Oritax (Powder) Instructions for Use

ATC Code

J01DD01 (Cefotaxime)

Active Substance

Cefotaxime (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A broad-spectrum third-generation cephalosporin antibiotic. It exerts a bactericidal effect by inhibiting bacterial cell wall synthesis.

The mechanism of action is due to the acetylation of membrane-bound transpeptidases and disruption of the cross-linking of peptidoglycans, which is necessary for providing strength and rigidity to the cell wall.

It is highly active against Gram-negative bacteria (resistant to other antibiotics): Escherichia coli, Citrobacter spp., Proteus mirabilis, Providencia spp., Klebsiella spp., Serratia spp., some strains of Pseudomonas spp., Haemophilus influenzae.

It is less active against Streptococcus spp. (including Streptococcus pneumoniae), Staphylococcus spp., Neisseria meningitidis, Neisseria gonorrhoeae, Bacteroides spp.

It is resistant to the action of most beta-lactamases.

Pharmacokinetics

It is rapidly absorbed from the injection site. Plasma protein binding is 40%.

It is widely distributed in body tissues and fluids. It reaches therapeutic concentrations in the cerebrospinal fluid, especially in meningitis.

It crosses the placental barrier and is excreted in breast milk in low concentrations. It is partially metabolized in the liver.

40-60% of the dose is excreted unchanged in the urine within 24 hours, 20% is excreted as metabolites.

Indications

Severe infectious and inflammatory diseases caused by microorganisms sensitive to cefotaxime, including: peritonitis, sepsis, abdominal infections and pelvic infections, lower respiratory tract infections, urinary tract infections, bone and joint infections, skin and soft tissue infections, infected wounds and burns, gonorrhea, meningitis, Lyme disease.

Prevention of infections after surgery.

ICD codes

Dosage Regimen

Reconstitute the powder with Water for Injection, Sodium Chloride 0.9%, or other compatible diluent according to the manufacturer’s instructions to achieve the required concentration.

For adults and children with body weight over 50 kg, administer 1-2 g every 4 to 12 hours by intramuscular (IM) or intravenous (IV) route (bolus or drip infusion).

For children with body weight less than 50 kg, the dosage is 50-180 mg/kg/day, divided into 2 to 6 equally spaced administrations.

Adjust the dosing interval based on infection severity and pathogen susceptibility. For severe infections, use shorter intervals (e.g., every 4-6 hours). For uncomplicated infections, longer intervals (e.g., every 12 hours) may be sufficient.

For gonorrhea, administer a single 1 g dose intramuscularly.

For surgical prophylaxis, administer a 1 g dose intramuscularly 30-90 minutes before the procedure.

Do not exceed the maximum daily dose of 12 g for adults. Do not exceed the maximum daily dose of 180 mg/kg for children under 50 kg.

In patients with renal impairment, reduce the total daily dose after an initial loading dose. For creatinine clearance less than 20 mL/min, administer half the standard dose at the standard interval.

Administer intramuscular injections deeply into a large muscle mass (e.g., gluteus maximus) to minimize pain. Divide doses exceeding 2 g and administer at different sites.

For intravenous bolus injection, administer slowly over 3-5 minutes. For intermittent infusion, infuse over 20-60 minutes.

Adverse Reactions

From the digestive system: nausea, vomiting, diarrhea, transient increase in liver transaminase activity, cholestatic jaundice, hepatitis, pseudomembranous colitis.

Allergic reactions: skin rash, itching, eosinophilia; rarely – angioedema.

From the hematopoietic system: with prolonged use in high doses, changes in peripheral blood picture are possible (leukopenia, neutropenia, thrombocytopenia, hemolytic anemia).

From the blood coagulation system: hypoprothrombinemia.

From the urinary system: interstitial nephritis.

Effects due to chemotherapeutic action: candidiasis.

Local reactions: phlebitis (with intravenous administration), pain at the injection site (with intramuscular administration).

Contraindications

Hypersensitivity to cefotaxime and other cephalosporins.

Use in Pregnancy and Lactation

The use of cefotaxime is not recommended in the first trimester of pregnancy.

Use in the second and third trimesters of pregnancy and during lactation is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or breastfed infant.

It should be borne in mind that after intravenous administration of cefotaxime at a dose of 1 g, the maximum concentration of the active substance in breast milk after 2-3 hours averages 0.32±0.09 µg/ml. At this concentration, a negative effect on the oropharyngeal flora of the child is possible.

In experimental studies on animals, no teratogenic or embryotoxic effects of cefotaxime were detected.

Use in Renal Impairment

Cefotaxime should be used with caution in renal impairment.

Pediatric Use

Cefotaxime should be used with caution in newborns.

Special Precautions

Cefotaxime should be used with caution in renal impairment, history of colitis, and in newborns.

In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible.

During treatment, a positive direct Coombs test and a false-positive urine glucose reaction may occur.

It should be used with caution concomitantly with “loop” diuretics.

Drug Interactions

Cefotaxime, by suppressing the intestinal flora, inhibits the synthesis of vitamin K. Therefore, with simultaneous use with drugs that reduce platelet aggregation (NSAIDs, salicylates, sulfinpyrazone), the risk of bleeding increases.

For the same reason, with simultaneous use with anticoagulants, an enhancement of the anticoagulant effect is noted.

With simultaneous use with aminoglycosides, polymyxin B, and “loop” diuretics, the risk of kidney damage increases.

With simultaneous use with drugs that reduce tubular secretion, the concentration of cefotaxime in blood plasma increases.

Probenecid slows down the excretion of cefotaxime by reducing its tubular secretion.

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.