Universal reference book for medicines
Name of the preparation: OSTALON ® CALCIUM-D (OSTALON ®CALCIUM-D)

Active substance: alendronic acid, calcium carbonate, colecalciferol

Type: Combined drug for the treatment of osteoporosis

Manufacturer: GEDEON RICHTER (Hungary) manufactured by BERES Pharmaceuticals (Hungary) and GEDEON RICHTER POLAND (Poland)
Composition, form of production and packaging
Set of tablets:

The tablets covered with a film shell of white color, round, biconcave, with engraving "M14" on one side.
(4 pcs in the blister).
1 tab.

alendronate sodium trihydrate 91.35 mg,

which corresponds to the content of alendronic acid 70 mg

Excipients: microcrystalline cellulose - 261.25 mg, silicon colloidal dioxide - 3.5 mg, croscarmellose sodium - 1.28 mg, magnesium stearate - 2.62 mg.

The composition of the film shell: chandelier LS103 - 7 mg (microcrystalline cellulose - 44%, carrageenan - 18%, macrogol 8000 - 38%).

Tablets covered with a film membrane of pale brownish-yellow color, oblong, with a risk on one side;
on the cross-section - the core of white color (14 pieces in a blister).
1 tab.

colcalciferol (Vit D 3 ) 10 μg (400 IU)

calcium carbonate 1.5 g,

which corresponds to a calcium content of 600 mg

Auxiliary substances: D, L -? Tocopherol - 0.008 mg, hydrogenated soybean oil 0.3 mg, gelatin 1.52 mg, sucrose 1.52 mg, corn starch 0.642 mg, maltodextrin 76 mg, polysorbate 80 2 mg, cellulose microcrystalline - 39 mg, copovidone - 17 mg, crospovidone - 8 mg, magnesium stearate - 4 mg.

The composition of the film sheath: sepiphilm 4202 yellow 50 mg (hypromellose 55-65%, macrogol 10-16%, talc 10-20%, titanium dioxide (E171) 5-15%, iron dye oxide yellow (E172) - 5%).

14 pcs.
(tab.) - blisters (2) +4 pcs. (tab.) - blisters (1) - packs of cardboard.
14 pcs.
(tab.) - blisters (6) +4 pcs. (tab.) - blisters (3) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2015.

PHARMACHOLOGIC EFFECT

Inhibitor of bone resorption in osteoporosis.

Alendronic acid , being a bisphosphonate, penetrates into the zones of active bone resorption, inhibits the resorption process, without directly affecting the formation of new bone tissue, which leads to an increase in bone mass.
During treatment, normal bone tissue is formed (in 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 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

Suction and distribution

Bioavailability when taken on an empty stomach for 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%. When taken in therapeutic doses, the concentration of the drug in the plasma is less than 5 ng / ml.
V d - 28 l (excluding bone tissue).
Binding to proteins - 78%.
Excretion

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%. T1/2 - 72 h, final T 1/2 - more than 10 years (reflects excretion from bone tissue). It is excreted mainly by the kidneys, a small amount is removed through the intestine.
Kolekaltsiferol

Bioavailability of colcalciferol in combination with alendronic acid is similar to the bioavailability of colcalciferol in isolated administration.

Calcium carbonate

Suction and distribution

Approximately 1 / 5-1 / 3 part of the orally administered drug is absorbed into the small intestine;
this process depends on the presence of vitamin D, pH, dietary characteristics 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.
Excretion

About 20% is excreted by the kidneys, the rest amount (80%) is removed through the intestine.

INDICATIONS

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

- osteoporosis in men (reduced risk of fractures);

- Osteoporosis, caused by a long reception of GCS.

DOSING MODE

Tablets containing alendronic acid , appointed inside, 1 tab.
1 time a week. The drug is recommended to be taken on the same day of the week.
The tablet is taken whole, in the morning on an empty stomach, with a glass of water, at least 30 minutes before the first meal, drinking beverages or other medicines.Tablets can not be chewed or rassasyvat.
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 2 tablets on the same day.
Tablets containing a combination of colcalciferol + calcium carbonate, is prescribed by mouth, 1 tab.
daily, after dinner or dinner, with a glass of water. Do not chew the tablet. On the day of taking alendronic acid, the drug should be taken no earlier than 3 hours after taking alendronic acid.
SIDE EFFECT

Adverse reactions associated with the administration of alendronic acid

Determination of the frequency of adverse reactions: often (> 1/100, <1/10), infrequently (> 1/1000, <1/100), rarely (> 1/10 000, <1/1000).

On the part of the digestive system: often (? 1/100, <1/10) - abdominal pain, indigestion, constipation, diarrhea, flatulence, ulcer of the esophagus, dysphagia, bloating, heartburn;
infrequently (? 1/1000, <1/100) - nausea, vomiting, gastritis, esophagitis, erosion of the esophagus, melena; rarely (? 1/10 000, <1/1000) - narrowing of the esophagus, oropharyngeal ulcer, perforation of the upper gastrointestinal tract, ulcer, bleeding (connection with treatment is not always unambiguous).
From the osteomuscular system: often (? 1/100, <1/10) - ossalgia, arthralgia, myalgia.

From the nervous system: often (? 1/100, <1/10) - headache;
irritability.
On the part of the skin: infrequently (? 1/1000, <1/100) - itching, rash, skin hyperemia.

Allergic reactions: rarely (? 1/10 000, <1/1000) - urticaria, angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis).

From the side of the organ of vision: rarely (? 1/10 000, <1/1000) - uveitis, scleritis.

Laboratory indicators: rarely (? 1/10 000, <1/1000) - transient, mildly expressed asymptomatic hypocalcemia and hypophosphatemia.

On the part of the body as a whole: rarely (? 1/10 000, <1/1000) - transient symptoms that most often appear at the beginning of treatment (myalgia, weakness, poor health, rarely body temperature), rash, photosensitization , asymptomatic hypocalcemia (often accompanied by predisposing factors) and hypophosphataemia.
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.
Adverse reactions associated with taking a combination of colcalciferol + calcium carbonate

From the digestive system: rarely (? 1/10 000, <1/1000) - constipation, flatulence, nausea, abdominal pain, diarrhea.

From the side of metabolism: infrequently (? 1/1000, <1/100) - hypercalcemia, hypercalciuria.

From the skin: rarely (? 1/10 000, <1/1000) - itching, rash, urticaria.

CONTRAINDICATIONS

For alendronic acid

- hypocalcemia;

- abnormalities of the esophagus and other factors that impede the passage of the esophagus (achalasia, stricture);

- the inability of the patient to remain in an upright position (stand or sit upright) for 30 minutes;

- chronic renal failure (CK <35 ml / min);

- Pregnancy;

- lactation period;

- childhood;

intolerance to the drug.

For the combination of colcalciferol + calcium carbonate

- hypercalcemia (including as a result of hyperparathyroidism primary or secondary);

- hypercalciuria;

- Calcium nephrolithiasis;

- hypervitaminosis D;

- sarcoidosis;

osteoporosis due to immobilization;

- pulmonary tuberculosis (active form);

- increased individual sensitivity to the components of the drug.

With caution should prescribe the drug for gastrointestinal diseases in the phase of exacerbation: dysphagia, esophagitis, gastritis, peptic ulcer of the stomach and duodenum.

PREGNANCY AND LACTATION

Ostalon ® Calcium-D is contraindicated in pregnancy and lactation.

APPLICATION FOR FUNCTIONS OF THE LIVER

Contraindication: chronic renal failure (CC <35 mL / min).

APPLICATION FOR CHILDREN

Contraindication: children's age.

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 is necessary, incl.
hypovitaminosis D and hypoparathyroidism.
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 osteonecrosis of the jaw, usually associated with tooth extraction and / or local infection (including osteomyelitis) in cancer patients who received mostly IV 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.
Before the appointment of bisphosphonate therapy to patients with concomitant risk factors (eg cancer, chemotherapy, radiation therapy, SCS, insufficient oral hygiene), it is necessary to undergo dental examination with appropriate preventive dental treatment.

Patients on treatment with bisphosphonates 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 you should not take kolkaltsiferol + calcium carbonate for 2 hours after eating sorrel, spinach, cereals.

Impact on the ability to drive vehicles and manage mechanisms

The adverse effects of drugs on the ability to drive vehicles and to engage in other activities that require concentration and speed of psychomotor reactions were not reported.

OVERDOSE

Alendronic acid

Symptoms: hypocalcemia, hypophosphatemia, as well as adverse reactions from the gastrointestinal tract (diarrhea, heartburn, esophagitis, gastritis or erosive-ulcerative gastrointestinal lesions).

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).
Calcaleciferol + calcium carbonate

Symptoms: hypervitaminosis D, hypercalcemia, which manifest anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, polyuria, pain in the bones, hypercreatinemia, hypercalciuria, arrhythmia.
With long-term use - calcification of blood vessels and tissues.
DRUG 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 a factor of 2 (the clinical value is not determined).

NSAIDs increase the side effects of alendronic acid from the digestive 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 use with ion-exchange resins such as colestyramine or laxatives can reduce absorption of vitamin D.

The combination of colcalciferol + calcium carbonate concurrently with tetracycline is possible either 2 hours before tetracycline is administered, or 4-6 hours after.

The combination of colcalciferol + calcium carbonate can increase the toxicity of cardiac glycosides.
Patients should conduct a study of the concentration of calcium, ECG.
With the simultaneous administration of sodium fluoride and a combination of 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 tablets containing a combination of colcalciferol + calcium carbonate for 2 hours after ingestion of foods high in oxalic acid (rhubarb, spinach).
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, dry place at a temperature of no higher than 25 ° C.
Shelf life - 2 years.
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