Spasmodic analgesic. A combination drug, which consists of non-narcotic analgesic – sodium metamizole (analgin), myotropic antispasmodic agent – pitophenone hydrochloride and m-cholinoblocking agent – phenpiveuria bromide.
Methamisole has analgesic, antipyretic and mild anti-inflammatory effects.
Pitophenone, like papaverine, has a direct myotropic effect on the smooth muscles of internal organs and causes them to relax.
Phenpiperinia bromide has an additional antispasmodic effect on the smooth muscles due to its m-cholinoblocking action.
Osteoarthritis and arthritis, Painful menstruation (algodysmenorrhea), Renal colic, Migraine, Lumbago, Gallic colic, GI spasms, Headache, Neuralgia, trigeminal neuralgia, Toothache, Rheumatoid arthritis, Colic, Pain after trauma and surgery, Sciatica, Biliary dyskinesia, Radiculitis, Back pain, Myalgia (muscle pain), Neck pain
- Pain syndrome (mild to moderately pronounced) in spasms of the smooth muscles of internal organs: Renal colic, spasm of the ureter and bladder;
- gastric colic, intestinal colic;
- biliary tract dyskinesia, postcholecystectomy syndrome, chronic colitis;
- aldysmenorrhea, pelvic organ diseases.
For short-term treatment: arthralgia, myalgia, neuralgia, sciatica.
As an adjunctive medicine: pain syndrome after surgical interventions and diagnostic procedures.
Sodium metamizole, Pitofenone, Phenpiperinia bromide
|Sodium metamizole||500 mg|
|pitophenone hydrochloride||2 mg|
|phenpivery bromide||20 µg|
How to take, the dosage
Parenterally (intravenously, intramuscularly).
Adults and adolescents over 15 years of age in acute severe colic are administered by 2 ml slowly (1 ml within 1 min) by IV; repeatedly after 6-8 h if necessary. For slow IV administration 2 ml of the drug is usually sufficient.
I/m inject 2 ml of the solution 2 times/day; daily should not exceed 4 ml. The duration of treatment is not more than 5 days.
I/m or intravenous Revalgin is administered to children depending on age in the following single doses:
|Age (body weight)||Dose for IV administration||Dose for intravenous administration|
|3-11 months (5-8 kg)||–||0.1-0.2 ml|
|1-2 years (9-15 kg)||0.1-0.2 ml||0.2-0.3 ml|
|3-4 years (16-23 kg)||0.2-0.3 ml||0.3-0.4 ml|
|5-7 years (24-30 kg)||0.3-0.4 ml||0.4-0.4 ml.5 ml|
|8-12 years (31-45 kg)||0.5-0.6 ml||0.6-0.6 ml.7 ml|
|12-15 years||0.8-1.0 ml||0.8-1.0 ml|
If necessary, repeated administration of the drug in the same doses may be prescribed.
The solution is incompatible in the same syringe with other medications.
The injectable solution should be warmed in the hand before administration.
Simultaneous use of Revalgin with other non-narcotic analgesics may lead to mutual enhancement of toxic effects.
Tricyclic antidepressants, oral contraceptives, allopurinol impair metabolism of metamizole in the liver and increase its toxicity.
Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effects of metamizole.
Concomitant use with cyclosporine reduces the blood levels of the latter.
Sedatives and tranquilizers increase the analgesic effect of sodium metamizole.
When co-administered with H1-histaminoblockers, butyrophenones, phenothiazines, amantadine and quinidine the m-cholinolytic effect may be increased.
In co-administration with ethanol – mutual enhancement of effects.
Concomitant use with chlorpromazine or other phenothiazine derivatives may lead to marked hyperthermia.
Rentgen contrasting drugs and colloidal blood substitutes should not be used during treatment with the drugs containing sodium metamizole.
Sodium metamizole, by displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin from binding to protein, may increase their potency.
The effect is enhanced by codeine, H2-histaminoblockers and propranololol (slows inactivation of sodium metamizole).
The solution for injection is pharmaceutically incompatible with other drugs.
Physician should be consulted if simultaneous use of the above and other medicinal products is necessary.
Do not use to relieve acute abdominal pain (until the cause is clarified).
It is not recommended to take ethanol during treatment with Revalgin.
Parenteral administration is usually used in emergency cases (renal or hepatic colic) and when oral administration is not possible (or absorption from the gastrointestinal tract is impaired). Particular caution is required when administering 2 ml of the solution and more (risk of severe BP decrease). The intravenous injection should be performed slowly in the supine position and under control of BP, HR and respiratory rate.
In prolonged (more than one week) use of the drug it is necessary to monitor the peripheral blood count and the functional state of the liver.
Impact on driving and operating machinery
When using the drug, it is not recommended to drive vehicles and engage in other potentially dangerous activities requiring rapid physical and mental reaction.
- oppression of medullary hematopoiesis;
- stable and unstable angina pectoris;
- chronic heart failure in decompensation;
- Chronic heart failureSevere hepatic or renal dysfunction;
- Glucose-6-phosphate dehydrogenase deficiency;
- acute intermittent porphyria;
- closed-angle glaucoma;
- prostate hyperplasia (with clinical manifestations);
- intestinal obstruction and megacolon;
- pregnancy (first trimester and last 6 weeks);
- lactation period;
- early childhood (under 3 months or with body weight less than 5 kg);
- high sensitivity to pyrazolone derivatives (butadione) and other components of the drug.
Patients with impaired hepatic or renal function, predisposition to arterial hypotension, bronchial asthma, hypersensitivity to NSAIDs or non-narcotic analgesics (including history of aspirin triad) should use the drug with caution and under medical supervision.
Children and adolescents under 18 years of age should use the drug only with the prescription.
In therapeutic doses the drug is usually well tolerated.
Allergic reactions (skin rash, itching, very rarely – anaphylactic shock, urticaria), angioedema are sometimes possible.
In single cases – a burning sensation in the epigastric region, dry mouth, headache.
Dizziness, decreased blood pressure, tachycardia, cyanosis are possible.
In long-term use, hematopoiesis disorders: thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unexplained fever, chills, sore throat, difficulty in swallowing, stomatitis, and the development of vaginitis or proctitis).
If prone to bronchospasm, it is possible to provoke an attack.
In very rare cases – malignant erythema exudative (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome).
Rarely (usually with prolonged use or high doses) – renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, staining of the purple color.
Very rare: decreased sweating, paresis of accommodation, difficulty in urination.
Local reactions: infiltrates may occur at the injection site if administered by injection.
Any side effects should be reported to the attending physician.
Symptoms: vomiting, decreased blood pressure, drowsiness, confusion, nausea, epigastric pain, liver and kidney malfunction, seizures.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
The drug is contraindicated in pregnancy (I trimester and last 6 weeks) and during lactation (breast-feeding).
In children and adolescents under 18 years of age the drug should be used only by prescription. In young children (under 3 months or with body weight less than 5 kg) the drug is contraindicated.
Spazmalin, Maxigan, Spasmalgon, Bral, Spazgan
|Conditions of storage|
At a temperature not exceeding 25 °C
Shreya Life Sciences Pvt. Ltd, India
solution for injection
Shreya Life Sciences Pvt. Ltd
Buy Revalgin, 5 ml 5 pcs. with delivery to USA, UK, Europe and over 120 other countries.