Pharmacological properties

Pharmacodynamics. renalgan — the combined medicine, okazyvt analgeziruyushchy and spasmolytic properties. three operating ingredients are a part of medicine: non-narcotic analgesic metamizole sodium (analginum), myotropic antispasmodic of a pitofenon hydrochloride and holinoblokiruyushchy means fenpiveriniya bromide. metamizol is derivative pyrazyl ketone. renders anesthetic, febrifugal and weak anti-inflammatory action. pitofenon, like a papaverine, has direct myotropic effect on unstriated muscles of internals and causes their relaxation. fenpiveriniya due to holinoblokiruyushchy action has additional spasmolytic effect on unstriated muscles.

Pharmacokinetics. At application in oil it is quickly soaked up. Metamizol has system bioavailability about 85%. Metamizol contacts blood plasma proteins for 50–60%. Gets through GEB and a placental barrier. Distribution volume — about 0.7 l/kg of body weight. Metamizol is exposed to intensive biotransformation in a liver, and its main metabolites are pharmacological active. The C _max in blood plasma (in relation to all metabolites) are established approximately in 30–90 min. It is allocated with kidneys in the form of metabolites, and only 3% of the marked-out amount of metamizol are removed in not changed look. T _½ — about 10 h

Indication

Symptomatic treatment at a pain syndrome in case of a spasm of unstriated muscles of internals: gastric and intestinal colic; renal colic at an urolithiasis; spastic dyskinesia of bilious ways; dysmenorrhea.

Use

Renalgan solution to apply to injections only in oil.

In oil 2–5 ml of solution for injections. If necessary introduction is repeated in 6–8 h. The maximum daily dose should not exceed 10 ml of solution for injections (5 g of metamizole sodium are equivalent). Treatment duration — 2–3 days. After achievement of therapeutic effect it is possible to pass to treatment with anesthetics and antispasmodics for oral administration. In the absence of therapeutic effect the therapy should be stopped.

Renalgan of a tablet. The single dose for adults and children is aged more senior than 15 years makes 1–2 tablets (better after a meal). Per day it is possible to accept up to 3 doses. In case of need repeated application is recommended in 6–8 h. The daily dose should not exceed 6 tablets. Use of medicine in the form of tablets is recommended as additional treatment after introduction of an injection form (no more than 5 days).

For children at the age of 12–15 years ½–1 a tablet. It is possible to appoint a single dose to 3 times a day.

Contraindication

Hypersensitivity to medicine components, pyrazyl ketone derivatives (phenylbutazone, Tribuzonum) or others npvp. a heavy liver or renal failure, megacolon, a sharp hepatic porphyria, suspicion of surgical pathology, adenoma of a prostate of ii and iii of degree, congenital deficiency glyukozo-6-fosfatdegidrogenazy, a tachyarrhythmia, closed-angle glaucoma, a prostatauxe with a tendency to an ischuria, impassability of a GIT (including mechanical impassability), an atony bilious or a bladder, violation from the system of blood formation (Agranulocytosis, a leukopenia, aplastic anemia), kollaptoidny states, dekompensirovanny heart failure, oh, hemolytic anemia.

Side effects

Allergic reactions: skin rash, a small tortoiseshell (including on a conjunctiva and a mucous membrane of a nasopharynx), an itch, it is rare — a Quincke's disease, an acute anaphylaxis, in isolated cases — a toxic epidermal necrolysis (Lyell's disease), Stephens's syndrome — Johnson, a hemorrhage.

from a digestive tract: discomfort, burning in epigastric area, dryness in a mouth, a lock, exacerbation of gastritis and stomach ulcer.

from central nervous system: headache, dizziness.

from an organ of sight: visual violations, accommodation violations.

from a cardiovascular system: arterial hypotension, tachycardia, violations of a warm rhythm.

from the system of blood: anemia, a granulocytopenia, a leukopenia, thrombocytopenia, the Agranulocytosis (it can be shown by the following symptoms: unmotivated fervescence, fever, sore throat, stomatitis, development of a vaginitis or proctitis).

from a respiratory system: bronchospasm.

from an urinary system: a renal failure, an oliguria, an anury, a proteinuria, coloring of urine in red color, interstitial nephrite, an ischuria, the complicated urination, OPN, a polyuria.

Others: sweating reduction.

Local reactions: infiltrates in the injection site.

Special instructions

At medicament treatment renalgan risk of development of anaphylactic reactions exists. at the first signs of hypersensitivity introduction of medicine it is necessary to stop and take urgent measures for knocking over of a state (epinephrine, glucocorticoids, antihistaminic medicines) immediately.

at persons with food and medicinal hypersensitivity or atopic diseases (hay fever, OH).

At treatment by metamizol the risk of developing of an agranulocytosis exists. Development of an agranulocytosis does not depend on a dose and it cannot be predicted. It can develop after the first dose or after repeated application. At the Renalgan medicament treatment of patients with hematologic diseases or having them in the anamnesis it is necessary to carry out the ratio assessment risk/advantage and to control the hematologic status during therapy.

In diseases of kidneys and a liver the mode of dosing should be selected individually because of possible side effects of metamizol on kidneys and lengthenings of T _½ metamizol metabolites at dysfunctions of hepatocytes.

should use Drug with care at patients with obstructive diseases of a digestive tract (achalasia, a piloroduodenalny stenosis). Repeated use of the medicine Renalgan in these cases can cause a delay of gastrointestinal contents and intoxication. Use of the medicine Renalgan for patients with a gastroesophageal reflux disease, an intestines atony, paralytic Ilheus, glaucoma, a myasthenia gravis, heart diseases (arrhythmia, an ischemic heart disease, stagnant heart failure) demands extra care and control of the doctor.

With care apply at treatment of patients with systolic arterial blood pressure 100 mm Hg. It is necessary to be careful at introduction of 2 ml of solution (risk of sharp decrease in the ABP).

Use during pregnancy and feeding by a breast. Drug is not used during pregnancy and feeding by a breast.

Children. Drug in the form of solution is not used at children aged up to 15 years, in the form of tablets — up to 12 years.

Ability to influence speed of response at control of vehicles or work with other mechanisms. Because of possibility of side reactions from nervous system (dizziness, accommodation violation) it is necessary to refrain from control of vehicles or work with other mechanisms demanding high speed of response.

Interaction

Combination with other medicines demands extra care because of the content of metamizol which is the inductor of enzymes.

At use of medicine should avoid alcohol intake as there is a probability of mutual potentiation of action.

to mutual strengthening of severity of side effects.

Tricyclic antidepressants, oral contraceptives, Allopyrinolum slow down metabolism of metamizol in a liver and enhance its toxicity.

Inductors of enzymes (barbiturates, phenylbutazone, glutetimid and other inductors of microsomal enzymes of a liver) weaken effect of metamizol.

Sedatives and tranquilizers strengthen the anesthetizing Renalgan's action.

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Renalgan reduces concentration of cyclosporine in blood plasma. In need of the combined use of above-mentioned and other medicines it is necessary to consult with the doctor. Antagonists of H ₂ - histamine receptors, codeine and propranolol at simultaneous application enhance effect of metamizole sodium.

Sarcolysine and mercazolil increase risk of development of a leukopenia.

Metamizole sodium increases hypoglycemic activity of oral antidiabetic means.

At simultaneous application metamizol can reduce activity of anticoagulants of a coumarinic row as a result of induction of enzymes.

At simultaneous use of Chlorpromazinum and other derivatives of a fenotiazin with metamizol the risk of emergence of a heavy hypothermia exists.

At simultaneous use of chloramphenicol and other myelotoxic means with metamizol the increased risk of oppression of function of marrow exists.

Metamizol much more increases _{value C of max} Chloroquinum in blood plasma.

Simultaneous application with other analgetics and NPVP increases risk of development of manifestations of hypersensitivity and emergence of other side effects.

Renalgan can be combined from hyoscine butylbromide, furosemide, glibenclamide.

should not be applied during treatment by metamizol X-ray contrast substances, colloidal blood substitutes and penicillin.

Incompatibility. Administration of Renalgan solution with other medicines in one syringe is inadmissible.

Overdose

Symptoms. at overdose, metamizol intoxication symptoms in a combination with cholinolytic effects prevail. the toksiko-allergic syndrome, symptoms of defeat of bodies of blood formation, gastrointestinal violations, in hard cases — symptoms of damage of a brain is most often noted. vomiting, dryness in a mouth, nausea, pain in epigastric area, sweating reduction, accommodation violation, arterial hypotension, drowsiness, confusion of consciousness, an abnormal liver function, kidneys, a spasm are possible.

Treatment. At suspicion on overdose it is necessary to stop immediately use of medicine and to take measures to its fastest removal from an organism (an artificial diuresis, introduction of water-salt solutions, if necessary — a hemodialysis, peritoneal dialysis). Symptomatic therapy. There is no specific antidote.

Storage conditions

Solution — in original packing at a temperature not above 25 °C; tablets — in the place protected from light at a temperature of 8-15 °C.