Analgin - instructions for use, dose, side effects, contraindications

Pharmacodynamics:Metamizole sodium is a derivative of pyrazolone. It has analgesic, antipyretic and weak anti-inflammatory action, the mechanism of which is associated with oppression of the synthesis of prostaglandins. By the mechanism of action is practically no different from other non-steroidal anti-inflammatory drugs.

Pharmacokinetics:

After intravenous administration, the half-life for metamizole sodium 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.

Indications:

Pain syndrome (mild to moderate): incl. headache, migraine, toothache, neuralgia, myalgia, radicular syndrome, algodismenorea; with renal, hepatic and biliary colic (in combination with antispasmodics).

Analgin can be used to reduce pain after surgical and diagnostic interventions.

The raised temperature of a body at "catarrhal" and other infectious-inflammatory diseases. The expediency of using the drug is decided in each case, depending on the severity, nature and tolerability of the fever.

Contraindications:

Hypersensitivity to pyrazolone derivatives (propiphenazone, phenazone or phenylbutazone);

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

- bronchial obstruction, rhinitis, urticaria, provoked by taking acetylsalicylic acid or other NSAIDs (including in anamnesis), condition after CABG;

- oppression of hematopoiesis (agranulocytosis, cytostatic or infectious neutropenia);

- marked violations of the liver or kidneys;

- hepatic porphyria;

- confirmed hyperkalemia, erosive and ulcerative changes in the mucous membrane of the stomach and duodenum, active gastrointestinal bleeding, inflammatory bowel disease, anemia, leukopenia;

- hereditary hemolytic anemia associated with a deficiency of glucose-6-phosphate dehydrogenase;

- pregnancy (especially in the first trimester and in the last 6 weeks), lactation period;

- Infant age (up to 3 months with a body weight of less than 5 kg).

Carefully:

Coronary heart disease, chronic heart failure, cerebrovascular disease, dyslipidemia / hyperlipidemia, diabetes mellitus, peripheral arterial disease, smoking, CC less than 60 ml / min, anamnestic data on the development of ulcerative lesions of the gastrointestinal tract, the presence of infection N. pylori, old age, long-term use of NSAIDs, frequent alcohol use, severe somatic diseases, simultaneous administration of oral glucocorticosteroids (incl. prednisolone), anticoagulants (incl. warfarin), antiplatelet agents (including acetylsalicylic acid, clopidogrel), selective serotonin reuptake inhibitors (incl. citalopram, fluoxetine, paroxetine, sertraline), intravenous administration to patients with systolic blood pressure below 100 mm Hg. or in case of instability of blood circulation (for example, against a background of myocardial infarction, multiple trauma, beginning shock).

Pregnancy and lactation:

During the first and last three months of pregnancy, you can not take analgin. From the fourth to the sixth months of pregnancy, taking analgin should be carried out on strict medical indications. After taking analgin, breast-feeding should be stopped for 48 hours.

Dosing and Administration:

Adults and adolescents 15 years and older: As a single dose, 1-2 ml of an analgin solution of 500 mg / ml or 2-4 ml of an analgin solution of 250 mg / ml (IM or IV) is recommended, the daily dose can be up to 4-8 ml of an injection solution of 500 mg / ml or an injectable solution of 250 mg / ml (not more than 2 g), divided into 2-3 doses.The maximum single dose may be 1 g (2 ml of a solution of 500 mg / ml or 4 ml of a solution of 250 mg / ml).

Children and newborns: Analginum can not be administered to newborns until the age of 3 months or with a body weight of less than 5 kg.

For children, analgin is prescribed in a dose of 5-10 mg per 1 kg of body weight (0.1-0.2 ml of a solution of 500 mg / ml or 0.2-0.4 ml of a solution of 250 mg / ml).

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 only intramuscular! (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. Intravenous administration should be slow (the injection rate is not more than 1 ml (500 mg metamizole sodium per minute)) in the supine position, while monitoring blood pressure, pulse and respiration rate.

Since there is a concern that the drop in arterial pressure of non-allergic genesis is dose-dependent, the amount of analgin solution more than 2 ml (1 g) should be administered with extreme caution.

Side effects:

From the urinary system: Renal failure, oliguria, anuria, proteinuria, rarely develop acute interstitial nephritis, urine staining in red color (due to the excretion of metabolites - rubazonovoy acid).

Allergic reactions: Rash, including conjunctiva and mucous membranes of the nose and throat, angioedema; in rare cases - malignant erythema multiforme (Stevens-Johnson syndrome), anaphylactic shock, toxic epidermal necrolysis (Lyell's syndrome), bronchospastic syndrome (not only the propensity to bronchospasm).

On the part of the organs of hematopoiesis: Leukopenia, thrombocytopenia, rarely agranulocytosis and immune origin.

Other: possible lowering of blood pressure, violation of heart rate. Local Reactions: with the / m introduction, infiltrates are possible at the injection site.

Overdose:

In case of overdose, consult a physician. May experience the following symptoms: nausea, vomiting, stomach pain, oliguria, hypothermia, lowering blood pressure, tachycardia, dizziness, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, acute renal and / or hepatic insufficiency, convulsions, paralysis of the respiratory musculature.

Treatment: symptomatic.There is no specific antidote for metamizole sodium. In the conditions of the medical institution - conducting forced diuresis, hemodialysis, with the development of convulsive syndrome - intravenous diazepam and high-speed barbiturates.

Interaction:

Simultaneous use of analgin with other non-narcotic analgesics can lead to mutual enhancement of toxic effects.

Tricyclic antidepressants, oral contraceptives and allo purinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity. Barbiturates and phenylbutazone weaken the action of analgin.

Analgin increases the effects of alcohol-containing beverages.

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

Metamizole sodium, displacing from the bond with protein oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin, increases their activity. Simultaneous use of analgin with cyclosporine reduces the level of the latter in the blood.

Thiamazole and sarcolysin increase the risk of developing leukopenia.

The effect is enhanced codeine, H2-histamine receptor blockers propranolol (slows inactivation).

Sedatives and tranquilizers increase the analgesic effect of analgin. Myelotoxic drugs increase the manifestation of hematotoxicity of the drug.

Because of the high likelihood of pharmaceutical incompatibility, metamizole should not be mixed with other drugs in the same syringe.

Special instructions:

Patients suffering from bronchial asthma and hay fever may develop sensitivity reactions.

With prolonged use (more than 7 days), you need 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.

Do not apply to relieve acute pain in the abdomen (until finding out the reasons).

To reduce the risk of developing adverse events from the gastrointestinal tract, a minimally effective dose should be used with the minimum possible short course.

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

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

Form release / dosage:

The solution for intravenous and intramuscular administration is 250 mg / ml and 500 mg / ml.

Packaging:

By 1 ml or 2 ml into neutral glass ampoules of grade НС-1 or НС-3.

5 ampoules per contour cell packaging made of polyvinyl chloride film.

2 contour squares in a pack of cardboard.

10 ampoules per carton box.

In each pack, the box is attached instruction for use, a knife for opening ampoules or a scarifier ampoule. When packing ampoules with a kink ring (white color), dots (white) and notches, the ampoule knife or scarifier does not insert.

Storage conditions:In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N001286 / 02

Date of registration:05.02.2009

Expiration Date:Unlimited

The owner of the registration certificate:BIOSINTEZ, PAO BIOSINTEZ, PAO Russia

Manufacturer: & nbsp

BIOSINTEZ, PAO Russia

Information update date: & nbsp27.08.2017

Illustrated instructions

Instructions

Analgin (Analgin)