Baralgin M, pills, 20 pcs.

Composition

1 tablet contains metamizole sodium 500 mg

. Pharmacological action

Pharmacological action-antispasmodic, analgesic, antipyretic, anti-inflammatory.

It blocks cyclooxygenase and reduces PG synthesis.

After oral administration, it is hydrolyzed in the gastrointestinal tract to form an active metabolite-4-methylaminoantipyrine (4-MMA), which is absorbed in the liver into 4-aminoantipyrine (4-AA), as well as pharmacologically inactive metabolites. After oral administration of 1 g of metamizole,58% of 4-MMA and 48% of 4-AA bind to plasma proteins.

The effective therapeutic plasma concentration of 4-MMA is reached in 20-40 minutes, and the_maximum concentration is reached in 2 hours.

Indications

• Severe acute or chronic pain syndrome for injuries and postoperative pain syndrome, colic, cancer, and other conditions where other therapeutic measures are contraindicated.

• Fever that is resistant to other treatments

Use during pregnancy and lactation

Baralgin M is contraindicated in pregnant women, nursing mothers and children of the first three months of life.

Contraindications

-Hypersensitivity to metamizole sodium and other components of the drug, as well as other pyrazolones (phenazone, propifenazone) or to pyrazolidines (phenylbutazone, oxyphenbutazone), including, for example, indications of a history of agranulocytosis when taking one of these drugs. – Disorders of bone marrow hematopoiesis (for example, after treatment with cytostatics) or diseases of the hematopoietic system. – Indications of a history of bronchospasm or other anaphylactic reactions (for example, urticaria, rhinitis, angioedema) when taking analgesic drugs such as salicylates, paracetamol, diclofenac, ibuprofen, Indometacin, naproxen. – Congenital insufficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis). – Children’s age (up to 15 years). – Pregnancy (first and third trimester). – Lactation period. – Acute intermittent hepatic porphyria (risk of developing porphyria attacks). If you have any of these diseases or conditions, consult your doctor before taking this medicine. With caution:- Hypotension (systolic blood pressure below 100 mm Hg), decreased blood volume, hemodynamic instability (myocardial infarction, multiple trauma, incipient shock), incipient heart failure, high fever (increased risk of a sharp drop in blood pressure). – Diseases in which a significant decrease in blood pressure may have an increased risk (patients with severe coronary heart disease and stenosis of the arteries of the brain). – Alcoholism. – Bronchial asthma, especially in combination with concomitant polypous rhinosinusitis; chronic urticaria and other types of atopy (allergic diseases in the development of which a significant role belongs to a hereditary predisposition to sensitization: pollinosis, allergic rhinitis, etc. ) (increased risk of anaphylactic/anaphylactoid reactions). – Alcohol intolerance (reaction to even small amounts of certain alcoholic beverages with symptoms such as itching, lacrimation and severe redness of the face) (increased risk of anaphylactic / anaphylactoid reactions). – Intolerance to dyes (for example, tartrazine) or preservatives (for example, benzoates) (increased risk of anaphylactic / anaphylactoid reactions). – Severe violations of liver and kidney function (low doses are recommended due to the possibility of slowing the elimination of metamizole sodium). – Pregnancy (second trimester). If you have any of these diseases or conditions, consult your doctor before taking this medicine.

Side effects

Side effects were classified according to the recommendations of the World Health Organization: very common (≥10%); common (≥1%, <10%); infrequently (≥0,1%, <1%); rarely (≥0,01%, <0,1%); very rare (Disorders of the heart rate unknown: Kounis syndrome (allergic angina or allergic myocardial infarction). Disorders of the immune systemreferences: metamizole sodium can cause anaphylactic or anaphylactoid reactions, which can be severe and life-threatening; in some cases, anaphylactic reactions can be fatal. If anaphylactic / anaphylactoid reactions develop, it is necessary to immediately stop taking the drug, take measures to provide emergency medical care to patients, and conduct a detailed clinical blood test. These reactions can occur even if the drug has been used many times before without any complications. These drug reactions may occur immediately or several hours after taking metamizole sodium, but they usually occur within one hour. Usually milder anaphylactic or anaphylactoid reactions occur in the form of skin and mucosal symptoms (itching, burning, hyperemia, urticaria, edema), shortness of breath, or complaints from the gastrointestinal tract. Milder reactions can progress to severe forms with generalized urticaria, severe angioedema (especially involving the larynx), severe bronchospasm, cardiac arrhythmias, a sharp decrease in blood pressure (sometimes preceded by an increase in blood pressure), and the development of circulatory shock. Very rarely: in patients with a complete or incomplete combination of bronchial asthma, recurrent nasal and paranasal sinus polyposis, and intolerance to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs (including in the anamnesis), intolerance reactions usually manifest as attacks of bronchial asthma. Frequency unknown: anaphylactic shock. Disorders of the skin and subcutaneous tissue often: in addition to the manifestations of anaphylactic/anaphylactoid reactions on the skin and mucous membranes listed above, a fixed drug rash may occur infrequently. Rarely: a rash may occur. Very rarely: it is possible to develop Stevens-Johnson syndrome or Lyell’s syndrome (toxic epidermal necrolysis). Disorders of the blood and lymphatic systemreferencesexternal links: leukopenia. Very rarely: agranulocytosis (including fatal cases), thrombocygopenia. Frequency unknown: aplastic anemia, pancytopenia, including fatal cases. These reactions are immunological in nature. They can occur even if the drug was previously taken many times without any complications. Typical symptoms of agranulocytosis are lesions of the mucous membranes (oral cavity and pharynx, anorectal area and genitals), sore throat, fever. It should be borne in mind that if the patient receives antibiotic therapy, then the typical manifestations of agranulocytosis may be minimally pronounced. The rate of erythrocyte sedimentation is significantly increased, while the increase in lymph nodes is weak or absent. Typical symptoms of thrombocytopenia are an increased tendency to bleed and the appearance of petechiae on the skin and mucous membranes. If the above-mentioned disorders of the blood and lymphatic system develop, it is necessary to stop taking the drug and conduct a detailed clinical blood test (see the section “Special instructions”).

Interaction

With cyclosporine

Metamizole sodium can reduce the concentration of cyclosporine in the blood serum, so when they are used together, cyclosporine concentrations should be monitored.

With other non-narcotic analgesics

Concomitant use of metamizole sodium with other non-narcotic analgesics may lead to a mutual increase in toxic effects.

With tricyclic antidepressants, oral contraceptives, allopurinol

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

With barbiturates, phenylbutazone and other inducers of microsomal liver enzymes

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

With sedatives and tranquilizers

Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium. Severe hypothermia may occur when metamizole sodium and chlorpromazine are co-administered.

With drugs that have a high protein binding (oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and Indometacin)

Metamizole sodium, replacing oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and Indometacin from plasma protein binding, enhances their effect.

With myelotoxic drugs

Myelotoxic drugs increase the manifestation of hematotoxicity of metamizole sodium.

With methotrexate

The addition of metamizole sodium to methotrexate treatment may increase the hematotoxic effect of methotrexate, especially in elderly patients.

Therefore, this combination should be avoided.

With thiamazole and sarcolysin

Thiamazole and sarcolysin increase the risk of leukopenia.

With codeine, H%^%2-histamine receptor blockers and propranolol

Codeine, H%^%2-histamine receptor blockers, and propranolol enhance the effects of metamizole sodium.

Radiopaque agents, colloidal blood substitutes and penicillin should not be used during treatment with metamizole sodium (increased risk of anaphylactic / anaphylactoid reactions).

With acetylsalicylic acid

When used together, metamizole sodium may reduce the effect of acetylsalicylic acid on platelet aggregation. Therefore, this combination should be used with caution in the treatment of patients taking low doses of acetylsalicylic acid for cardioprotection (prevention of thrombosis). With bupropion

Metamizole sodium may reduce the concentration of bupropion in the blood, which should be taken into account when using metamizole sodium and bupropion simultaneously.

How to take, course of administration and dosage

In tablets, adults are prescribed 1-2 tablets. Baralgin up to 4 times a day.

The maximum daily dose is no more than 8 tablets.

Overdose

Symptoms

If you overdose, you may experience the following symptoms: nausea, vomiting, abdominal pain, decreased kidney function/acute renal failure with oliguria (for example, due to the development of interstitial nephritis), more rarely symptoms from the central nervous system (dizziness, drowsiness, tinnitus, delirium, impaired consciousness, coma, convulsions) and a sharp decrease in blood pressure (sometimes progressing to shock), as well as heart rhythm disorders (tachycardia), hypothermia, shortness of breath, acute agranulocytosis, hemorrhagic syndrome, acute liver failure, paralysis respiratory muscles. After taking high doses, the elimination of a non-toxic metabolite (rubazonic acid) through the kidneys can cause a red staining of the urine.

Treatment

If no more than 1-2 hours have passed after taking the drug, then you can induce vomiting, conduct gastric lavage through a probe; give saline laxatives, activated charcoal. In case of overdose, forced diuresis is indicated. Main metabolite (4-N-methylaminoantipyrine) It can be eliminated by hemodialysis, hemofiltration, hemoperfusion, or plasma filtration. With the development of convulsive syndrome-intravenous administration of diazepam and fast-acting barbiturates.

Special instructions

In patients with bronchial asthma, taking the drug can provoke the development of an attack.

Storage conditions

In a dark place, at a temperature of 8-25 °C

Shelf life

4 years

Active ingredient

Metamizole sodium

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Pregnant women only in the second trimester as prescribed by a doctor, For adults, Children over 15 years of age, Children as prescribed by a doctor

Indications

Urolithiasis, Flu, Migraines, Insect Bites, Osteoarthritis and Arthritis, Sciatica, Colds, Gallstone Disease

Weight

Weight: 8 gr.