Composition, form of production and packaging
The tablets covered with a film shell of almost white color, oval, on one side are printed with black ink "RENAGEL 800".
1 tab.
sevelamer 800 mg
[PRING] silicon colloidal dioxide - 3.2 mg, stearic acid - 3.2 mg, purified water - 64.2 mg.
The composition of the membrane: low molecular weight hypersensitivity E5 - 13.4-20.0 mg, high-molecular-weight hypersensitivity E15 - 13.4-20.0 mg, diacetylated monoglycerides - 8.0-12.0 mg.
Composition of ink for the inscription (Opakoud WB NS-78-17715 black): iron oxide black (E172) - 22%, hypromellose (E464) - 7%, isopropyl alcohol - 12%, propylene glycol - 10%, purified water - 49%.
180 pcs. - bottles of high-density polyethylene (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2015.
PHARMACHOLOGIC EFFECT
The drug for the treatment of hyperphosphatemia. Sevelamer is a poly (allylamine hydrochloride) polymer that is not absorbed from the digestive tract. Binding phosphates in the digestive tract, reduces the concentration of phosphates in the blood serum.
Sevelamer does not contain calcium, therefore, when using the drug, the incidence of episodes of hypercalcemia is lower than that of patients receiving calcium-containing phosphate binding drugs. In clinical trials, it has been proven that the effect on the level of phosphorus and calcium in the blood is retained when taking the drug for one year.
PHARMACOKINETICS
The drug is not absorbed from the digestive tract.
INDICATIONS
- prevention of hyperphosphataemia in adult patients with renal insufficiency, who are on hemodialysis;
- Hyperphosphatemia in adult patients on hemodialysis;
- as part of complex therapy aimed at preventing bone damage due to kidney disease and including calcium supplements, 1,25-dihydroxyvitamin D 3 or one of its analogues.
DOSING MODE
The drug is taken orally, with food. Tablets should be swallowed whole, without chewing.
For patients who do not receive phosphate binding agents, the dose should be selected individually based on the measurement of serum phosphate concentration, as shown in the table:
The level of serum phosphate in patients who do not receive phosphate binding agents The initial dose of Renagel В®
1.76-2.42 mmol / l (5.5-7.5 mg / dl) at 800 mg (1 tab.) 3 times / day
> 2.42 mmol / l (> 7.5 mg / dL) for 1600 mg (2 tablets) 3 times / day
When used as an alternative preparation that binds phosphates , RenagelВ® should be given in equivalent doses in terms of 1 mg of body weight in comparison with the calcium preparations that bind the phosphates that the patient has taken before. Serum phosphate concentration should be carefully monitored and the dose of RenagelВ® taken in such a way that serum phosphate levels decrease to 1.76 mmol / L (5.5 mg / dL) or lower. Before reaching a stable level of serum phosphate, the latter should be monitored every two or three weeks, after which the indicator should also be monitored regularly.
The dose can vary from 800 mg (1 tab.) To 4 g (5 tab.) At each meal. The average daily dose of the drug is 7 g.
SIDE EFFECT
The following side effects were noted during clinical trials and are regarded as probably related to the use of RenagelВ®.
Determination of the frequency of side effects: very often (> 1/10), often (> 1/100, <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 - arterial hypotension, arterial hypertension.
Dermatological reactions: very often - itching; often - a rash.
Other: often - pains of different locations, pharyngitis.
Most of these cases are often observed in patients in stage 5 of chronic renal failure and are not necessarily associated with the use of RenagelВ®.
When used in clinical practice: very rarely - intestinal obstruction.
CONTRAINDICATIONS
- hypophosphatemia;
- intestinal obstruction;
- children and adolescence under 18;
- Hypersensitivity to the components of the drug.
With caution should be used in inflammatory bowel diseases, gastrointestinal motility disorders (including constipation), extensive surgical operations on the gastrointestinal tract in anamnesis.
PREGNANCY AND LACTATION
The safety of the drug Renagel В® in women during pregnancy and lactation (breastfeeding) is not established. RenagelВ® should be given to pregnant or lactating women only in case of emergency, after a careful analysis of the relationship between the expected benefit of therapy for the mother and the potential risk to the fetus or infant.
In experimental studies on animals, embryotoxic or fetotoxic effects of sevelamer were not detected.
APPLICATION FOR FUNCTIONS OF THE LIVER
It is used according to the indications.
APPLICATION FOR CHILDREN
Safety and effectiveness of the drug in children and adolescents under the age of 18 years is not established.
SPECIAL INSTRUCTIONS
In patients on peritoneal dialysis, the efficacy and safety of the drug has not been studied.
Since data on the application of sevelamer for more than 1 year are currently not available, its possible absorption and accumulation can not be completely ruled out with long-term admission.
Use in Pediatrics
Safety and effectiveness of the drug in children and adolescents under the age of 18 years is not established.
Impact on the ability to drive vehicles and manage mechanisms
Not found.
OVERDOSE
Cases of overdose are not described.
When taking a healthy volunteer drug in a daily dose of 14 g (equivalent to 17 tablets of 800 mg) for 8 days, no undesirable effects were observed.
DRUG INTERACTION
Studies on drug interactions in patients on hemodialysis have not been conducted.
In studies of drug interactions in healthy volunteers, Renagel В® had no effect on the bioavailability of digoxin, warfarin, enalapril, and metoprolol. Bioavailability of ciprofloxacin decreased by approximately 50% when administered together with Renagel in a single dose study. Therefore, Renagel В® should not be administered simultaneously with ciprofloxacin.
Renagel В® may influence the bioavailability of other drugs. With the appointment of any medication for which a decrease in bioavailability may be clinically significant and affect safety or efficacy, it should be taken at least 1 hour before or 3 hours after taking Renagel; if this is not possible, the doctor should monitor the concentration in the blood plasma of the simultaneous drug used.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, in a tightly closed bottle, at a temperature of no higher than 25 В° C. Shelf life - 2 years.
