Talcef (Powder) Instructions for Use

Marketing Authorization Holder

Ipca Laboratories Ltd. (India)

ATC Code

J01DD01 (Cefotaxime)

Active Substance

Cefotaxime (Rec.INN registered by WHO)

Dosage Forms

	Talcef	Powder for preparation of solution for injections 1 g: vial 1 pc.
		Powder for preparation of solution for injections 250 mg: vial 1 pc.
		Powder for preparation of solution for injections 500 mg: vial 1 pc.

Dosage Form, Packaging, and Composition

Powder for preparation of solution for injections white or slightly yellow in color.

Vials of colorless glass (1) – cardboard packs.

Powder for preparation of solution for injections white or slightly yellow in color.

Vials of colorless glass (1) – cardboard packs.

Powder for preparation of solution for injections white or slightly yellow in color.

Vials of colorless glass (1) – cardboard packs.

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

Cefotaxime is a broad-spectrum third-generation cephalosporin antibiotic. It exerts a bactericidal effect by inhibiting the synthesis of the bacterial cell wall.

The mechanism of action is due to the acetylation of membrane-bound transpeptidases and the disruption of peptidoglycan cross-linking, 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 organ 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 surgical intervention.

ICD codes

Dosage Regimen

Administer the dosage by intramuscular or intravenous injection (bolus or drip).

For adults and children weighing over 50 kg, administer 1-2 g every 4-12 hours.

For children weighing less than 50 kg, administer 50-180 mg/kg/day in 2-6 divided doses.

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.

For uncomplicated gonorrhea, administer a single 1 g dose intramuscularly.

For severe infections such as sepsis or meningitis, use the higher end of the dosage range.

For surgical prophylaxis, administer a single 1 g dose 30-90 minutes pre-operatively.

Adjust the dosing interval for patients with severe renal impairment.

After reconstitution, use the solution immediately or store as directed; do not use if particulate matter or discoloration is present.

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 the 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 in the first trimester of pregnancy is not recommended.

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 found.

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 are possible.

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 25°C (77°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.