Active substanceMetamizol sodium + Pitofenone + Fentpiverinia bromideMetamizol sodium + Pitofenone + Fentpiverinia bromide
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  • Dosage form: & nbspinjection
    Composition:

    1 ml of the solution contains:

    Active ingredients: metamizole sodium (analgin) - 500 mg,

    pentophenone hydrochloride - 2 mg,

    fenpiperinium bromide - 0.02 mg.

    Excipients: sodium metabisulphite, disodium edetate, potassium

    dihydrogen phosphate, sodium hydroxide, water for injection.

    Description:

    Transparent solution, from colorless to pale yellow.

    Pharmacotherapeutic group:Analgesic non-narcotic and antispasmodic.
    ATX: & nbsp

    N.02.B.B.52   Metamizole sodium in combination with other drugs, excluding psycholeptics

    Pharmacodynamics:

    Revagin is a combined drug, which includes: non-narcotic analgesic metamizol sodium (analgin), myotropic antispasmodic pituophenone hydrochloride and M-anticholinic blocking agent fenpiverinia bromide. Metamizole has analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fentipierinium bromide due to M-holinoblokiruyuschego action has an additional antispasmodic effect on smooth muscle.

    Indications:

    Pain syndrome with spasms of smooth muscles of internal organs including: renal colic, hepatic colic, biliary colic, intestinal colic, biliary dyskinesia, algodismenorea. For short-term symptomatic treatment: arthralgia, neuralgia, ischialgia.

    As an auxiliary medicine: pain syndrome after surgical interventions and diagnostic procedures.

    Contraindications:

    Hypersensitivity to pyrazolone derivatives (butadione) and other components of the drug; oppression of bone marrow hematopoiesis; stable and unstable angina; chronic heart failure in the stage of decompensation; marked violations of the liver or kidneys; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia; acute "intermittent" porphyria; closed-angle form of glaucoma; hyperplasia of the prostate (with clinicalmanifestations); intestinal obstruction and megacolon; collapse; pregnancy (first trimester and the last 6 weeks); lactation period; early childhood (up to 3 months or body weight less than 5 kg).

    Carefully:

    With caution and under the supervision of a doctor, the drug should be administered to patients with impaired liver or kidney function, with a tendency to arterial hypotension, bronchial asthma, increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics (including the "aspirin" triad in the anamnesis). For children and adolescents under 18, the drug should be used only as directed by a doctor.

    Pregnancy and lactation:contraindicated
    Dosing and Administration:

    Parenterally (intravenously, intramuscularly).

    Adults and adolescents over 15 years of age with acute severe colic are administered intravenously slowly (1 ml for 1 minute) 2 ml each; if necessary, again after 6-8 hours. For slow intravenous administration, usually 2 ml of the drug is sufficient.

    Intramuscularly inject 2 ml of solution 2 times a day; daily should not exceed 4 ml. The duration of treatment is not more than 5 days.

    Intramuscularly or intravenously, Revalgine is administered to children according to their age in the following single doses:

    3-11 months (5-8 kg) - only in / m 0,1-0,2 ml;

    1-2 years (9-15 kg) - in / in - 0,1-0,2 ml, in / m - 0,2-0,3 ml;

    3-4 years (16-23 kg) - in / in - 0,2-0,3 ml, in / m - 0,3-0,4 ml;

    5-7 years (24-30 kg) - in / in - 0,3-0,4 ml; in / m - 0,4-0,5 ml;

    8-12 years (31-45 kg) - in / in - 0,5-0,6 ml, in / m - 0,6-0,7 ml;

    12-15 years old / in and in / m - 0,8-1,0 ml.

    If necessary, repeated administration of the drug in the same doses may be prescribed.

    The solution is incompatible in one syringe with other drugs.

    Before the injection of the injection solution, it should be warmed in the hand.

    Side effects:

    In therapeutic doses, the drug is usually well tolerated. Sometimes allergic reactions are possible (skin rash, itching, very rarely anaphylactic shock, urticaria), angioedema. In rare cases - a burning sensation in the epigastric region, dry mouth, headache.

    Possible dizziness, lowering blood pressure, tachycardia, cyanosis. With prolonged admission, hematopoietic disorders: thrombocytopenia, leukopenia, agranulocytosis (can be manifested by the following symptoms: unmotivated fever, chills, sore throat, difficulty swallowing, stomatitis, and the development of vaginitis or proctitis).With propensity to bronchospasm may provoke an attack.

    In very rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). Rarely (usually with prolonged administration or administration of high doses) - impaired renal function;

    oliguria, anuria, proteinuria, interstitial nephritis, urine staining in red. Very rarely - reducing sweating, paresis of accommodation, difficulty urinating.

    Local reactions: with intramuscular injection, infiltrates are possible at the site of administration.

    All side effects should be reported to your doctor.

    Overdose:

    Symptoms: vomiting, lowering blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, impaired liver and kidney function, convulsions.

    Treatment: gastric lavage, the appointment of activated charcoal, symptomatic therapy.

    Interaction:

    The simultaneous use of revalgine with other non-narcotic analgesics may lead to a mutual enhancement of toxic effects.

    Tricyclic antidepressants, oral contraceptives, allopurinol disrupt metamizole metabolism in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole.

    Simultaneous use with cyclosporine reduces the level of the latter in the blood. Sedatives and tranquilizers increase the analgesic effect of metamizole sodium.

    When joint appointment with H1-gistaminoblokatorami, butirofenonami,

    phenothiazines, amantadine and quinidine, an enhancement of M-cholinolytic action is possible.

    When combined with ethanol - mutual enhancement of effects. Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia. Radiopaque drugs and colloid blood substitutes should not be used during treatment with drugs containing metamizol sodium. Metamizol sodium, displacing out of association with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, can increase the severity of their action.

    The effect is enhanced codeine, H2-histamin blockers and propranolol (slows the inactivation of metamizole sodium).

    The solution for injection is pharmaceutically incompatible with other drugs.

    If you need to use these and other medications at the same time, you should consult your doctor.

    Special instructions:

    Do not use to relieve acute pain in the abdomen (until finding out the cause).

    During the treatment with the drug, alcohol should not be used; It is not recommended to drive vehicles and engage in other potentially hazardous activities requiring quick physical and mental reaction. Parenterate injection is usually used in emergency cases (renal or hepatic colic) and in cases when oral intake is impossible (or absorption from the gastrointestinal tract is impaired). Special care is required when injection of 2 ml of solution and more (risk of a sharp decrease in blood pressure). Intravenous injection should be administered slowly, in prone position and under the control of blood pressure, heart rate and respiratory rate. With prolonged (more than a week) application of the drug, control of the picture of peripheral blood and the functional state of the liver is necessary.

    Effect on the ability to drive transp. cf. and fur:not described
    Form release / dosage:

    injection for 2 ml or 5 ml in ampoule ampoules. By 5 or 10 ampoules in a pallet of high-density polyethylene.

    1, 2, 3, 4, 5 pallets together with the instruction for use are placed in a cardboard box.

    Packaging:ampoules of dark glass (10) -pallets
    ampoules of dark glass (3) -pallets
    ampoules of dark glass (5) -pallets
    Storage conditions:

    Store at a temperature not exceeding 25 ° C, out of the reach of children.

    Shelf life:

    3 years. Do not use later than the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:П N014484 / 02-2002
    Date of registration:31.10.2008
    The owner of the registration certificate:Shraya Life Senses Pvt. Ltd.Shraya Life Senses Pvt. Ltd. India
    Manufacturer: & nbsp
    Representation: & nbspSHREYA LIFE SENENSIZ Pvt.Ltd. SHREYA LIFE SENENSIZ Pvt.Ltd. India
    Information update date: & nbsp13.10.2010
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