Pancef^® (Tablets, Granules) Instructions for Use

ATC Code

J01DD08 (Cefixime)

Active Substance

Cefixime (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Third generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A broad-spectrum semi-synthetic third-generation cephalosporin antibiotic for oral administration. It acts bactericidally. The mechanism of action is due to the inhibition of the synthesis of the pathogen’s cell membrane. Cefixime is resistant to the action of beta-lactamases produced by most gram-positive and gram-negative bacteria.

In vitro, Cefixime is active against gram-positive bacteria Streptococcus agalactiae; gram-negative bacteria Haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, Klebsiella oxytoca, Pasteurella multocida, Providencia spp., Salmonella spp., Shigella spp., Citrobacter amalonaticus, Citrobacter diversus, Serratia marcescens.

In vitro and in clinical practice, Cefixime is active against gram-positive bacteria Streptococcus pneumoniae, Streptococcus pyogenes; gram-negative bacteria Haemophilus influenzae, Moraxella (Branhamella) catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae.

The following are resistant to cefixime: Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes, most Staphylococcus spp. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.

Pharmacokinetics

When taken orally, the bioavailability of cefixime is 40-50%, regardless of food intake; however, the C_max of cefixime in serum is reached 0.8 hours faster when the drug is taken with food. Plasma protein binding, mainly with albumin, is 65%. About 50% of the dose is excreted in the urine unchanged within 24 hours, about 10% of the dose is excreted in the bile.

The T_1/2 is dose-dependent and is 3-4 hours. In patients with impaired renal function with a CC of 20 to 40 ml/min, T_1/2 increases to 6.4 hours, with a CC of 5-10 ml/min – to 11.5 hours.

Indications

Infectious and inflammatory diseases caused by susceptible microorganisms: pharyngitis, tonsillitis, sinusitis, acute and chronic bronchitis, otitis media, uncomplicated urinary tract infections, uncomplicated gonorrhea.

ICD codes

Dosage Regimen

Tablets, Granules

For adults and children over 12 years of age weighing more than 50 kg, the daily dose is 400 mg (once a day or 200 mg twice a day). The duration of the treatment course is 7-10 days. For uncomplicated gonorrhea – 400 mg as a single dose.

For children under 12 years of age – 8 mg/kg of body weight once a day or 4 mg/kg every 12 hours.

For infections caused by Streptococcus pyogenes, the course of treatment should be at least 10 days.

In case of impaired renal function (with CC from 21 to 60 ml/min) or in patients on hemodialysis, the daily dose should be reduced by 25%.

With CC≤20 ml/min or in patients on peritoneal dialysis, the daily dose should be reduced by half.

Adverse Reactions

From the digestive system: dry mouth, anorexia, diarrhea, nausea, vomiting, abdominal pain, flatulence, transient increase in the activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, jaundice, gastrointestinal candidiasis, dysbacteriosis; rarely – stomatitis, glossitis, pseudomembranous enterocolitis.

From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, hemolytic anemia.

From the central nervous system: dizziness, headache.

From the urinary system: interstitial nephritis.

Allergic reactions: skin itching, urticaria, skin hyperemia, eosinophilia, fever.

Contraindications

Hypersensitivity to cephalosporins and penicillins.

Use in Pregnancy and Lactation

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

If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

In case of impaired renal function (with CC from 21 to 60 ml/min) or in patients on hemodialysis, the daily dose should be reduced by 25%. With CC≤20 ml/min, the daily dose should be reduced by half.

Pediatric Use

Should be used with caution in children under 6 months of age.

Geriatric Use

Should be used with caution in elderly patients.

Special Precautions

Should be used with caution in elderly patients, patients with chronic renal failure or a history of pseudomembranous colitis, and in children under 6 months of age.

With prolonged use, disruption of the normal intestinal microflora is possible, which can lead to the growth of Clostridium difficile and cause the development of severe diarrhea and pseudomembranous colitis.

In patients with a history of allergic reactions to penicillins, manifestations of hypersensitivity to cephalosporin antibiotics are possible.

During treatment, a positive direct Coombs test and a false-positive urine glucose reaction are possible.

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.