Cetyl Lupin (Tablets) Instructions for Use

ATC Code

J01DC02 (Cefuroxime)

Active Substance

Cefuroxime (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Second generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A second-generation cephalosporin antibiotic for parenteral use. It acts bactericidally (disrupts the synthesis of the bacterial cell wall by binding to the main target proteins). It is active against a wide range of pathogens, including beta-lactamase-producing strains.

It is highly active against gram-positive microorganisms, including strains resistant to penicillins (except for methicillin-resistant strains): Staphylococcus aureus, Streptococcus pyogenes, beta-hemolytic streptococci, Streptococcus pneumoniae, Group B streptococci (Streptococcus agalactiae), Streptococcus mitis (viridans group), most Clostridium spp. (except Clostridium difficile); gram-negative microorganisms: Escherichia coli, Klebsiella spp., Proteus mirabilis, Providencia spp., Proteus rettgeri, Haemophilus influenzae, including strains resistant to ampicillin; Haemophilus parainfluenzae, including strains resistant to ampicillin; Moraxella catarrhalis, Neisseria gonorrhoeae, including penicillinase-producing and non-producing strains, Neisseria meningitidis, Salmonella spp., Borrelia burgdorferi; gram-positive and gram-negative anaerobes Peptococcus spp., Peptostreptococcus spp., Fusobacterium spp., Propionibacterium spp.

Not susceptible to cefuroxime: Clostridium difficile, Pseudomonas spp., Campylobacter spp., Acinetobacter calcoaceticus, Listeria monocytogenes, methicillin-resistant strains of Staphylococcus aureus, Staphylococcus epidermidis, Legionella spp., Streptococcus (Enterococcus) faecalis, Morganella morganii, Proteus vulgaris, Enterobacter spp., Citrobacter spp., Serratia spp., Bacteroides fragilis.

Pharmacokinetics

Cefuroxime is rapidly absorbed from the gastrointestinal tract, with optimal absorption achieved when taken with food. C_max in serum (4.1 mg/L for a 250 mg dose, 7.0 mg/L for a 500 mg dose) is observed approximately 2-3 hours after administration with food.

Plasma protein binding is 33-50% (depending on the determination method).

Cefuroxime is not metabolized.

T_1/2 is 1-1.5 hours. It is eliminated from the body by glomerular filtration and tubular secretion, unchanged in the urine. With simultaneous administration of probenecid, AUC increases by 50%.

The T_1/2 of cefuroxime increases with impaired renal function.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to cefuroxime: upper respiratory tract infections, ENT organ infections (sinusitis, tonsillitis, pharyngitis, otitis media); lower respiratory tract infections (acute bacterial bronchitis and exacerbation of chronic bronchitis, pneumonia); urinary tract infections (pyelonephritis, cystitis, urethritis); skin and soft tissue infections (furunculosis, pyoderma, impetigo); gonorrhea, acute uncomplicated gonococcal urethritis and cervicitis; treatment of early-stage Lyme disease (borreliosis) and prevention of late stages of this disease in adults and children from 3 months of age (in appropriate dosage forms).

The sensitivity of bacteria to cefuroxime varies by region and over time. Where possible, local susceptibility data should be taken into account.

ICD codes

Dosage Regimen

Tablets

The dosage regimen and duration of therapy are set individually depending on the indications, clinical situation, and age.

For optimal absorption, Cefuroxime should be taken with food.

For adults with most infections, the recommended dose is 250 mg twice a day; for severe infections – 500 mg twice a day (for uncomplicated gonorrhea, 1 g as a single dose).

The standard course of therapy is about 7 days (from 5 to 10 days); for borreliosis, the course duration is from 10 to 21 days.

It is recommended to reduce the dose of cefuroxime in patients with severe renal impairment to compensate for delayed excretion.

When treating children, the dose is calculated based on body weight and age. For most infections, the dose for children aged 3 months to 12 years (in appropriate dosage forms) is 10 mg/kg twice a day, but not more than 250 mg per day.

For otitis media and more severe infections, the recommended dose is 15 mg/kg twice a day, but not more than 500 mg per day.

Adverse Reactions

Adverse reactions when using cefuroxime are usually mild, short-term, and reversible.

Infectious and parasitic diseases Common – overgrowth of fungi of the genus Candida.

From the hematopoietic system Common – eosinophilia; Uncommon – positive Coombs test, thrombocytopenia, leukopenia (sometimes severe); Very rare – hemolytic anemia.

Cephalosporins are absorbed on the surface of red blood cell membranes, binding to antibodies to cephalosporins, which leads to a positive Coombs test result (which may affect cross-matching) and in very rare cases – to hemolytic anemia.

From the immune system: hypersensitivity reactions, including Uncommon – skin rash; Rare – urticaria, itching; Very rare – drug fever, serum sickness, and anaphylaxis.

From the nervous system Common – headache, dizziness.

From the digestive system Common – gastrointestinal disorders, including diarrhea, nausea, abdominal pain; Uncommon – vomiting; Rare – pseudomembranous colitis.

From the liver and biliary tract: Common – transient increase in liver enzyme activity; Very rare – jaundice (mainly cholestatic), hepatitis.

From the skin and subcutaneous tissues Very rare – erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (exanthematous necrolysis).

Contraindications

Hypersensitivity to cefuroxime, other cephalosporin antibiotics, and other excipients; history of severe hypersensitivity reactions (including anaphylactic reactions) to other beta-lactam antibiotics (penicillins, monobactams, and carbapenems); children under 3 months of age.

Caution should be exercised when prescribing to patients with a history of non-severe allergic reactions to penicillins, monobactams, and carbapenems; impaired renal function; gastrointestinal diseases (including history, as well as ulcerative colitis); in pregnant women and during breastfeeding.

Use in Pregnancy and Lactation

During pregnancy, Cefuroxime should be used only if the expected benefit to the mother outweighs the potential risk to the fetus.

There is no experimental evidence of embryopathic and teratogenic effects of cefuroxime, but, as with the use of other drugs, it should be prescribed with caution in the first months of pregnancy.

Cefuroxime is excreted in breast milk, so caution should be exercised when prescribing it to nursing women.

Use in Renal Impairment

Caution should be exercised when prescribing to patients with impaired renal function.

Pediatric Use

Can be used in children from 3 months of age in appropriate dosage forms according to indications, in recommended doses and regimens.

Special Precautions

Caution should be exercised when using in patients with a history of non-severe allergic reactions to penicillins, monobactams, and carbapenems, since the possible risk of developing cross-hypersensitivity reactions should be taken into account.

Before starting treatment, a detailed history should be taken regarding previous hypersensitivity reactions to penicillins, cephalosporins, or other substances causing allergic reactions in the patient. If an allergic reaction occurs, treatment with cefuroxime should be discontinued and appropriate alternative therapy initiated. In case of serious anaphylactic reactions, epinephrine should be administered to the patient immediately. Oxygen therapy, intravenous corticosteroids, and airway management, including intubation, may also be required.

During treatment, renal function should be monitored, especially in patients receiving Cefuroxime in high doses.

During the administration of cefuroxime, a false-positive urine reaction for glucose is possible.

Taking cefuroxime may lead to overgrowth of fungi of the genus Candida; long-term use may cause the growth of other resistant microorganisms (e.g., enterococci and Clostridium difficile), which may require discontinuation of treatment.

Cases of pseudomembranous colitis have been described with antibiotic use, the severity of which can range from mild to life-threatening. Therefore, it is necessary to conduct a differential diagnosis of pseudomembranous colitis in patients with diarrhea that occurred during or after a course of antibiotic treatment. If the diarrhea is prolonged or severe, or the patient experiences abdominal cramps, treatment with cefuroxime should be discontinued immediately and the patient should be examined.

When treating Lyme disease with cefuroxime, a Jarisch-Herxheimer reaction may occur, which is due to the bactericidal activity of the drug against the causative spirochete Borrelia burgdorferi. Patients should be informed that these symptoms are a typical consequence of antibiotic use for this disease and resolve spontaneously.

Effect on ability to drive vehicles and operate machinery

Since taking cefuroxime may cause dizziness, patients should be cautioned about precautions when driving vehicles or operating machinery.

Drug Interactions

Drugs that reduce gastric acidity may cause a decrease in the bioavailability of cefuroxime compared to that observed after taking the drug on an empty stomach, and also negate the effect of increased absorption after food intake.

Cefuroxime may affect the intestinal flora, leading to reduced reabsorption of estrogens and, accordingly, to reduced effectiveness of combined oral contraceptives.

A false-negative result may be observed when performing the ferrocyanide test, so it is recommended to use the glucose oxidase or hexokinase method to determine blood and/or plasma glucose levels.

Cefuroxime does not affect the results of determining creatinine concentration by the alkaline picrate method.

Concomitant administration with “loop” diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration, and increases the T_1/2 of cefuroxime.

When taken concomitantly with aminoglycosides and diuretics, the risk of nephrotoxic effects increases.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.