Revalgin

Revalgin – the combined drug having cholinolytic, analgeziruyushchy and spasmolytic effect.

Form of release and structure

Dosage forms of release of Revalgin:

• Tablets: flat, round, white, with a dividing groove and the cut-off edges (on 10 or 20 pieces in strips, on 1-5 or 10 strips in a cardboard pack);
• Solution for injections: transparent, from pale yellow color to colourless (in ampoules on 1, 2 or 5 ml, on 3, 5 or 10 ampoules in polyethylene pallets, on 1-5 pallets in a cardboard pack).

Active agents as a part of 1 tablet:

• Bromide a fenpiveriniya – 0,1 mg;
• Metamizol – 500 mg;
• Hydrochloride of a pitofenon – 5 mg.

Auxiliary components: talc, starch, lactose, magnesium stearate, microcrystallic cellulose, colloid silicon dioxide.

Active agents as a part of 1 ml of injection solution:

• Bromide a fenpiveriniya – 0,02 mg;
• Metamizole sodium – 500 mg;
• Hydrochloride of a pitofenon – 2 mg.

Auxiliary components: dihydropotassium phosphate, sodium metabisulphite, sodium hydroxide, эдетат dinatrium, water for injections.

Indications to use

• Pain syndrome of weak or moderate expressiveness at spasms of smooth muscles of internals, including enterospasms, renal and bilious gripes, a dysmenorrhea and other spastic conditions of internals;
• Head, migrenozny and joint pains, neuralgia, ischialgia, mialgiya (for a short symptomatic treatment);
• The period after carrying out surgical and diagnostic interventions (as supportive application for reduction of pains);
• The increased body temperature at diseases of catarrhal and infectious and inflammatory genesis (for tablets).

Contraindications

Absolute:

• The expressed functional disturbances of kidneys or a liver;
• Tachyarrhythmia;
• Closed-angle glaucoma;
• Gastrointestinal impassability and megacolon;
• Kollaptoidny states;
• Genetic absence (for tablets) or deficit (for injection solution) glyukozo-6-fosfatdegidrogenazy;
• Prostatauxe at which the tendency to an ischuria is observed (for tablets);
• Diseases of system of blood (for tablets);
• Oppression of a marrowy hemopoiesis (for injection solution);
• Unstable and stable stenocardia (for injection solution);
• Dekompensirovanny chronic heart failure (for injection solution);
• The acute alternating porphyria (for injection solution);
• The prostate hyperplasia proceeding with clinical manifestations (for injection solution);
• First trimester and last 6 weeks of pregnancy, lactation period;
• Age up to 3 months (or weight is less than 5 kg; for injection solution) and up to 5 years (for tablets);
• Hypersensitivity to drug components, and also to pyrazyl ketone derivatives.

Relative (Revalgin appoint with care in the presence of the following diseases / states):

• Tendency to arterial hypotension, bronchospasm, bronchial asthma;
• Functional disturbances of a liver and/or kidneys;
• The increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics (including "an aspirinovy triad" in the anamnesis);
• Age up to 18 years (for injection solution).

Route of administration and dosage

Tablets
Revalgin accept inside, it is more preferable – after food.

The recommended dosing mode (a single dose at frequency rate of reception 2-3 times a day):

• Adults and children of 15 years: 1-2 tablets. As much as possible – 6 tablets a day. The course should not exceed 5 days;
• Children (only on medical appointment): 6-8 years –1/2 tablets; 9-12 years – 3/4 tablets; for children of 13-15 years –1 tablet.

Change of the specified scheme of administration of drug is possible only to destination the specialist.

Injection solution
Revalgin enter intravenously or intramusculary.

At acute heavy gripes to adults and children of 15 years Revalgin enter intravenously slowly 2 ml (within 1 minute on 1 ml), in case of need in 6-8 hours repeat administration of drug.

Intramusculary solution is entered by 2 times a day on 2 ml (as much as possible – 4 ml a day).

Duration of a course should not exceed 5 days.

The recommended dosing mode for children depending on age and the weight (intramuscular/intravenous administration):

• 3-11 months (5-8 kg): 0,1-0,2/0 ml;
• 1-2 years (9-15 kg): 0,2-0,3/0,1-0,2 ml;
• 3-4 years (16-23 kg): 0,3-0,4/0,2-0,3 ml;
• 5-7 years (24-30 kg): 0,4-0,5/0,3-0,4 ml;
• 8-12 years (31-45 kg): 0,6-0,7/0,5-0,6 ml;
• 12-15 years: 0,8-1/0,8-1 ml.

In the presence of indications perhaps repeated administration of solution in the same dose.

It is impossible to combine in one syringe Revalgin with other substances / medicines.

Before introduction injection solution needs to be warmed in a hand.

Side effects

At observance of the recommended therapeutic doses Revalgin, as a rule, is had well. During therapy development of dizziness, tachycardia, cyanosis, a lowering of arterial pressure can be observed.

Long therapy can cause disturbances of a hemopoiesis in the form of thrombocytopenia, a leukopenia, an agranulocytosis (symptoms: stomatitis, pharyngalgia, unmotivated rise in temperature, swallowing difficulty, fever, and also development of the phenomena of a proctitis or vaginitis).

In case of existence of tendency to a bronchospasm the attack can develop.

Probable side reactions:

• Sometimes: allergic reactions (in the form of skin rash, an itch; seldom or never – an acute anaphylaxis, a small tortoiseshell), a Quincke's disease;
• Seldom (most often at long therapy or at purpose of high doses): intersticial nephrite, renal failures, an anury, an oliguria, a proteinuria, coloring of urine in red color;
• Very seldom (including isolated cases): the complicated urination, accommodation paresis, decrease in sweating, a toxic epidermal necrolysis (Lyell's disease), a malignant exudative erythema (Stephens-Johnson's syndrome), dryness in a mouth, burning sensation in epigastric area, a headache.

At intramuscular introduction local reactions in the form of infiltrates in an injection site can develop.

In cases of development of side effects it is necessary to consult with the specialist.

Special instructions

At long (longer than 7 days) Revalgin's use it is necessary to control a pattern of peripheral blood and indicators of a functional condition of a liver.

Coloring of urine in red color is in certain cases possible (because of metamizol metabolites).

It is not necessary to apply Revalgin to stopping of acute abdominal pains before diagnosis.

During therapy it is impossible to apply alcohol.

Parenteral administration of Revalgin is appointed, as a rule, in case of emergency (at renal or hepatic colic), at disturbance of absorption from digestive tract and at impossibility of administration of drug inside.

Because of high risk of a sharp lowering of arterial pressure at introduction more than 2 ml of solution it is necessary to be careful. Intravenously Revalgin it is necessary to enter slowly, in horizontal position and under control of arterial pressure, a respiration rate and heart rate.

To manage motor transport and to be engaged in other potentially dangerous works which performance demands bystry mental and physical reactions it is not recommended.

Medicinal interaction

At the combined use of Revalgin with some medicinal means / substances the following effects can be observed:

• Sedatives and tranquilizers: strengthening of anesthetizing Revalgin's action;
• Other non-narcotic analgesics: mutual strengthening of toxic effects;
• Ethanol: mutual strengthening of effects;
• Indirect anticoagulants, peroral hypoglycemic drugs, indometacin and glucocorticosteroids: increase in expressiveness of their action;
• Tricyclic antidepressants, peroral contraceptives, Allopyrinolum: disturbance of metabolism of metamizol in a liver, increase in its toxicity;
• Phenylbutazone, barbiturates and other inductors of microsomal enzymes of a liver: weakening of effect of metamizol;
• Cyclosporine: decrease in its level in blood;
• Colloid blood substitutes and X-ray contrast medicines: interaction development (the combination is not recommended);
• _{H1-gistaminoblokatory}, phenyl propyl ketones, fenotiazina, амантадин and quinidine: strengthening of m - cholinolytic action;
• Chlorpromazinum or other derivatives of a fenotiazin: development of the expressed hyperthermia;
• _{H2-gistaminoblokatory}, codeine, propranolol: delay of an inactivation and strengthening of effect of metamizole sodium.

Pharmaceutical injection solution of Revalgin is incompatible with other substances / medicines.

Terms and storage conditions

To store in the place, dry, unavailable to children, at a temperature up to 25 °C.

Period of validity – 3 years.