Baralgin M solution for injection. 500mg / ml, 5 ml # 5

• Pain syndrome of various etiologies (mild to moderate severity);

• fever.

Adults and adolescents 15 years and older: as a single dose, it is recommended 1-2 ml of 50% (500 mg / 1 ml) Baralgin M solution (i / m or i / v), the daily dose can be up to 4 ml of injection solution (no more 2 d), divided into 2-3 doses. The maximum single dose may be 1 g (2 ml of a 50% solution).

Children and newborns: Baralgin M should not be taken by newborns under the age of 3 months or with a body weight of less than 5 kg.

For children, Baralgin M is prescribed in a dose of 50-100 mg per 10 kg of body weight (0.1-0.2 ml of a 50% solution).

A single dose can be prescribed up to 2-3 times a day. It is recommended to warm the solution to body temperature before administration.

For children aged 3-12 months, the introduction is carried out only in / m (the child's body weight is from 5 to 9 kg).

If the drug is administered too quickly, a critical drop in blood pressure and shock may occur. IV administration should be carried out slowly (the rate of administration is not more than 1 ml (500 mg of metamizole) per minute) in the supine position, while monitoring blood pressure, pulse and respiratory rate.

Since there is a fear that the fall in blood pressure of non-allergic genesis is dose-dependent, the amount of Baralgin M solution more than 2 ml (1 g) should be administered with extreme caution.

Solution for intravenous and intramuscular administration in the form of a transparent, colorless or slightly colored liquid.

1 ml

metamizole sodium 500 mg

Excipients: water d / i - up to 1 ml.

• Hepatic porphyria;

• congenital deficiency of glucose-6-phosphate dehydrogenase;

• I and IIl trimester of pregnancy;

• bronchial asthma (including those induced by the intake of acetylsalicylic acid, salicylates or other non-steroidal anti-inflammatory drugs);

• diseases accompanied by bronchospasm;

• development of anaphylactoid reactions (urticaria, rhinitis, edema) in response to salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen;

• severe violations of liver and kidney function;

• severe hematopoietic disorders (agranulocytosis, cytoplastic and infectious neutropenia);

• contraindicated in newborns under the age of 3 months or with a body weight of less than 5 kg;

• hypersensitivity to metamizole - the active substance, as well as other components of the drug, or other pyrazolones (isopropylaminophenazole, propiphenazone, phenazone or phenylbutazone).

In infants aged 3 to 12 months, the IV route is contraindicated.

With care: systolic blood pressure below 100 mm Hg, circulatory instability (myocardial infarction, multiple trauma, incipient shock), kidney disease (pyelonephritis, glomerulonephritis, including a history), prolonged ethanol abuse.

pharmachologic effect

Baralgin M refers to non-narcotic drugs derived from pyrazolone.
It has analgesic, antipyretic and mild anti-inflammatory effects.

In terms of the mechanism of action, it practically does not differ from other non-steroidal analgesic drugs.

Pharmacokinetics

After intravenous administration, T1 / 2 for metamizole is 14 minutes. Approximately 96% is excreted in the urine as metabolites.

The connection of the active metabolite with blood plasma proteins is 50-60%.

Mainly excreted by the kidneys.

At therapeutic doses, it passes into breast milk

Side effect

Side effects were classified as follows: very frequent (> 10%), frequent (> 1, <10%), infrequent (> 0.1, <1%), rare (> 0.01, <0.1% ), very rare (<0.01%).

Allergic reactions: urticaria, including on the conjunctiva and mucous membranes of the nasopharynx, Quincke's edema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic shock.

From the side of hematopoiesis: leukopenia, rarely agranulocytosis and thrombocytopenia of immune genesis.

From the urinary system: impaired renal function, oliguria, anuria, proteinuria, very rarely the development of acute interstitial nephritis, urine staining red (due to the release of a metabolite - rubazonic acid).

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

Others: a decrease in blood pressure, a violation of the heart rhythm is possible.

Application during pregnancy and lactation

During the I and III trimester of pregnancy, you cannot take Baralgin M. From the fourth to sixth months of pregnancy, Baralgin M should be taken according to strict medical indications.

After taking Baralgin M, breastfeeding should be stopped for 48 hours.

Application for violations of liver function

In patients with impaired liver function, it is recommended to avoid taking high dosages of metamizole sodium.

Application for impaired renal function

In patients with impaired renal function, it is recommended to avoid taking high doses of metamizole sodium.

Application in children

Children and newborns: Baralgin M should not be taken by newborns under the age of 3 months or with a body weight of less than 5 kg.

For children, Baralgin M is prescribed in a dose of 50-100 mg per 10 kg of body weight (0.1-0.2 ml of a 50% solution).

A single dose can be prescribed up to 2-3 times a day. It is recommended to warm the solution to body temperature before administration.

For children aged 3-12 months, the introduction is carried out only in / m (the child's body weight is from 5 to 9 kg).

special instructions

When treating patients receiving cytostatic agents, the administration of metamizole sodium should be carried out only under the supervision of a physician.

During pregnancy, especially in the first 3 months and the last 3 months, no non-steroidal anti-inflammatory drugs should be used.

There is an increased risk of developing hypersensitivity reactions to metamizole sodium:

• in patients with bronchial asthma, especially with concomitant polyps in
  the nasal sinuses;

• in patients with chronic urticaria;

• in patients with alcohol intolerance;

• in patients with intolerance to dyes (eg tartrazine) or preservatives (eg benzoate).

With prolonged use, it is necessary to control the peripheral blood picture. Against the background of taking metamizole sodium, agranulocytosis may develop, and therefore, if an unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, erosive and ulcerative lesions of the oral cavity, vaginitis or proctitis is detected, immediate withdrawal of the drug is necessary.

It is unacceptable to use the drug to relieve acute abdominal pain (until the cause is clarified).

In patients with impaired liver and kidney function, it is recommended to avoid taking metamizole sodium in high dosages.

For intramuscular injection, a long needle must be used.

Overdose

The following symptoms may appear: nausea, vomiting, stomach pain, oliguria, hypothermia, decreased blood pressure, tachycardia, shortness of breath, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal or hepatic failure, convulsions, paralysis respiratory muscles.

Treatment is symptomatic. There is no specific antidote for metamizole. It is possible to carry out forced diuresis, hemodialysis; with the development of convulsive syndrome - intravenous administration of diazepam and fast-acting barbiturates.

Drug interactions

The simultaneous intake of alcohol and metamizole is mutually reflected in their effects. When used in conjunction with cyclosporine, there may be a decrease in the concentration of cyclosporine in the blood. The simultaneous use of metamizole with other non-narcotic analgesics can 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.

Sedatives and tranquilizers enhance the analgesic effect of the drug. Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

Radiopaque contrast agents, colloidal blood substitutes and penicillin should not be used during treatment with metamizole.

Metamizole, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin from the connection with the protein, increases their activity.

Myelotoxic drugs increase the manifestation of the drug's hematotoxicity. Thiamazole and sarcolysin increase the risk of developing leukopenia. The effect is enhanced by codeine, histamine H2 blockers and propranolol.

Due to the high likelihood of pharmaceutical incompatibility, metamizole cannot be mixed with other drugs in the same syringe.