Universal reference book for medicines
Product name: OSVAREN (OSVAREN)

Active substance: calcium acetate, magnesium carbonate

Type: The drug for the treatment of hyperphosphataemia

Manufacturer: FREZENIUS JV (Russia) manufactured by ARTESAN PHARMA (Germany)
Composition, form of production and packaging
The tablets covered with a film membrane
from white to light yellow color, oblong, with risk from one side;
on the fault: the core of the tablet is white or almost white.
1 tab.

Calcium acetate 435 mg

magnesium hydroxycarbonate 235 mg

Excipients: pregelatinized starch, corn starch, sucrose, gelatin, croscarmellose sodium, magnesium stearate.

Sheath composition: castor oil ordinary oil, hypromellose.

180 pcs.
- cans of high-density polyethylene.
INSTRUCTION FOR THE SPECIALIST.

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

PHARMACHOLOGIC EFFECT

OsvaRen is intended for the treatment of patients with chronic renal failure.
Such patients can not excrete phosphates through the kidneys in normal amounts, which leads to hyperphosphataemia. Diet or elimination of phosphates are insufficient measures therefore, phosphate-binding drugs should be used to reduce the absorption of phosphate in the digestive tract. Because calcium acetate and magnesium carbonate are phosphate binders, they, together with food phosphates, form poorly soluble calcium and magnesium phosphate salts that are excreted through the intestine. Calcium acetate reaches its maximum phosphate binding capacity at pH values ​​of 6-8.Therefore, Oswara is also suitable for phosphate binding in patients with hypo- or anacidic conditions.
PHARMACOKINETICS

Absorption

In the event that food phosphates or other nutrients do not cause precipitation of magnesium complexes, the dissolved magnesium ions remain bioavailable and absorbed in the intestine.

The absorption of orally administered magnesium in healthy people depends on the amount of its intake.
The experiments showed that the rate of absorption in patients who took 1.5 mmol of magnesium per day was 65%, and in patients who took 40 mmol of magnesium per day, this value was only 11%. Dissolved calcium ions are bioavailable and can be absorbed through the intestinal tract until calcium forms insoluble calcium complexes with phosphate contained in food or other nutrients. Calcium is actively absorbed in the duodenum and the proximal part of the jejunum, and to a lesser extent, in the more distally located segments of the small intestine. The absorption of calcium is controlled by hormonal regulatory mechanisms. The absorption coefficient increases at higher doses and with hypocalcemic states, and decreases with age. AT
depending on the concentration of vitamin D and the calcium doses taken, the relative absorption may be 10-35%.
The assignment of higher doses will only result in a slight increase in the absorbed amount. Normal daily intake with food is approximately 1000 mg.
Distribution

The total magnesium content in the body is about 20-28 g. In healthy adults, about 53% of the total magnesium of the body is in bones, 27% in muscles, 19% in soft tissues, and less than 1% in extracellular.
Most of the intracellular magnesium is in bound form.
In a person with a body weight of 70 kg, the total calcium content in the body is approximately 1250 g (31 moles), 99% of which are found in bones and teeth.Approximately 1 g is in the plasma and extracellular fluid, and from 6 to 8 g - directly in the tissues.
Depending on the measurement methods, the reference values ​​for serum total calcium vary from laboratory to laboratory, and within the normal range are 2.15-2.57 mmol / l. Approximately 40 to 45% of this amount is associated with plasma proteins, approximately 8 to 10% form complexes with citrate-type ions, and 45 to 50% are in a dissociated state in the form of free ions.
Excretion

Orally prescribed magnesium salts are excreted through the kidneys and intestines.
Small amounts enter the breast milk. Magnesium passes the placental barrier. Under physiological conditions, calcium is excreted in approximately equal amounts in urine and intestines. Parathyroid hormone, vitamin D and thiazide diuretics reduce urinary calcium excretion, while other diuretics (loop diuretics), calcitonin and growth hormone, increase renal excretion. Urinary calcium excretion decreases in the early stages of renal failure. Urinary calcium excretion increases during pregnancy. Calcium is also excreted by sweat glands. Calcium passes the placental barrier and is distributed into breast milk.
INDICATIONS

Treatment of hyperphosphataemia associated with chronic renal failure in patients on dialysis (hemodialysis, peritoneal dialysis).

DOSING MODE

From 3 to 10 tablets with film coating per day, depending on the serum phosphate level.
The daily dose should be divided according to the number of meals a day (usually three times a day).
The recommended starting dose is three tablets daily.

If necessary, the dosage can be increased up to a maximum of 12 tablets with film coating per day.

To achieve the maximum phosphate binding effect, Osvaren should only be taken with food;
tablets can not be crushed or chewed.
To facilitate swallowing, tablets should be taken with a small amount of liquid.

If the patient has difficulty swallowing the tablet because of its size, if necessary, the tablet can be broken in half along the separation label, so the two halves of the tablet can be taken directly one after another.
In this case, the tablets should be divided into halves immediately before taking in order to avoid the appearance of a taste of acetic acid.
Because the speed and / or extent of absorption of other oral medications may vary with simultaneous use with Oswaren, no other oral medication should be taken within 2 hours before and 3 hours after taking Oswaren.

In the case of a missed dose, the next dose should be taken at the usual time (no attempt should be made to make up the missed dose).

It can be used for a long time.

SIDE EFFECT

Determination of the frequency of adverse reactions: very often -? 1/10, often - from? 1/100 to <1/10, sometimes - from? 1/1000 to <1/100, rarely - from? 1/10000 to <1 / 1000, very rarely - <1/10000, unknown (can not be estimated from the available data).

Gastrointestinal disorders: often - softening of the stool, irritation of the gastrointestinal tract, such as nausea, anorexia, sensation of a full stomach, belching, constipation, diarrhea.

Disorders of metabolism and nutrition: often - hypercalcemia, both asymptomatic and accompanied by symptoms;
asymptomatic hypermagnesemia. Mild hypercalcemia (Ca> 2.6 mmol / L) may occur in approximately 1% of patients and may be asymptomatic or manifest with symptoms such as constipation, anorexia, nausea and vomiting; sometimes - hypercalcemia, from moderate to severe, accompanied by symptoms; Hypermagnia, accompanied by symptoms. Hypercalcemia of higher degrees (Ca> 3.0 mmol / L) can occur in approximately 0.1% of patients and may be accompanied by heart rhythm disturbances, confusion, lethargy, delirium, stupor and in very severe cases - coma.
Patients should note that if any of these symptoms are found, consult a doctor;
very rarely - hyperkalemia, magnesium-induced bone mineralization; rarely - allergic reactions (hypersensitivity) to calcium acetate, magnesium carbonate or any of the components of the drug Oswara.
CONTRAINDICATIONS

- hypophosphatemia;

- hypercalcemia with or without clinical symptoms, for example, as a result of vitamin D overdose, paraneoplastic syndrome (bronchial carcinoma, breast cancer, renal cell carcinoma, plasmacytoma), bone metastases, sarcoidosis or immobilization osteoporosis;

- elevated serum magnesium levels, greater than 2 mmol / l, and / or hypermagnesia symptoms;

- Atrioventricular block III degree;

myasthenia gravis;

- hypersensitivity to active substances or to any of the excipients;

- Children's age (up to 18 years).

PREGNANCY AND LACTATION

There are no available data on animal studies and Oswara's clinical studies.
It is not known whether Oswaren can cause embryonic defects if administered during pregnancy, and whether it can affect fertility. Therefore, Oswara should be prescribed only to those pregnant women whose potential benefits from using the drug clearly outweigh the risks.
Calcium acetate and magnesium carbonate are excreted in breast milk.
Breastfeeding is not recommended during Oswaren's treatment.
APPLICATION FOR CHILDREN

Contraindicated in children and adolescents under 18 years.

SPECIAL INSTRUCTIONS

Carefully

Use should be made with caution (only with continuous monitoring of serum calcium, magnesium and phosphate), only in the case of severe hyperphosphataemia exceeding the phosphorus-calcium product of 5.3 mmol 2 / L 2 , if available:

- refractory to therapy,

- refractory hyperkalemia,

- clinically relevant bradycardia or an atrioventricular block of the second degree with bradycardia.

You should avoid taking calcium salts in patients with calcium kidney stones, or anamnesis of kidney stones.
Calcium salts should be given cautiously to patients with diseases associated with hypercalcemia, such as sarcoidosis and certain malignant diseases.
Continuous monitoring of serum phosphate, magnesium and calcium, as well as phosphorus-calcium product, should be carried out even more carefully in case of simultaneous administration of vitamin D and thiazide diuretics.

The use of phosphate binding drugs should be preceded by advising the patient on diet, regarding the consumption of phosphates, and may depend on the type of dialysis treatment that has been prescribed to the patient.

High doses and long-term use of Oswara can lead to hypermagnesemia.
Hypermagneemia is mainly asymptomatic, but in some cases, systemic manifestations can occur.
If patients with chronic renal insufficiency receive Osvaren, they may develop episodes of hypercalcemia, especially with the combined use of vitamin D metabolites.

Patients should be warned about possible symptoms of hypercalcemia.

In the case of hypercalcemia and / or hypermagiaemia, the dose should be reduced or discontinued depending on the degree of hypercalcemia.

In the case of long-term treatment, Osvaren, attention should be paid to the progression (or appearance) of calcification of vascular and soft tissues.
The risk decreases with a decrease in the phosphorus-calcium product <4.5 mmol 2 / l 2 .
In patients taking digitalis glycosides, Osvaren should be used under ECG control and with monitoring the serum calcium level.

Large amounts of calcium salts in the digestive tract can lead to precipitation of fatty acids and bile acids in the form of calcium salts.
This can lead to constipation.
Patients should take note and consult before taking antacids containing calcium or magnesium salts to avoid additional calcium or magnesium load.

In case of diarrhea, the dosage of Osvaren should be reduced.

OsvaRen contains sucrose.
Because of the presence of sucrose, patients with rare hereditary pathologies of fructose intolerance, glucose / galactose malabsorption or insulinase sucrose deficiency should not take this medication.
Oswara contains sodium.
This should be noted for patients on a diet with a controlled sodium content.
The separative risk is only intended to simplify the breakdown of the tablet and facilitate swallowing, rather than to separate the tablets into equal doses.

Keep container with medicine tightly closed, for - protection against humidity.
Use the drug for four weeks after the first opening of the can.
Oswara does not have any influence on the ability to drive and operate machinery.

OVERDOSE

Acute hypermagnia (both asymptomatic and acute systemic toxicity) suppresses both central and peripheral nervous activity, inhibiting the release of acetylcholine.Systemic toxic effects should be expected at a serum concentration of 2.5 mmol / l, severe neurotoxic side effects appear at a concentration of 3 mmol / L and higher.At concentrations ranging from 2.5 to 5.0 mmol / l, gastrointestinal disorders (nausea, anorexia, constipation), spasm of smooth muscle of the bladder, muscle weakness, lethargy, absence of deep tendon reflexes, and violation of atrioventricular and ventricular conduction are observed.
At serum magnesium levels of 5-10 mmol / l, arterial hypotension caused by vasodilation, paralytic ileus, flaccid paralysis and coma are observed. At a level above 10 mmol / l, respiratory arrest and cardiac arrest occur.
The initial symptoms of hypercalcemia are muscle weakness and gastrointestinal disorders (abdominal pain, constipation, nausea and vomiting).
Severe hypercalcemia is characterized by impaired consciousness (eg, lethargy, disorientation, stupor, in critical cases also coma) and drowsiness. In patients with a serum calcium level of more than 3.5 mmol / l, the hypercalcemic crisis can occur with such symptoms: polyuria, polydipsia; nausea, anorexia, constipation, pancreatitis (infrequently);arrhythmia, shortening of QT-interval, adynamia, hypertension; muscle weakness, up to pseudo-paralysis; psychosis, somnolence, up to coma.
A prolonged overdose can lead to the development of adynamic osteopathy.

Emergency therapy:

In addition to symptomatic treatment, hypermagnesemia therapy consists in reducing the magnesium concentration in dialysate and reducing the dose of Osvaren.

In the case of hypercalcemia (serum calcium level> 2.5 mmol / l), dialysate calcium (up to 1.25 mmol / L) and / or Oswaren's dose should be reduced, in addition to symptomatic therapy.
If the value of serum calcium exceeds 2.75 mmol / l, Oswaren should be temporarily discontinued and, if necessary, a calcium-free phosphate binding drug should be used. Hypercalcemic crisis (serum calcium level> 3.5 mmol / l) requires dialysate therapy free of calcium. During treatment with calcium-free dialysate, the serum calcium concentration should be carefully monitored to minimize the risk of hypocalcemia-and adverse cardiovascular reactions.
DRUG INTERACTION

To prevent interaction between osvaren and other drugs in a joint appointment, no other oral medication should be taken within 2 hours before and within three hours after taking Oswaren.

Oswaren affects the absorption of tetracyclines, bisphosphonates, fluoride compounds, certain fluoroquinolones (gyrase inhibitors) such as ciprofloxacin, norfloxacin, certain cephalosporins (cefpodoxime, cefuroxime), ketoconazole, estramustine and anticholinergics, zinc, urso-and chenodeoxycholic acids, and

halofaintrin.

In case of additional treatment with oral iron preparations, attention should be paid to the fact that simultaneous intake of magnesium can affect the absorption of iron.

Vitamin D and its derivatives increase the absorption of calcium.
Thiazide diuretics reduce renal excretion of calcium. In the case of concomitant administration of Oswaren and thiazide diuretics or vitamin D derivatives, it is necessary to monitor the serum calcium level.
The simultaneous use of estrogens (estradiol) or preparations of vitamin A with calcium salts can also increase the absorption of calcium.

Calcium increases the effect of digitalis glycosides (digoxin), which can lead to digitalis intoxication, including the risk of arrhythmia.
In digitalized patients, care should be taken when prescribing Oswaren, ECG monitoring is mandatory. Calcium can reduce the pharmacological effects of verapamil and probably other blockades of calcium channels. The appointment of epinephrine in patients with elevated serum calcium levels can lead to severe arrhythmias.
The combination of magnesium carbonate, hydroxide and aluminum hydroxide with levothyroxine can cause an increase in the absorption of levothyroxine.

Magnesium salts can adsorb digoxin into the digestive tract, reducing its bioavailability.
Adsorption of nitrofurans may occur, which reduces the bioavailability and, possibly, the antibacterial effect of this drug. In addition, gastrointestinal absorption of penicillamine may be reduced, possibly with a decrease in its pharmacological effects.
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 and protected from moisture at a temperature of no higher than 25 ° C.

Shelf life - 3 years.
The drug should be used before the date indicated on the package. After the expiration date, the drug should not be used.
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