Baralgin M tabs 500mg #100

Baralgin M instruction

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Pharmacokinetics

Metamizol is well and rapidly absorbed in the gastrointestinal tract. After oral administration, Metamizole is completely metabolized to form active 4-N-methylaminoantipirin. Communication of an active metabolite with proteins of a blood plasma - 50-60%. Predominantly excreted by the kidneys. After administration of 1 g of Metamizole, the renal clearance for 4-N-methylaminoantipirin was 5 ml + 2 ml / min. The elimination half-life is 2.7 hours.
In patients with cirrhosis of the liver, the half-life of 4-N-methylaminoantipyrine increased threefold and was about 10 hours.

Pharmacodynamics

Baralgin M refers to non-narcotic agents derived from pyrazolone. It has analgesic, antipyretic and weak anti-inflammatory action.
The mechanism of action is associated with inhibition of prostaglandin synthesis.

Indications for use

- severe pains and pains resistant to another treatment
- fever resistant to other treatment

Dosage and administration

The single dose for adults and adolescents over 15 years old is 500 mg (1 tablet). The maximum single dose can reach 1000 mg (2 tablets). Unless otherwise prescribed, a single dose can be taken up to 2-3 times per day. The maximum daily dose is 3000 mg (6 tablets). The duration of treatment is not more than 5 days when prescribed as an anesthetic and no more than 3 days as an antipyretic.
Tablets should be taken with enough water.
Increasing the daily dose of Baralgin M or the duration of treatment is possible only under the supervision of a physician.

Side effects of Baralgin M

Seldom

- malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, anaphylactic and anaphylactoid reactions, in rare cases life-threatening
- leukopenia
- disorders of the gastrointestinal tract

Very rarely

- impaired renal function, in some cases oliguria, anuria or proteinuria, the development of acute interstitial nephritis, urine staining in red (due to the release of the metabolite - rubazonic acid)
- agranulocytosis with typical symptoms, including inflammatory lesions of the mucous membrane (for example, oral cavity and pharynx, anorectal, genital), sore throat, fever (possibly fatal), thrombocytopenia (which increases bleeding tendency and petechiae on the skin and mucous membranes)

Sometimes

- itching, burning, redness, urticaria, dyspnea, angioedema
- renal failure, oliguria, anuria, proteinuria
- possible reduction of blood pressure (transient hypotension
up to a sharp fall), increased blood pressure, heart rhythm disturbance

Contraindications

- Hypersensitivity to metamizole or other pyrazolones (phenazone, propifenazone) or pyrazolidines (phenylbutazone, oxyphenbutazone), including previously transferred agranulocytosis while taking one of these drugs
- dysfunction of the bone marrow, for example, after treatment with cytostatics, or diseases of the blood-forming organs
- bronchial asthma and diseases associated with bronchospasm
- development of anaphylactoid reactions (urticaria, rhinitis, angioedema) when taking analgesics: salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen
- hypersensitivity to excipients in the preparation
- acute intermittent hepatic porphyria (the risk of attacks of porphyria)
- congenital deficiency of glucose-6-phosphate dehydrogenase (risk of hemolysis)
- pronounced disorders of the liver and kidneys
- pronounced hematopoietic disorders: agranulocytosis, cytoplastic and infectious neutropenia
- pregnancy (first and last trimester)
- lactation period
- children's age up to 15 years (drug in the form of tablets)

Drug interactions

Baralgin M enhances the sedative effect of alcohol. When used in conjunction with cyclosporin, there may be a decrease in the concentration of cyclosporin in the blood, therefore its concentration should be monitored. The simultaneous use of Baralgin M with other non-narcotic analgesics can lead to mutual enhancement of toxic effects.
Tricyclic antidepressants, oral contraceptives, allopurinol violate the metabolism of metamizol in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the effect of Baralgin M.
Sedatives and tranquilizers increase the anesthetic effect of Baralgin M. Simultaneous use with chlorpromazine or other phenothiazine derivatives may lead to the development of severe hyperthermia.
Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during treatment with Baralgin M.
Metamizole, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity from a protein-related relationship.
Tiamazole and sarkolizin increase the risk of leukopenia. The effect is enhanced by codeine, histamine H2-blockers and propranolol.

special instructions

When treating patients receiving cytotoxic drugs, Baralgin M should be administered only under medical supervision.
With prolonged use, it is necessary to control the picture of peripheral blood.
Metamizole agranulocytosis is an immune-allergic reaction and lasts at least a week. It is observed extremely rarely, can be severe and lead to life-threatening conditions. The occurrence of agranulocytosis does not depend on the dosage of Baralgin M and may occur at any time of treatment.
With the appearance of unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, erosive and ulcerative lesions of the oral cavity requires the immediate abolition of Baralgin M. In the case of neutropenia (less than 1,500 neutrophils / mm3), treatment should be stopped immediately and the blood composition should be monitored until normal levels are restored.
Anaphylactic shock occurs more often in patients with a history of allergic reactions. Therefore, metamizole should be administered with caution to patients with asthma and atopic dermatitis.
When choosing a route of administration, it is necessary to take into account that the parenteral route of administration is associated with an increased risk of anaphylactic / anaphylactoid reactions. In particular, the risk group consists of patients:
- bronchial asthma, especially with concomitant polyposis rhinosinusitis
- with chronic urticaria
- with alcohol intolerance (patients even react to small amounts of alcohol by sneezing, tearing and redness of the face). Alcohol intolerance can serve as an indicator of undiagnosed "analgesic" asthma syndrome
- with intolerance to dyes (for example, tartrazine) or preservatives (for example, benzoate).
Prior to the appointment of Baralgin M, you must carefully interview the patient. When identifying the risk of anaphylactoid reactions should carefully weigh the "benefit-risk" ratio. If a drug is prescribed to a patient at risk, strict medical supervision is necessary to take adequate measures.

Single cases of hypotensive reactions

The use of Metamizole may cause hypotensive reactions in some cases. These reactions are most often dose-dependent and occur in patients after intravenous administration.
In patients with initially existing hypotension, reduced volume of BCC, dehydration, circulatory disorders, or incipient circulatory failure, normalization of hemodynamics is necessary.
Special care is required when prescribing to patients with systolic blood pressure below 100 mm Hg. or with instability of blood circulation due to the development of heart failure in myocardial infarction, multiple injuries, shock; with anamnestic indications of kidney disease (pyelonephritis, glomerulonephritis) and with a long alcoholic history.
It is unacceptable to use Baralgin M to relieve acute abdominal pain (until the cause is clarified).
In patients with impaired liver and kidney function, it is recommended to avoid Baralgin M in high dosages.

Pregnancy and breastfeeding

Metamizole is a weak inhibitor of prostaglandin synthesis, and its use does not exclude the likelihood of premature closure of the arterial duct, as well as the occurrence of perinatal complications due to impaired platelet aggregation of the mother and newborn, therefore, Baralgin M cannot be taken during the first and last three months of pregnancy. From the fourth to the sixth month of pregnancy, Baralgin M should be taken for strict medical reasons.
Metamizole metabolites are excreted in breast milk. In this regard, after taking Baralgin M breastfeeding should be terminated for 48 hours.

Features of the effect of Baralgin M on the ability to drive a vehicle or potentially dangerous machinery

If the recommended dosing regimen is observed, no changes in concentration and attention are observed. However, if you exceed the dose may decrease the concentration and speed of psychomotor reactions, especially when taken jointly with alcohol.

Overdose

In case of overdose, consult a physician. Symptoms include nausea, vomiting, stomach pain, oliguria, hypothermia, lowering blood pressure, tachycardia, dizziness, tinnitus, dizziness, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal or hepatic failure, coma, arrhythmias , convulsions, paralysis of the respiratory muscles.
Treatment is symptomatic. There is no specific antidote for metamizol. It is possible to conduct forced diuresis, hemodialysis; with the development of convulsive syndrome - intravenous administration of diazepam and high-speed barbiturates. The main metabolite of metamizol (4-methylaminoantipirin) can be derived by hemodialysis, hemofiltration, hemoperfusion and plasma exchange.

Release form and packaging

On 10 tablets in a blister strip packaging from a foil of aluminum / polyvinyl chloride.
2 packs together with instructions for medical use in the state and Russian languages ​​are put in a cardboard box.

Storage conditions

Store at a temperature from 8 ° C to 25 ° C in a dark place.
Keep out of the reach of children!
Shelf life - 4 years
After the expiration date does not apply.

Terms of sell

The prescription is not required to buy Baralgin M.