Brufica Plus
Brufica Plus: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Brufica Plus
ATX code: M01AE51
Active ingredient: ibuprofen (Ibuprofen), paracetamol (Paracetamol)
Manufacturer: Highlans Laboratories Pvt. Ltd. (Higlance Laboratories Pvt. Ltd.) (India)
Description and photo update: 2019-05-07
Prices in pharmacies: from 278 rubles.
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Brufica Plus is a combined analgesic and antipyretic agent for children.
Release form and composition
Dosage form - suspension for oral administration: viscous consistency, from light orange to orange color liquid, with a characteristic odor and fruit taste (60 and 100 ml each in dark glass or polyethylene bottles, equipped with a lid with a first opening control, or a first opening control + child protection system; 1 bottle in a cardboard box complete with a measuring spoon, a syringe dispenser and instructions for the use of Brufica Plus).
Composition of 5 ml suspension:
- active substances: paracetamol - 162.5 mg; ibuprofen - 100 mg;
- auxiliary components: sodium carmellose, propyl parahydroxybenzoate, methyl parahydroxybenzoate, sucrose, sorbitol, aspartame, sodium benzoate, magnesium aluminosilicate, polysorbate 80, sodium citrate, citric acid monohydrate, glycerol, purified water, pineapple flavor, sun orange flavor, dye.
Pharmacological properties
Pharmacodynamics
Brufica Plus is a combined preparation with analgesic, antipyretic and anti-inflammatory effects.
The mechanism of action is explained by the ability of the active substances of the drug to inhibit the biosynthesis of prostaglandins - mediators of pain and inflammation.
The effect of the combination of ibuprofen with paracetamol is higher than when these active components of the drug are used separately.
Pharmacokinetics
Paracetamol:
- absorption: the substance is well absorbed in the gastrointestinal tract. The maximum plasma concentration reaches within 0.5–2 hours;
- distribution: 15% of the dose binds to plasma proteins, paracetamol penetrates the blood-brain barrier;
- metabolism: 90–95% of the dose received undergoes biotransformation in the liver, of which about 80% enters into conjugation reactions with sulfates and glucuronic acid, resulting in the formation of inactive metabolites; about 17% of the dose is hydroxylated, resulting in the formation of eight active metabolites, which are further conjugated with glutathione, resulting in the formation of pharmacologically inactive metabolites. If there is not enough glutathione in the body, then active metabolites are able to block the enzyme systems of hepatocytes and, as a result, cause their necrosis. In addition, the CYP2E1 isoenzyme is also involved in the metabolism of paracetamol;
- excretion: the drug is excreted by the kidneys in the form of metabolites, mainly in the form of conjugates, no more than 5% of paracetamol is excreted unchanged. The half-life of metabolites is 1–4 hours, the half-life of the unchanged substance is 4–5 hours.
Ibuprofen:
- absorption: after oral administration it is well absorbed, the maximum concentration reaches within 1-2 hours;
- distribution: up to 90% of the substance binds to plasma proteins, slowly penetrates into the joint cavity, as well as into the synovial tissue, where it lingers and creates more concentrations than in plasma;
- metabolism: ibuprofen is metabolized in the liver; about 60% of the pharmacologically inactive R-form slowly converts to the active S-form;
- excretion: excreted mainly by the kidneys in the form of metabolites (unchanged - less than 1%), to a lesser extent - with bile; the half-life is 2 hours.
Indications for use
The drug is used symptomatically - to reduce pain and inflammation, it has no effect on the progression of the disease.
Indications for the use of Brufica Plus are:
- increased body temperature in the following cases: post-vaccination reactions, childhood infectious diseases, influenza, acute respiratory and other infectious and inflammatory diseases;
- mild to moderate pain syndrome: migraine, headache and toothache, muscle pain (including with sprains), pain with injuries and burns, sore throat and ears, neuralgia, and other types of pain.
Contraindications
Absolute:
- active liver disease or severe liver failure;
- severe renal failure with creatinine clearance (CC) less than 30 ml / min;
- blood coagulation disorders (including hemophilia and hemorrhagic diathesis);
- confirmed hyperkalemia;
- condition after coronary artery bypass grafting;
- decompensated cardiovascular failure;
- cerebrovascular or other bleeding;
- complete / incomplete combination of bronchial asthma, polyposis rhinosinusitis (recurrent polyposis of the nasal mucosa and paranasal sinuses) with intolerance to acetylsalicylic acid and / or other non-steroidal anti-inflammatory drugs (NSAIDs);
- erosive and ulcerative diseases of the digestive tract (including peptic ulcer of the stomach and duodenum, ulcerative colitis, Crohn's disease); peptic ulcer bleeding in the active phase or in history (two or more confirmed episodes of peptic ulcer or ulcer bleeding);
- a history of bleeding or perforation of gastrointestinal ulcers caused by the use of NSAIDs;
- rare hereditary fructose intolerance;
- III trimester of pregnancy;
- period of breastfeeding;
- children under 2 years old;
- the simultaneous use of other medicines containing paracetamol and / or ibuprofen;
- hypersensitivity to any component of Brufica Plus.
Brufica Plus should be used with caution in case of moderate renal failure (CC 30-60 ml / min), impaired liver function (including Gilbert's syndrome), dehydration, cerebrovascular and severe somatic diseases, bronchial asthma and allergic reactions in the stage exacerbation or history, fluid retention and edema, arterial hypertension and / or heart failure, peripheral arterial disease, diabetes mellitus, dyslipidemia / hyperlipidemia, genetic absence of the enzyme glucose-6-phosphate dehydrogenase, systemic lupus erythematosus and other Shar autoimmune connective tissue diseases (), blood diseases of unknown etiology (leukopenia, anemia, thrombocytopenia), the presence of Helicobacter pylori infection, colitis (including ulcerative colitis), enteritis, gastritis,a history of one episode of gastric ulcer or bleeding ulcers in the gastrointestinal tract, concomitant use of oral glucocorticosteroids (including prednisolone), antiplatelet agents (including acetylsalicylic acid and clopidogrel), anticoagulants (including warfarin), selective serum reuptake inhibitors (including cytalotramone) paroxetine, fluoxetine and sertraline), as well as in the I – II trimester of pregnancy and old age.as well as in the I – II trimester of pregnancy and old age.as well as in the I – II trimester of pregnancy and old age.
Brufica Plus, instructions for use: method and dosage
Suspension Brufic Plus is indicated for oral administration. The drug is taken when symptoms appear (in case of an increase in body temperature or the development of pain).
Shake the bottle thoroughly before taking. For accurate dosing, use the supplied syringe / measuring spoon.
Recommended single doses of Brufica Plus, depending on the child's age and body weight:
- 2-3 years (10-15 kg) - 5 ml;
- 4-6 years (16-21 kg) - 7.5 ml;
- 7-9 years old (22-26 kg) - 10 ml;
- 10-11 years old (27-32 kg) - 12.5 ml;
- 12-14 years old (33-43 kg) - 15 ml.
The maximum frequency of admission is 3 times a day.
To reduce elevated body temperature, use Brufica Plus for no more than 3 days, for relief of pain syndrome - no more than 5 days. If symptoms persist after this period, medical advice is required.
Using vials with a measuring syringe included:
- Shake the bottle well.
- Insert the syringe tightly into the neck of the bottle.
- Collect the suspension to the desired mark by turning the bottle upside down and gently pulling the plunger down.
- Return the bottle to its original position and gently remove the syringe by rotating.
- Place the syringe in the child's oral cavity and smoothly release the suspension by slowly pressing the plunger.
- Rinse the syringe with warm water and dry.
Side effects
Possible side effects of Brufica Plus (by frequency of development are classified as follows: very often - ≥ 1/10, often - from ≥ 1/100 to <1/10, infrequently - from ≥ 1/1000 to <1/100, rarely - from ≥ 1/10 000 to <1/1000, very rarely - <1/10 000, frequency unknown - data not available):
- from the immune system: infrequently - hypersensitivity, including nonspecific allergic and anaphylactic reactions, eosinophilia, allergic rhinitis, skin manifestations (urticaria, pruritus, angioedema, purpura, exfoliative and bullous dermatoses, such as Stevens-Johnson syndrome, syndrome Lyell, toxic epidermal necrolysis, erythema multiforme), reactions from the respiratory tract (shortness of breath, bronchospasm, dyspnea, bronchial asthma or its exacerbation); very rarely - severe hypersensitivity reactions, including swelling of the tongue, larynx and face, shortness of breath, tachycardia, arterial hypotension (Quincke's edema, anaphylaxis, severe anaphylactic shock);
- on the part of the blood and lymphatic system: very rarely - hematopoietic disorders, such as anemia, hemolytic anemia, aplastic anemia, pancytopenia, thrombocytopenia, leukopenia and agranulocytosis. Their first signs are sore throat, flu-like symptoms, fever, severe weakness, superficial oral ulcers, subcutaneous hemorrhages, nosebleeds, bruising and bleeding of unknown etiology;
- on the part of the kidneys and urinary tract: very rarely - papillary necrosis, compensated and decompensated acute renal failure (especially with prolonged use of Brufica Plus, in combination with the appearance of edema and an increase in the concentration of urea in the blood plasma);
- from the hepatobiliary system: very rarely - liver dysfunction;
- from the gastrointestinal tract: infrequently - abdominal pain, dyspepsia, nausea; rarely - vomiting, flatulence, diarrhea, constipation; very rarely - ulcerative stomatitis, bloody vomiting, melena, peptic ulcer, gastritis, perforation or gastrointestinal bleeding; frequency unknown - exacerbation of ulcerative colitis and Crohn's disease;
- on the part of the cardiovascular system: the frequency is unknown - peripheral edema, increased blood pressure, heart failure; with prolonged use - the risk of thrombotic complications (for example, myocardial infarction, stroke);
- from the nervous system: infrequently - headache; very rarely in patients with autoimmune diseases - aseptic meningitis;
- from the respiratory system and mediastinal organs: frequency unknown - shortness of breath, bronchospasm, bronchial asthma;
- laboratory indicators: a decrease in hematocrit, hemoglobin, creatinine clearance and glucose concentration in blood plasma, an increase in plasma creatinine concentration and hepatic transaminase activity, an increase in bleeding time;
- others: very rarely - edema, including peripheral.
Overdose
Symptoms: abdominal pain, nausea, vomiting, headache, tinnitus, metabolic acidosis, decreased blood pressure, tachycardia, bradycardia, acute renal failure, coma. Possible manifestations of a hepatotoxic effect with the development of hepatonecrosis associated with paracetamol.
In case of taking an excessive dose of Brufica Plus, gastric lavage should be performed, if no more than an hour has passed, then activated charcoal should be taken. As therapeutic measures, alkaline drinking, the introduction of SH-group donors, and precursors of the synthesis of glutathione-methionine and N-acetylcysteine, forced diuresis and symptomatic therapy are indicated. The need for additional therapeutic measures (intravenous administration of N-acetylcysteine, further administration of methionine) is determined depending on the concentration of paracetamol in the blood and the time elapsed since its administration.
Overdose cases are extremely rare, however, if the recommended dose is exceeded, it is recommended to immediately consult a doctor.
special instructions
The likelihood of developing adverse reactions can be minimized if you take Brufica Plus in the smallest effective dose in the minimum possible course.
With long-term treatment, the peripheral blood picture, the functional state of the kidneys and liver should be monitored.
In the event of symptoms of gastropathy, a thorough examination of the patient is required, including a fecal occult blood test, a complete blood count (determination of hemoglobin), and esophagogastroduodenoscopy.
Even with a slight excess of the recommended dose, the risk of severe liver damage increases in patients with glutathione deficiency, developing as a result of starvation, exhaustion, eating disorders, HIV infection, cystic fibrosis (cystic fibrosis).
Brufica Plus can cause fluid retention, edema and increased blood pressure, therefore it should be used with caution in patients with hypertension (current or history) and / or chronic heart failure.
If it is necessary to conduct an analysis to determine the level of sugar or uric acid in the blood, the patient should warn the doctor about taking the drug.
If it becomes necessary to determine 17-ketosteroids, Brufica Plus should be canceled 48 hours before the study.
You should not use ethanol (including ethanol-containing drugs) during the treatment period.
Influence on the ability to drive vehicles and complex mechanisms
If drowsiness, dizziness, lethargy or visual impairment develop, it is recommended to refrain from performing activities that require speed of reactions or increased attention.
Application during pregnancy and lactation
Brufica Plus is contraindicated in the third trimester of pregnancy. In the I-II trimesters of pregnancy and lactation, the drug should be used with caution.
Pediatric use
For children under 2 years of age, the appointment of Brufica Plus is contraindicated.
With impaired renal function
- severe renal failure (CC <30 ml / min): use of Brufica Plus is contraindicated;
- renal failure (CC 30-60 ml / min), including dehydration: treatment can be carried out only after consulting a doctor, under his close supervision.
For violations of liver function
- active liver disease, severe hepatic failure: use of Brufica Plus is contraindicated;
- liver dysfunction, including Gilbert's syndrome: treatment can be carried out only after consulting a doctor, under his close supervision.
Use in the elderly
Elderly patients during the treatment period should be under close medical supervision.
Drug interactions
- glucocorticosteroids: the risk of ulceration and gastrointestinal bleeding increases;
- diuretics and antihypertensive drugs, such as angiotensin-converting enzyme (ACE) inhibitors and angiotensin II antagonists: their effectiveness may decrease, Brufica Plus's nephrotoxicity increases;
- methotrexate: there is a risk of an increase in its plasma concentration;
- thrombolytic drugs, anticoagulants (warfarin): their effect may increase;
- cyclosporine: the risk of developing nephrotoxicity increases;
- lithium preparations: an increase in its level in the blood is possible;
- zidovudine: the risk of hematotoxicity increases, cases of hemarthrosis and hematomas are known to develop in HIV-positive patients with hemophilia;
- cardiac glycosides: their concentration in the blood plasma may increase, as a result of which a decrease in the glomerular filtration rate and aggravation of heart failure are possible;
- antiplatelet agents and selective serotonin reuptake inhibitors: there is a possibility of gastrointestinal bleeding;
- quinolone antibiotics: convulsions may occur;
- inhibitors of liver microsomal enzymes: the risk of hepatotoxic action decreases;
- mifepristone: its effectiveness decreases (Brufiq Plus can be taken only after an 8–12 day break);
- metoclopramide, domperidone: the rate of absorption of paracetamol increases;
- cholestyramine: the rate of absorption of paracetamol decreases;
- tacrolimus: increased risk of nephrotoxicity;
- uricosuric drugs: their effectiveness decreases;
- chloramphenicol, chloramphenicol: the time of their excretion increases 5 times, which increases the risk of intoxication;
- barbiturates, diphenin, phenytoin, carbamazepine, primidone and other anticonvulsants, phenylbutazone, butadione, flumecinol, zidovudine, rifampicin, ethanol, St. …
Analogs
The analogues of Brufica Plus are Brustan, Ibuklin, Ibuklin Junior, Next, Nurofen Long, Khairumat, etc.
Terms and conditions of storage
Keep out of the reach of children, in a dry place at a temperature not exceeding 25 ° C. Do not freeze.
Shelf life - 3 years, after the first opening of the bottle - 6 months.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Brufic Plus
The drug appeared on the pharmaceutical market relatively recently, so reviews about Brufik Plus are few, but mostly positive: the drug quickly and effectively reduces fever in case of various colds, infectious and inflammatory diseases, is well tolerated, does not cause side effects.
Price for Brufica Plus in pharmacies
The approximate price for Brufica Plus for 1 bottle of 100 ml is 340 rubles.
Brufica Plus: prices in online pharmacies
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Drug name Price Pharmacy |
|
Brufica Plus for heat and pain for children 100 ml 278 r Buy |
|
Brufica Plus 100 mg + 162.5 mg / 5 ml oral suspension 100 ml 1 pc. 278 r 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 only and does not replace the official instructions. Self-medication is hazardous to health!
