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Metamizole Sodium

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Available since: 2019-09-19

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Clinical Pharmacology

Analgesic non-narcotic agent.

It has analgesic, antipyretic and weak anti-inflammatory effects, the mechanism of which is associated with inhibition of prostaglandin synthesis. It is a derivative of pyrazolone.

Pharmacokinetics

When administered intravenously: onset of action - after 5-10 minutes, the maximum effect - after 5-30 minutes, the duration of action - up to 2 hours. Metabolized in the liver, a slight concentration of unchanged metamizole sodium is found in plasma, excreted by the kidneys. In therapeutic doses, penetrates into breast milk.

Indications

Pain syndrome (mild to moderate): incl. neuralgia, myalgia, arthralgia, biliary colic, intestinal colic, renal colic, injuries, burns, decompression sickness, shingles, orchitis, sciatica, myositis, postoperative pain, headache, toothache, algomenorrhea. Feverish syndrome (infectious and inflammatory diseases, insect bites - mosquitoes, bees, gadflies, etc., post-transfusion complications).

The drug is intended for symptomatic therapy, reducing pain and inflammation at the time of use, does not affect the progression of the disease.

Composition

Active ingredient: metamizole sodium - 250 mg or 500 mg;

excipient: water for injection - up to 1 ml.

Metamizole Sodium is marketed under different brands and generic names, and comes in different dosage forms:

Brand name	Manufacturer	Country	Dosage form
Analgin	PFK Obnovlenie	Russia	solution
Analgin	Pharmstandard	Russia	pills
Analgin	Novosibirsk plant of medical preparations	Russia	capsules
			pills
Baralgin M	Sanofi-aventis	France	ampoules
	Grotex Ltd	Russia	solution
Analgin	PFK Obnovlenie	Russia	pills
Analgin-quinine	Sopharma	Bulgaria	pills
Baralgin M	Sanofi-aventis	India	pills

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Dosage and Administration

The dose depends on the severity of pain or fever, as well as individual susceptibility to the action of analgesics.

Capsules should be swallowed whole with a sufficient amount of liquid (for example, a glass of water).

Initially, the lowest effective dose should be applied.

The maximum effect of the drug develops, as a rule, 30-60 minutes after ingestion.

A single dose for adults and adolescents over 15 years old (weighing> 53 kg) is 500-1000 mg (1-2 capsules). With insufficient effect, a single dose is allowed up to 4 times per day. The maximum daily dose is 4000 mg (8 capsules). The duration of treatment is not more than 5 days as an anesthetic and no more than 3 days as an antipyretic.

Elderly patients

Elderly patients need to reduce the dose, because they can be reduced excretion of metamizole sodium metabolites.

Severe general condition and violation of creatinine clearance

Patients with a severe general condition and impaired creatinine clearance need to reduce the dose, since they can reduce the excretion of metamizole sodium metabolites.

Kidney or liver failure

Since in patients with impaired renal function or liver, the rate of elimination of the drug is reduced, it is necessary to avoid repeated intake of high doses. With short-term use, dose reduction is not required. There is no long-term experience.

Adverse reactions

Undesirable reactions are classified as follows, according to the WHO (World Health Organization) classification: very often (≥1 / 10), often (≥1 / 100 to <1/10), infrequently (≥1 / 1000 to <1/100), rarely (≥1 / 10,000 to <1/1000), very rarely (up to

Heart disorders

Frequency unknown: Kounis syndrome (allergic coronary syndrome, manifested by clinical and laboratory signs of angina caused by inflammatory mediators).

Immune system disorders

Seldom: anaphylactic / anaphylactoid reactions.

Very rare: analgesic bronchial asthma.

Frequency unknown: anaphylactic shock.

Metamizole sodium can cause anaphylactic or anaphylactoid reactions, which in very rare cases can be severe and life threatening. They can occur even if previously the drug was taken many times without any complications.

Such drug reactions can develop immediately or several hours after taking Metamizole, usually within one hour.

In milder cases, they manifest as skin symptoms and symptoms of the mucous membranes (itching, burning, flushing, urticaria, edema) or shortness of breath, or complaints of the gastrointestinal tract. In severe cases, these reactions turn into generalized urticaria, severe angioedema (especially with the involvement of the larynx), severe bronchospasm, cardiac arrhythmia, a sharp decrease in blood pressure (which is sometimes preceded by an increase in blood pressure) and the development of circulatory shock. In individuals with analgesic bronchial asthma syndrome with intolerance to analgesic drugs, these reactions manifest themselves in the form of attacks of bronchial asthma.

Violations of the skin and subcutaneous tissue

Infrequently: fixed medicinal dermatitis.

Seldom: skin rash.

Frequency unknown: Stevens-Johnson syndrome, Lyell's syndrome (toxic epidermal necrolysis).

Disorders of the croca and lymphatic system

Rarely: leukopenia.

Very rarely: agranulocytosis, including fatal cases and thrombocytopenia.

The frequency is unknown: aplastic anemia, pancytopenia, including cases with a fatal outcome.

These reactions are immunological reactions in nature. They can occur even if previously the drug was taken many times without any complications.

Typical symptoms of agranulocytosis are lesions of the mucous membranes (corneal cavity and pharynx, anorectal region and genital organs), sore throat, fever. However, when using antibiotics, these phenomena may be mild. Sometimes, but not always, there is a slight enlargement of the lymph nodes or spleen. The erythrocyte sedimentation rate increases significantly, the granulocyte content is sharply reduced, or they are not detected. Typically, hemoglobin, red blood cell and platelet counts remain normal, but deviations may occur. Typical symptoms of thrombocytopenia are an increased tendency to bleeding and the appearance of petechiae on the skin and mucous membranes.

If there is an unexpected deterioration in the general condition, the fever does not subside or new or painful ulcerations appear on the mucous membranes, especially in the mouth, nose or throat, the treatment tactics involves the immediate cancellation of the drug, without waiting for the results of laboratory tests.

With the development of pancytopenia, the drug should be canceled and a complete blood count should be monitored until its indicators return to normal (see "Special Instructions").

Vascular disorders

Infrequently: the isolated arterial hypotension.

After taking the drug, an isolated transient decrease in blood pressure (possibly pharmacologically due and not accompanied by other manifestations of anaphylactic / anaphylactoid reactions) is possible; in rare cases, a decrease in blood pressure can be very pronounced. In fever, a dose-dependent dramatic decrease in blood pressure is also possible without other signs of a hypersensitivity reaction.

Night and urinary tract disorders

Very rare: impaired renal function.

Frequency unknown: interstitial nephritis.

In very rare cases, patients with impaired renal function may experience acute impairment of renal function (acute renal failure), in some cases with oliguria, anuria, or proteinuria.

Common disorders

Infrequently: the urine may stain red due to the presence of a metabolite, rubazonic acid, in the urine.

- Hypersensitivity to metamizole sodium and other pyrazolone derivatives, as well as pyrazolidine, for example, phenylbutazone (including patients who have undergone agranulocytosis due to the use of these drugs), or other components of the drug;

Contraindications

- Analgesic asthma or analgesic intolerance (as urticaria-angioedema), i.e. patients with bronchospasm or other forms of anaphylactoid reactions (eg, urticaria, rhinitis, angioedema) in response to the use of salicylates, paracetamol or nonsteroidal anti-inflammatory drugs, such as diclofenac, ibuprofen, indomethacin or naproxen;

- Violation of bone marrow hematopoiesis (for example, after cytostatic therapy) or diseases of the blood-forming organs;

- Hereditary deficiency of glucose-6-phosphate dehydrogenase (hemolysis);

- Acute intermittent hepatic porphyria (risk of developing attacks of porphyria);

- Pregnancy and breastfeeding period;

- Children's age up to 15 years.

Carefully:

- Arterial hypotension (systolic blood pressure below 100 mm. Mercury), reduction in circulating blood volume, hemodynamic instability (myocardial infarction, multiple trauma, starting shock), incipient heart failure, high fever (increased risk of a sharp decrease in blood pressure).

- Diseases in which a significant reduction in blood pressure may have an increased risk (patients with severe coronary artery disease and stenosis of cerebral arteries).

- Chronic alcohol abuse.

- 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 the hereditary susceptibility to sensitization: pollinosis, allergic rhinitis, etc.) (increased risk of anaphylactic / anaphylactoid reactions).

- Alcohol intolerance (reaction to even minor amounts of certain alcoholic beverages with symptoms such as itching, tearing and severe facial flushing) (increased risk of anaphylactic / anaphylactoid reactions).

- Intolerance of dyes (for example, tartrazine) or preservatives (for example, benzoates) (increased risk of anaphylactic / anaphylactoid reactions).

- Severe dysfunction of the liver and kidneys (the use of low doses is recommended due to the possibility of slowing down the removal of metamizole sodium).

If you have one of the listed diseases / conditions, be sure to consult your doctor before taking the drug.

Drug interactions

With cyclosporine

Metamizole sodium can cause a decrease in plasma concentration of cyclosporine, therefore, when used simultaneously, the concentration of cyclosporine should be controlled.

With chlorpromazine

With the simultaneous use of metamizole sodium and chlorpromazine may develop severe hypothermia.

With methotrexate

The simultaneous use of metamizole sodium and methotrexate or other myelotoxic drugs can enhance the hematotoxicity of the latter, especially in elderly patients. Therefore, this combination should be avoided.

With other non-narcotic analgesics

The simultaneous use of metamizole sodium with other non-narcotic analgesics can lead to mutual enhancement of toxic effects.

With tricyclic antidepressants, oral contraceptives, allopurinol

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

With barbiturates, phenylbutazone and other inducers of liver microsomal enzymes

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

With sedatives and tranquilizers

Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.

With drugs that have a high binding to plasma proteins (oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin)
Metamizole sodium, displacing oral hypoglycemic agents, indirect anticoagulants, glucocorticosteroids and indomethacin from their association with plasma proteins, increases their activity.

With thymazole

Timazol increases the risk of leukopenia.

With codeine, H2-histamine receptor blockers and propranolol

Codeine, H2-histamine receptor blockers and propranolol enhance the effects of metamizole sodium.

With acetylsalicylic acid (ASA)

With simultaneous use of metamizole sodium can reduce the effect of ASA on platelet aggregation. Therefore, this combination should be used with caution in the treatment of patients taking ASA as an antiplatelet agent.

With bupropion

Metamizole sodium can reduce the concentration of bupropion in the blood, which should be taken into account while applying them.

With other drugs

Buryat is known that pyrazolone derivatives can interact with indirect anticoagulants, captopril, lithium and triamterene, as well as affect the effectiveness of antihypertensive drugs and diuretics. Drug interaction of metamizole sodium with these drugs has not yet been studied. Due to the increased risk of anaphylactic / anaphylactoid reactions during treatment with metamizole sodium, no radiopaque substances, colloid blood substitutes, and penicillin should be used.

Pregnancy and Lactation

Use during pregnancy and during breastfeeding is contraindicated.

Pregnancy

Metamizole sodium penetrates the placental barrier. Data on the use of metamizole sodium during pregnancy is limited. According to the results of preclinical studies, the teratogenic effect of metamizole sodium was not found in rats and rabbits, fetotoxicity was observed in high doses. Since there are no adequate data on use in humans, metamizole sodium should not be taken in the first trimester of pregnancy, in the second trimester of pregnancy metamizole sodium can be used only if the expected benefit to the mother outweighs the potential risk to the fetus. Despite the fact that metamizole sodium weakly inhibits prostaglandin synthesis, we cannot exclude the possibility of premature (intrauterine) closure of the arterial (Botalov) duct, as well as perinatal complications due to impaired platelet aggregation in the mother or newborn. Therefore, metamizole sodium is contraindicated in the third trimester of pregnancy.

Lactation period

Metamizole sodium metabolites penetrate into breast milk, so when using the drug, as well as within 48 hours after taking the last dose, you must stop breastfeeding.

Special instructions

The drug contains a derivative of pyrazolone - Metamizole sodium, which occasionally can cause life-threatening shock and agranulocytosis (see section "Side effect"). Patients who experience anaphylactoid reactions in response to the use of metamizole sodium are also at risk of developing in response to the use of other non-narcotic analgesics / NSAIDs.

Patients who experience anaphylactic or other immune mediated reactions (eg, agranulocytosis) in response to the use of metamizole sodium are also at risk of developing in response to the use of other pyrazolones and pyrazolidines.

Agranulocytosis

If there are signs of agranulocytosis or thrombocytopenia (see the section "Side effect"), the drug should be immediately canceled and a complete blood count should be performed (with a definition of leukocyte formula). Termination of therapy should not be delayed until the results of laboratory studies.

Pancytopenia

With the development of pancytopenia, the drug should be immediately canceled and a complete blood count should be monitored until its indicators return to normal (see the “Side Effects” section). All patients should be advised to immediately seek medical attention if any signs and symptoms resembling blood disorders (for example, general weakness, infections, persistent fever, hematomas, bleeding, pallor) occur during treatment.

Anaphylactic / Anaphylactoid Reactions

Before using Metamizole sodium, a thorough patient interview should be conducted. In identifying the risk of anaphylactoid reactions, the use of the drug is allowed only after a thorough assessment of possible risks and the expected benefits. If a decision is made to use metamizole sodium, strict medical supervision must be made for the patient and emergency measures should be prepared.The increased risk of hypersensitivity reactions to metamizole sodium causes the following conditions: analgesic bronchial asthma or intolerance to analgesics (like urticaria-angioedema) (see section "Contraindications"); bronchial asthma, especially accompanied by rhinosinusitis and nasal polyposis; chronic urticaria; intolerance to dyes (for example, tartrazine) or preservatives (for example, benzoates); alcohol intolerance, against the background of which, even when taking a small amount of alcoholic beverages, patients experience sneezing, tearing and severe facial flushing. Alcohol intolerance may indicate a previously unspecified analgesic bronchial asthma (see section "Contraindications))).

In susceptible patients, anaphylactic shock may occur, so extra caution should be exercised in patients with bronchial asthma or atopy.

Severe skin reactions

Against the background of the use of Metamizole, life-threatening skin reactions have been described: Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN). If signs of SSD or TEN appear (such as a progressive skin rash, often accompanied by blistering or ulceration of the mucous membrane), treatment with metamizol should be stopped immediately and never be renewed. Patients should be informed about the signs and symptoms of these diseases. They should carefully monitor skin reactions, especially during the first weeks of treatment.

Isolated antihypertensive reactions

Metamizole sodium can cause hypotensive reactions (see also the section "Side Effects"). These reactions may be dose-dependent. The risk of such reactions is also increased when: previous hypotension, decreased blood volume or dehydration, unstable hemodynamics or acute circulatory disorders (for example, in patients with myocardial infarction or trauma), in patients with high fever. In this regard, in such patients should be a detailed diagnosis and set them for careful monitoring. In order to reduce the risk of antihypertensive reactions, preventive measures (for example, cardiovascular resuscitation) may be required. In patients in whom lowering blood pressure should be avoided at all costs (for example, in severe ischemic heart disease or significant stenosis of cerebral arteries), Metamizole sodium may be used only with careful monitoring of hemodynamic parameters.

Abdominal pain

It is unacceptable to use the drug to relieve acute abdominal pain (to determine their cause).

Impaired renal or hepatic function

In patients with impaired renal or hepatic function, Metamizole sodium is allowed only after a rigorous evaluation of the benefits and risks, while observing all the necessary precautions.

Impact on the ability to drive trans. Wed and fur .:

In the recommended dose range, the effect on concentration and speed of psychomotor reactions has not been established. When taking high doses, it is recommended to use caution when driving vehicles, working with mechanisms and practicing other potentially hazardous activities that require increased concentration of attention and quickness of psychomotor reactions.

Overdosage

Do not exceed the recommended dose and duration of use!

Symptoms

Acute overdose is manifested by nausea, vomiting, abdominal pain, impaired renal function / acute renal failure (for example, as a manifestation of interstitial nephritis) and, rarely, central nervous system symptoms (dizziness, drowsiness, coma, convulsions) and a decrease in blood pressure, leading to tachycardia and shock, cardiac arrhythmia (tachycardia), hypothermia, dyspnea, acute agranulocytosis, hemorrhagic syndrome, respiratory muscle paralysis.

With a high overdose, the excretion of rubazonic acid may turn urine red.

Treatment

The specific antidote is not known.In the case of a recent overdose, in order to limit the supply of the drug to the body, primary detoxification (for example, gastric lavage) or sorption therapy (for example, activated charcoal) is carried out. The main metabolite (4N-methylaminoantipirin) is removed during hemodialysis, hemofiltration, hemoperfusion and plasma filtration.

Treatment of overdose, as well as the prevention of serious complications, may require general and special intensive medical observation and treatment.