Composition, form of production and packaging
The solution for injections is transparent, from colorless to pale yellow.
1 ml
metamizole sodium 500 mg
pituophenone hydrochloride 2 mg
fenpiverinia bromide 20 Ојg
[PRING] sodium metabisulphite, disodium edetate, potassium dihydrogen phosphate, sodium hydroxide, water d / u.
1 ml - ampoules of dark glass (5) - polyethylene trays (1) - cardboard packs.
The solution for injections is transparent, from colorless to pale yellow.
1 ml of 1 amp.
metamizole sodium 500 mg 1 g
pituophenone hydrochloride 2 mg 4 mg
fenpiverinia bromide 20 Ојg 40 Ојg
[PRING] sodium metabisulphite, disodium edetate, potassium dihydrogen phosphate, sodium hydroxide, water d / u.
2 ml - ampoules of dark glass (5) - polyethylene trays (1) - cardboard packs.
The solution for injections is transparent, from colorless to pale yellow.
1 ml of 1 amp.
metamizole sodium 500 mg 2.5 g
pituophenone hydrochloride 2 mg 10 mg
fenpiverinia bromide 20 Ојg 100 Ојg
[PRING] sodium metabisulphite, disodium edetate, potassium dihydrogen phosphate, sodium hydroxide, water d / u.
5 ml - dark glass ampoules (5) - polyethylene pallets (1) - cardboard packs.
INSTRUCTION FOR THE SPECIALIST.
The product description was approved by the manufacturer for the 2009 print edition.
PHARMACHOLOGIC EFFECT
Spasmoanalgesic. Combined drug, which includes non-narcotic analgesic - metamizole sodium (analgin), myotropic antispasmodic - petophenone hydrochloride and m-holinoblokiruyuschee means - fenpiveriiiya 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, incl. renal colic, hepatic colic, biliary colic, intestinal colic;
- biliary dyskinesia;
- algodismenorea.
For short-term symptomatic treatment:
- Arthralgia;
- neuralgia;
- ischialgia.
As an auxiliary drug:
- pain syndrome after surgical interventions and diagnostic procedures.
DOSING MODE
Parenteral (in / in, / m).
Adults and adolescents over 15 years of age with acute severe colic are injected slowly / 1 ml every 1 min for 2 ml; if necessary, again after 6-8 hours. For slow intravenous administration, usually 2 ml of the drug is sufficient.
In / m inject 2 ml of solution 2 times / day; daily should not exceed 4 ml. The duration of treatment is not more than 5 days.
In / m or in / in Revalgin is prescribed to children according to their age in the following single doses:
Age (body weight) Dose for intravenous administration Dose for I / m 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 0.4-0.5 ml
8-12 years (31-45 kg) 0.5-0.6 ml 0.6-0.7 ml
12-15 years old 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 one syringe with other drugs.
Before the injection of the injection solution, it should be warmed in the hand.
SIDE EFFECT
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 temperature rise, chills, sore throat, difficulty swallowing, stomatitis, and the development of the phenomena 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) - renal dysfunction, oliguria, anuria, proteinuria, interstitial nephritis, dyeing red eyes.
Very rarely: decreased sweating, paresis of accommodation, difficulty urinating.
Local reactions: with the / m introduction, infiltrates are possible at the injection site.
All side effects should be reported to your doctor.
CONTRAINDICATIONS
- oppression of bone marrow hematopoiesis;
- stable and unstable angina;
- chronic heart failure in the stage of decompensation;
- marked violations of the liver or kidney;
- deficiency of glucose-6-phosphate dehydrogenase;
- Tachyarrhythmia;
- acute intermittent porphyria;
- the closed-angle form of glaucoma;
- hyperplasia of the prostate (with clinical manifestations);
- intestinal obstruction and megacolon;
- collapse;
- Pregnancy (I trimester and the last 6 weeks);
- lactation period;
- early childhood (up to 3 months or with a body weight of less than 5 kg);
- hypersensitivity to pyrazolone derivatives (butadione) and other components of the drug.
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 NSAIDs 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 the doctor.
PREGNANCY AND LACTATION
Contraindicated: pregnancy (I trimester and the last 6 weeks); lactation period.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution and under the supervision of a doctor, the drug should be used for patients with impaired renal function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution and under the supervision of a doctor, the drug should be administered to patients with impaired liver function.
APPLICATION FOR CHILDREN
For children and adolescents under 18, the drug should be used only as directed by the doctor. In early childhood (up to 3 months or with a body weight of less than 5 kg) is contraindicated.
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.
Parenteral administration is usually used in emergency cases (renal or hepatic colic) and in those cases when ingestion is impossible (or absorption from the digestive tract is impaired). Special caution is required with the introduction of 2 ml of solution and more (risk of a sharp decrease in blood pressure). In / in the injection should be done slowly, in the supine 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.
Impact on the ability to drive vehicles and manage mechanisms
During drug treatment it is not recommended to drive vehicles and engage in other potentially hazardous activities requiring quick physical and mental reaction.
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.
DRUG 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 co-administered with H 1 -gistaminoblockers, butyrophenones, phenothiazines, amantadine and quinidine, m-cholinolytic action may be enhanced.
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 colloidal blood substitutes should not be used during treatment with drugs containing metamizole sodium.
Metamizole sodium, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, may increase the severity of their action.
The effect is enhanced by codeine, H 2 -gistaminoblockers 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.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
Store at a temperature not exceeding 25 В° C, out of the reach of children. Shelf life - 3 years. Do not use later than the expiry date printed on the package.
