Revalgin, Ampoules 5ml, 5pcs

Composition

Auxiliary substances:

sodium metabisulfite,

disodium edetate,

potassium dihydrogen phosphate,

sodium hydroxide,

d/i water.

Pharmacological action

Spasmoanalgesic. A combination drug, which includes a non-narcotic analgesic-metamizole sodium (analgin), a myotropic antispasmodic agent-pitofenone hydrochloride and an m-holinoblokiruyushchy agent-fenpiveriiia bromide.

Metamizole has analgesic, antipyretic and weak anti-inflammatory effects.

Pitofenone, like papaverine, has a direct myotropic effect on the smooth muscles of internal organs and causes its relaxation.

Fenpiverinium bromide has an additional antispasmodic effect on smooth muscles due to its m-holinoblocking effect.

Indications

• pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of the ureter and bladder;
• biliary colic, intestinal colic;
• biliary dyskinesia, postcholecystectomy syndrome, chronic colitis;
• algodismenorrhea, pelvic diseases.

For short-term treatment: arthralgia, myalgia, neuralgia, sciatica.

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

Use during pregnancy and lactation

The drug is contraindicated during pregnancy (I trimester and the last 6 weeks) and during lactation (breastfeeding).

Use in children

Children and adolescents under 18 years of age should use the drug only as prescribed by a doctor. In early childhood (up to 3 months or with a body weight of less than 5 kg) is contraindicated.

Contraindications

• oppression of bone marrow hematopoiesis;
• stable and unstable angina;
• congestive heart failure in the stage of decompensation;
• severe liver or kidney disease;
• deficiency of glucose-6-phosphate dehydrogenase;
• tachyarrhythmia;
• acute intermittent porphyria;
• form-closure glaucoma;
• prostatic hyperplasia (clinical manifestations);
• ileus and megacolon;
• collapse;
• pregnancy (I trimester and the last 6 weeks);
• lactation;
• early childhood (up to 3 months or weighing less than 5 kg);
• hypersensitivity to pyrazolones derivatives (phenylbutazone) and other components of the drug.

With caution and under the supervision of a doctor, the drug should be used in patients with impaired liver or kidney function, with a tendency to hypotension, bronchial asthma, increased individual sensitivity to NSAIDs or non-narcotic analgesics (including “aspirin triad” in the anamnesis).

Children and adolescents under 18 years of age should use the drug only as prescribed by a doctor.

Side effects

In therapeutic doses, the drug is usually well tolerated.

Sometimes allergic reactions (skin rash, pruritus, very rarely – anaphylactic shock, urticaria), angioedema are possible.

In isolated cases-a burning sensation in the epigastric region, dry mouth, headache.

Possible dizziness, decreased blood pressure, tachycardia, cyanosis.

With prolonged use-hematopoietic disorders: thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unmotivated fever, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of vaginitis or proctitis phenomena).

With a tendency to bronchospasm, it is possible to provoke an attack.

In very rare cases – malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).

Rarely ( usually with prolonged use or high doses) – impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, red eye staining.

Very rare: decreased sweating, paresis of accommodation, difficulty urinating.

Local reactions: with intravenous use, infiltrates at the injection site are possible.

All side effects should be reported to your doctor.

Interaction

Concomitant use of Revalgin with other non-narcotic analgesics can lead to a mutual increase in toxic effects.

Tricyclic antidepressants, oral contraceptives, and allopurinol disrupt the metabolism of metamizole in the liver and increase its toxicity.

Barbiturates, phenylbutazone, and other inducers of microsomal liver enzymes weaken the effect of metamizole.

Concomitant use with cyclosporine reduces the level of the latter in the blood.

Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.

When co-administered with_H1-histamine blockers, butyrophenones, phenothiazines, amantadine and quinidine, the m-cholinolytic effect may be enhanced.

When combined with ethanol-mutual enhancement of effects.

Concomitant use with chlorpromazine or other phenothiazine derivatives may lead to severe hyperthermia.

Radiopaque drugs and colloidal blood substitutes should not be used during treatment with drugs containing metamizole sodium.

Metamizole sodium, replacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and Indometacin from protein binding, may increase the severity of their action.

The effect is enhanced by codeine, _H2-histamine blockers and propranolol (slows down the inactivation of metamizole sodium).

The solution for injection is pharmaceutically incompatible with other medicinal products.

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

How to take, course of use and dosage

Parenterally (IV, iv).

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

In / m,2 ml of the solution is administered 2 times / day; the daily dose should not exceed 4 ml. The duration of treatment is not more than 5 days.

IV or iv Revalgin is prescribed to children, depending on their age, in the following single doses: :

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

The solution in the same syringe is incompatible with other medications.

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

Overdose

Symptoms: vomiting, low blood pressure, drowsiness, confusion, nausea, epigastric pain, impaired liver and kidney function, convulsions.

Treatment: gastric lavage, use of activated charcoal, symptomatic therapy.

Special instructions

Do not use for relief of acute abdominal pain (until the cause is determined).

During treatment with the drug Revalgin is not recommended to take ethanol.

Parenteral use is usually used in emergency cases (renal or hepatic colic) and in cases when oral use is impossible (or absorption from the gastrointestinal tract is impaired). Special care is required when introducing 2 ml of the solution or more (risk of a sharp decrease in blood pressure). Intravenous injection should be carried out slowly, in a supine position and under the control of blood pressure, heart rate and respiratory rate.

With prolonged (more than a week) use of the drug, it is necessary to monitor the picture of peripheral blood and the functional state of the liver.

Influence on the ability to drive motor vehicles and manage mechanisms

During treatment with the drug, it is not recommended to drive vehicles or engage in other potentially dangerous activities that require rapid physical and mental response.

Form of production

Revalgin ampoules.

Storage conditions

At a temperature not exceeding 25 °C

Shelf life

3 years

Active ingredient

Metamizole sodium, Pitofenone, Fenpiverinium bromide

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as prescribed by a doctor, for children as prescribed by a doctor

Indications

Migraine, Sciatica, Trigeminal Neuralgia, Gastrointestinal Spasm, Sciatica, Arthrosis and Arthritis, Biliary Dyskinesia, Lumbago, Rheumatoid Arthritis