I took tablets - a drug that has a good analgesic, antipyretic, and anti-inflammatory spectrum of action. The drug has a wide list of indications and contraindications, so before using it is necessary to consult a doctor.
Registration number: P N012121/01 dated 23.08.2010
Trade name of the drug: BRAL
Dosage form: tablets
Photo of the packaging of tablets I took 505 mg, where the composition of the tablets and storage conditions are indicated
I took the pills
Each tablet contains:
Active substances: metamizole sodium - 500 mg; pitofenone hydrochloride - 5 mg; fenpiverinium bromide - 0.1 mg
Excipients: lactose, corn starch (anhydrous), povidone, methylhydroxybenzoate, purified talc, magnesium stearate.
Description
Pale yellow, round, flat tablets with bevelled edges, scored on one side and engraved "MICRO" on the other side.
Pharmacotherapeutic group: analgesic (non-narcotic analgesic + antispasmodic)
ATC Code: NO2BB52
Pharmacological properties
Metamizole sodium (analgin) has an analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone hydrochloride, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fenpiverinium bromide, due to m-hopinoblocking action, has an additional antispasmodic effect on smooth muscles.
Took indications for use
Pain syndrome with spasms of smooth muscles of internal organs - renal and biliary colic, intestinal spasms, dysmenorrhea and other spastic conditions of internal organs, as well as headache and migraine pain. It can be used for short-term symptomatic treatment of arthrapgia, neuralgia, sciatica, myapgia.
As an aid, it can be used to reduce pain after surgical and diagnostic interventions.
Took contraindications
Hypersensitivity to pyrazolone derivatives (butadione) and other components of the drug; granulocytopenia, severe violations of the liver or kidneys; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia, acute "intermittent" porphyria; angle-closure glaucoma; prostatic hyperplasia; intestinal obstruction and megacolon; diseases of the blood system; collaptoid states; pregnancy (first trimester and last 6 weeks); lactation period; children's age (up to 5 years); increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics.
I took pills: analogues are cheaper
Take pills: dosage and method of application
Adults and children over 15 years old taken orally (preferably after meals) usually 1-2 tablets 2-3 times a day. The daily dose should not exceed 6 tablets. Duration of reception 1 no more than 5 days. An increase in the daily dose of the drug or the duration of treatment is possible only under medical supervision.
Dosages for children. For children, the drug should be given only as directed by a doctor. Dosage for children 5-7 years old - half a tablet, 8-12 years old - three quarters of a tablet, 13-15 years old - one tablet 2-3 times a day. Other dosage regimens are possible only after consultation with a doctor.
Took side effects
In therapeutic doses, the drug is usually well tolerated. Sometimes allergic reactions are possible (skin rash, itching, very rarely - anaphylactic shock). In isolated cases - a burning sensation in the epigastric region, dry mouth, headache, dizziness, lowering blood pressure, tachycardia, cyanosis. With prolonged use - cases of violations of the blood system (thrombocytopenia, leukopenia, agranulocytosis). With a tendency to bronchospasm, provoking an attack is possible. In very rare cases, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), decreased sweating, accommodation paresis, urinary retention. Rarely (usually with long-term use or high doses) - impaired renal function: oliguria, anuria, proteinuria, interstitial nephritis, urine staining red.
All side effects should be reported to your doctor.
Carefully
With caution and under the supervision of a physician, the drug should be used in patients with impaired liver or kidney function, with a tendency to hypotension, bronchospasm. Children and adolescents (under 18 years of age) should use the drug only on prescription.
Overdose
Symptoms: vomiting, lowering blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, impaired liver and kidney function, convulsions.
Treatment: gastric lavage, administration of activated charcoal, symptomatic therapy.
Interaction with other drugs
Simultaneous use of Brala with other non-narcotic analgesics can lead to mutual enhancement of effects. Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of mvtamizole in the liver and increase its toxicity. Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium. Simultaneous use with cyclosporine reduces the level of the latter in the blood. Sedatives and tranquilizers enhance the analgesic effect of the drug. When used together with ethanol - mutual enhancement of effects. If necessary, the simultaneous use of these and other drugs should consult with your doctor.
special instructions
During the period of treatment with the drug, you can not take alcohol; it is not recommended to drive vehicles and engage in other potentially hazardous activities that require quick physical and mental reactions. Use in nursing mothers requires cessation of breastfeeding. With prolonged (more than 5 days) use of the drug, it is necessary to control the pattern of peripheral blood and the functional state of the liver.
Release form
10 tablets in a PVC/aluminum blister or aluminum strip.
1, 2 or 10 blisters or strips, together with instructions for use, in a cardboard pack.
10 blisters or strips with 10 instructions for use in a carton box.
Photo of a blister of tablets Bral
Best before date
5 years. Do not use after the expiration date indicated on the package.
Photo of the packaging of tablets I took, where the series, date of manufacture and expiration date are indicated
Storage conditions
In a dry, dark place at a temperature not exceeding 25°C.
Keep out of the reach of children!
Terms of dispensing from pharmacies
Without recipe.
I took a photo of the packaging of tablets, where the price is indicated
Manufacturer
Micro Labs Limited, India
Claims should be sent to the address of the representative office of the company:
115230, Moscow, st. Nagatinskaya, house 2/2, entrance 2, floor 4.
Phone/Fax: 111-61-35/937-27-70
I took the tablets for internal use, annotation (instruction for use) in photographs
Photo of instructions for taking tablets, part 1
Photo of instructions for taking tablets, part 2
Tablets Took: reviews about the drug
Irina Anastaseeva, Nizhny Tagil
I started taking this drug for renal colic. I was told that this drug relieves pain well. To be honest, I didn't notice much result from it. I have only a little eliminated the pain, but not completely.
Alexandra Svetova, Omsk
I took it for toothache, as the instructions say that the drug has an analgesic effect. But he didn't help me. Then I understood, of course, why - after all, it should be taken only for pain or spasms of smooth muscles. And dentistry has nothing to do with it.
Ekaterina Popova, Moscow
An excellent tool. The drug has a good analgesic effect. Although the instructions for the drug do not say that it can be used for painful periods, but I took it. And the drug helps me a lot.
Polina Romanova, Kolchugino
With a headache, especially with a strong one, the drug does not help. Moreover, severe nausea arose from him, which tormented me for two days. I didn’t really like the pills, one might say, I didn’t like them at all. After all, I was very tormented by a side reaction from them.
Anastasia Ivanova, Kursk
For kidney pain, I took No-shpa tablets, but they did not bring a positive result, so I had to buy another drug. This time at the pharmacy they recommended me taking pills for renal colic. They relieved the pain well, and it did not bother me until late in the evening, although I took the pill at 10 am.
Alexey Tsvitaev, Kemerovo
Started taking it for headaches. I just often have a headache after an accident, and I constantly take pills. I bought myself this new imported drug I took. He just shocked me. I had a severe allergic reaction from the pills. At first, my whole face was sprinkled, then the rash moved to the body. This is such an expensive drug, it does not help, but only causes side effects.
Zhanna Ivanova, Sergiev Posad
I once had an intestinal spasm, it is very unpleasant, I had to turn to my friend, who at that time worked as a pharmacist. She recommended this drug to me, which can help me eliminate this spasm. I started taking the pills strictly according to the instructions. However, the pills didn't work very well. They are able to eliminate the spasm only for a couple of hours, then I had to take the pill again. Therefore, so that I would not have an overdose, I began to combine them with No-shpa. I was so much calmer, because I didn’t harm my body much with one drug. After all, this Bral has a rather serious composition.
Zinaida Kustovaya, Vladimir
A good and especially inexpensive drug that can be used for mild headaches. But with a severe headache, the drug does not help at all. And if it helps, it eliminates the pain for several hours. This is probably the only disadvantage of such a cheap drug.
Alexandra Damanova, Berdsk
I took the tablets, my friend recommended me. I once suffered from a severe headache for a long time. I bought this drug, and nothing happened after taking the first pill. I then took another pill, and there was no effect either. They probably just don’t help me, because they are just perfect for a friend.
Metamizole sodium (metamizole sodium)
- pitofenone hydrochloride (pitofenone)
- fenpiveriniya bromide (fenpiverinium bromide)
Composition and form of release of the drug
Solution for intravenous and intramuscular administration yellowish, transparent.
Excipients: hydrochloric acid, water for injections.
5 ml - dark glass ampoules (5) - plastic blister packs (1) - cardboard packs.
pharmachologic effect
Combined analgesic and antispasmodic agent. The combination of the components of the drug leads to a mutual enhancement of their pharmacological action.
Metamizole sodium- a derivative of pyrazolone, has an analgesic, antipyretic and weak anti-inflammatory effect, the mechanism of which is associated with inhibition of prostaglandin synthesis.
Pitophenone hydrochloride has a direct myotropic effect on the smooth muscles of the internal organs and causes its relaxation (papaverine-like action).
Fenpiverinium bromide has an m-anticholinergic effect and has an additional myotropic effect on smooth muscles.
Pharmacokinetics
Metamizole sodium
After oral administration, metamizole sodium is rapidly absorbed from the gastrointestinal tract. In the intestinal wall, it is hydrolyzed to form an active metabolite. Unchanged metamizole sodium in the blood is not determined (only after intravenous administration it is found in the blood in a small concentration and quickly becomes inaccessible for determination). After i / m administration, the active substances of the drug are rapidly and largely absorbed from the injection site.
Plasma protein binding is 50-60%. When taken in therapeutic doses, it is excreted in breast milk.
Metamizole sodium undergoes intensive biotransformation in the liver. The main metabolites are 4-methylaminoantipyrine, 4-formylaminoantipyrine, 4-aminoantipyrine and 4-acetylaminoantipyrine. Approximately 20 additional metabolites have been identified, including glucuronic acid derivatives. The main four metabolites are found in the cerebrospinal fluid. It is excreted mainly by the kidneys.
Pitophenone
Rapidly absorbed from the gastrointestinal tract when taken orally. C max in blood plasma is reached in 30-60 minutes. It is rapidly distributed in organs and tissues, does not penetrate through the BBB.
Metabolized in the liver by oxidative reactions. Excreted with urine. T 1/2 is 1.8 hours.
Fenpiverinium bromide
When taken orally, it is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is achieved within 1 hour. Does not penetrate the BBB. It is excreted unchanged in the urine 32.4-40.4%, with bile - 2.3-5.3%.
Indications
Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of the ureter and bladder; biliary colic; biliary dyskinesia; ; intestinal colic; chronic colitis; algomenorrhea; diseases of the pelvic organs.
For short-term treatment of arthralgia; myalgia; neuralgia, sciatica.
As an auxiliary drug for pain after surgery and diagnostic procedures.
Contraindications
Severe hepatic and / or renal failure; oppression of bone marrow hematopoiesis; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia; severe angina; decompensated chronic insufficiency; collapse; angle-closure glaucoma; prostatic hyperplasia (with clinical manifestations); intestinal obstruction; megacolon; pregnancy (especially the first trimester and the last 6 weeks); lactation period; children's age up to 3 months or body weight less than 5 kg (for intravenous administration); children's age up to 5 years (for tablets); hypersensitivity (including to pyrazolone derivatives).
WITH caution: renal/liver failure; bronchial asthma; tendency to arterial hypotension; hypersensitivity to NSAIDs; urticaria or acute rhinitis provoked by taking or other NSAIDs.
Dosage
inside
Adults and adolescents over 15 years old: 1-2 tab. 2-3 times / day, without chewing, with a small amount of liquid.
Children aged 12-14 years: single dose - 1 tab., Maximum daily dose - 6 tab. (1.5 tab. 4 times / day), children aged 8-11 years - 0.5 tab., The maximum daily dose is 4 tab. (1 tab. 4 times / day), children aged 5-7 years - 0.5 tab., The maximum daily dose - 2 tab. (0.5 tab. 4 times / day).
Parenterally (in / in, in / m)
Adults and adolescents over 15 years of age with acute severe colic are injected intravenously slowly (1 ml over 1 minute), 2 ml; if necessary, re-introduce after 6-8 hours. V / m - 2-5 ml of the solution 2-3 times / day. The maximum daily dose should not exceed 10 ml (corresponding to 5 g of metamizole sodium).
The duration of the course of treatment is determined depending on the clinical symptoms and etiopathogenesis of the disease, but should not exceed 5 days.
Calculation of the dose for children with intravenous and intramuscular administration: 3-11 months (5-8 kg) - only intramuscularly - 0.1-0.2 ml; 1-2 years (9-15 kg) - in / in - 0.1-0.2 ml, in / m - 0.2-0.3 ml; 3-4 years (16-23 kg) - in / in - 0.2-0.3, in / m - 0.3-0.4 ml; 5-7 years (24-30 kg) - in / in - 0.3-0.4 ml, in / m - 0.4-0.5 ml; 8-12 years (31-45 kg) - in / in - 0.5-0.6 ml, in / m - 0.6-0.7 ml; 12-15 years - in / in and / m - 0.8-1 ml.
Before the introduction of the injection solution, it should be warmed in the hand.
Side effects
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), bronchospasm, anaphylactic shock.
From the hematopoietic system: thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unmotivated rise in temperature, chills, difficulty swallowing, stomatitis, as well as the development of vaginitis or proctitis).
From the side of the cardiovascular system: decrease in blood pressure.
From the urinary system: impaired renal function, oliguria, anuria, proteinuria, interstitial nephritis, urine staining red.
Anticholinergic effects: dry mouth, decreased sweating, paresis of accommodation, tachycardia, difficulty urinating.
Local reactions: with i / m administration, infiltrates are possible at the injection site.
Overdose
Symptoms: nausea, vomiting, gastralgia, hypothermia, decreased blood pressure, tachycardia, shortness of breath, tinnitus, drowsiness, delirium, impaired consciousness, acute agranulocytosis, hemorrhagic syndrome, oliguria, acute renal and / or liver failure, convulsions, paralysis of the respiratory muscles.
Treatment: gastric lavage, the use of activated charcoal, water-salt solutions, forced diuresis, hemodialysis; with the development of a convulsive syndrome - in / in the introduction of diazepam and high-speed barbiturates.
drug interaction
Histamine H1 receptor blockers, butyrophenones, phenothiazines, tricyclic antidepressants, amantadine and quinidine- it is possible to increase the m-anticholinergic action.
or other phenothiazine derivatives- possible development of severe hyperthermia.
Non-narcotic analgesics, tricyclic antidepressants, oral hormonal contraceptives and allopurinol- increase the toxicity of the drug.
Phenylbutazone, barbiturates and other microsomal enzyme inducers- decrease in the effectiveness of metamizole sodium.
Sedatives and anxiolytics (tranquilizers)- increased analgesic action of metamizole sodium.
Radiopaque drugs, colloidal blood substitutes and penicillin- combinations with drugs containing metamizole sodium should not be used.
- possible decrease in the concentration of cyclosporine in the blood.
Oral hypoglycemic agents, indirect anticoagulants, corticosteroids and indomethacin- metamizole sodium displaces these agents from the connection with proteins, as a result of which an increase in the severity of their action is possible.
Thiamazole and cytostatics- increased risk of leukopenia.
Myelotoxic drugs: increased hematotoxic effect of the drug.
Codeine, histamine H2 receptor blockers, propranolol- increased effect of the drug due to a slowdown in the inactivation of metamizole sodium.
ethanol- enhancing the effects of ethanol.
Solution for injection is pharmaceutically incompatible with other drugs.
special instructions
With prolonged (more than a week) treatment, it is necessary to control the pattern of peripheral blood and the functional state of the liver.
If agranulocytosis is suspected or if thrombocytopenia is present, the drug should be discontinued.
The use of the drug for the relief of acute abdominal pain is unacceptable until the cause of the disease is clarified.
Intolerance is very rare, but the risk of developing anaphylactic shock after intravenous administration of the drug is relatively higher than after oral administration.
In patients with atopic bronchial asthma and hay fever, the risk of developing allergic reactions increases.
Parenteral administration of the drug should be used only in cases where oral administration is not possible or absorption from the gastrointestinal tract is impaired.
In / in the injection should be carried out slowly, with the patient lying down and under the control of blood pressure, heart rate and respiratory rate.
Special care must be taken when administering more than 2 ml of solution (there is a risk of a sharp decrease in blood pressure).
For intramuscular injection, a long needle must be used.
In the treatment of children under the age of 5 years and patients receiving cytostatics, the use of metamizole sodium should be carried out only under medical supervision.
It is possible to stain urine red due to the release of a metabolite (it has no clinical significance).
Influence on the ability to drive vehicles and control mechanisms
During treatment, caution should be exercised for drivers of vehicles and persons engaged in potentially hazardous activities that require quick psychomotor reactions.
Pregnancy and lactation
The use of the drug is contraindicated during pregnancy (especially in the first trimester and in the last 6 weeks). The use of the drug is contraindicated in severe liver failure.
With caution, the drug should be prescribed for liver failure.
Russian name
Metamizole sodium + Pitophenone + Fenpiverinium bromideLatin name of the substances Metamizole sodium + Pitophenone + Fenpiverinium bromide
Metamizolum natrium + Pitofenonum + Fenpiverini bromidum ( genus. Metamizoli natrii + Pitofenoni + Fenpiverini bromidi)Pharmacological group of substances Metamizole sodium + Pitophenone + Fenpiverinium bromide
Nosological classification (ICD-10)
Characteristics of substances Metamizole sodium + Pitophenone + Fenpiverinium bromide
A combination of active ingredients with analgesic non-narcotic action + antispasmodic action.
Pharmacology
pharmachologic effect- anti-inflammatory, antipyretic, analgesic, antispasmodic.Pharmacodynamics
A combination of analgesic and antispasmodic active substances, the combination of which leads to the mutual potentiation of their pharmacological action.
Metamizole sodium is a pyrazolone derivative that has analgesic, antipyretic and anti-inflammatory effects.
Pitophenone has a direct myotropic antispasmodic effect on smooth muscles (papaverine-like action).
Fenpiverinium bromide has an m-anticholinergic effect and has an additional myotropic antispasmodic effect on smooth muscles.
Pharmacokinetics
Absorption. After intramuscular administration, metamizole sodium is rapidly absorbed. The systemic bioavailability of metamizole sodium is about 85%.
Distribution. Communication with plasma proteins of metamizole sodium is 50-60%. Penetrates through the BBB and the placental barrier. V d - about 0.7 l / kg. Pitophenone and fenpiverinium bromide do not penetrate the BBB.
Metabolism. Metamizole sodium undergoes intensive biotransformation in the liver. Its main metabolite, 4-methylaminoantipyrine (MAA), is metabolized in the liver to form other metabolites, incl. pharmacologically active 4-aminoantipyrine (AA). Plasma C max (all metabolites) are reached in approximately 30-90 minutes. Four main metabolites of metamizole sodium: MAA, active; 4-aminoantipyrine, active; 4-formylaminoantipyrine, inactive; 4-acetylaminoantipyrine, inactive.
Pitophenone and fenpiverinium bromide are metabolized in the liver, mainly by oxidation.
Withdrawal. Metamizole sodium is excreted by the kidneys in the form of metabolites, about 3% - unchanged. T 1/2 - about 10 hours. In therapeutic concentrations, it passes into breast milk.
T 1/2 of pitofenone and fenpiverinium bromide is about 10 hours.
Almost 90% of pitofenone and fenpiverinium bromide are excreted by the kidneys in the form of metabolites and 10% - through the intestines unchanged.
Impaired liver function. T 1/2 MAA (active metabolite) in patients with impaired liver function increases by about 3 times. Such patients are advised to reduce the dose.
Impaired kidney function. In patients with impaired renal function, there is a decrease in the elimination of some metabolites. Such patients are advised to reduce the dose.
Application of substances Metamizole sodium + Pitophenone + Fenpiverinium 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 nephrolithiasis, spastic biliary dyskinesia, algomenorrhea); short-term symptomatic treatment of arthralgia, neuralgia, sciatica, myalgia (pain relief); as an auxiliary drug to reduce pain after surgery and diagnostic procedures; reduction of elevated body temperature in 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); severe hepatic and / or renal failure; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmia; severe angina; decompensated chronic heart failure; angle-closure glaucoma; prostatic hyperplasia (with clinical manifestations); intestinal obstruction; megacolon; collapse; atony of the gallbladder and bladder; pregnancy; lactation period.
In / in the introduction: infancy (up to 1 year) or body weight less than 9 kg.
In / m introduction: infancy (up to 3 months) or body weight less than 5 kg.
Inside: tablets are not used in children under 5 years of age.
Application restrictions
Renal and / or liver failure; bronchial asthma; tendency to arterial hypotension; hypersensitivity to other NSAIDs or non-narcotic analgesics; urticaria and / or acute rhinitis provoked by taking acetylsalicylic acid or other NSAIDs.
For children and adolescents under 18 years of age, use only as directed by a doctor.
Use during pregnancy and lactation
The use is contraindicated during pregnancy (especially in the first trimester and the last 6 weeks) and during breastfeeding, because. possible premature closure of the arterial (Botallova) duct and perinatal complications due to the effect of metamizole sodium on the ability of maternal and fetal platelets to aggregate.
Side effects of substances Metamizole sodium + Pitophenone + Fenpiverinium bromide
Adverse reactions (HP) are grouped by systems and organs in accordance with the dictionary MedDRA and WHO HP HP classification: very often (≥1/10); often (≥1/100 to<1/10); нечасто (≥1/1000 до <1/100); редко (≥1/10000 до <1/1000); очень редко (<1/10000); частота неизвестна (частота не может быть определена на основе имеющихся данных).
The adverse reactions listed below are mainly caused by metamizole sodium, which is part of the combination of metamizole sodium + pitofenone + fenpiverinium bromide.
From the blood and lymphatic system: rarely - leukopenia; very rarely - agranulocytosis, thrombocytopenia, anemia (hemolytic anemia, aplastic anemia). The risk of agranulocytosis cannot be predicted. Agranulocytosis can also occur in patients who have taken metamizole sodium in the past without the appearance of similar HP.
From 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 the cessation of administration, but may occur after a few hours. They usually develop within the first hour after injection. Milder reactions appear as typical skin and mucosal reactions (eg, itching, burning, redness, urticaria, edema - local or general), shortness of breath and, rarely, gastrointestinal complaints. Mild reactions can turn into more severe forms with generalized urticaria, severe angioedema (including laryngospasm), severe bronchospasm, cardiac arrhythmias, lowering blood pressure (sometimes with a previous increase in blood pressure).
For this reason, if any skin hypersensitivity reaction, symptoms of impaired renal function or hematotoxic reactions occur, the use of the drug should be stopped immediately.
Very rarely - an attack of bronchial asthma (in patients with aspirin asthma), circulatory shock. Shock may be accompanied by cold sweat, dizziness, drowsiness, depression of consciousness, pallor of the skin, a feeling of squeezing in the heart area, shallow breathing or tachypnea, tachycardia, cold extremities, a pronounced drop in blood pressure. At the first sign of shock, the use of 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, decreased sweating.
In the event of any skin reactions, the use of the medicinal product should be discontinued immediately.
From the nervous system: dizziness, headache.
From the senses (vision): visual disturbances, disturbance of accommodation.
From the side of the heart: infrequently - palpitations, tachycardia, cardiac arrhythmias, cyanosis.
From the vascular side: infrequently - arterial hypotension, hyperemia.
Hypotensive reactions rarely occur during or after use. They may or may not be accompanied by other symptoms of anaphylactoid or anaphylactic reactions.
Rarely - such reactions may be the result of a sharp decrease in blood pressure. Rapid administration increases the risk of hypotensive reactions.
A critical decrease in blood pressure without other signs of hypersensitivity is dose-dependent and may manifest as hyperpyrexia.
From the gastrointestinal tract: frequency 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 side of the liver and biliary tract: hepatitis.
From the urinary system: rarely - proteinuria, oliguria, anuria, polyuria, interstitial nephritis, urine staining red, difficulty urinating, impaired renal function; frequency unknown - urinary retention.
From the respiratory system: bronchospasm.
General disorders and disorders at the injection site: with parenteral use - asthenia, pain at the injection site and local reactions.
Interaction
The solution for intravenous and intramuscular administration is pharmaceutically incompatible with other drugs.
With blockers of H 1 -histamine receptors, derivatives of butyrophenone and phenothiazine, amantadine and quinidine. With simultaneous use with H1-histamine receptor blockers, derivatives of butyrophenone and phenothiazine, tricyclic antidepressants, amantadine and quinidine, it is possible to increase the m-anticholinergic action of the combination of metamizole sodium + pitofenone + fenpiverinium bromide.
With alcohol. Enhances the effects of ethanol.
With other non-narcotic analgesic drugs. 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 microsomal enzyme inducers. 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) enhance the analgesic effect of the combination metamizole sodium + pitofenone + fenpiverinium bromide.
Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.
With radiopaque substances, colloidal blood substitutes, penicillin. X-ray contrast agents, colloidal blood substitutes and penicillin should not be used during treatment with drugs containing metamizole sodium (increased risk of anaphylactic / anaphylactoid reactions).
with cyclosporine. Metamizole sodium can reduce the concentration of cyclosporine in the blood serum, therefore, with the simultaneous use of a combination of metamizole sodium + pitofenone + fenpiverinium bromide with cyclosporine, the concentration of cyclosporine should be monitored.
With drugs that have a high connection with plasma proteins (oral hypoglycemic agents, indirect anticoagulants, corticosteroids and indomethacin). Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, corticosteroids and indomethacin from the connection with plasma proteins, increases their activity.
With myelotoxic drugs. Myelotoxic drugs increase the manifestation of hematotoxicity.
with methotrexate. The addition of methotrexate to treatment may enhance 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 enhance the effects of metamizole sodium.
Overdose
Symptoms: nausea, vomiting, pain in the epigastric region, decreased blood pressure, tachycardia, acute agranulocytosis, hemorrhagic syndrome, hypothermia, oliguria, shortness of breath, tinnitus, drowsiness, delirium, confusion, impaired liver and kidney function, convulsions, paralysis of the respiratory muscles.
Treatment: symptomatic therapy.
Routes of administration
In / in, in / m, inside.
Precautions of substances Metamizole sodium + Pitophenone + Fenpiverinium bromide
When treating children under 5 years of age and patients receiving cytostatic drugs, treatment with a combination of metamizole sodium + pitophenone + fenpiverinium bromide should be carried out 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 is recommended due to a possible increase in T 1/2 of metamizole sodium.
When choosing the route of administration, it should be taken into account that parenteral use is associated with a higher risk of anaphylactic / anaphylactoid reactions. Parenteral use is recommended in cases where oral administration is not possible or absorption from the gastrointestinal tract is impaired.
An increased risk of developing hypersensitivity reactions to metamizole sodium + pitophenone + fenpiverinium bromide metamizole sodium, which is part of the combination, is caused by the following conditions: bronchial asthma, especially in combination with polypous rhinosinusitis; chronic urticaria; alcohol intolerance (hypersensitivity to alcohol), against the background of which, even when taking a small amount of certain alcoholic beverages, patients experience sneezing, watery eyes and severe reddening of the face (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 conduct a thorough patient survey. In case of identification of the risk of developing an anaphylactoid reaction, the use is possible only after assessing the risk/benefit ratio. In the case of using the combination in such patients, strict medical monitoring of their condition is necessary and the availability of emergency aid in case of anaphylactic / anaphylactoid reactions is mandatory.
Anaphylactic shock may occur in predisposed patients, so the combination of metamizole sodium + pitofenone + fenpiverinium bromide should be used with caution in patients with asthma or atopy.
Against the background of the use of metamizole sodium, life-threatening skin reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, have been described. If symptoms of these diseases appear (such as a progressive skin rash, often with blisters or mucosal lesions), treatment with a combination of metamizole sodium + pitophenone + fenpiverinium bromide should be stopped immediately and not restarted.
During therapy with metamizole-containing drugs, agranulocytosis may develop. It lasts at least a week, does not depend on the dose, can be severe, life-threatening and even lead to death of the patient. In this regard, when symptoms appear, possibly associated with neutropenia (fever, chills, sore throat, difficulty swallowing, stomatitis, erosive and ulcerative lesions of the oral cavity, vaginitis or proctitis, a decrease in the number of neutrophils in peripheral blood - less than 1500 mm 3), it is necessary to stop treatment with a combination of metamizole sodium + pitofenone + fenpiverinium bromide and consult a doctor.
If the patient receives antibiotic therapy, then the typical manifestations of agranulocytosis may be minimally pronounced. ESR increases significantly, while lymph node enlargement is mild or absent. Typical symptoms of thrombocytopenia are an increased tendency to bleed 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 parameters of a detailed blood test until they normalize.
All patients should be aware that if symptoms of a pathological change in the blood (for example, general malaise, infections, persistent fever, hematomas, bleeding, pallor of the skin) appear while using the combination of metamizole sodium + pitofenone + fenpiverinium bromide, you should immediately consult a doctor .
BRAL® (BRAL®)
(metamizole sodium + pitofenone + fenpiverinium bromide)
(metamisole sodium + pitofenone hydrochloride + fenpiverinium bromide)
Registration number: P N012121/02 dated 04/14/2006
Trade name: BRAL®
Dosage form: solution for intravenous and intramuscular administration
1 ml of solution contains:
Active substances:
metamizole sodium (analgin) - 500 mg
pitofenone hydrochloride - 2 mg
fenpiverinium bromide - 0.02 mg
Excipients: hydrochloric acid, water for injection.
Description:
Clear yellowish solution.
PHARMACOTHERAPEUTIC GROUP:
Analgesic (non-narcotic analgesic + antispasmodic).
ATX code: NO2BB52
PHARMACHOLOGIC EFFECT
Took - a combination drug, which includes: non-narcotic analgesic metamizole sodium (analgin), myotropic antispasmodic pitofenone hydrochloride and M-anticholinergic agent fenpiverinium bromide. Metamizole sodium has an analgesic, antipyretic and weak anti-inflammatory effect. Pitophenone hydrochloride, like papaverine, has a direct myotropic effect on the smooth muscles of the internal organs and causes it to relax. Fenpiverinium bromide, due to the M-anticholinergic action, has an additional antispasmodic effect on smooth muscles.
INDICATIONS FOR USE
Pain syndrome (mild or moderate) with spasms of smooth muscles of internal organs: renal colic, spasm of the ureter and bladder, biliary colic, intestinal colic, biliary dyskinesia, postcholecystectomy syndrome, algomenorrhea.
For short-term symptomatic treatment: arthralgia, neuralgia, myalgia, sciatica.
As an auxiliary drug: pain syndrome after surgical interventions and diagnostic procedures.
CONTRAINDICATIONS
Hypersensitivity to pyrazolone derivatives (butadione) and other components of the drug; oppression of bone marrow hematopoiesis; stable and unstable angina; chronic heart failure in the stage of decompensation; severe violations of the liver and / or kidneys; deficiency of glucose-6-phosphate dehydrogenase; tachyarrhythmias; acute "intermittent" porphyria; angle-closure glaucoma; prostatic hyperplasia (with clinical manifestations); intestinal obstruction and megacolon; collapse; pregnancy (first trimester and last 6 weeks); lactation period; children's age (up to 3 months or body weight less than 5 kg).
Carefully
With caution and under the supervision of a physician, the drug should be used in patients with impaired liver or kidney function, with a tendency to arterial hypotension, bronchial asthma, increased individual sensitivity to non-steroidal anti-inflammatory drugs or non-narcotic analgesics (including the "aspirin" triad in history). For children and adolescents under 18 years of age, the drug should be used only as directed by a doctor.
METHOD OF APPLICATION AND DOSES
Parenterally (intravenously, intramuscularly).
Adults and adolescents over 15 years of age with acute severe colic are injected slowly 2 ml intravenously (1 ml for 1 minute); if necessary, repeat after 6-8 hours. For slow intravenous administration, 2 ml of the drug is usually sufficient.
Intramuscularly injected 2 ml of solution 2 times a day; the daily dose should not exceed 4 ml. The duration of treatment is not more than 5 days.
The solution is incompatible in one syringe with other drugs.
Before the introduction of the injection solution, it should be warmed in the hand.
SIDE EFFECT
In therapeutic doses, the drug is usually well tolerated. Sometimes allergic reactions are possible (skin rash, itching, very rarely - anaphylactic shock, urticaria), angioedema. In isolated cases - a burning sensation in the epigastric region, dry mouth, headache.
Perhaps dizziness, lowering blood pressure, tachycardia, cyanosis. With prolonged use - hematopoietic disorders: thrombocytopenia, leukopenia, agranulocytosis (may be manifested by the following symptoms: unmotivated rise in temperature, chills, sore throat, difficulty swallowing, stomatitis, as well as the development of vaginitis or proctitis). With a tendency to bronchospasm, provoking an attack is possible.
In very rare cases, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome). Rarely (usually with prolonged use or high doses) - impaired renal function: oliguria, anuria, proteinuria, interstitial nephritis, urine staining red. Very rarely - decreased sweating, paresis of accommodation, difficulty urinating.
Local reactions: with intramuscular injection, infiltrates are possible at the injection site.
All side effects should be reported to your doctor.
OVERDOSE
Symptoms: vomiting, lowering blood pressure, drowsiness, confusion, nausea, pain in the epigastric region, impaired liver and kidney function, convulsions.
Treatment: symptomatic therapy.
INTERACTION WITH OTHER DRUGS
Simultaneous use of Brala® with other non-narcotic analgesics can lead to mutual enhancement of toxic effects.
Tricyclic antidepressants, oral contraceptives, allopurinol disrupt the metabolism of metamizole sodium in the liver and increase its toxicity.
Barbiturates, phenylbutazone and other inducers of microsomal liver enzymes weaken the action of metamizole sodium.
Simultaneous use with cyclosporine reduces the level of the latter in the blood.
Sedatives and tranquilizers enhance the analgesic effect of metamizole sodium.
When co-administered with H1-histamine blockers, butyrophenones, phenothiazines, amantadine and quinidine, an increase in the M-anticholinergic effect is possible.
When used together with ethanol - mutual enhancement of effects.
Simultaneous use with chlorpromazine or other phenothiazine derivatives can lead to the development of severe hyperthermia.
Radiopaque drugs and colloidal blood substitutes should not be used during treatment with drugs containing metamizole sodium.
Metamizole sodium, displacing oral hypoglycemic drugs, indirect anticoagulants, glucocorticosteroids and indomethacin from the connection with the protein, can increase the severity of their action.
Thiamazole and cytostatics increase the risk of developing leukopenia. The effect is enhanced by codeine, H2-histamine blockers and propranolol (slows down the inactivation of metamizole sodium).
Solution for injection is pharmaceutically incompatible with other drugs.
If you need the simultaneous use of these and other drugs, you should consult your doctor.
SPECIAL INSTRUCTIONS
Do not use for the relief of acute abdominal pain (until the cause is clarified). During the period of treatment with the drug, you can not take alcohol; it is not recommended to drive vehicles and engage in other potentially hazardous activities that require quick physical and mental reactions.
Parenteral administration is usually used in emergency cases and in cases where ingestion is not possible (or absorption from the gastrointestinal tract is impaired). Special care is required when administering 2 ml of solution or more (risk of a sharp decrease in blood pressure). Intravenous injection should be carried out slowly, in the supine position and under the control of blood pressure, heart rate and respiratory rate. With prolonged (more than a week) use of the drug, it is necessary to control the pattern of peripheral blood and the functional state of the liver.
RELEASE FORM
Solution for intramuscular and intravenous administration; 5 ml in dark hydrolytic glass ampoules.
5 ampoules in a blister pack made of uncoated PVC film (pallet).
1 cell package (pallet) together with instructions for use in a cardboard box.
BEST BEFORE DATE
3 years. Do not use later than the expiry date indicated on the package.
STORAGE CONDITIONS
In a dry, dark place, at a temperature not exceeding 25 C.
Keep out of the reach of children!
TERMS AND CONDITIONS OF DISCOUNT FROM PHARMACIES
On prescription.
MANUFACTURER
"Micro Labs Limited", India
Representation in the Russian Federation: Russia, Moscow, Leninsky Prospekt, 148, office 57/58.
Spasmalgon is a combined analgesic with pronounced antispasmodic activity. Spazmalgon contains three active ingredients - metamizole sodium, pitofenone hydrochloride and fenpiverinium bromide.
The mechanism of action of the drug and its pharmacological effects are based on the pharmacological properties of the active components that make up its composition.
Metamizole sodium is a non-steroidal anti-inflammatory drug, a pyrazolone derivative. Metamizole sodium has a pronounced analgesic effect, has an anti-inflammatory and antipyretic effect. The mechanism of action of metamizole sodium is associated with its ability to inhibit the activity of the cyclooxygenase enzyme, as a result of which the metabolism of arachidonic acid is disturbed and the synthesis of pro-inflammatory prostaglandins, prostacyclins and thromboxane is reduced. Metamizole sodium belongs to the group of non-selective non-steroidal anti-inflammatory drugs and equally inhibits the activity of both isoforms of the cyclooxygenase enzyme - cyclooxygenase-1 and cyclooxygenase-2. Due to a decrease in the amount of prostaglandins in the focus of inflammation, a decrease in the sensitivity of chemoreceptor endings of afferent neurons of pain sensitivity to bradykinin and histamine is noted. In addition, a decrease in the amount of prostaglandins in the focus of inflammation leads to a decrease in the production of endogenous biologically active substances involved in the inflammatory response. Thus, metamizole sodium has an analgesic result by reducing the activity of the inflammatory process and reducing the action of inflammatory mediators on pain endings. The antipyretic effect of the drug is associated with a decrease in the amount of prostaglandins in the thermoregulatory center in the hypothalamus.
Pitophenone hydrochloride - a derivative of piperidine, has antispasmodic myotropic activity. The drug has a papaverine-like effect, causes a decrease in tone and relaxation of smooth muscles. Pitophenone hydrochloride helps to eliminate pain caused by spasm of the smooth muscles of the internal organs.
Fenpiverinium bromide is a drug of the M-anticholinergic group, containing quaternary nitrogen in its structure. The drug relieves spasm of the smooth muscle layer of the internal organs, lowers the tone and lowers the motility of the stomach and intestines, relaxes the smooth muscles of the urinary and biliary tract.
The pharmacologically active substances that make up the drug Spazmalgon mutually reinforce each other's therapeutic effects.
The pharmacokinetic properties of the drug are presented on the basis of the pharmacokinetic parameters of metamizole sodium, since at the moment there are no reliable data on the pharmacokinetics of pitofenone hydrochloride and fenpiverinium bromide.
When used orally, metamizole sodium is normally absorbed in the gastrointestinal tract. In the walls of the intestine, the drug is hydrolyzed to form a pharmacologically active substance, the peak concentration of the active substance in the blood plasma is observed 30-120 minutes after oral administration.
With parenteral administration, the bioavailability of the drug is about 85%.
The active substance partially binds to plasma proteins. Metabolized in the liver with the formation of pharmacologically active metabolites. It is excreted mainly by the kidneys in the form of metabolites, a small part is excreted by the liver. About 3% of the drug is excreted from the body in the form of unchanged metamizole. The amount of drug that undergoes biotransformation is individual for each patient and depends on many factors, including the genetically determined type of acetylation.
In patients suffering from cirrhosis of the liver, there is a change in the clearance of metamizole.
Indications for use
The drug Spazmalgon in the form of tablets is used for the symptomatic treatment of patients suffering from pain syndrome of mild or moderate intensity, including the drug is indicated for such diseases:
Diseases of the urinary tract, which are accompanied by pain and urination disorders, including inflammatory diseases of the urinary system and urolithiasis.
Gastric and intestinal colic, diseases of the digestive tract, which are accompanied by spasm of the smooth muscles of the intestine and stomach and pain.
Biliary dyskinesia, cholelithiasis.
The drug Spazmalgon in the form of tablets is also used to relieve pain of mild or moderate intensity in primary and secondary dysmenorrhea.
If necessary, the drug can be used for the symptomatic treatment of pain in patients suffering from diseases of the musculoskeletal system and neuralgia. But in this case, the drug is proposed to be used for a short time.
The drug Spasmalgon in the form of a solution for injection is used to relieve severe pain caused by spasms of smooth muscles, including:
Spasm of the smooth muscles of the ureter and bladder, as well as renal colic, which are accompanied by pain of mild to moderate intensity.
Diseases of the liver and biliary tract, which are accompanied by severe pain, including hepatic (biliary) colic, biliary dyskinesia, sphincter of Oddi dysfunction (postcholecystectomy syndrome).
Diseases of the gastrointestinal tract, which are accompanied by pains of a spastic nature, including intestinal colic and chronic colitis.
Diseases of the pelvic organs, which are accompanied by pain syndrome of mild and moderate intensity.
Pain relief in primary and secondary dysmenorrhea.
Mode of application
The drug Spasmalgon in the form of tablets is taken orally, the tablet is swallowed whole, without crushing or chewing, drinking plenty of water. If necessary, the tablet can be divided. The duration of the course of treatment and dosage of the drug is determined by the attending physician individually for each patient, depending on the nature of the disease and the individual characteristics of the patient.
For the treatment of spastic pain, adults and adolescents over the age of 15 are often prescribed 1-2 tablets of medication 2-3 times a day. It is not suggested to take more than 6 tablets per day.
For the treatment of spastic pain, children aged 13 to 15 years are often prescribed 1 tablet of medication 2-3 times a day. It is not recommended to take more than 3 tablets per day.
For the treatment of spastic pain, children aged 9 to 12 years are often prescribed 1/2 tablet of the drug 2-3 times a day. It is not suggested to take more than 2 tablets per day.
The drug Spazmalgon in the form of a solution for injection is used only for intramuscular injection. The duration of the course of treatment and dosage of the drug is determined by the attending physician individually for each patient, depending on the nature of the disease and the individual characteristics of the patient.
Adults and adolescents over the age of 15 years for the treatment of spastic pain are often prescribed 2-5 ml of medication 2-3 times a day. It is suggested to observe the interval between injections of the drug for at least 6 hours. It is not suggested to administer more than 10 ml of medication per day.
The drug is not suggested to be taken for more than 3 days in a row, unless otherwise prescribed by the attending physician.
In the absence of the necessary therapeutic effect, the use of the drug is stopped. If there is a positive trend, therapy is continued with Spazmalgon in the form of tablets.
Side effects
When using the drug Spasmalgon in patients, the development of such side effects was noted:
From the gastrointestinal tract: nausea, vomiting, dry mouth, pain in the epigastric region, exacerbation of chronic diseases of the gastrointestinal tract, including peptic ulcer and gastritis.
From the side of the cardiovascular system and the hematopoietic system: increased blood pressure, arrhythmia, increased heart rate, leukopenia, agranulocytosis, thrombocytopenia, anemia, granulocytopenia.
From the side of the central nervous system: headache, dizziness, irritability, visual disturbances.
From the urinary system: difficulty urinating, oliguria, polyuria, anuria, proteinuria, urine staining bright red. In isolated cases, mainly in patients who took the drug for a long time, the development of impaired renal function and interstitial nephritis is noted.
Allergic reactions: skin rash, itching, urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis, Lyell's syndrome. In isolated cases, the development of anaphylactoid reactions, including Quincke's edema and anaphylactic shock, was noted. Patients with a tendency to bronchospasm and patients suffering from bronchial asthma are likely to develop bronchospasm during therapy with Spasmalgon.
In the event of the development of side effects when using the drug Smazmalgon, it is suggested to consult your doctor, as some side effects require discontinuation of the drug (including side effects such as impaired renal function, hematopoietic disorders and hypersensitivity reactions).
Contraindications
Increased individual sensitivity to the components of the drug and other drugs of the group of non-steroidal anti-inflammatory drugs;
- increased individual sensitivity to pyrazolone derivatives;
- suspicion of surgical pathology;
- dysfunction of the hematopoietic system, including agranulocytosis, leukopenia, aplastic anemia;
- the drug is contraindicated in patients suffering from severe hepatic and / or renal failure, acute hepatic porphyria, as well as a decrease in the tone of the urinary and / or gallbladder;
- the drug is not prescribed to patients suffering from angle-closure glaucoma, tachyarrhythmia and deficiency of glucose-6-phosphate dehydrogenase;
Spasmalgon is contraindicated in case of obstruction of the gastrointestinal tract, megacolon, collaptoid conditions.
In addition, the drug is not prescribed to patients suffering from prostate adenoma, which is accompanied by urination disorders.
It is not recommended to prescribe the drug to women during pregnancy and lactation, as well as to children under the age of 15 years.
The drug is prescribed with caution to patients with hay fever, bronchial asthma and allergic rhinitis, as they have an increased risk of developing hypersensitivity reactions.
The drug is prescribed with caution to patients suffering from diseases of the liver and / or kidneys, obstructive diseases of the gastrointestinal tract, gastroesophageal reflux disease, decreased intestinal tone, glaucoma, paralytic ileus and diseases of the cardiovascular system.
The drug should be used with caution in patients whose work is associated with the management of potentially dangerous mechanisms and driving a car.
Pregnancy
At the moment, there are no convincing data on the safety of the drug during pregnancy.
If it is necessary to use the drug during lactation, it is suggested to temporarily stop breastfeeding. Restoration of breastfeeding is likely not earlier than 48 hours after the last dose of the drug.
Interaction with other drugs
Metamizole, which is part of the drug Spasmalgon, is considered an enzyme inducer, therefore, the simultaneous use of Spazmalgon with other drugs should be under the strict supervision of the attending physician.
The drug is incompatible with ethyl alcohol, so you should refrain from drinking alcohol and taking medications containing ethyl alcohol during the period of therapy with Spasmalgon.
With simultaneous use, the drug reduces the effectiveness of coumarin anticoagulants.
With the simultaneous use of drugs with phenothiazine derivatives, including chlorpromazine, there is a risk of developing severe hypothermia.
Spasmalgon, when used simultaneously, reduces plasma concentrations of cyclosporine.
Metamizole, which is part of the drug Spasmalgon, increases the risk of developing toxic lesions of the bone marrow due to the use of chloramphenicol and other drugs that have a myelotoxic effect.
Barbiturates, phenylbutazone and other enzyme inducers, when used simultaneously, reduce the therapeutic result of metamizole.
With the simultaneous use of the drug with tricyclic antidepressants, allopurinol and oral contraceptives, an increase in the toxic effect of metamizole is noted.
Non-steroidal anti-inflammatory drugs, when used simultaneously with Spasmalgon, increase the risk of side effects.
There is an increase in the analgesic effect of the drug when used simultaneously with tranquilizers and sedative drugs.
With the combined use of drugs with drugs containing quinine, there is an increase in anticholinergic action.
The drug Spazmalgon in the form of a solution for injection is prohibited to be mixed with other injection solutions in one syringe.
A combination of the drug Spasmalgon with furosemide, glibenclamide and hyoscinbutyl bromide is allowed.
Overdose
When using excessive doses of the drug, patients develop symptoms of metamizole intoxication in combination with anticholinergic effects. Most often, patients develop a toxic-allergic syndrome. With a further increase in dosage, patients develop disorders of the gastrointestinal tract and the central nervous system.
There is no specific antidote. In case of an overdose of the drug in the form of tablets, gastric lavage and the intake of enterosorbents are indicated. In case of an overdose of the drug, regardless of the form of release, measures are taken to speed up the removal of the drug from the body, including forced diuresis, the introduction of aqueous saline solutions and hemodialysis. If necessary, carry out symptomatic therapy.
Release form
Solution for injections of 2 ml in dark glass ampoules, 5 ampoules in blister packs, 1 or 2 blister packs in a cardboard box.
Solution for injections of 5 ml in dark glass ampoules, 5 ampoules in blister packs, 1 or 2 blister packs in a cardboard box.
Tablets of 10 pieces in a blister, 2 blisters in a carton.
Storage conditions
The drug is recommended to be stored in a dry place away from direct sunlight at a temperature not exceeding 25 degrees Celsius.
The shelf life of the drug in the form of a solution for injection is 5 years.
The shelf life of the drug in the form of tablets is 3 years.
Synonyms
Baralgetas, Revalgin, Plenalgin, Spazgan.
Compound
1 tablet of Spazmalgon contains:
Metamizole sodium - 500 mg;
Pitophenone hydrochloride - 5 mg;
Fenpiverinium bromide - 0.1 mg;
Excipients, including lactose monohydrate.
1 ml solution for injection Spasmalgon contains:
Metamizole sodium - 500 mg;
Pitophenone hydrochloride - 2 mg;
Fenpiverinium bromide - 20 mcg;
Excipients.
