Baralgin M injection solution ampoules 5 ml 5 pcs
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Active ingredients
Metamizole Sodium
Release form
Solution
Composition
1 ml (1 amp.): Metamizole sodium 500 mg (2.5 g). Adjuvants: water d / and - up to 1 ml.
Pharmacological effect
Baralgin M is a non-narcotic agent, a derivative of pyrazolone. It has analgesic, antipyretic and weak anti-inflammatory effects. By the mechanism of action it does not differ from other nonsteroidal analgesic drugs.
Pharmacokinetics
After the on / in the introduction of T1 / 2 for metamizol is 14 minutes. Approximately 96% is excreted in the urine as metabolites. The active metabolite is associated with plasma proteins - 50-60%. It is mainly excreted by the kidneys. At therapeutic doses, penetrates into breast milk.
Indications
Baralgin M is a non-narcotic agent, a derivative of pyrazolone. It has analgesic, antipyretic and weak anti-inflammatory effects. By the mechanism of action it does not differ from other nonsteroidal analgesic drugs.
Contraindications
- hepatic porphyria; - congenital deficiency of glucose-6- phosphate dehydrogenase; - I and IIl trimester of pregnancy; - bronchial asthma (including induced by the use of acetylsalicylic acid, salicylates or other nonsteroidal anti-inflammatory drugs); - diseases accompanied by bronchospasm; reactions (urticaria, rhinitis, edema) in response to salicylates, paracetamol, diclofenac, ibuprofen, indomethacin, naproxen; - pronounced disorders of the liver and kidneys; - pronounced disorders of blood formation (agran ocytosis, cytoplastic and infectious neutropenia); is contraindicated in newborns under 3 months or with a body weight less than 5 kg; - hypersensitivity to metamizole - the active substance, as well as other components of the drug, or other pyrazolones (isopropylaminophenazole, propifenazone, phenazone or phenylbutazone). Infants aged 3 to 12 months are contraindicated in / in the route of administration.
Precautionary measures
Do not exceed the recommended dose. With caution: systolic blood pressure below 100 mm Hg, circulatory instability (myocardial infarction, multiple trauma, incipient shock), kidney disease (pyelonephritis, glomerulonephritis, including a history of ethanol), prolonged abuse of ethanol.
Use during pregnancy and lactation
During the first and third trimester of pregnancy, Baralgin M cannot be taken. From the fourth to the sixth month of pregnancy, Baralgin M should be taken for strict medical reasons. After taking Baralgin M, breastfeeding should be stopped for 48 hours.
Dosage and administration
Adults and adolescents 15 years and older: 1-2 ml of 50% (500 mg / 1 ml) of Baralgin M solution (IM or IV) is recommended as a single dose, the daily dose can be up to 4 ml of injection solution (no more than 2 g), divided into 2-3 doses. The maximum single dose can be 1 g (2 ml of 50% solution). Children and newborns: Baralgin M should not be taken in newborns under 3 months of age or with a body weight less than 5 kg. Children Baralgin M is prescribed 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 administered up to 2-3 times per day. It is recommended to heat the solution to body temperature before the injection. For children aged 3-12 months, the introduction is carried out only in / m (the body weight of the child is from 5 to 9 kg). If the drug is administered too fast, a critical drop in blood pressure and shock can be observed. Intravenous administration should be carried out slowly (injection rate not more than 1 ml (500 mg of metamizol) per minute) in the supine position, with control of blood pressure, pulse and respiration rate. Since there is a fear that non-allergic blood pressure drop is dose-dependent, the amount Baralgin M solution over 2 ml (1 g) should be injected with extreme caution.
Side effects
Side effects were classified as follows: very frequent (more than 10%), frequent (more than 1, less than 10%), not frequent (more than 0.1, less than 1%), rare (more than 0.01, less than 0.1%), very rare (less than 0, 01%). Allergic reactions: urticaria, including, on the conjunctiva and mucous membranes of the nasopharynx, angioedema, in rare cases - malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome, an acute respiratory syndrome, bronchospastic syndrome, an inflammatory syndrome, bronchospastic syndrome, an inflammatory syndrome, bronchospinal syndrome, an acute inflammatory syndrome, an acute respiratory syndrome; . From the side of blood-forming organs: leukopenia, rarely agr nulocytosis 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 in red (due to the release of the metabolite - rubazonic acid). Local reactions: v / m the introduction of possible infiltrates at the injection site. Other: possible reduction of blood pressure, heart rhythm disturbances.
Overdose
The following symptoms may appear: nausea, vomiting, stomach pain, oliguria, hypothermia, lowering blood pressure, tachycardia, shortness of breath, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal or hepatic insufficiency, seizures, paralysis 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 - in / in the introduction of diazepam and high-speed barbiturates.
Interaction with other drugs
The simultaneous intake of alcohol and metamizol mutually affects their effects. When used in conjunction with cyclosporin, there may be a decrease in the concentration of cyclosporin in the blood. Simultaneous use of Metamizole with other non-narcotic analgesics can lead to mutual enhancement of toxic effects. Tricyclics are similar to antidepressants, oral contraceptives, allopurinol interfere with Metamizole metabolism in the liver and increase its toxicity. analgesic effect of the drug. Simultaneous use with chlorpromazine or other phenothiazine derivatives may lead to the development of severe hyperthermia. X-ray contrast agents, colloid blood substitutes, and penicillin should not be used during the treatment with Metamizole. Metamizole, displacing oral hypoglycemic drugs, direct anti-drugs, because of anti-drugs, does not need to be applied to any other kind of drugs. their activity. Myelotoxic drugs enhance the manifestation of the hematotoxicity of the drug. Tiamazole and sarkolizin 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 cannot be mixed with other drugs in the same syringe.
special instructions
When treating patients receiving cytotoxic drugs, Metamizole sodium should be taken only under medical supervision. During pregnancy, especially in the first 3 months and the last 3 months,No nonsteroidal anti-inflammatory drugs should be used. There is an increased risk of 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 (for example, tartrazin) or to preservatives (for example, benzoate). With prolonged use, it is necessary to control the picture of peripheral blood. While 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 drug withdrawal is necessary. 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. use a long needle.