Brustan - Instructions For Use, Price, Reviews, Tablets, Suspension

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Brustan

Brustan: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Brustan

ATX code: M01AE51

Active ingredient: ibuprofen + paracetamol (ibuprofen + paracetamol)

Manufacturer: Madras Pharmaceuticals (India), Ranbaxi Laboratories Limited (India)

Description and photo update: 2019-26-08

Prices in pharmacies: from 100 rubles.

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Brustan is a combined non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic action.

Release form and composition

Dosage forms of Brustan:

• film-coated tablets: biconvex, oval, orange, on one side with black food ink, the inscription RANBAXY (10 pcs. in blisters, 1 blister in a cardboard box);
• suspension for oral administration: syrupy liquid with a characteristic odor, yellow (60 or 100 ml in dark glass bottles, 1 bottle with a measuring spoon in a cardboard box).

1 tablet contains:

• active ingredients: paracetamol - 0.325 g, ibuprofen - 0.4 g;
• auxiliary components: corn starch, calcium hydrogen phosphate, purified talc, povidone, isopropanol;
• film shell: film-forming suspension opadry orange 06G53189 (hypromellose 15cP, hypromellose 5cP, sunset yellow dye, titanium dioxide, macrogol, sodium lauryl sulfate, propylene glycol), purified water.

5 ml of suspension contains:

• active ingredients: paracetamol - 0.125 g, ibuprofen - 0.1 g;
• auxiliary components: propyl hydroxybenzoate, methyl parahydroxybenzoate, disodium edetate, colloidal silicon dioxide, sodium carmellose, sucrose, glycerol, sodium citrate, sodium hydrosulfite, xanthan gum, citric acid monohydrate, polysorbate 80, peach flavor1 (ST 5921) -00014-11), quinoline yellow dye, sodium citrate, purified water.

Pharmacological properties

Pharmacodynamics

Brustan is a combination drug with anti-inflammatory, analgesic and antipyretic effects.

The first active ingredient is ibuprofen, a propionic acid derivative from the group of non-steroidal anti-inflammatory drugs (NSAIDs). Possesses peripheral anti-inflammatory properties. In addition, it has antipyretic and rapidly targeted analgesic effects. The mechanism of its action is due to the ability to indiscriminately block cyclooxygenase 1 (COX-1) and cyclooxygenase 2 (COX-2) and, as a result, inhibit the synthesis of prostaglandins - mediators of inflammation, pain and hyperthermic reaction.

The second active ingredient is paracetamol, which has a central analgesic effect. Its mechanism of action is due to its ability to indiscriminately block COX, mainly in the central nervous system, affecting the centers of pain and thermoregulation. The effect of paracetamol on COX in inflamed tissues is neutralized by cellular peroxidases, which explains the almost complete absence of significant anti-inflammatory activity. Due to the lack of influence on the synthesis of prostaglandins in peripheral tissues, there is no negative effect on water-salt metabolism and the mucous membrane of the gastrointestinal tract.

Pharmacokinetics

Ibuprofen

After entering the gastrointestinal tract, ibuprofen is rapidly absorbed. The maximum concentration reaches within 1–2 hours.

Actively binds to plasma proteins - by 90–99%. It slowly penetrates into the joint cavity, accumulates in the synovial fluid, where it creates higher concentrations in comparison with blood plasma. There are no signs of cumulation with prolonged use.

After absorption, approximately 60% of the pharmacologically inactive R-form is slowly transformed into the active S-form. Ibuprofen is metabolized in the liver to form two inactive metabolites (hydroxylated and carboxylated compounds).

The half-life (T _1/2) is 2 ± 0.5 hours. It is excreted: by the kidneys - more than 90%, of which unchanged - no more than 1%, the rest - with bile in the form of metabolites and their conjugates.

Paracetamol

Once in the gastrointestinal tract, paracetamol is rapidly absorbed. The maximum concentration (C _max) reaches within 10-60 minutes. The C _max level is 5–20 μg / ml.

The connection with plasma proteins is no more than 10%, it increases slightly in case of an overdose. Glucuronide and sulfate metabolites do not bind to plasma proteins even in sufficiently high concentrations.

The drug is evenly distributed in the body fluids, penetrates the blood-brain barrier, in small amounts (<1%) - into breast milk.

Approximately 90–95% of paracetamol is biotransformed in the liver, resulting in the formation of inactive conjugates with glucuronic acid (60%), taurine (35%) and cysteine (3%), as well as a small amount of deacetylated and hydroxylated metabolites. In children, the ability to form conjugates with glucuronic acid is lower than in adults.

A small part of the paracetamol dose is hydroxylated by microsomal enzymes, resulting in the formation of highly active N-acetyl-n-benzoquinone imine, which is rendered harmless by binding to sulfhydryl groups of glutathione in the liver. In case of paracetamol overdose, N-acetyl-n-benzoquinone imine can accumulate and cause liver damage.

The drug is excreted by the kidneys mainly in the form of sulfate and glucuronide conjugates, unchanged - <5%.

The period T _1/2 is 2-3 hours, with concomitant liver cirrhosis, it increases slightly.

In elderly patients, paracetamol clearance decreases, T _1/2 increases.

Indications for use

• fever in acute respiratory infections (acute respiratory diseases), influenza, post-vaccination reactions, childhood infections, other infectious and inflammatory diseases, accompanied by an increase in body temperature - as an antipyretic;
• pain syndrome of mild to moderate severity, including migraine, neuralgia, pain in diseases of the ENT organs (throat, ears), headache and toothache, lumbago, myalgia, tendovaginitis, fibrositis, arthralgia (in rheumatoid arthritis, osteoarthritis, gout), spondyloarthritis, pain with injuries of the musculoskeletal system and soft tissues (bruises, sprains, dislocations, fractures), algomenorrhea, pain after surgery - as a pain reliever.

Contraindications

Absolute:

• erosive and ulcerative lesions of the gastrointestinal tract (GIT), gastric bleeding in the active phase;
• intestinal inflammation;
• blood pathology (hypocoagulation, leukopenia, hemophilia);
• the period after the operation for coronary artery bypass grafting (for tablets);
• severe liver failure;
• severe renal failure, including confirmed hyperkalemia;
• III trimester of pregnancy;
• period of breastfeeding (lactation);
• children's age: suspension - up to 2 years, tablets - up to 12 years;
• history of attacks of bronchial obstruction, rhinitis, urticaria (complete or partial syndrome of intolerance to acetylsalicylic acid - urticaria, rhinosinusitis, polyps of the nasal mucosa and bronchial asthma) provoked by the intake of aspirin (salicylates) or other NSAIDs;
• hypersensitivity to paracetamol, ibuprofen, acetylsalicylic acid or other NSAIDs and to other components of Brustan.

According to the instructions, Brustan is taken with caution in congestive heart failure, ischemic heart disease, arterial hypertension, cerebrovascular disease, dyslipidemia, diabetes mellitus, peripheral arterial disease, smoking, frequent alcohol consumption, hyperbilirubinemia, liver cirrhosis with portal hypertension, hepatic and / or renal insufficiency, nephrotic syndrome, deficiency of glucose-6-phosphate dehydrogenase, gastric ulcer and 12 duodenal ulcer (in history), gastritis, blood diseases of unknown etiology (anemia), in I – II trimesters of pregnancy and in old age.

Instructions for the use of Brustan: method and dosage

The duration of therapy is determined by the doctor depending on the nature of the disease and the therapeutic effect of Brustan.

The course of therapy with the drug as an antipyretic - no more than 3 days, as an anesthetic - no more than 5 days. If the fever persists for more than 3 days, you should consult a doctor.

Film-coated tablets

Brustan tablets are taken orally after a meal.

Recommended dosing regimen, if there are no other prescriptions:

• children 12-15 years old (weighing> 40 kg): 1 pc. 3 times / day;
• adults and children over 15 years old: 1 pc. 3-4 times / day with an interval of 6-8 hours, but no more than 4 tablets.

Oral suspension

Suspension Brustan is taken orally, thoroughly shaking the bottle before use, accurately measuring the dose of the drug with the supplied 5 ml double-sided measuring spoon.

Single dosage depending on the body weight (age) of the child (number of measuring spoons / volume of suspension in ml):

• 10-15 kg (2-3 years) - 1/5;
• 16-21 kg (4-6 years old) - 1.5 / 7.5;
• 22-26 kg (7-9 years old) - 2/10;
• 27–32 kg (10–11 years old) - 2.5 / 12.5;
• 33–43 kg (12–14 years old) - 3/15.

Brustan is taken 3-4 times / day with an interval of 6-8 hours, but no more than 4 times / day.

Side effects

Side effects due to the use of Brustan are rare, but the following reactions from organs and systems are possible:

• gastrointestinal tract (GIT): NSAID-gastropathy (decreased appetite, heartburn, nausea, vomiting, abdominal pain, constipation / flatulence; rarely - ulceration of the gastrointestinal tract, complicated in some cases by perforation and bleeding), dryness / irritation of the oral mucosa, ulceration of the gum mucosa, pain in the mouth;
• hepatobiliary system: hepatitis;
• cardiovascular system (CVS): tachycardia, heart failure, increased blood pressure (BP);
• central and peripheral nervous system: dizziness, headache, insomnia, nervousness / irritability, anxiety, psychomotor agitation, depression, confusion, hallucinations, drowsiness; rarely - aseptic meningitis (more often in patients with autoimmune diseases);
• hematopoietic system: anemia (including hemolytic and aplastic), thrombocytopenic purpura and thrombocytopenia, leukopenia, agranulocytosis;
• respiratory system: shortness of breath, bronchospastic syndrome;
• sense organs: hearing impairment (ringing / tinnitus), visual impairment (blurred vision / diplopia, toxic optic neuritis, scotoma, irritation and dryness of the eyes, swelling of the eyelids and conjunctiva of allergic genesis);
• urinary system: nephrotic syndrome (edema), allergic nephritis, cystitis, polyuria, acute renal failure;
• allergic reactions: pruritus, skin rash (erythematous or urticaria), anaphylactoid reactions, Quincke's edema, anaphylactic shock, fever, bronchospasm / dyspnoea, Stevens-Johnson syndrome (erythema multiforme exudative), eosinophilia, Lyme epidermis syndrome rhinitis;
• laboratory data: may increase - serum creatinine concentration, bleeding time, hepatic transaminase activity; may decrease - serum glucose concentration, hematocrit or hemoglobin level, creatinine clearance.

Overdose

Overdose symptoms are: nausea, vomiting, epigastric pain, tinnitus, headache, metabolic acidosis, decreased blood pressure, acute renal failure, tachycardia, bradycardia, coma. There may be a hepatotoxic effect associated with paracetamol up to hepatonecrosis.

For the treatment of the condition, within an hour after taking Brustan, gastric lavage should be carried out, activated charcoal should be given, the patient should be provided with an abundant alkaline drink, forced diuresis, SH-group donors and glutathione synthesis precursors methionine and N-acetylcysteine should be introduced. The need for additional therapeutic measures should be determined depending on the concentration of paracetamol in the blood and on the time that has elapsed since its administration. It is also recommended to carry out symptomatic treatment in the complex.

The likelihood of an overdose is extremely small and occurs very rarely, but if this happens, you should immediately consult a doctor.

special instructions

Treatment is carried out with the lowest effective dose as soon as possible.

During therapy, it is necessary to monitor the peripheral blood picture and the functional state of the liver and kidneys.

At the first signs of gastropathy, observation of the patient is required with a thorough examination, including esophagogastroduodenoscopy, a blood test for hemoglobin and hematocrit, an analysis for occult blood contained in the feces. In order to prevent the development of NSAID gastropathy, Brustan is recommended to be combined with prostaglandin E preparations, for example, misoprostol.

The simultaneous administration of Brustan with indirect anticoagulants requires monitoring of the blood coagulation system.

During therapy, it is necessary to refrain from taking alcohol (ethanol) and performing types of work that require an increased concentration of attention and speed of psychomotor reaction.

Before using Brustan in childhood, consultation with a pediatrician is mandatory, especially if the child has:

• bronchial asthma, urticaria;
• chronic heart failure;
• liver / kidney pathology;
• history of peptic ulcer disease, gastritis, ulcerative colitis, gastrointestinal bleeding;
• a course of therapy with other pain relievers;
• taking indirect anticoagulants (drugs for oral administration that reduce blood clotting), drugs to lower blood pressure, diuretics (drugs to increase urination), lithium drugs, methotrexate.

Influence on the ability to drive vehicles and complex mechanisms

Brustan can cause central nervous system side effects that can affect the speed of reactions and the ability to concentrate (for example, dizziness). In this regard, during the period of treatment, it is recommended to refrain from performing potentially dangerous types of work, including driving a car and controlling complex mechanisms.

Application during pregnancy and lactation

In experimental studies, the mutagenic, teratogenic and embryotoxic effects of the drug components have not been established. Nevertheless, Brustan is prohibited from admission in the third trimester of pregnancy, in the first and second trimesters and during breastfeeding, it can be used strictly according to the doctor's prescription, under his supervision.

Childhood use

Brustan tablets are contraindicated in children under 12 years of age, suspension - up to 2 years.

With impaired renal function

It is contraindicated to take Brustan in patients with severe renal insufficiency (creatinine clearance less than 30 ml / min), as well as in the case of progressive kidney disease.

In renal failure with creatinine clearance of 30 to 60 ml / min Brustan must be taken with caution.

For violations of liver function

It is contraindicated to take Brustan in patients with severe hepatic insufficiency, as well as in the presence of active liver diseases.

With mild to moderate liver failure, as well as with liver cirrhosis with portal hypertension, Brustan must be taken with caution.

Use in the elderly

Elderly patients should be treated with caution.

Drug interactions

• barbiturates, rifampicin, phenytoin, phenylbutazone, ethanol, tricyclic antidepressants (inducers of microsomal oxidation): increase the production of hydroxylated active metabolites, increasing the risk of developing severe hepatotoxic reactions;
• inhibitors of microsomal oxidation: reduce the risk of hepatotoxicity;
• vasodilators, including slow calcium channel blockers and angiotensin-converting enzyme (ACE) inhibitors: their hypotensive activity decreases;
• furosemide and hydrochlorothiazide, uricosuric drugs: a decrease in natriuretic, diuretic and uricosuric efficacy is possible;
• indirect anticoagulants, antiplatelet agents, fibrinolytics: their effect is enhanced, increasing the risk of hemorrhagic complications;
• glucocorticosteroids, colchicine, estrogens, ethanol: the ulcerogenic effect is enhanced, concomitant bleeding is possible;
• oral hypoglycemic drugs and insulin: their effect is enhanced;
• antacids and cholestyramine: reduce the absorption of ibuprofen;
• digoxin, lithium preparations and methotrexate: their concentration in the blood increases;
• caffeine: enhances the analgesic effect of the drug;
• acetylsalicylic acid (ASA): ibuprofen inhibits its antiplatelet and anti-inflammatory effects; in patients receiving low doses of ASA as an antiplatelet drug, it is possible to increase the incidence of acute coronary insufficiency after the start of taking Brustan;
• anticoagulants and thrombolytic drugs (streptokinase, alteplase, sertraline, urokinase), serotonin reuptake inhibitors (citalopram, paroxetine, fluoxetine): the risk of serious gastrointestinal bleeding increases;
• cefoperazone, cefotetan, cefamandol, plikamycin, valproic acid: increase the incidence of hypoprothrombinemia;
• myelotoxic drugs: increase the hematotoxicity of Brustan;
• cyclosporine and gold preparations: increase the effect of ibuprofen on the formation of prostaglandins in the kidneys (this is expressed by an increase in nephrotoxicity), ibuprofen, in turn, increases the plasma concentration of cyclosporine and the likelihood of developing its hepatotoxicity;
• tubular secretion blockers: increase the plasma concentration of ibuprofen, inhibiting its excretion from the body.

Analogs

Brustan's analogs are: Next, Bolaren, Ibuklin, Nurofen, Gripomed, Novalgin, Payremol, Tilofen, Lugakold, Parafeks, etc.

Terms and conditions of storage

Store out of reach of children, at a temperature not exceeding 25 ° C; tablets - protect from moisture and light, suspension - do not freeze.

Shelf life: tablets - 3 years, suspension - 2 years.

Terms of dispensing from pharmacies

Available without a prescription.

Reviews about Brustan

Reviews about Brustan are mostly positive. Patients describe it as an effective and fast acting antipyretic, anti-inflammatory and analgesic agent. The disadvantages include a large list of contraindications and possible side effects, as well as a relatively high cost, but many consider it justified.

Price for Brustan in pharmacies

The approximate price of Brustan in the form of film-coated tablets is 126-158 rubles. per pack of 10 The cost of the suspension is currently unknown.

Brustan: prices in online pharmacies

Drug name Price Pharmacy

Brustan 400 mg + 325 mg film-coated tablets 10 pcs. RUB 100 Buy

Brustan tablets p.p. 725mg 10 pcs. 124 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes and does not replace the official instructions. Self-medication is hazardous to health!