Xorim (Powder) 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

Cephalosporin antibiotic of the second generation. It acts bactericidally (disrupts the synthesis of the bacterial cell wall). It has a broad spectrum of antimicrobial activity.

Active against the following microorganisms

Aerobes, Gram-positive

Staphylococcus spp. (methicillin-susceptible ), including Staphylococcus aureus (methicillin-susceptible ), Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus group B ( Streptococcus agalactiae), Streptococcus mitis (group viridans) (and other beta-hemolytic streptococci ), most Clostridium spp.

Aerobes, Gram-negative

Escherichia coli, Haemophilus influenzae, including strains resistant to ampicillin ; Haemophilus parainfluenzae, including strains resistant to ampicillin ; Klebsiella spp.; Moraxella catarrhalis; Neisseria gonorrhoeae, including penicillinase-producing and non-producing strains ; Proteus mirabilis; Providencia spp. including Providencia rettgeri; Neisseria meningitidis; Salmonella spp.; Borrelia burgdorferi; Bordetella pertussis; Shigellae spp.

Anaerobes

Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp, Fusobacterium spp..

Moderately susceptible microorganisms

Acinetobacter spp., Citrobacter spp., Enterobacter spp., Morganella morganii.

Resistant

Bacteroides fragilis, Clostridium difficile, Enterococcus spp., Listeria monocytogenes, Proteus vulgaris, Pseudomonas spp., Serratia spp., Legionella spp., Staphylococcus spp . (methicillin-resistant); Mycobacterium spp; Acinetobacter calcoaceticus; Campylobacter spp.

Pharmacokinetics

After IM injection of 0.75 g, C_max in plasma of 27 µg/ml is reached after 45 minutes, and 8 hours after administration the drug is present in plasma in detectable concentrations.

After IV administration of 0.75 and 1.5 g, C_max in plasma is reached after 15 minutes and is 50 and 100 µg/ml, respectively. The therapeutic concentration is maintained for 5.3 and 8 hours, respectively.

Cefuroxime is well distributed throughout the organs and tissues of the body; therapeutic concentrations are determined in pleural fluid, sputum, bone tissue, soft tissues, synovial and intraocular fluids.

In meningitis, it penetrates the blood-brain barrier.

About 50% of cefuroxime is bound to plasma proteins. The drug crosses the placenta and passes into breast milk. Cefuroxime is not metabolized.

The plasma half-life is about 70 minutes; in patients with impaired renal function and in newborns, the plasma half-life increases to 2-2.5 hours.

It is excreted by the kidneys through glomerular filtration and tubular secretion. Within 24 hours after parenteral administration, Cefuroxime is almost completely (85-90%) excreted by the kidneys unchanged, with most of the drug excreted within the first 6 hours, and a small amount is excreted with bile.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms, including:

• Infections of the respiratory tract and ENT organs: acute and chronic bronchitis, pneumonia, lung abscess, postoperative infectious diseases of the chest organs, otitis media, sinusitis, tonsillitis and pharyngitis;
• Infections of the urinary tract: acute and chronic pyelonephritis, cystitis and asymptomatic bacteriuria;
• Gonorrhea;
• Infections of the skin and soft tissues: cellulitis, erysipelas, wound infection, pyoderma, impetigo, furunculosis, erysipeloid;
• Infections of bones and joints: osteomyelitis and septic arthritis;
• Pelvic infections;
• Septicemia, meningitis, peritonitis;
• Lyme disease (borreliosis);

Prevention of infections after surgical interventions.

ICD codes

Dosage Regimen

Powder

IM, IV (bolus, drip).

Doses for adults

0.75 g three times a day. In cases of more severe infections, the dose can be increased to 1.5 g three times a day.

If necessary, the interval between injections can be reduced to 6 hours (daily dose from 3 to 6 g).

Treatment is continued for 48-72 hours after the symptoms of the disease disappear.

Doses for children over 3 months

From 30 to 100 mg/kg/day in three to four divided doses. For most infections, a dose of 60 mg/kg/day is used.

Doses for newborns and children under 3 months

30 mg/kg/day in 2-3 divided doses.

Gonorrhea (for adults)

1.5 g as a single dose (two doses of 750 mg IM in different areas, for example, in both gluteal muscles).

Meningitis

Adults: 3 g IV every 8 hours.

Infants and older children: 150-250 mg/kg/day IV in 3-4 divided doses.

Newborns initial dose is 100 mg/kg/day IV in 2-3 divided doses.

Prevention of postoperative complications

During abdominal, orthopedic and pelvic surgeries, the usual dose is 1.5 g IV at induction of anesthesia. Additional administration of two doses of 0.75 g IM after 8 and 16 hours after surgery is possible. For cardiac, pulmonary, esophageal and vascular surgeries, the usual dose is 1.5 g IV at induction of anesthesia, followed by 0.75 g IM three times a day for the next 24-48 hours.

During total joint replacement surgery, before mixing the methyl methacrylate cement polymer with the liquid monomer, 1.5 g of Xorim powder can be added to each of its packages.

Pneumonia

IM or IV. 1.5 g 2-3 times a day, 7-10 days.

Exacerbation of chronic bronchitis

IM or IV, 0.75 g 2-3 times a day, 5-10 days.

Dosage regimen in renal impairment

In patients with creatinine clearance above 20 ml/min, it is not necessary to reduce the standard dose of the drug (750 mg-1.5 g three times a day).

The dosage regimen in children with impaired renal function is adjusted in accordance with the recommendations for adults.

Patients on continuous hemodialysis using an arteriovenous shunt or on high-speed hemofiltration in intensive care units are prescribed 750 mg twice a day; for patients on low-speed hemofiltration, doses recommended for renal impairment are prescribed.

Patients on hemodialysis require an additional dose of 0.75 g of Xorim at the end of each dialysis procedure.

Rules for preparation of solutions

Xorim 0.75 g: for preparation of solution for IM administration

Add 3 ml of Water for Injections to the vial; shake gently to obtain a suspension.

Xorim 1.5 g is not intended for intramuscular administration.

Xorim 0.75 g and 1.5 g: for preparation of solution for IV administration

Add at least 6 ml of solvent (Water for Injections, 0.9% Sodium Chloride solution or 5% Glucose solution) to the 0.75 g vials and at least 15 ml to the 1.5 g vials; shake gently to obtain a clear solution.

Xorim 1.5 g: for preparation of solution for infusion

Add 50 ml of solvent (Water for Injections, 0.9% Sodium Chloride solution or 5% Glucose solution) to the vial; shake gently to obtain a clear solution.

The content and concentrations of Xorim used in the form of a solution are given in the table below.

Adverse Reactions

The frequency of adverse effects is characterized as very common (>10%), common (>1% <10%), infrequent (>0.1% <1%), rare (>0.01% < 0.1%) and very rare (< 0.01%).

From the hematopoietic system: decrease in hemoglobin level, eosinophilia, leukopenia, neutropenia and thrombocytopenia; very rare – hemolytic anemia.

Allergic reactions: chills, skin itching, rash, urticaria; rarely – serum sickness, multiform exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis, drug fever; very rare – bronchospasm, anaphylactic shock, vasculitis.

From the central nervous system: infrequently – headache, dizziness; very rare – agitation, nervousness, confusion, convulsions.

From the digestive system: nausea, vomiting, cramps and abdominal pain, diarrhea, ulceration of the oral mucosa; infrequently – transient increase in the activity of “liver” enzymes (ALT, AST), alkaline phosphatase and LDH, hyperbilirubinemia; rarely – pseudomembranous colitis; very rare – jaundice.

From the urinary system: dysuria, increase in serum creatinine and urea levels, especially in patients with impaired renal function; infrequently – renal impairment, acute interstitial nephritis.

Other: candidiasis, superinfection, hearing loss, perineal itching, vaginitis.

Local reactions: with IM administration – irritation, infiltration and pain at the injection site, with IV administration – phlebitis.

Laboratory parameters: false-positive Coombs test (may affect the results of cross-matching blood tests).

Contraindications

• Hypersensitivity to cefuroxime or other cephalosporins, penicillins, carbapenems.

With caution: chronic renal failure, neonatal period, prematurity, bleeding and gastrointestinal diseases (including history, ulcerative colitis), debilitated and exhausted patients, pregnancy.

Use in Pregnancy and Lactation

The use of the drug during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use the drug during lactation, the issue of discontinuing breastfeeding should be decided.

Use in Renal Impairment

Use with caution in chronic renal failure.

Pediatric Use

With caution: neonatal period, prematurity.

Special Precautions

In patients with a history of allergic reactions to penicillins, hypersensitivity to cephalosporin antibiotics may develop. During treatment, renal function should be monitored, especially in patients receiving the drug in high doses. Treatment is continued for 48-72 hours after the symptoms disappear; in case of infections caused by Streptococcus pyogenes, the course of treatment is at least 7-10 days. When treating patients, the risk of developing pseudomembranous colitis should be taken into account. If colitis develops, the use of the drug should be discontinued and appropriate treatment should be started.

During treatment, a false-positive direct Coombs test and a false-positive urine test for glucose are possible. In patients receiving Cefuroxime, it is recommended to use glucose oxidase or hexokinase tests when determining blood glucose concentration.

Overdose

Symptoms: increased excitability of the cerebral cortex with the development of convulsions.

Treatment symptomatic therapy, hemodialysis or peritoneal dialysis.

Drug Interactions

Concomitant administration of “loop” diuretics slows tubular secretion, reduces renal clearance, increases plasma concentration and increases the half-life of cefuroxime.

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

Pharmaceutically compatible with aqueous solutions containing up to 1% lidocaine hydrochloride, 0.9% sodium chloride solution, 5 and 10% dextrose solution, 0.18% sodium chloride and 4% dextrose solution, 5% dextrose and 0.9% sodium chloride solution, Ringer’s solution, Hartmann’s solution, sodium lactate solution, heparin (10 U/ml and 50 U/ml) in 0.9% sodium chloride solution. Pharmaceutically incompatible with aminoglycosides, sodium bicarbonate solution.

Storage Conditions

List B.

The drug should be stored in a place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

The prepared solution is stored in a place protected from light at a temperature of 2° – 8°C (46.4°F).

Shelf Life

Shelf life – 2 years.

The shelf life of the prepared solution is 24 hours. Do not use the drug after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

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.