Cefutil film-coated tablets 500 mg blister No. 10




Cefutil tablets are intended for the treatment of infections in adults and children over 3 months of age:
Acute streptococcal tonsillitis and pharyngitis; Acute bacterial sinusitis; Acute otitis media; Exacerbation of chronic bronchitis caused by pathogens sensitive to cefuroxime axetil; Cystitis; Pyelonephritis; Uncomplicated skin and soft tissue infections; Early manifestations of Lyme disease.Composition
Active ingredient: cefuroxime;
1 tablet contains cefuroxime (in the form of axetil) 250 mg, 500 mg;
Excipients: microcrystalline cellulose, croscarmellose sodium, sodium starch (type A), sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate, Opadry OY-L white *, FD&C blue dye No. 1 (E 133), polyethylene glycol 6000;
* - composition of Opadry OY-L white: lactose monohydrate, titanium dioxide (E 171), hydroxypropylmethylcellulose; polyethylene glycol.
Contraindication
Hypersensitivity to cephalosporin antibiotics, cefuroxime or to any of the components of the drug; history of severe hypersensitivity reactions (e.g. anaphylactic reactions) to any other type of beta-lactam antibiotics (penicillins, monobactams and carbapenems).Method of application
Antibiotic susceptibility varies by region and may change over time. Local antibiotic susceptibility data should be consulted if necessary.
Usually the duration of treatment is 7 days (can be from 5 to 10 days).
For better absorption, it is recommended to take the drug after meals.
The tablets cannot be broken, so they are not prescribed to patients who cannot swallow them. It is recommended to prescribe the drug in the form of a suspension to children.
Cefuroxime acetyl tablets and cefuroxime acetyl granules for suspension are NOT bioequivalent, therefore these dosage forms are not interchangeable when converted in milligrams.
Cefuroxime is also available as a sodium salt for parenteral use. This allows sequential therapy with a single antibiotic when switching from parenteral to oral administration, if clinically indicated.
Application features
Pregnant women
There are limited data on the use of cefuroxime in pregnant women. Animal studies have not shown any adverse effects of cefuroxime axetil on pregnancy, embryonal and foetal development, parturition or postnatal development. The drug should be administered to pregnant women only if the potential benefit outweighs the potential risk.
Children
There is no experience with the use of cefuroxime axetil in the treatment of children under 3 months of age.
Drivers
Since the drug may cause dizziness, patients should be warned to drive a car and operate other machinery with caution.
Overdose
Overdose of cephalosporins may cause brain irritation and neurological complications, including encephalopathy, convulsions, and coma. Symptoms of overdose may occur if the dose of the drug has not been appropriately adjusted for patients with impaired renal function.
Serum levels of cefuroxime can be reduced by hemodialysis and peritoneal dialysis.
Side effects
Infections and infestations: common (≥ 1 in 100 and < 1 in 10) - Candida overgrowth.
Blood and lymphatic system disorders: common (≥ 1 in 100 and <1 in 10) - eosinophilia.
Cephalosporins as a class have the property of being absorbed on the surface of the erythrocyte membrane and interacting with antibodies there, which can lead to a positive Coombs test (impact on blood compatibility) and (very rarely) to hemolytic anemia.
Immune system disorders: hypersensitivity reactions.
Nervous system: often (≥ 1 in 100 and <1 in 10) - headache, dizziness.
Gastrointestinal tract: common (≥ 1 in 100 and < 1 in 10) - gastroenterological disorders, including diarrhea, nausea, abdominal pain.
On the part of the liver: sometimes (≥ 1 in 100 and <1 in 10) - transient increase in liver enzymes (ALT, AST, LDH).
Interaction
Concomitant use with probenecid results in a significant reduction in the maximum concentration, area under the serum concentration-time curve and half-life of cefuroxime. Therefore, concomitant use with probenecid is not recommended.
Concomitant use with oral anticoagulants may lead to an increase in the INR (international normalized ratio).
Storage conditions
Store in the original packaging at a temperature not exceeding 30 °C.
Keep out of reach of children.
Shelf life - 3 years.
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