Renagel

General characteristics. Structure:

Active agent contains 800 mg of a sevelamer.
Excipients:
Silicon dioxide colloid, the stearic acid, water purified. Structure of a cover: a gipromelloza low-molecular E5, a gipromelloza high-molecular E15, diacetylized monoglycerides, the water purified. Texts are put with paint which contains ferrous oxide black E172, E464 gipromelloza, isopropyl alcohol, propylene glycol and the water purified.

Description. Oval tablets, film coated, almost white color, on one party it is printed with black ink "Renagel 800".

Pharmacological properties:

Pharmacodynamics. Sevelamer - the polymer which is not soaking up in digestive tract weed (allylamine a hydrochloride). Connecting phosphates in a digestive tract, reduces concentration of phosphates in blood serum. Sevelamer does not contain calcium therefore at use of this drug the frequency of episodes of development of a hypercalcemia is lower on
to comparison with that at the patients using calcium the containing drugs connecting phosphates. During clinical trials it is proved that impact on the level of phosphorus and calcium in blood remains at administration of drug within one year.

Pharmacokinetics. It is not soaked up in digestive tract.

Indications to use:

Prevention of a hyperphosphatemia at the adult patients with a renal failure who are on a hemodialysis.
Renagel is shown at a hyperphosphatemia at the adult patients who are on a hemodialysis. Renagel it is necessary to apply as a part of the complex therapy directed to the prevention of damage of bones in connection with a disease of kidneys and including calcium additives, 1,25 D3 dihydroxyvitamin or one of its analogs.

Route of administration and doses:

Inside, during food. Tablets should be swallowed entirely, without chewing. For the patients who are not receiving the means connecting phosphates, the dosage should be selected individually on the basis of measurement of concentration of phosphates in blood serum, as shown in the following table:
Level of phosphates of blood serum at the patients who are not receiving the means connecting phosphates
Initial dose of tablets Renagel
800 mg
1.76 - 2.42 mmol/l (5.5-7.5 mg/dl)>        2.42 mmol/l (> 7.5 mg/dl)
3 times a day on 1 tablet                       3 times a day on the 2nd tablet
If Renagel is appointed as the alternative drug connecting phosphates it it is necessary to appoint in equivalent doses in recalculation 1 mg to 1 mg in comparison with the calcic drugs connecting phosphates which the patient accepted before. It is necessary to watch carefully concentration of phosphates in blood serum and to select a drug dose Renagel so that the level of phosphates in blood serum decreased to 1,76 mmol/l (5.5 mg/dl) or below. Before achievement of stable level of phosphates in blood serum it is necessary to control the last each two or three weeks then it is also necessary to exercise regular control of this indicator. The dosage can vary from 1st to 5 tablets on 800 mg at each meal. The average daily dose makes 7 g of a sevelamer.
Renagel it is necessary to accept during food and to adhere at the same time to the established diet. It is necessary to swallow of tablets entirely. They cannot be chewed.

Features of use:

Safety and efficiency of this drug at treatment of patients aged up to 18 years is not established.
At patients to whom peritoneal dialysis is carried out efficiency and safety of drug was not studied.
As data on drug use a sevelamer within more than one year are absent so far, it is impossible to exclude completely its possible absorption and accumulation at long reception
Pregnancy and lactation
Safety of drug Renagel at women during pregnancy and feeding by a breast is not established. In researches on animals embriotoksichesky or fetotoksichesky effects of drug a sevelamer are not revealed. Renagel should appoint pregnant women or the feeding women only in case of explicit need after the careful analysis of the ratio expected positive effects for mother and risk for a fruit or the child.
Influence on ability of driving and on work with mechanisms
It is not revealed.

Side effects:

The undesirable effects noted during clinical trials and regarded as possibly connected using a prepart Renagel, are listed in the table and classified as very often met (> 1/10) and often met (> 1/100, <1/10).
Gastrointestinal frustration
Very often met: Nausea, vomiting, the abdominal cavity pain, a lock, diarrhea, dyspepsia which are Often met: Meteorism
Frustration from the central nervous system
Very often met: A headache the Cardiovascular frustration which are Very often met: Hypotension, hypertensia General frustration
Very often met: Pain of various localization
Skin changes
Very often met: An itch Often met: Rash
Infectious complications
Often met: Pharyngitis
The majority of these cases is often observed at patients in 5 stages of a chronic renal failure and are not necessarily connected using drug Renagel.
At use of drug in clinical practice intestinal impassability was seldom or never observed.

Interaction with other medicines:

Researches on interaction at patients on a hemodialysis were not conducted.
In researches of medicinal interaction on healthy volunteers, Renagel did not exert impact on bioavailability of digoxin, warfarin, enalapril and a metoprolol. Bioavailability of ciprofloxacin decreased approximately by 50% at joint primeneiya with Renagel in a research of a single dose. Therefore Renagel should not be accepted along with ciprofloxacin.
Renagel can exert impact on bioavailability of other medicines. At administration of any medicine for which reduction of bioavailability can have clinically significant effect on safety or efficiency this medical product has to be applied not less than in one hour or three hours after administration of drug Renagel, or the doctor has to consider the level of drugs in blood.

Contraindications:

Hypersensitivity to a sevelamer or to any other of drug components, a hypophosphatemia, intestinal impassability, children's age up to 18 years.
With care - inflammatory diseases of intestines, disturbance of motility of digestive tract (including a lock), extensive surgeries on digestive tract in the anamnesis.

Overdose:

Cases of overdose are not described.
At reception by healthy volunteers of drug in a daily dose to 14 g (it is equivalent to 17 tablets on 800 mg) within eight days of undesirable effects it is noted.

Storage conditions:

In densely closed bottle at a temperature not above 25 °C. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

180 tablets in a bottle from polyethylene of high density with a polypropylene cover with protection against children and the sealed covering collapsing at the first opening. 1 bottle with the instruction on a medical use in a cardboard pack.