Celamerex - instructions for use, doses, side effects, contraindications

Active substanceSevelamerSevelamer

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Renagel®

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Genzyme Europe BV Netherlands

Celamex

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FarmSirma Soteks, ZAO Russia

Dosage form: & nbspfilm coated tablets

Composition:

1 film-coated tablet contains, as an active substance, sevelamer carbonate, based on dry matter, 800 mg.

Excipients: lactose monohydrate - 286.25 mg, silicon dioxide colloid - 5.50 mg, zinc stearate - 8.25 mg.

The composition of the shell: macrogol and polyvinyl alcohol copolymer - 19.80 mg, talc - 13.20 mg.

Description:

oval biconvex tablets coated with a white to white film cover with a yellowish hue, with SVL engraving on one side. On the cross section, the nucleus is white to white with a yellowish hue of color.

Pharmacotherapeutic group:hyperphosphataemia treatment

ATX: & nbsp

C.01.E.X Other combination drugs for the treatment of heart disease

Pharmacodynamics:

An agent for the treatment of hyperphosphatemia. Polymer of allylamine carbonate, not absorbed in the gastrointestinal tract. Binding phosphates in the digestive tract, reduces their concentration in the blood serum. The drug does not contain Ca and therefore does not cause hypercalcemia, observed against the background of other

drugs that excrete phosphates, which contain Ca2 + in their composition. The effect on the concentration of phosphorus in the blood is preserved when taking the drug for 1 year.

Pharmacokinetics:

Not absorbed in the gastrointestinal tract. It is impossible to exclude completely possible systemic absorption and cumulation during long-term use.

Indications:

Hyperphosphatemia in chronic renal failure in patients on hemodialysis or peritoneal dialysis, as part of complex therapy, including preparations of Ca, colcalciferol or its analogs.

SELAMEREX® is indicated for hyperphosphatemia in adult patients on hemodialysis. CELAMEREX® should be used as part of a comprehensive therapy aimed at preventing bone damage due to kidney disease and including calcium supplements, 1,25-hydroxyvitamin D3 or one of its analogues.

Contraindications:

increased sensitivity to sevelamer or to auxiliary substances of the preparation;

hypophosphatemia;

intestinal obstruction;

children under 18 years of age (safety and efficacy of the drug in children under 18 years old has not been studied).

Carefully:

Inflammatory diseases of the gastrointestinal tract, impaired motility of the gastrointestinal tract (including constipation), surgical operations on the gastrointestinal tract (history), dysphagia, difficulty swallowing, the simultaneous application of antiarrhythmic and antiepileptic drugs, pregnancy, breastfeeding.

Pregnancy and lactation:

For pregnant women, the safety of the sevelamer is not established. In animal studies, there is no evidence that sevelamer caused embryotoxicity, were absent. SELAMEREKS '' should be prescribed to pregnant women only if there is a clear need and after a thorough analysis of the risks versus the benefits to the mother and fetus.

For nursing mothers, the safety of the sevelamer is not established. SELAMEREKS "should be administered to nursing women only if there is a clear need and after a thorough analysis of the risks and benefits for mother and child.

Dosing and Administration:

Inside. SELAMEREX * should be taken while eating. Tablets are swallowed whole (without chewing).

For patients who do not receive phosphate binding medicines, the dosage should be selected individually based on the measurement of serum phosphate concentration:

Concentration of serum phosphates in patients not receiving phosphate binding agents	Initial dose of CELAMEREX®
1.76-2.42 mmol / L (5.5 to 7.5 mg / ml)	800 mg 3 times a day
> 2.42 mmol / l (> 7.5 mg / ml)	1600 mg 3 times a day

For patients receiving drugs, phosphate binders (preparations of Ca2 +): Assign in equivalent doses in terms of 1 mg of preparations containing Ca2 + (on the basis), which the patient took earlier.

The dose varies from 800 to 4000 mg, the maximum daily dose is 7 g. The dose is selected taking into account the concentration of phosphates in the blood serum (the required decrease to 1.76 mmol / L (5.5 mg / dl) and lower).

The phosphate concentration is monitored every 2-3 weeks until stabilization is achieved.

SELAMEREX® should be taken with food and adhere to the established diet.

Side effects:

The frequency of side effects noted when taking sevelamer is given in accordance with the classification of the World Health Organization (WHO): very often (more than 1/10), often (more than 1/100 and less than 1/10).

From the digestive system: very often - nausea, vomiting, pain in the abdominal cavity, constipation, diarrhea, indigestion; often - flatulence.

From the side of the central nervous system: very often - a headache.

From the cardiovascular system: very often - an increase or decrease in blood pressure.

From the skin: very often - itching; often - a rash.

Other: very often - pain of different locations; often pharyngitis.

In clinical practice, there was very rarely an intestinal obstruction. Side effects often occur in patients in the terminal stage of chronic renal failure.

Overdose:

No cases of overdose have been reported in patients. In case of an overdose, consult a doctor immediately.

Interaction:

Reduces the bioavailability of ciprofloxacin by 50%. Medicines for which a decrease in bioavailability may be of clinical importance should be applied 1 hour before or 3 hours after taking CELAMEREX®.

Effects of drugs ciclosporin, mycophenolate mofetil and tacrolimus can be weakened when taking the drug SELAMEREX®.

Deficiency of thyroid hormones can occasionally develop in some people,taking SELAMEREX® together with levothyroxine.

Special instructions:

If you forget to take one dose of medicine - skip it. Take the next dose at the usual time during meals. Do not take a double dose, do not try to make up the missed one.

With the use of CELAMEREX®, there may be a lack of vitamins A, D, E, K, folic acid in the blood. Therefore, additional prescription of these vitamins is possible.

If you are taking medication to treat cardiac arrhythmia or epilepsy, you should consult your doctor about taking the CELAMEREX® medication.

Effect on the ability to drive transp. cf. and fur:

Effects on the ability to drive vehicles and other mechanisms that require increased concentration of attention are not revealed.

Form release / dosage:Tablets, film-coated, 800 mg.

Packaging:

For 30, 60, 90 and 180 tablets in polymeric bottles for medicines with polymeric caps screwed on, protected from children and controlled by the first opening or without protection from children and control of the first autopsy.

1 bottle with instructions for use in a pack of cardboard.

Storage conditions:

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 the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-002733

Date of registration:28.11.2014

The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia

Manufacturer: & nbsp

POLPHARMA PHARMACEUTICAL WORKS, S.A. Poland

Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia

Information update date: & nbsp14.09.2015

Illustrated instructions

Instructions

Celamex (Selamerex)