Universal reference book for medicines
Product name: BARALGIN ® M (BARALGIN M)

Active ingredient: metamizole sodium

Type: Analgesic-antipyretic

Manufacturer: AVENTIS PHARMA (India)
Composition, form of production and packaging
The solution for intravenous and /
or injection is colorless or slightly colored, transparent.

1 ml of 1 amp.

metamizole sodium 500 mg 2.5 g

Auxiliary substances: water d / and (up to 1 ml).

5 ml - dark glass ampoules (5) - packings of cellular contour plastic (1) - packs cardboard.

INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Baralgin M refers to non-narcotic drugs, derivatives of pyrazolone.

It has analgesic, antipyretic and weak anti-inflammatory action.

By the mechanism of action is practically no different from other non-steroidal analgesic drugs.

PHARMACOKINETICS

After intravenous administration, T 1/2 for metamizole is 14 minutes.
Approximately 96% is excreted in the urine in the form of metabolites.
The association of the active metabolite with the blood plasma proteins is 50-60%.

It is mainly excreted by the kidneys.

In therapeutic doses penetrates into breast milk.

INDICATIONS

- pain syndrome of different etiology (mild to moderate severity);

- fever.

DOSING MODE

Adults and adolescents 15 years and older:
As a single dose, 1-2 ml of 50% (500 mg / 1 ml) of the solution of Baralgina M (IM or IV) is recommended, the daily dose can be up to 4 ml of the injection solution (not more than 2 g), divided into 2- 3 reception. The maximum single dose can be 1 g (2 ml of 50% solution).
Children and newborns:
Baralgin M should not be taken to newborns before the age of 3 months or at a body weight of less than 5 kg.
Children Baralgin M is given in a dose of 50-100 mg per 10 kg of body weight (0.1-0.2 ml of 50% solution).

A single dose can be prescribed up to 2-3 times a day.
Before administration, the solution is recommended to be heated to body temperature.
For children aged 3-12 months, the introduction is carried out only in / m (body weight of the child from 5 to 9 kg).

With too rapid administration of the drug, a critical drop in blood pressure and shock can occur.
In / in the introduction should be done slowly (the rate of administration is not more than 1 ml (500 mg metamizole) per minute) in the supine position, with control over the blood pressure, pulse and respiration rate.
Since there is a concern that the drop in blood pressure of non-allergic genesis is dose-dependent, the amount of Baralgina M solution greater than 2 ml (1 g) should be administered with extreme caution.

SIDE EFFECT

Side effects were classified as follows: very frequent (> 10%), frequent (> 1, <10%), not frequent (> 0.1, <1%), rare (> 0.01, <0.1% ), very rare (<0.01%).

Allergic reactions: urticaria, including 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 hematopoiesis: leukopenia, rarely agranulocytosis and thrombocytopenia of immune genesis.

On the part of the urinary system: a violation of the kidneys, oliguria, anuria, proteinuria, very rarely the development of acute interstitial nephritis, staining the urine in red (due to the release of the metabolite - rubric acid).

Local reactions: with the / m introduction, infiltrates are possible at the injection site.

Other: a decrease in blood pressure, a violation of the heart rhythm.

CONTRAINDICATIONS

- hepatic porphyria;

- congenital deficiency of glucose-6-phosphate dehydrogenase;

- I and IIl trimester of pregnancy;

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

- diseases accompanied by bronchospasm;

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

- marked violations of the liver and kidneys;

- severe hematopoiesis disorders (agranulocytosis, cytoplastic and infectious neutropenia);

- contraindicated in newborns under the age of 3 months or at 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 (isopropylaminofenazole, propiphenazone, phenazone or phenylbutazone).

Infants aged 3 to 12 months are contraindicated in / in the route of administration.

With caution: systolic blood pressure is below 100 mmHg, blood circulation instability (myocardial infarction, multiple trauma, beginning shock), kidney disease (pyelonephritis, glomerulonephritis including in history), prolonged abuse of ethanol.

PREGNANCY AND LACTATION

Baralgin M can not be taken during the first and third trimester of pregnancy.
From the fourth to the sixth months of pregnancy, the reception of Baralgina M should be carried out under strict medical conditions.
After taking Baralgin M, breastfeeding should be stopped for 48 hours.

APPLICATION FOR FUNCTIONS OF THE LIVER

In patients with impaired renal function, it is recommended to avoid metamizole sodium at high dosages.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

In patients with impaired liver function, it is advisable to avoid metamizole sodium at high dosages.

APPLICATION FOR CHILDREN

Children and newborns: Baralgin M should not be given to newborns before the age of 3 months, or with a body weight of less than 5 kg.

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

A single dose can be prescribed up to 2-3 times a day.
Before administration, the solution is recommended to be heated to body temperature.
For children aged 3-12 months, the introduction is carried out only in / m (body weight of the child from 5 to 9 kg).

SPECIAL INSTRUCTIONS

In the treatment of patients receiving cytotoxic drugs, the use of metamizole sodium should only be performed under the supervision of a physician.

During pregnancy, especially in the first 3 months and the last 3 months, you can not use any non-steroidal anti-inflammatory drugs.

The increased risk of hypersensitivity reactions to metamizole sodium is available:

- in patients with bronchial asthma, especially with concomitant polyps in

the area of ​​the nasal sinuses;

- in patients with chronic urticaria;

- in patients with alcohol intolerance;

- in patients with intolerance to dyes (for example, tartrazine) or to preservatives (for example, benzoate).

With prolonged use, it is necessary to monitor the picture of peripheral blood.
Against the background of taking metamizole sodium, the development of agranulocytosis is possible, therefore, if an unmotivated rise in temperature, chills, sore throats, difficulty swallowing, stomatitis, erosive-ulcerative lesions of the oral cavity, vaginitis or proctitis is required, immediate withdrawal of the drug is necessary.
It is inadmissible to use the drug to relieve acute pain in the abdomen (until finding out the cause).

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

With the / m introduction it is necessary to use a long needle.

OVERDOSE

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

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 diazepam and high-speed barbiturates.
DRUG INTERACTION

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 cyclosporin in the blood. The simultaneous use of metamizole 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.

Sedatives and tranquilizers increase the analgesic effect of the drug.
Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.
Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during metamizole treatment.

Metamizole, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroid agents and indomethacin, increases their activity.

Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.
Thiamazole and sarcolysin increase the risk of developing leukopenia. The effect is enhanced by codeine, histamine H2 blockers and propranolol.
Because of the high likelihood of pharmaceutical incompatibility, metamizole should not be mixed with other drugs in the same syringe.

TERMS OF RELEASE FROM PHARMACY

On prescription.

TERMS AND CONDITIONS OF STORAGE

Store at a temperature of 8 ° C to 25 ° C in a dark place.
Keep out of the reach of children! Sh
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