Extranil - instructions for use, dose, side effects, contraindications

Active substanceIkodextrinIkodextrin

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solution perit. dial.

Dosage form: & nbspSolution for peritoneal dialysis

Composition:1 liter of solution contains:
Active substances:
Ikodextrin 75 g
Sodium chloride 5.4 g
Calcium chloride 257 mg
Magnesium chloride 51 mg
Sodium lactate 4.5 g
Excipients:
Sodium hydroxide or acid to pH 6.6
hydrochloric acid for
correction of pH
Water for injection up to 1 liter
Theoretical osmolarity: 284 mOsm / l
Content of electrolytes:
Sodium 133 mmol / L, 133 mEq / L
Calcium 1.75 mmol / l, 3.5 mEq / L
Magnesium 0.25 mmol / L, 0.5 mEq / L

Description:A clear solution of light yellow color

Pharmacotherapeutic group:Solutions for peritoneal dialysis

ATX: & nbsp

B.05.D Solutions for peritoneal dialysis

Pharmacodynamics:Ikodextrin is a water-soluble dextrose polymer, a starch derivative. Acts as an osmotic agent with intraperitoneal administration during a continuous outpatient peritoneal dialysis (CAPD). A 7.5% solution is approximately isoosmolar blood serum, but allows ultrafiltration with a duration of up to 12 h with CAPD. Caloric content is reduced compared to hyperosmolar glucose solutions.The volume of ultrafiltrate is comparable with that obtained with the use of a 3.86% solution of glucose in the CAPD. Does not affect the concentration of glucose and insulin in the blood. Ultrafiltration is preserved during episodes of peritonitis. The recommended dose is limited to a single exchange every 24 hours within the CAPD or automated peritoneal dialysis (AED).

Pharmacokinetics:With daily use for night dialysis, the concentration of carbohydrate polymer in the blood reaches an equilibrium concentration in about 7-10 days. The polymer is hydrolyzed by amylase into smaller fragments, which are excreted by peritoneal dialysis (PD). For glucose oligomers consisting of less than 9 subunits (G9), the recorded equilibrium plasma concentration was 1.8 mg / ml. There was also an increase to 1.1 mg / ml of serum maltose (G2), but no significant changes in osmolality were observed. When the drug in question was used in AG1D with a long interval between dialysis procedures, the concentration of maltose reached 1.4 mg / ml, however, serum osmolality significantly changed.
Long-term effects of increasing the concentration of maltose and polymers of glucose in plasma are unknown, but at the current time there is no reason to believe that they may be unfavorable.

Indications:The drug EKSTRANIL recommended for use once a day as a replacement for a peritoneal exchange of dextrose solution during CAPD or APD in chronic renal failure (CRF). The drug is especially recommended for patients with infringement of ultrafiltration when using dextrose solutions, since it is able to prolong the time of effective application of CAPD in this category of patients.
Like all solutions for PD, the drug EKSTRANIL should be used with caution and after careful assessment of potential risks and benefits in patients with impaired breathing function, potassium deficiency, digestive disorders.

Contraindications:The drug EKSTRANIL is contraindicated in patients with:
known allergy to starch-based polymers (eg, corn starch) and / or icodextrin
-individual intolerance of maltose and isomaltose
-Glycogen storage diseases (glycogenoses)
-previous heavy lactic acidosis
-not eliminated mechanical defects that can interfere with effective PD or increase the risk of infection
- documented loss of peritoneal function or extensive adhesions, which worsen the peritoneal function
acute renal failure
The drug EKSTRANIL is not recommended for use in children under the age of 18 years.

Carefully:In conditions associated with abdominal integrity disorders, including rupture of the peritoneum or diaphragm, due to surgery or trauma, until complete recovery, abdominal tumors, abdominal wall infections, hernias, fecal fistulas, colostomas or ileostomies, frequent episodes of diverticulitis, inflammation or bowel ischemia, large polycystic kidneys and other conditions associated with violations of the integrity of the peritoneum or intraperitoneal cavities.
Recently transferred aortic valve transplantation and severe pulmonary diseases.
Like all solutions for PD, the drug EKSTRANIL should be used with caution and after careful assessment of potential risks and benefits in patients with impaired breathing function, potassium deficiency, digestive disorders.

Pregnancy and lactation:Appropriate data on the use of the drug in pregnant and lactating women are absent. The drug EKSTRANIL can be given to pregnant and lactating women only for emergency indications after a careful assessment of the ratio of possible risk to the fetus and benefit to the mother.
Breastfeeding period
It is not known whether the drug EXTRANIL penetrates into breast milk. Risk for newborns and infants can not be ruled out. It is necessary to assess the need to stop breastfeeding or stop the use of the drug EXTRANIL, taking into account the benefits of breastfeeding for the baby and the benefits of therapy for the mother.

Dosing and Administration:Doses
Recommended for use during the longest period between the PAND or ADF procedures.
The type of therapy, the frequency of sessions, the volume of the solution for one exchange session, the period of residence of the solution in the abdominal cavity and the duration of dialysis should be determined by the responsible physician, the management of the treatment of each particular patient.
Adult patients and elderly people
The use of the solution is limited to once a day.The volume of the solution is usually 2 liters. An increase in the volume of the injected solution up to 2.5 l may be necessary in the following cases: in patients with a body surface area of more than 1.85 m 2; with anuria; if additional ultrafiltration is required to maintain a fluid balance; with a weekly urea clearance of less than 1.7. The volume of the solution to be filled should be reduced to 1.5 liters if the patient experiences a feeling of raspirapiya in the abdominal cavity. The procedure for removing the solution used and the introduction of a new solution should be performed within 10-20 minutes; the rate of removal / administration of the solution should not create discomfort for the patient.
The residence time of the solution in the abdominal cavity at CAPD is about 6-12 hours, with APD - 14-16 hours.
Patients of childhood
Safety and efficacy not established.
It is not recommended for patients under 18 years of age.
Introduction
Precautions to be taken before applying the drug. Exclusively for intraperitoneal use. Not for intravenous administration. The drug should be used with a comfortable pace for the patient. Entered volume is determined by the attending physician.
For greater patient comfort, solutions for PD can be pre-heated in an external bag up to 37 ° C. It is allowed to use only dry heat (for example, heating pad, heating plate). Solutions should not be heated in water or in a microwave oven to avoid injury or discomfort to the patient.
During the procedure, the AP should follow the rules of asepsis. The drained fluid should be checked for fibrin or turbidity, which may indicate the presence of peritonitis.
Do not use the solution if it is not transparent, changed color, contains foreign particles, there are signs of leakage of the solution from the container or if the packaging is not sealed.
Only for single use.
Dispose of unused solution residues after a single use.

Side effects:

This section indicates the adverse reactions that have been recorded in patients entering clinical trials and in the postmarketing period.
The frequency was evaluated using the following criteria: very frequent (≥ 1/10), frequent (from ≥ 1/100 to <1/10), infrequent (from ≥ 1/1000 to <1/100).rare (from ≥ 1/10 000 to <1/1000), very rare (<1/10 000). Within each grouped frequency group, undesirable effects are presented in descending order of severity.
Undesirable reactions noted in clinical studies

System-Organ Class	Preferred term MedDRA	Frequency*
Infectious and parasitic diseases	Flu	Infrequently
	Furuncle	Infrequently
	Infection	Infrequently
Violations of the blood and lymphatic system	Anemia	Infrequently
	Leukocytosis	Infrequently
	Eosinophilia	Infrequently
	Thrombocytopenia	_**
	Leukopenia	_**
Immune system disorders	Vasculitis	_**
	Hypersensitivity	_**
Disorders from the endocrine system	Breaking from the parathyroid gland	_**
Disorders from the metabolism and nutrition	Dehydration	Often
	Hypovolemia	Often
	Hypoglycaemia	HOften
	Hyponatremia	Infrequently
	Hyperglycaemia	Infrequently
	Hypervolaemia	Infrequently
	Anorexia	Infrequently
	Hypochloremia	Infrequently
	Hypomagnesemia	Infrequently
	Hyponrotheinemia	Infrequently
	Hypoglycemic shock	_**
	Violation of the water balance	_**
Disorders of the psyche	Pathology of Thinking	HOften
	Anxiety	Infrequently
	Nervousness	HOften
Violations from the nervous	Dizziness	Often
systems	Headache	Often
	Hyperkinesia	HOften
	Paresthesia	HOften
	Agevzia	HOften
	Hypoglycemic coma	_**
	Burning sensation	_**
NAReye-sight	Blurred vision	_**
NARhearing impairment and labyrinthine disorders	Noise in ears	Often
Heart Disease	Cardiovascular disorders	HOften
	Tazycardia	HOften
Vascular disorders	Reduction of blood pressure	Often
	Increased blood pressure	Often
	Orthostatic loweredue blood pressure	HOften
Disturbances from the respiratory system, chest and mediastinal organs	ABOUTtlung cancer	HOften
	Dyspnea	HOften
	Cough	HOften
	Hiccups	HOften
	Laffective disorders	HOften
	Bronchospasm	_**
Disorders from the gastrointestinal tract	Abdominal pain	Often
	Bloating	_**
	Intestinal obstruction	HOften
	Peritonitis	HOften
	Bloody peritoneal exudate	HOften
	Diarrhea	HOften
	Stomach ulcer	HOften
	Gastritis	HOften
	Gastrointestinal disorders	HOften
	Vomiting	HOften
	Constipation	HOften
	Dyspepsia	HOften
	Nausea	HOften
	Dry mouth	HOften
	Flatulence	HOften
	Ascites	_**
	Inguinal hernia	_**
	Discomfort in the stomach	_**
Disturbances from the skin and subcutaneous tissues	Exfoliative dermatitis	Often
	Rash (including macular, papular, erythematous)	Often
	Itching	Often
	Hives	HOften
	Bullous dermatitis	HOften
	Psoriasis	HOften
	Cutaneous ulcer	HOften
	Eczema	HOften
	Nail disorders	HOften
	Skin disorders	HOften
	Dryness of the skin	HOften
	Skin discoloration	HOften
	Toxic epidermal necrolysis	_**
	Erythema multiforme	_**
	Edema Quincke	_**
	Generalized urticaria	_**
	Toxic skin rashes	_**
	Periorbital edema	_**
	Dermatitis (including contact and allergic)	_**
	Erythema	_**
	Blisters	_**
Disturbances from musculoskeletal and connective tissue	Pain in the bones	HOften
	Muscle spasms	HOften
	Myalgia	HOften
	Neck Pain	HOften
	Arthralgia	_**
	Backache	_**
	Musculoskeletal pain	_**
Disorders from the kidneys and urinary tract	Renal pain	HOften
General disorders and disorders at the site of administration	Peripheral edema	Often
	Asthenia	Often
	Chest pain	HOften
	Complications associated with the introduction of a catheter	HOften
	Edema of the face	HOften
	Edema	HOften
	Pain	HOften
	Fever	_**
	Chills	_**
	Feeling of discomfort	_**
	Erythema at the site of insertion of the catheter	_**
	Inflammation at the site of insertion of the catheter	_**
	Reactions caused by injection (pain at the infusion site)	_**
Impact on the results of laboratory and instrumental studies	Decreased diuresis	_**
	Abnormal results of laboratory tests	Often
	Increased activity of alanine amine transferase	HOften
	Increase in activity of aspartate-transferase	HOften
	Increased activity of alkaline phosphatase of blood	HOften
	Inconsistency with the norm of a functional liver test	HOften
	Decreased body weight	HOften
	Weight gain	HOften
	Interaction with medical devices *	HOften

* For example, the effect of icodextrin on the measurement of glucose by special medical products

** Due to the limited population in the study, the frequency estimate is not presented.

Undesirable reactions noted in the postmarketing period

In addition to the undesirable reactions noted in clinical studies, the following adverse reactions were observed in the postmarketing period.Infectious and parasitic diseases: fungal peritonitis, bacterial peritonitis, infections in the field of catheter introduction, infections associated with the introduction of a catheter.

Violations from the blood and lymphatic system: thrombocytopenia, and leukopenia. Impaired immune system: vasculitis, serum sickness, hypersensitivity.

Disorders from the metabolism and nutrition: shock hypoglycemia, hyperhydration, imbalance of fluid.

Impaired nervous system: hypoglycemic coma, burning sensation. Impaired vision: blurred vision.

Disturbances from the respiratory system, chest and mediastinal organs: bronchospasm, stridor.

Disorders from the gastrointestinal tract: sclerosing encapsulating peritonitis, aseptic peritonitis *, turbid peritoneal exudate, intestinal obstruction, ascites, inguinal hernia, abdominal discomfort.

Disturbances from the skin and subcutaneous tissues: toxic epidermal necrolysis, multiform erythema, angioedema, generalized urticaria.toxic skin rash, face swelling, periorbital edema, exfoliation rash, skin peeling, prurigo, rash (including macular, papular, erythematous), dermatitis (including allergic and contact), drug rash, erythema, onychomadesis, cracked skin, blisters.

Disturbances from the musculoskeletal and connective tissue: arthralgia, back pain, musculoskeletal pain.

Violations of the genitals and breast: swelling of the penis, swelling of the scrotum.

General disorders and disorders at the site of administration: discomfort, fever, chills, malaise, insufficient drug effect, ineffective drug, erythema in the area of catheter insertion, inflammation in the area of catheter insertion, response to administration (including pain at the infusion site, pain in the drip site). Trauma, intoxication and complications of manipulation: interaction with the device.

* The term of the lowest level

If any of the side effects indicated in the manual are aggravated or you notice any other side effects not listed in the instructions, inform your doctor.

Overdose:Data on the effects of overdose are not available.Continuous use of more than one package of the drug within 24 hours can increase plasma concentrations of carbohydrate metabolites and maltose. The effects of this increase are unknown, but there may be an increase in plasma osmolality.
In case of an overdose with the drug should continue PD with the use of solutions based on glucose or with hemodialysis.
The introduction of excessive amounts of the drug into the abdominal cavity may be accompanied by bloating, a feeling of overflow and / or dyspnea.
Measures in case of introduction of excessive volume of the drug consist in removing the solution from the abdominal cavity by means of drainage.

Interaction:Studies of interactions with the drug EXTRANIL have not been conducted. Concentrations in the blood of dialysable drugs may decrease as a result of the PD. If necessary, substitution therapy should be provided. Drug interactions - laboratory tests:
- Measurement of blood glucose concentration should be performed using a glucose-specific method to prevent the maltose caused by the distortion of the result.Methods based on pyrroloquinoline quinone-dependent pinocode dehydrogenase (GDH-PQQ) or glucose-chromogenic oxidoreductase (GDO) should not be used. For some glucometers and test strips, whose action is based on the use of flavinadenine dinucleotide-pocosode dehydrogenase (GDH-FAD), cases of false overestimation of glucose concentration due to the presence of maltose in the analyzed solution are described. See section "Special instructions".
- In patients using the drug EXTRANIL, there was a marked decrease in serum amylase activity.
Some added drugs may be incompatible with the drug EXTRANIL.
- Addition of potassium
Potassium is not added to the solutions of the drug EKSTRANIL, since dialysis can be performed for the purpose of correcting hyperkalitmia. With a normal potassium content in the blood serum or with hypokalemia, the addition of potassium chloride at concentrations up to 4 meq / l can be shown to prevent severe hypokalemia, which should be done only under the guidance of a doctor and after an accurate determination of the potassium concentration in the serum and in the body as a whole.
- Adding insulin
Addition of insulin to the drug Extraneal assessed in six patients with type 1 diabetes, in which the CAPD held in end-stage renal failure. Extraneal revealed no influence of the drug on insulin absorption from the peritoneal cavity or the activity of insulin in regard to the carbohydrate metabolism. It is proper to perform monitoring blood glucose concentrations when Extraneal begin to be used in patients with diabetes mellitus, and if necessary, adjust the insulin dose (see. The "Special instructions"),
- Addition of heparin
Clinical studies of drug interaction with heparin have not been conducted. In vitro studies showed no incompatibility of heparin with the drug EXTRANIL.
- Addition of antibiotics
No official clinical studies of drug interaction were conducted. Studies in vitro compatibility Extraneal preparation and subsequent use of antibiotics has shown no effect pas minimum inhibitory concentration: vancomycin, cefazolin, ampicillin, ampicillin / fluklokasatsillina, ceftazidime, gentamycin and amfogerina B.
However, aminoglycosides should not be mixed with picillins because of their chemical incompatibility.

Special instructions:Patients with diabetes should regularly check the concentration of glucose in the blood, and the dose of insulin and other drugs used in hyperglycemia should be adjusted after treatment. Determination of blood glucose concentration should be carried out using a method specific for glucose to exclude the effect of maltose on the result. Methods based on GDH-PQQ or GDO should not be used. In addition, the use of certain glucometers and test strips using the GDH-FAD method also leads to a false overestimation of glucose values due to the presence of maltose. For information on the effect of icodextrin or maltose on the results or about false overestimation of the results of glucose determination, you should contact the manufacturers of used glucometers and test strips. If methods based on GDH-PQQ, GDO or GDH-FAD are used, then patients receiving EXTRANIL can be found to have false-negative hyperglycemia, which can lead to the use of insulin at higher doses than the ego is necessary.This can cause hypoglycemia, which can result in loss of consciousness, coma, neurological disorders and death. In addition, false negative hyperglycemia due to interaction with maltose can mask true hypoglycemia, allowing it to proceed without appropriate treatment provided under such conditions, which can lead to similar consequences. Falsely elevated glucose concentrations when using glucometers and test strips to determine blood glucose concentrations based on GDH-PQQ. GDO or GDH-FAD, can be recorded for up to two weeks after discontinuation of drug therapy. Because glucose meters based on GDH-PQQ, GDO or GDH-FAD can be used in hospitals, it is important that health care providers conducting peritoneal dialysis using the drug carefully study the instructions attached to the blood glucose test kit including test strips) to ensure the compatibility of the kit with the drug EXTRANIL. To avoid the introduction of incorrect doses of insulin, all patients should be instructed,who are on therapy with the drug EKSTRANIL, so that in case of hospitalization they notify doctors about the possibility of these interactions.
Sclerosing encapsulating peritonitis (SIP) is considered a known rare complication of PD therapy. SIP was noted in patients using solutions for PD, including EKSTRANIL. Occasionally with the drug EXTRANIL marked SIP fatal.
Patients with severe lactic acidosis should not be prescribed therapy with solutions for PD based on lactate (see section "Contraindications"). In patients with conditions that are known to increase the risk of developing lactic acidosis [eg, severe arterial hypotension or sepsis, which may be associated with acute renal failure; congenital metabolic disorders; treatment with drugs such as metformin and nucleoside / nucleotide reverse transcriptase inhibitors (NRTIs)], it is necessary to monitor the occurrence of lactic acidosis before and during therapy with solutions for PD based on lactate.
In case of an individual appointment, the potential interaction between dialysis treatment and therapy directed at other available diseases should be taken into account.Serum potassium concentrations should be carefully monitored in patients taking cardiac glycosides.
In case of development of peritonitis, the choice and dose of antibiotics should, if possible, be based on the results of identification studies and studies of the sensitivity of the isolating microorganism (s). Before determining the microorganism (s), broad-spectrum antibiotics can be prescribed. Occasionally, severe hypersensitivity reactions were observed during the use of the drug, such as toxic epidermal necrolysis, angioedema, serum sickness, erythema multiforme and vasculitis. Anaphylactic shock or anaphylactoid reactions may develop. If a hypersensitivity reaction is suspected, the solution should be immediately discontinued and the solution removed from the abdominal cavity and countermeasures taken according to clinical indications.
It is necessary to carefully monitor the state of the water balance and constantly monitor the patient's body weight in order to avoid hyper or hypohydration.
Periodically, it is necessary to monitor the water balance, indicators of general and biochemical blood tests and concentration of electrolytes, including magnesium and bicarbonate.At low serum magnesium concentrations, magnesium supplements for oral administration or solutions for PD can be used. containing high concentrations of magnesium. During the PD, significant losses of protein, amino acids, water-soluble vitamins and other drugs may occur, which may require substitution therapy.
The effectiveness and safety of the drug in children is not studied, therefore, use in patients under 18 years is not recommended.
Clinical data on the effect on fertility are not available.

Effect on the ability to drive transp. cf. and fur:When performing PD in patients with terminal stage of renal failure, side effects may occur that can affect the ability to drive vehicles and perform other potentially dangerous activities requiring increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Solution for peritoneal dialysis 7.5% in plastic containers "Vaflesks" single 1500, 2000, 2500 ml or double in the system "Twin Nog" but 1500, 2000, 2500 ml.

Packaging:The container or system is packed in a plastic bag.
For 4, 5 or 6 containers, together with instructions for use in a cardboard box (for hospitals).

Storage conditions:Store at a temperature not exceeding 30 ° C. Do not freeze.
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:P N 015395/01

Date of registration:11.12.2008

The owner of the registration certificate:Baxter Khelskea SABaxter Khelskea SA Ireland

Manufacturer: & nbsp

BAXTER HEALTHCARE, S.A. Ireland

Representation: & nbspBaxter Baxter USA

Information update date: & nbsp2016-01-19

Illustrated instructions

Instructions

Extranil (Extraneal)