Instruction for use: Metamizole sodium + Pitofenone + Fenpiverinium bromide (Metamizolum natrium+ Pitofenonum+ Fenpiverini bromidum)

Pharmacological groups

NSAIDs - Pyrazolones in combinations

Nosological classification (ICD-10)

J06 Acute upper respiratory infections of multiple and unspecified

Frequent colds viral diseases, Infections of the upper respiratory tract, Acute respiratory disease influenza character, for colds Pain, Acute colds,Cold, respiratory infection,Seasonal colds, Pain in infectious and inflammatory diseases of the upper respiratory tract, Bacterial infections of the upper respiratory tract, Bacterial respiratory infections, Viral disease of the respiratory tract, Viral respiratory tract infections, Inflammatory disease of the upper respiratory tract, Inflammation of the upper respiratory tract disease, Inflammation of the upper respiratory tract illness with difficult sputum, Inflammatory airway disease, Secondary infections with colds, Shortness of sputum in acute and chronic respiratory diseases, Upper respiratory tract infection, Infections of the upper respiratory tract, Respiratory Tract Infections, Infections of the respiratory tract and lungs, Infectious-inflammatory diseases of the upper respiratory tract, Infectious-inflammatory diseases of the upper respiratory tract and ENT-organs, Infectious-inflammatory diseases of the upper respiratory tract in children and adults, Infectious-inflammatory diseases of the upper respiratory tract, Infectious inflammation of the airways,respiratory infection, Qatar upper respiratory tract, Catarrh of the upper respiratory tract, Catarrhal disease of the upper respiratory tract, Catarrhal symptoms of the upper respiratory tract, Coughing with a cold, SARS, ARI, ARI with rhinitis phenomena, Acute respiratory infection, Acute infectious and inflammatory disease of the upper respiratory tract, Acute respiratory disease, Sore throat or nose, Respiratory viral infections, Respiratory diseases, Respiratory infections, Recurrent respiratory infections, Secondary infection with influenza, cold in the chest, Feverish condition with flu usitis, acute sinusitis, genyantritis, purulent sinusitis

K59.8.1 * intestines Dyskinesia

Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), intestinal hypomotility, Hypotonic dyskinesia of the colon, GIT Dyskinesia, Dyskinesia gastrointestinal atony with events,colon Dyskinesia,Gastrointestinal spasm, Intestinal colic, Colic in infants, Spastic bowel dyskinesia, Spastic colon dyskinesia, Baby colic

K82.8.0 * Dyskinesia of the gallbladder and biliary tract

Biliary obstruction, Biliary reflux gastritis, Biliary reflux esophagitis, biliary sludge, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Gipermotornaya biliary dyskinesia, Hypokinesia of the gall bladder, Hypokinetic dyskinesia of the gallbladder, Biliary dyskinesia, Dyskinesia of the gallbladder,Dyskinesia of biliary tract, biliary colic, Bile reflux,Violation of bile secretion, Violation of the outflow of bile, Subacute and chronic diseases of the biliary tract, The spasm of the biliary tract, Biliary tract spasm, Spastic biliary dyskinesia, Spasmodic dyskinesia of the gallbladder, Spastic condition of the gastrointestinal tract

M25.5 Pain in the joint

Arthralgia, Pain syndrome in musculo-articular diseases, Pain syndrome in osteoarthritis, Pain syndrome in osteoarthritis, Pain syndrome in acute inflammatory diseases of the musculoskeletal system, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the joints, Soreness of the joints, Soreness of joints in severe physical exertion, Painful inflammatory joint damage, Painful conditions of the musculoskeletal system, Painful joint conditions, Painful traumatic affection of joints, Pain in the musculoskeletal system, Pain in Shoulder Joints, Pain in the joints, Joint pain, Joint pain with injuries, Musculoskeletal pain, Pain with osteoarthritis, Pain in the pathology of the joints, Pain in rheumatoid arthritis, Pain in chronic degenerative bone diseases, Pain in chronic degenerative joint diseases, Bone-joint pain, Joint pain, Arthritic pain of rheumatic origin, Articular pain syndrome, Joint pain, Rheumatic pain, Rheumatic pains

M54.3 Sciatica

Ishialgia, Neuralgia of the sciatic nerve, Sciatic neuritis

M79.1 Myalgia

Myofascial pain syndromes ,Pain syndrome in musculo-articular diseases, Pain syndrome in chronic inflammatory diseases of the musculoskeletal system, Pain in the muscles, Tenderness of muscles, Muscular soreness in severe physical exertion, Painful conditions of the musculoskeletal system, Pain in the musculoskeletal system, Pain in the muscles, Pain at rest, Muscle aches, Muscle pain, Musculoskeletal pain, Myalgia, Muscle pain, Muscle pain at rest, Muscle pain, Muscular pain of non-rheumatic origin, Muscle pain of rheumatic origin, Acute muscle pain, Rheumatic pain, Rheumatic pains, Myofascial syndrome, Fibromyalgia

M79.2 Neurology and neuritis, unspecified

Pain syndrome with neuralgia, Brachialgia, Occipital and intercostal neuralgia, Neuralgia, Neuralgic pain, Neuralgia, Neuralgia of intercostal nerves,Neuralgia of the posterior tibial nerve, Neuritis, Neuritis traumatic, Neuritis, Neurological Pain Syndromes, Neurological contractures with spasms, Acute neuritis, Peripheral neuritis,Post-traumatic neuralgia,Severe pain of a neurogenic nature, Chronic neuritis, Essential neuralgia

N23 Renal colic unspecified

Pain in renal colic, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), renal Colic, ureteral colic, Renal colic, Renal colic with urolithiasis, Kidney disease, Spasm of smooth muscle in diseases of the urinary system, The spasm of the urinary tract, The spasm of the ureter, The spasm of the ureters, Spasms of the urinary tract, Spasms of the urinary tract

N94.6 Dysmenorrhea Unspecified

Pain during menstruation, Functional disorders of the menstrual cycle, Menstrual cramps, Emmeniopathy, Pain during menstruation, Painful menstrual irregularities, algomenorrhea, algomenoreya, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Disalgomenoreya, dysmenorrhea, Dysmenorrhea (essential) (Exfoliative), menstrual disorder, menstruation painful, metrorrhagia, Violation of the menstrual cycle, Menstrual irregularities, Prolaktinzavisimoe menstrual disorders, Prolaktinzavisimoe menstrual dysfunction, Pain spasm of smooth muscles of internal organs, Spasmodic dysmenorrhea, Primary disalgomenoreya

R25.2 Cramp and spasm

Muscle spasms in tetanus, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea),Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Painful muscle spasm, mimic spasm, spasticity, Muscle spasms, Muscle spasms of central origin, Muscle spasms, Neurological contracture with spasms, Night cramps in the extremities, Night leg cramps, Symptomatic convulsive state, West syndrome, Smooth muscle spasm, Spasm of vascular smooth muscle, muscle spasm, The spasm of the striated muscles due to organic diseases of the CNS, Skeletal muscle spasm, The spasms of smooth muscles of internal organs, The spasms of skeletal muscles, Spastic condition of striated muscle, Spastic pain, Spasmodic state of smooth muscle, Spasticity skeletal muscle, muscle cramps, convulsions, Leg cramps, Seizures of central origin, convulsive states, Spastic syndrome, Convulsive status in children, Tonic seizures, Cerebral spastic syndrome, Phenomenon jackknife

R50.0 Fever with chills

High fever, Heat, Chills, elevated temperature, hyperthermia, Prolonged fever, Feverish syndrome, Fervescence, Increased body temperature in infectious and inflammatory diseases, fever Symptoms, febrile syndrome, Febrile state, Fever, Fever in infectious and inflammatory diseases, Fever with SARS, Fever with cold, Fever for colds, febrility, Feverish condition with flu, Feverish state in infectious and inflammatory diseases , Feverish state of infectious diseases and in the postoperative period, Feverish condition for colds, Febrile of different genesis, Feverish syndrome on the background of infectious diseases, Feverish syndrome in infectious and inflammatory diseases, Feverish syndrome with colds, Feverish syndrome of different genesis, Increased temperature for colds, Increased temperature at catarrhal and infectious and inflammatory diseases, Increased body temperature in cold, etc., Increased body temperature in cold and other infectious and inflammatory diseases, Increased body temperature in cold and other infectious and inflammatory diseases, Fever during pregnancy, Fever with thrombocytopenia, Febrile reaction in blood transfusion

R52.0 Acute pain

Acute pain syndrome, Acute pain syndrome with osteoarthritis, Acute pain syndrome of traumatic origin, Severe pain of a neurogenic nature, Severe pain, Pain syndrome at delivery

R52.9 Unspecified Pain

Pain after cholecystectomy, Pain shooting, Non-malignant pain, Obstetric and gynecological pain, Pain syndrome, Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain of inflammatory genesis, Pain than cancer genesis, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after injuries, Pain after the removal of hemorrhoids, Pain at the non-rheumatic inflammation of nature, Pain in inflammatory lesions of the peripheral nervous system, Pain in diabetic neuropathy, Pain in acute inflammatory diseases of the musculoskeletal system, Pain when the tendon pathology, Pain smooth muscle spasm, Pain spasm of smooth muscles (renal and biliary colic, intestinal spasms, dysmenorrhea), Pain spasm of smooth muscles of internal organs, Pain spasm of smooth muscles of internal organs (kidney and biliary colic, intestinal spasms, dysmenorrhea), Pain in trauma syndrome, Pain with injuries and after surgical interventions, Pain in chronic inflammatory diseases of the musculoskeletal system, Pain with duodenal ulcer, Pain syndrome in gastric ulcer, Pain syndrome in gastric ulcer and duodenal ulcer, pain, Pain during menstruation, pain syndromes, painful condition, Painful foot fatigue, Sore gums when wearing dentures, Soreness of the cranial nerves exit points, Painful menstrual irregularities, Painful dressings, Painful muscle spasm, Painful teeth growth, Melosalgia, Pain in the area of the surgical wound, Pain in the postoperative period, Pain in the body, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain after surgery, The pains of the flu, Pain in diabetic polyneuropathy, Pain for burns, Pain during sexual intercourse, Pain during diagnostic procedures, Pain during therapeutic procedures, for colds Pain, Pain in sinusitis, Pain in trauma, Pain traumatic, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, Pain after surgery, postoperative Pain, Pain postoperative and posttraumatic, posttraumatic pain, Pain when swallowing, Pain in infectious and inflammatory diseases of the upper respiratory tract, The pain of burns, The pain in traumatic muscle injury, Pain in trauma, The pain of tooth extraction, The pain of traumatic origin, Pain caused by spasm of smooth muscles, Expressed pain syndrome, Expressed pain syndrome, traumatic origin, Postoperative pain, Post-traumatic pain, Post-traumatic pain syndrome, Torpid pain, Traumatic pain, Traumatic pain, Mild pain, Moderately severe pain, Moderate pain, Polyarthralgia with polymyositis

R68.8.0 * Inflammatory syndrome

Painful syndrome of inflammatory genesis, Pain syndrome with inflammation of non-rheumatic nature, Pain syndrome with inflammatory lesions of the peripheral nervous system, Painful inflammation of the shoulder joint, Painful inflammation after trauma or surgery, Painful inflammation after surgery, Painful hemorrhoids, Inflammation of the tympanic membrane, Inflammation of the larynx, Inflammation of the gums, Inflammation of cellulose, Inflammation of lymph nodes, Tonsillitis, Inflammation of muscles, Inflammation of soft tissues, Inflammation of the mouth, Inflammation after surgery and trauma, Inflammation after orthopedic surgery, Inflammation after trauma, Inflammation in rheumatoid arthritis, Inflammation of the middle ear, Inflammatory gum disease, Inflammatory diseases of the eyelids, Inflammatory eye diseases, Inflammatory swelling of soft tissues, Inflammatory processes, Inflammatory processes after surgical interventions, Inflammatory process, Inflammatory Syndrome, Inflammatory syndrome of non-rheumatic origin, Inflammatory syndrome after surgery, Purulent infections, Infringements of function of a liver of an inflammatory etiology, Acute inflammation of the musculoskeletal tissue, Pre-inflammatory soft tissue inflammation

T88.9 Complication of surgical and medical care, unspecified

Pain in the postoperative period, Pain in the postoperative period after orthopedic surgery, Pain syndrome after diagnostic procedures, Pain after surgery Diagnostic, Pain after surgery, Pain after orthopedic surgery, Pain after the removal of hemorrhoids, Pain in the application of excimer laser, Pain with injuries and after surgical interventions, Pain syndromes in the dental practice, Painful diagnostic intervention, Painful diagnostic manipulations, Painful instrumental diagnostic procedures, Painful instrumental manipulation, Painful treatments, Painful manipulations, Painful dressings, Painful therapeutic interventions, Pain in the area of the surgical wound, Pain in the postoperative period, Pain after diagnostic procedures, Pain after orthopedic surgery, Pain during diagnostic procedures, Pain during therapeutic procedures, Pain in orthopedics, The pain in the postoperative period, Pain after diagnostic procedures, The pain after sclerotherapy, The pain after dental surgery, postoperative Pain, Pain postoperative and posttraumatic, The pain of tooth extraction, Inflammation after surgery or injury, Inflammation after orthopedic surgery, Inflammation after surgery, The inflammatory syndrome after surgery, Festering postoperative fistula, Operating wound, Complications after tooth extraction

Z100 * CLASS XXII Surgical practice

Abdominal surgery, adenomectomy, Amputation, Coronary angioplasty, Angioplasty of the carotid arteries, Antiseptic skin treatment for wounds, Antiseptic Hand, Appendectomy, atherectomy, Balloon coronary angioplasty, Vaginal hysterectomy, The coronary bypass, Interventions in the vagina and cervix, Interventions on the bladder, Intervention in the mouth, Restoration and reconstructive surgery, Hand hygiene of medical personnel, Gynecologic surgery, Gynecological intervention, Gynecological surgery, Hypovolemic shock during operations, Disinfection of purulent wounds, Disinfection of wounds edges, Diagnostic intervention, Diagnostic procedures, Cervical Diathermocoagulation, Long-surgery, Replacing the fistula catheters, Infection in orthopedic surgery, Artificial heart valve, cystectomy, Short-term outpatient surgery, Short-term operation, Short surgical procedures, Krikotireotomiya, Blood loss during surgery, Bleeding during surgery and in the postoperative period, Kuldotsentez, laser photocoagulation, laser coagulation, retinal laser coagulation, Laparoscopy, Laparoscopy in Gynecology, CSF fistula, Small gynecological operations, Small surgical procedures, Mastectomy and subsequent plastic, mediastinotomy, Microsurgical operations on the ear, Mukogingivalnye operation, suturing, Minor surgery, neurosurgical operation, Immobilization of the eyeball in ophthalmic surgery, testectomy, pancreatectomy, Perikardektomiya, The period of rehabilitation after surgery, The period of, convalescence after surgery, Percutaneous transluminal coronary angioplasty, Pleural thoracentesis, Pneumonia postoperative and posttraumatic, Preparation for surgical procedures, Preparation for surgery, Preparation of the surgeon's hands before surgery, Preparation of the colon for surgical procedures, Postoperative aspiration pneumonia in neurosurgical and thoracic surgery, Postoperative nausea, Postoperative bleeding, postoperative granuloma, postoperative shock, The early postoperative period, myocardial revascularization, Radiectomy, gastric Resection, bowel resection, uterine Resection, liver Resection, enterectomy, Resection of part of the stomach, Reocclusion of the operated vessel, Bonding tissues during surgical procedures, Removal of sutures, Condition after eye surgery, Condition after surgery, Condition after surgery in the nasal cavity, Condition after gastrectomy, Status after resection of the small intestine, Condition after tonsillectomy, Condition after removal of the duodenum, Condition after phlebectomy, Vascular surgery, Splenectomy, Sterilization of surgical instruments, Sterilization of surgical instruments, sternotomy, Dental surgery, Dental intervention in periodontal tissues, strumectomy, Tonsillectomy, Thoracic surgery, total gastrectomy, Transdermal intravascular coronary angioplasty, Transurethral resection, Turbinektomiya, Removal of a tooth, cataract surgery, Removal of cysts, tonsillectomy, Removal of fibroids, Removing the mobile primary teeth, Removing polyps, Removing broken tooth, Removal of the uterus body, Removal of sutures, Urethrotomy, Fistula likvoroprovodyaschih ways, Frontoetmoidogaymorotomiya, Surgical infection, Surgical treatment of chronic limb ulcersm, Surgery, The surgery in the anal area, The surgery on the colon, Surgical practice, The surgical procedure, Surgical interventions, Surgery on the gastrointestinal tract, Surgical procedures on the urinary tract, Surgical procedures on the urinary system, Surgical intervention of the genitourinary system, Surgical procedures on the heart, Surgical manipulation, surgery, Surgery on the veins, Surgical intervention, Vascular surgery, Surgical treatment of thrombosis, cholecystectomy, Partial gastric resection, transabdominal hysterectomy, Percutaneous transluminal coronary angioplasty, Percutaneous transluminal angioplasty, Coronary artery bypass, tooth Extirpation, Extirpation of milk teeth, pulpectomy, pulsative cardiopulmonary bypass, tooth Extraction, teeth Extraction, cataract extraction, Electrocoagulation, endourological intervention, episiotomy, Etmoidotomiya, Complications after tooth extraction

Characteristics of Metamizol sodium + Pitophenone + Fenpiverinia bromide

Combination of active substances with analgesic non-narcotic effect + antispasmodic action.

Pharmacology

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

Pharmacodynamics

The combination of analgesic and antispasmodic active substances, the combination of which leads to mutual potentiation of their pharmacological action.

Metamizole sodium - a derivative of pyrazolone, has an analgesic, antipyretic and anti-inflammatory effect.

Pitophenone has a direct myotropic antispasmodic effect on smooth muscles (papaverin-like action).

Fentiverinia bromide has m-anticholinergic action and has an additional myotropic antispasmodic effect on smooth muscles.

Pharmacokinetics

Absorption. After the / m introduction metamizole sodium is rapidly absorbed. Systemic bioavailability of metamizole sodium is about 85%.

Distribution. The connection with plasma proteins metamizole sodium is 50-60%. It penetrates the GEB and the placental barrier. Vd - about 0,7 l / kg. Pitophenone and fenpiverinia bromide do not penetrate the BBB.

Metabolism. Metamizole sodium is subjected to intensive biotransformation in the liver. Its main metabolite, 4-methylaminoantipyrine (MAA), is metabolized in the liver with the formation of other metabolites, incl. pharmacologically active 4-aminoantipyrine (AA). Plasma Cmax (of all metabolites) is reached after approximately 30-90 minutes. The four main metabolites of metamizole sodium are: MAA, active; 4-aminoantipyrine, active; 4-formylaminoantipyrine, inactive; 4-acetylaminoantipyrine, inactive.

Pitophenone and fenpiverinia bromide are metabolized in the liver, mainly by oxidation.

Excretion. Metamizole sodium is excreted by the kidneys in the form of metabolites, about 3% - in unchanged form. T1 / 2 - about 10 hours. In therapeutic concentrations penetrates into breast milk.

T1 / 2 pituopenone and fenpiverinia bromide is about 10 h.

Almost 90% of the pituopenone and fenpiverinia bromide are excreted by the kidneys in the form of metabolites and 10% - through the intestine in unchanged form.

Violation of the function of the liver. T1 / 2 MAA (active metabolite) in patients with impaired liver function increases approximately 3-fold. Such patients are recommended to lower the dose.

Impaired renal function. In patients with impaired renal function, a decrease in the elimination of certain metabolites is observed. Such patients are recommended to lower the dose.

Application of Metamizol sodium + Pitophenone + Fenpiverinia bromide

Short-term symptomatic treatment of acute pain syndrome of varying severity with spasms of smooth muscles of internal organs (including gastric and intestinal colic, renal colic in case of nephrolithiasis, spastic dyskinesia of bile ducts, algodismenorea); short-term symptomatic treatment of arthralgia, neuralgia, ischialgia, myalgia (cupping of pain syndrome); as an auxiliary drug for reducing pain after surgery and diagnostic procedures; decrease in elevated body temperature for colds and other infectious and inflammatory diseases.

Contraindications

Hypersensitivity, incl. to pyrazolone derivatives; oppression of bone marrow hematopoiesis; disorders of bone marrow hematopoiesis (for example, due to treatment with cytostatics) or diseases of the hematopoietic system (agranulocytosis, leukopenia, aplastic anemia); marked hepatic and / or renal insufficiency; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia; severe angina; decompensated chronic heart failure; angle-closure glaucoma; hyperplasia of the prostate (with clinical manifestations); intestinal obstruction; megacolon; collapse; atony of the gallbladder and bladder; pregnancy; lactation period.

In / in (intravenous) administration: infant age (up to 1 year) or body weight less than 9 kg.

Intramuscularly (intramuscular) introduction: infant age (up to 3 months) or body weight less than 5 kg.

Inside: tablets are not used in children under 5 years.

Restrictions for use

Renal and / or liver failure; bronchial asthma; propensity to arterial hypotension; hypersensitivity to other NSAIDs (non-steroidal anti-inflammatory drugs) or non-narcotic analgesics; urticaria and / or acute rhinitis, triggered by the use of acetylsalicylic acid or other NSAIDs.

Children and adolescents under 18 years of age should be used only as prescribed by the doctor.

pregnancy and lactation

The use is contraindicated in pregnancy (especially in the first trimester and the last 6 weeks) and in the period of breastfeeding, tk. possible premature closure of the arterial (Botallova) duct and perinatal complications due to the effect of metamizole sodium on the ability of platelets of the mother and fetus to aggregate.

Side effects

Undesirable reactions (HP) are grouped by systems and organs according to the MedDRA dictionary and the HP development classification of WHO (World Health Organization): very often (≥1 / 10); often (≥1 / 100 to <1/10); infrequently (≥1 / 1000 to <1/100); rarely (≥1 / 10000 to <1/1000); very rarely (<1/10000); the frequency is unknown (the frequency can not be determined from the available data).

The undesirable reactions listed below are mainly caused by metamizol sodium, which is a combination of metamizole sodium + pituopenone + fenpiverinia bromide.

On the part of the blood and lymphatic system: rarely - leukopenia; very rarely - agranulocytosis, thrombocytopenia, anemia (hemolytic anemia, aplastic anemia). The risk of the appearance of agranulocytosis can not be predicted. Agranulocytosis can occur in patients who have taken metamizole sodium in the past without the appearance of similar HP.

On the part of the immune system: rarely - anaphylactic shock, anaphylactic or anaphylactoid reactions, especially after parenteral use. Such reactions may occur during the administration of the drug or immediately after discontinuation of administration, but may occur within a few hours. They usually develop within the first hour after the injection. Lighter reactions manifest themselves in the form of typical reactions from the skin and mucous membranes (for example, itching, burning, redness, urticaria, edema - local or general), dyspnea and rarely - complaints from the gastrointestinal tract. Light reactions can go into more severe forms with generalized urticaria, severe angioedema, including laryngospasm, severe bronchospasm, cardiac rhythm disturbance, lowering blood pressure (sometimes with a previous increase in blood pressure).

For this reason, if any skin reaction of hypersensitivity occurs, symptoms of renal dysfunction or hematotoxic reactions, the drug should be discontinued immediately.

Very rarely - an attack of bronchial asthma (in patients with aspirin asthma), circulatory shock. Shock can be accompanied by cold sweat, dizziness, drowsiness, oppression of consciousness, pallor of the skin, a feeling of squeezing in the heart, superficial breathing or tachypnea, tachycardia, cold extremities, marked drop in blood pressure. At the first signs of shock, the drug should be discontinued and appropriate emergency measures taken.

From the skin and subcutaneous tissue: infrequently - fixed drug exanthema; rarely - maculopapular and other types of rashes, Lyell's syndrome or Stevens-Johnson syndrome, angioedema, sweating.

In the event of any skin reactions, the use of the drug should be immediately discontinued.

From the nervous system: dizziness, headache.

From the sense organs (vision): visual disturbances, violation of accommodation.

From the heart: infrequent - a feeling of palpitation, tachycardia, heart rhythm disturbances, cyanosis.

From the side of the vessels: infrequently - arterial hypotension, hyperemia.

Hypotensive reactions can rarely occur during or after application. They may or may not be accompanied by other symptoms of anaphylactoid or anaphylactic reactions.

Rarely - such reactions can be the result of a sharp decrease in blood pressure. Rapid administration increases the risk of hypotensive reactions.

A critical reduction in blood pressure (BP) without other signs of hypersensitivity is dose-dependent and may manifest as hyperpyrexia.

On the part of the gastrointestinal tract (gastrointestinal tract): the frequency is unknown - dry mouth, nausea, vomiting, abdominal pain and discomfort, constipation, exacerbation of gastritis and gastric ulcer; in rare cases - vomiting with an admixture of blood and intestinal bleeding, the formation of ulcers, a burning sensation in the epigastric region.

From the liver and biliary tract: hepatitis.

From the urinary system: rarely - proteinuria, oliguria, anuria, polyuria, interstitial nephritis, urine staining in red, difficulty urinating, impaired renal function; frequency unknown - urinary retention.

From the respiratory system: bronchospasm.

General disorders and disorders at the site of administration: for parenteral use - asthenia, pain at the injection site and local reactions.

Interaction

Solution for iv (intravenous) and IM (intramuscular) administration is pharmaceutically incompatible with other drugs.

With H1-histamine receptor blockers, butyrophenone and phenothiazine derivatives, amantadine and quinidine. When used simultaneously with H1-histamine receptor blockers, butyrophenone and phenothiazine derivatives, tricyclic antidepressants, amantadine and quinidine, the m-cholinoblock effect of the combination of metamizole sodium + pitofenone + fenpiperinium bromide can be enhanced.

With alcohol. Enhances the effects of ethanol.

With other non-narcotic analgesic drugs (drug). Simultaneous use with other non-narcotic analgesic drugs can lead to mutual enhancement of toxic effects.

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

With barbiturates, phenylbutazone and other inducers of microsomal enzymes. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.

With sedatives and tranquilizers. Sedative drugs and anxiolytic drugs (tranquilizers) increase the analgesic effect of the combination of metamizole sodium + pitofenion + fenpiverinia bromide.

Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.

With radiopaque substances, colloidal blood substitutes, penicillin. Radiocontrast agents, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizole sodium (an increased risk of anaphylactic / anaphylactoid reactions).

With cyclosporine. Metamizole sodium can reduce the concentration of cyclosporine in the blood serum, so when using a combination of metamizole sodium + pituopenone + fenpiverinia bromide with cyclosporine, the concentrations of cyclosporin should be monitored.

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

With myelotoxic drugs. Myelotoxic drugs increase the appearance of hematotoxicity.

With methotrexate. The addition to treatment with methotrexate may increase the hematotoxic effect of the latter, especially in elderly patients. Therefore, this combination should be avoided.

With thiamazole and sarcolysin. Simultaneous use with thiamazole and sarcolysin increases the risk of developing leukopenia.

With codeine, H2-histamine receptor blockers and propranolol. Codeine, H2-histamine receptor blockers and propranolol increase the effects of metamizole sodium.

Overdose

Symptoms: nausea, vomiting, epigastric pain, lowering blood pressure, tachycardia, acute agranulocytosis, hemorrhagic syndrome, hypothermia, oliguria, dyspnea, tinnitus, drowsiness, delirium, confusion, liver and kidney function disorders, seizures, respiratory muscle paralysis .

Treatment: symptomatic therapy.

Routes of administration

In / in (intravenously), in / m (intramuscularly), inside.

Precautions

In the treatment of children under 5 years of age and patients receiving cytotoxic drugs, treatment with a combination of metamizole sodium + pitofenon + fenpiperinia bromide should be performed only under medical supervision.

In patients older than 65 years, as a rule, dose adjustment is not required. If such patients have renal or hepatic insufficiency, a dose reduction due to a possible increase in T1 / 2 metamizole sodium is recommended.

When choosing the method of administration, it should be borne in mind that parenteral use is associated with a higher risk of anaphylactic / anaphylactoid reactions. Parenteral application is recommended to use in cases when oral intake is impossible or impaired absorption from the digestive tract (gastrointestinal tract).

The increased risk of hypersensitivity reactions to the combination of metamizole sodium + pitofenone + fenpiverinia bromide metamizole sodium in the combination of the following conditions: bronchial asthma, especially in combination with polypous rhinosinusitis; chronic urticaria; alcohol intolerance (increased sensitivity to alcohol), against which even with the intake of a small amount of some alcoholic drinks, patients experience sneezing, lacrimation, and severe reddening (alcohol intolerance may indicate a previously unidentified aspirin asthma syndrome); intolerance or hypersensitivity to dyes (eg tartrazine) or preservatives (eg benzoate). Before using the combination, it is necessary to thoroughly examine the patient. If the risk of developing an anaphylactoid reaction is detected, the application is only possible after an assessment of the risk / benefit ratio. If a combination is used, these patients need strict medical control over their condition and necessarily have the means to provide them with emergency care in case of anaphylactic / anaphylactoid reactions.

In predisposed patients, anaphylactic shock may occur, so patients with asthma or atopy should be cautioned with a combination of metamizole sodium + pitofenion + phenpiverinium bromide.

On the background of the use of metamizole sodium, life-threatening skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been described. When symptoms of these diseases appear (such as a progressive skin rash, often with blisters or mucosal lesions), treatment with a combination of metamizole sodium + pitofenion + fenpiperinium bromide should be discontinued immediately and not re-started.

During therapy with metamizol-containing drugs, the development of agranulocytosis is possible. It lasts at least a week, does not depend on the dose, can be heavy, endanger life and even lead to the death of the patient. In this connection, when symptoms appear that may be related to neutropenia (fever, chills, sore throat, difficulty swallowing, stomatitis, erosive ulcerous oral cavity, vaginitis or proctitis, a decrease in the number of neutrophils in the peripheral blood is less than 1500 mm3), it is necessary discontinue treatment with a combination of metamizole sodium + pitofenon + fenpiverinia bromide and consult a doctor.

If the patient receives antibiotic therapy, typical manifestations of agranulocytosis can be minimally expressed. ESR increases significantly, while lymph node enlargement is weak or absent. Typical symptoms of thrombocytopenia are increased tendency to bleeding and the appearance of petechiae on the skin and mucous membranes.

In the case of pancytopenia, treatment should be stopped immediately, it is necessary to monitor the indicators of the developed blood test until normalization.

All patients should be aware that when symptoms of abnormal blood changes (eg general malaise, infection, persistent fever, formation of hematomas, bleeding, pale skin) occur with the combination of metamizole sodium + pitofenon + fenpiperinium bromide, you should immediately consult a doctor .

The administration of a metamizol-containing drug can induce individual hypotensive reactions. These reactions may depend on the dose of the drug and are more likely to occur after parenteral administration. To avoid the development of severe hypotensive reactions, the following recommendations should be adhered to: IV / IV (intravenous) administration of the drug should be slow, lying down; it is necessary to monitor blood pressure (BP), heart rate (heart rate) and respiration; patients with existing hypotension, reduced BCC (circulating blood volume), dehydration, instability of hemodynamics, or initial stage of circulatory failure require normalization of hemodynamics; Care should be taken when treating patients with high body temperature.

Patients who need to avoid a reduction in blood pressure (for example, with severe coronary heart disease (ischemic heart disease) or stenosis of blood vessels supplying the brain), therapy should be carried out only with close monitoring of hemodynamics.

During treatment - refrain from drinking alcohol.

It is inadmissible to use acute pains in the abdomen for relief (until finding out their cause).

In patients with impaired liver or kidney function, it is advisable to avoid the use in high doses because of the reduced rate of excretion of the combination.

In / in (intravenous) administration should be carried out very slowly (no more than 1 ml / min), so that at the first signs of anaphylactic / anaphylactoid reactions the injection could be stopped and the risk of certain hypotensive reactions minimized. With the / m introduction it is necessary to use a needle for IM (intramuscular) administration.

Against the background of the application, it is possible to stain the urine red because of the presence of the metabolite-rubric acid in it (it has no clinical significance).

Influence on the ability to drive vehicles and mechanisms. The active substance - fenpiverinia bromide - has holinoliticheskoe effect and can cause dizziness and violation of accommodation. Patients who drive vehicles or work with machines should be warned about possible side effects of the combination. Activities that require increased attention should be discontinued until the side effects disappear.