symptoms that most often appear at the beginning of treatment (myalgia, weakness, poor health, in rare cases, fever); rash; photosensitization; asymptomatic hypocalcemia (often accompanied by predisposing factors) and hypophosphatemia. In the treatment of bisphosphonates, cases of development of osteonecrosis of the upper and lower jaw in patients with cancer on the background of antitumor treatment are described.

    From the gastrointestinal tract: narrowing of the esophagus; oropharyngeal ulcer; perforation of the upper gastrointestinal tract; ulcer; bleeding; However, the relationship with treatment is not always unambiguous.

    From the side of the organ of vision: uveitis; sclerite.

    Laboratory indicators: transient, mildly expressed asymptomatic hypocalcemia and hypophosphataemia.

    Side effects associated with taking a combination of colcalciferol + calcium carbonate.

    Infrequently (> 1/1000, <1/100)

    Metabolism and malabsorption of nutrients: hypercalcemia and hypercalciuria.

    Rarely (1/10000, <1/1000)

    From the gastrointestinal tract: constipation; flatulence; nausea; abdominal pain and diarrhea.

    From the skin: itching; rash; hives.

    Overdose:

    Alendronic acid: hypocalcemia, hypophosphatemia, as well as adverse reactions from the gastrointestinal tract: diarrhea, heartburn, esophagitis, gastritis or erosive-ulcerative lesions of the gastrointestinal tract.

    Treatment: milk or calcium - containing antacids to bind the drug. Due to the risk of irritation of the esophagus, do not induce vomiting, the patient should be given a vertical position (standing or sitting).

    Kolekaltsiferol + calcium carbonate: hypervitaminosis D and hypercalcemia. Symptoms of hypercalcemia include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, polyuria, bone pain, hypercreatininemia, hypercalciuria, arrhythmia.With prolonged use, calcinosis of blood vessels and tissues.

    In case of symptoms of overdose, see a doctor.

    Interaction:

    Simultaneous use of preparations of calcium, antacids and other drugs reduces the absorption of alendronic acid. The interval between taking drugs should be at least 1 hour.

    Ranitidine increases the bioavailability of alendronic acid by 2 times (the clinical value is not determined).

    Nonsteroidal anti-inflammatory drugs increase the side effects of alendronic acid from the gastrointestinal tract.

    Thiazide diuretics reduce the excretion of calcium. Because of the increased risk of hypercalcemia, serum calcium should be monitored regularly throughout the course of treatment with thiazide diuretics.

    GCS decreases calcium absorption. During the course of treatment of GCS, it may be necessary to increase the dose of the combination of colcalciferol + calcium carbonate. Simultaneous application with ion-exchange resins such as colestyramine or laxatives can reduce the absorption of vitamin D.

    Applying a combination colcalciferol + calcium carbonate Simultaneously with tetracycline it is possible either 2 hours before tetracycline reception, or 4-6 hours after. Combination colcalciferol + calcium carbonate can increase the toxicity of cardiac glycosides. Patients should conduct a study of calcium concentration, electrocardiography. With the simultaneous administration of sodium fluoride and colcalciferol + calcium carbonate, the interval between taking drugs should be at least 3 hours.

    Oxalic acid prevents absorption of calcium, because forms insoluble complexes with calcium ions. The patient should not take colcalciferol + calcium carbonate within 2 hours after intake of foods with a high content of oxalic acid (rhubarb, spinach).

    Special instructions:

    For alendronic acid

    To reduce the irritating effect on the esophagus, it should be taken immediately after the morning ascent, with a full glass of water, after taking it, do not lie down for 30 minutes (it is dangerous to use if the patient is unable to stand or sit for 30 minutes). Admission before bed or in the horizontal position increases the risk of esophagitis.

    In patients with hypocalcemia prior to treatment with alendronic acid, corrective therapy of mineral metabolism disorders, including hypovitaminosis D and hypoparathyroidism, is necessary.

    In the course of treatment, due to the positive effect of alendronic acid on the bone mineral density, there may be a slight asymptomatic decrease in the concentration of calcium and phosphate in the blood serum.

    When taking bisphosphonates (especially with concomitant therapy with GCS), it is necessary to ensure adequate intake of calcium and vitamin D with food or in the form of medications.

    There are reports of an osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis) in cancer patients receiving mainly intravenous bisphosphonates. Many of these patients also received chemotherapy and GCS. There are also reports of osteonecrosis of the jaw in patients with osteoporosis receiving oral bisphosphonates.

    Prior to the appointment of bisphosphonate therapy to patients with concomitant risk factors (eg, cancer, chemotherapy, radiation therapy,inadequate oral hygiene) it is necessary to undergo dental examination with appropriate preventive treatment of teeth.

    Patients on bisphosphonate treatment should avoid invasive dental procedures whenever possible. In patients who are on therapy with bisphosphonates, with developed osteonecrosis of the jaw, dental surgical interventions can lead to deterioration. If surgical intervention is necessary, it should be taken into account that there is no data on the possibility of reducing the risk of developing an osteonecrosis of the jaw after the bisphosphonate has been withdrawn.

    For the combination of colcalciferol + calcium carbonate

    To avoid an overdose, additional intake of vitamin D from other sources should be considered.

    The intake of food containing oxalates (sorrel, spinach) and phytidine (cereals) reduces the absorption of calcium, so do not take colcalciferol + calcium carbonate for two hours after taking sorrel, spinach, cereals.

    Effect on the ability to drive transp. cf. and fur:On the adverse effects of drugs on the ability to drive and engage in other activities,requiring concentration of attention and speed of psychomotor reactions, was not reported.
    Form release / dosage:

    Tablets covered with a film shell in a set of 2 types:

    cola celciferum 400 IU + calcium carbonate 1500 mg and alendronic acid 70 mg.

    Packaging:

    Tablets kolokaltsiferola + calcium carbonate: on 14 tablets covered with a film sheath in a blister of PVC / Al.

    Tablets of alendronic acid: 4 tablets coated with a film membrane in a blister from Al / Al.

    Ostalon® Calcium-D

    Each 2 blisters of colcalciferol + calcium carbonate and 1 blister of alendronic acid tablets or every 6 blisters of tablets of colcalciferol + calcium carbonate and 3 blisters of alendronic acid tablets together with instructions for use in a cardboard pack.

    Storage conditions:

    Store in a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001387/10
    Date of registration:25.02.2010 / 14.01.2013
    Expiration Date:Unlimited
    The owner of the registration certificate:GEDEON RICHTER, OJSC GEDEON RICHTER, OJSC Hungary
    Manufacturer: & nbsp
    Representation: & nbspGEDEON RICHTER OJSC GEDEON RICHTER OJSC Hungary
    Information update date: & nbsp14.06.2017
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