Composition, form of production and packaging
The tablets covered with a film cover from white to white with a yellowish shade of color, oval, biconcave, with engraving "SVL" on one side; on the cross-section the nucleus is white to white with a yellowish hue of color.
1 tab.
sevelamer 800 mg
[PRING] lactose monohydrate - 286.25 mg, silicon dioxide colloid - 5.5 mg, zinc stearate - 8.25 mg.
The composition of the shell: macrogol and polyvinyl alcohol copolymer - 19.8 mg, talc - 13.2 mg.
30 pcs. - vials polymeric (1) - packs cardboard.
60 pcs. - vials polymeric (1) - packs cardboard.
90 pcs. - vials polymeric (1) - packs cardboard.
180 pcs. - vials polymeric (1) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2017.
PHARMACHOLOGIC EFFECT
The drug for the treatment of hyperphosphatemia, the polymer of allylamine carbonate, not absorbed from the digestive tract. Binding phosphates in the digestive tract, reduces their concentration in the blood serum. The drug does not contain Ca 2+ and therefore does not cause hypercalcemia, observed against the background of the use of other drugs that release phosphate, which contain Ca 2+ .
The effect on the concentration of phosphorus in the blood is preserved when taking the drug for 1 year.
PHARMACOKINETICS
It is not absorbed from the digestive 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 2+ , colcalciferol or its analogues;
- Hyperphosphatemia in adults on hemodialysis.
Celamerix В® 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 D 3, or one of its analogues.
DOSING MODE
Is taken orally during a meal. Tablets should be swallowed whole, without chewing.
For patients who do not receive phosphate binding medicines, the dose should be selected individually based on the measurement of the serum phosphate concentration:
Serum phosphate concentrations in patients not receiving phosphate binding agents The initial dose of Selamex В®
1.76-2.42 mmol / l (5.5-7.5 mg / ml) of 800 mg 3 times / day
> 2.42 mmol / l (> 7.5 mg / ml) to 1600 mg 3 times / day
For patients receiving drugs, phosphate binders (preparations of Ca 2+ ): Assign in equivalent doses in terms of 1 mg of preparations containing Ca 2+ (on the basis of) that 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 (necessary 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.
Selamex В® should be taken while eating and adhere to the established diet.
SIDE EFFECT
The frequency of side effects noted when taking sevelamer is given in accordance with the WHO classification: very often (> 1/10), often (> 1/100 and <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.
CONTRAINDICATIONS
- hypersensitivity to sevelamer or to auxiliary substances of the drug;
- 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).
Precautions: GI inflammatory diseases, gastrointestinal motility disorder (including constipation), gastrointestinal surgery (in the anamnesis), dysphagia, difficulty swallowing, simultaneous use with antiarrhythmic and antiepileptic drugs, pregnancy, the period of breastfeeding.
PREGNANCY AND LACTATION
For pregnant women, the safety of the sevelamer is not established. In animal studies, there was no evidence that sevelamer caused embryotoxicity. Selamex В® should be given to pregnant women only if there is an obvious need and after a thorough analysis of the risk-benefit relationship for the mother and fetus.
For nursing mothers, the safety of the sevelamer is not established. Selamex В® should be given to lactating women only if there is an obvious need and after a thorough analysis of the risk-benefit relationship for the mother and child.
APPLICATION FOR FUNCTIONS OF THE LIVER
The drug is used according to the indications.
SPECIAL INSTRUCTIONS
If the patient forgot to take one dose of the drug - you should skip it. The next dose is taken at the usual time during meals. Do not take a double dose, do not try to make up the missed dose.
With the use of Selamex В®, there may be a deficiency of vitamins A, D, E, K, folic acid in the blood. Therefore, additional administration of these vitamins may be required.
If the patient is taking medication to treat arrhythmia or epilepsy, it is necessary to consult a doctor about taking Selamex В® .
Impact on the ability to drive vehicles and manage mechanisms
Effects on the ability to drive vehicles and other mechanisms that require increased concentration of attention are not revealed.
OVERDOSE
No cases of overdose have been reported in patients.
In case of an overdose, the patient should immediately consult a doctor.
DRUG 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 Selamex В® .
The effects of ciclosporin, mycophenolate mofetil and tacrolimus may be weakened when taking Selamex В® .
Deficiency of thyroid hormones can occasionally develop in some patients taking Celamerex В® along with levothyroxine.
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 В° C. Shelf life - 2 years.
