Selamerex, 800 mg 180 pcs

A drug for the treatment of hyperphosphatemia, a polymer of allylamine carbonate, not absorbed from the gastrointestinal tract. By binding phosphates in the digestive tract, it reduces their concentration in blood serum.

The drug does not contain Ca²⁺ and therefore does not cause the hypercalcemia seen with other phosphate withdrawal medications that contain Ca²⁺.

The effect on blood phosphorus concentrations is maintained when the drug is taken for 1 year.

Indications

• Hyperphosphatemia in chronic renal failure in patients on hemodialysis or peritoneal dialysis – as part of comprehensive therapy including Ca²⁺, colecalciferol or its analogues;

• Hyperphosphatemia in adults on hemodialysis.

Selamerex^® should be used as part of a comprehensive therapy to prevent bone damage due to kidney disease and include calcium supplements, 1.25-hydroxyvitamin D₃ or one of its analogues.

Active ingredient

Sevelamer

Composition

1 film-coated tablet contains as the active ingredient sevelamer carbonate, in terms of dry substance 800 mg.

Auxiliary substances:

Lactose monohydrate – 286.25 mg,

Silicon dioxide colloid – 5.50 mg,

Zinc stearate – 8.25 mg.

Shell composition:

Macrogol and polyvinyl alcohol copolymer – 19.80 mg, talc – 13.20 mg.

How to take, the dosage

It is taken orally with meals. Tablets should be swallowed whole without chewing.

For patients not receiving any phosphate-binding medication, the dose should be adjusted individually based on measurement of serum phosphate concentration:

For patients receiving phosphate-binding medications (Ca²⁺ drugs): Prescribe in equivalent doses per 1 mg of Ca²⁺ (base) medications the patient was previously taking.

The dose ranges from 800 to 4000 mg, with a maximum daily dose of 7 g. The dose is adjusted for serum phosphate concentrations (reduction to 1.76 mmol/L (5.5 mg/dL) and below is necessary).

Phosphate concentrations are monitored every 2-3 weeks until they have stabilized.

Selamerex^® should be taken with meals and the established diet.

Interaction

Reduces the bioavailability of ciprofloxacin by 50%. Medicinal products for which decreased bioavailability may be clinically relevant should be used 1 h before or 3 h after administration of CELAMEREX®.

The effects of the drugs cyclosporine, mycophenolate mofetil and tacrolimus may be impaired when taking CELAMEREX®.

Thyroid hormone deficiency may occasionally develop in some people taking CELAMEREX® together with levothyroxine.

Special Instructions

If a patient forgets to take one dose, skip it. The next dose should be taken at the usual time with a meal. Do not take a double dose; do not try to make up for a missed dose.

When using Celamerex^® it is possible that vitamins A, D, E, K, folic acid may become deficient in the blood. Therefore, additional administration of these vitamins may be required.

If a patient is taking medications to treat arrhythmias or epilepsy, a physician should be consulted about taking Selamerex^®.

Influence on driving and operating ability

There is no effect on the ability to drive vehicles and other mechanisms requiring increased concentration.

Contraindications

• hypophosphatemia;
• intestinal obstruction;
• high sensitivity to sevelamer or the drug’s excipients;
• children under 18 years of age (the safety and effectiveness in children under 18 years has not been studied).

With caution:

Inflammatory diseases of the gastrointestinal tract, disorders of gastrointestinal motility (including constipation), gastrointestinal surgery (history), dysphagia, difficulty swallowing, concomitant use with antiarrhythmic and antiepileptic drugs, pregnancy, breastfeeding period.

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Side effects

The incidence of side effects noted when taking svelamer is given according to the WHO classification: very common (>1/10), common (>1/100 and <1/10).

Digestive system disorders: very common – nausea, vomiting, abdominal pain, constipation, diarrhea, dyspepsia; common – flatulence.

CNS disorders: very often – headache.

Cardiovascular system disorders: very often – increase or decrease of BP.

Skin: very often – itching; often – rash.

Others: very often – pain in various localizations; often – pharyngitis.

In clinical practice, intestinal obstruction was very rarely observed.

Side effects occur more frequently in patients in the terminal stage of chronic renal failure.

Overdose

No cases of overdose have been reported in patients.

Pregnancy use

The safety of svelamer for pregnant women has not been established. There was no evidence in animal studies that selamer caused embryotoxicity. Celamerex^® should be administered to pregnant women only if clearly needed and after a careful analysis of the risk-benefit ratio for the mother and fetus.

The safety of selamerex has not been established for breastfeeding mothers. Celamerex^® should only be prescribed to breastfeeding women if clearly needed and after a careful analysis of the risk-benefit ratio for the mother and baby.