Lyforan (Powder) Instructions for Use

Marketing Authorization Holder

Lyka Labs, Ltd. (India)

ATC Code

J01DD01 (Cefotaxime)

Active Substance

Cefotaxime (Rec.INN registered by WHO)

Dosage Forms

	Lyforan	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 from almost white to pale yellow.

Glass vials with a volume of 7.5 ml (1) – cardboard packs.

Powder for preparation of solution for injections from almost white to pale yellow.

Glass vials with a volume of 7.5 ml (1) – cardboard packs.

Powder for preparation of solution for injections from almost white to pale yellow.

Glass vials with a volume of 10 ml (1) – cardboard boxes.

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

Semi-synthetic antibiotic of the cephalosporin group of the third generation for parenteral use.

It acts bactericidally. It has a broad spectrum of action. It is resistant to the action of most beta-lactamases.

Highly active againstgram-negative microorganisms resistant to other antibiotics: Escherichia coli, Citrobacter diversus, Proteus mirabilis, Proteus indole, Providencia spp., Klebsiella spp., Serratia spp., some strains of Pseudomonas spp., Haemophilus influenzae. Less active against gram-positive cocci, mainly staphylococci.

Pharmacokinetics

Absorption

After intramuscular administration, it is rapidly absorbed. C_max of cefotaxime in plasma is reached 0.5 hours after injection. The bactericidal concentration in the blood persists for more than 12 hours.

Distribution

Cefotaxime penetrates well into tissues and body fluids; it is found in effective concentrations in pleural, peritoneal, and synovial fluids. It penetrates the blood-brain barrier.

Metabolism and Excretion

Cefotaxime is biotransformed in the body to form an active metabolite.

It is excreted in the urine: 30% unchanged and about 20% as a metabolite. Partially excreted in the bile.

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug

• Respiratory tract infections;
• Urinary tract infections, kidney infections;
• ENT organ infections;
• Septicemia;
• Endocarditis;
• Meningitis;
• Skin and soft tissue infections;
• Bone and joint infections;
• Intra-abdominal infections (including peritonitis);
• Gynecological infections, gonorrhea;
• Wound and burn infections.

ICD codes

Dosage Regimen

The drug is administered intramuscularly (deeply), intravenously as a bolus (slowly over 3-5 minutes) or intravenously as a drip (over 50-60 minutes).

For adults and children over 12 years old, the drug is prescribed at a dose of 1 g every 12 hours. For severe infections, the dose is increased to 3-4 g/day (1 g 3-4 times/day). The maximum daily dose is 12 g.

For children under 12 years old (including newborns), the drug is prescribed at a dose of 50-100 mg/kg of body weight/day with intervals between administrations from 6 to 12 hours. For premature infants, the daily dose should not exceed 50 mg/kg of body weight.

In case of severe renal impairment (CrCl ≤ 10 ml/min), the daily dose of the drug should be reduced by half.

Rules for preparation of injection solutions

To prepare a solution for intramuscular injection, dissolve 250 mg or 500 mg of the drug in 2 ml (respectively 1 g in 4 ml) of sterile water for injections. A 1% lidocaine solution can also be used as a solvent for intramuscular injection.

For intravenous bolus injection, 500 mg – 1 g of cefotaxime is dissolved in 4 ml (2 g in 10 ml) of sterile water for injections.

For intravenous drip infusion, dissolve 2 g of the drug in 100 ml of 0.9% sodium chloride solution or 5% dextrose solution.

Adverse Reactions

Allergic reactions skin rash, fever, anaphylactic shock.

From the digestive system dyspepsia, impaired liver function tests, increased ALP level; rarely – pseudomembranous colitis.

From the hematopoietic system eosinophilia, leukopenia, neutropenia, agranulocytosis, hemolytic anemia.

Other increased urine nitrogen content, increased body temperature.

Local reactions pain, hyperemia, swelling at the injection site.

Contraindications

• Children under 2.5 years of age (for intramuscular administration);
• Hypersensitivity to cephalosporins.

The drug should be prescribed with caution in case of impaired liver and kidney function.

Use in Pregnancy and Lactation

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

Cefotaxime is excreted in breast milk, so if it is necessary to use Lyforan during lactation, breastfeeding should be discontinued.

Use in Hepatic Impairment

The drug should be prescribed with caution in case of impaired liver function.

Use in Renal Impairment

The drug should be prescribed with caution in case of impaired kidney function. In case of severe renal impairment (CrCl ≤ 10 ml/min), the daily dose of the drug should be reduced by half.

Special Precautions

Before prescribing Lyforan, it is necessary to collect an allergic history, especially regarding indications of allergic reactions to beta-lactam antibiotics. Cross-allergy between penicillins and cephalosporins is known. In patients with a history of allergic reactions to penicillin, the drug should be used with extreme caution.

If hypersensitivity reactions occur (which can be severe and even fatal), the drug should be discontinued.

If the duration of treatment with the drug exceeds 10 days, it is necessary to monitor the peripheral blood picture.

With simultaneous use of Lyforan and potentially nephrotoxic drugs (aminoglycoside antibiotics, diuretics), it is necessary to monitor kidney function (due to the risk of nephrotoxic action).

During treatment, a false-positive Coombs test may appear.

False-positive results may occur when determining the level of glucose in the urine by non-enzymatic methods (for example, the Benedict method).

Overdose

Data on cases of Lyforan drug overdose have not been provided.

Drug Interactions

With simultaneous use, Lyforan may potentiate the toxic effect of drugs that have a nephrotoxic effect.

Pharmaceutical interaction

Lyforan solution is incompatible with solutions of other antibiotics in the same syringe or dropper.

Storage Conditions

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

Shelf Life

Shelf life – 3 years.

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.