Revalgin (Tablets, Solution) Instructions for Use

ATC Code

N02BB52 (Metamizole sodium in combination with other drugs, except psycholeptics)

Active Substances

Metamizole sodium (Rec.INN registered by WHO)

Pitofenone (Rec.INN registered by WHO)

Fenpiverinium bromide (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Spasm analgesic

Pharmacotherapeutic Group

Non-narcotic analgesic agent (non-narcotic analgesic + spasmolytic)

Pharmacological Action

Spasm analgesic. A combined drug, which includes a non-narcotic analgesic – metamizole sodium (analgin), a myotropic spasmolytic agent – Pitofenone hydrochloride and an m-cholinoblocking agent – Fenpiverinium bromide.

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

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

Fenpiverinium bromide, due to its m-cholinoblocking action, provides an additional spasmolytic effect on smooth muscles.

Indications

• Pain syndrome with spasms of smooth muscles of internal organs, including renal colic, hepatic colic, biliary colic, intestinal colic;
• Biliary dyskinesia;
• Algodysmenorrhea.

For short-term symptomatic treatment

• Arthralgia;
• Neuralgia;
• Sciatica.

As an auxiliary medicinal product

• Pain syndrome after surgical interventions and diagnostic procedures.

ICD codes

Dosage Regimen

Solution

Parenterally (IV, IM).

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

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

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

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

The solution is incompatible in the same syringe with other medicinal products.

Before administration, the injection solution should be warmed in the hand.

Tablets

Adults and adolescents over 15 years are prescribed orally (preferably after meals) 1-2 tablets 2-3 times/day. The daily dose should not exceed 6 tablets. The duration of administration is not more than 5 days.

An increase in the daily dose of the drug or the duration of treatment is possible only under medical supervision.

In children, the drug is used only as prescribed by a doctor. Dosage for children 6-8 years -1/2 tablet; for children 9-12 years – 3/4 tablet; for children 13-15 years – 1 tablet; frequency of administration – 2-3 times/day.

Other dosage regimens are possible only after consultation with a doctor.

Adverse Reactions

In therapeutic doses, the drug is usually well tolerated.

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

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

Possible dizziness, decreased blood pressure, tachycardia, cyanosis.

With prolonged use – hematopoiesis disorders thrombocytopenia, leukopenia, agranulocytosis (may manifest with the following symptoms: unmotivated fever, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of vaginitis or proctitis).

In case of tendency to bronchospasm, an attack may be provoked.

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 urine coloration.

Very rarely: decreased sweating, accommodation paresis, difficult urination.

Local reactions with IM administration, infiltrates at the injection site are possible.

All side effects should be reported to the attending physician.

Contraindications

• Suppression of bone marrow hematopoiesis;
• Stable and unstable angina pectoris;
• Chronic heart failure in the stage of decompensation;
• Severe impaired liver or kidney function;
• Glucose-6-phosphate dehydrogenase deficiency;
• Tachyarrhythmia;
• Acute intermittent porphyria;
• Closed-angle glaucoma;
• Prostatic hyperplasia (with clinical manifestations);
• Intestinal obstruction and megacolon;
• Collapse;
• Pregnancy (I trimester and last 6 weeks);
• Lactation period;
• Early childhood (up to 3 months or with body weight less than 5 kg);
• Hypersensitivity to pyrazolone derivatives (butadione) and other components of the drug.

With caution and under medical supervision, the drug should be used in patients with impaired liver or kidney function, with a tendency to arterial 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.

Use in Pregnancy and Lactation

Contraindicated: pregnancy (I trimester and last 6 weeks); lactation period.

Use in Hepatic Impairment

With caution and under medical supervision, the drug should be used in patients with impaired liver function.

Use in Renal Impairment

With caution and under medical supervision, the drug should be used in patients with impaired kidney function.

Pediatric Use

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 body weight less than 5 kg) it is contraindicated.

Special Precautions

Do not use to relieve acute abdominal pain (until the cause is clarified).

During treatment with the drug, alcohol should not be used.

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

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

Effect on ability to drive vehicles and mechanisms

During treatment with the drug, it is not recommended to drive vehicles and engage in other potentially hazardous activities that require speed of physical and mental reactions.

Overdose

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

Treatment gastric lavage, administration of activated charcoal, symptomatic therapy.

Drug Interactions

Simultaneous use of Revalgin with other non-narcotic analgesics may lead to mutual enhancement of toxic effects.

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

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

Simultaneous 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, enhancement of the m-cholinolytic effect is possible.

When used concomitantly with ethanol – mutual enhancement of effects.

Simultaneous use with chlorpromazine or other phenothiazine derivatives may lead to the development of severe hyperthermia.

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

Metamizole sodium, displacing oral hypoglycemic medicinal products, indirect anticoagulants, glucocorticosteroids and indomethacin 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 injection solution is pharmaceutically incompatible with other medicinal products.

If it is necessary to use the specified and other drugs simultaneously, you should consult your doctor.

Storage Conditions

Store at a temperature not exceeding 25°C (77°F), in places inaccessible to children.

Shelf Life

Shelf life – 3 years. Do not use after the expiration date printed on the package.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.