DRUG TITLE

Suprax (Cefixime)

Pharmacological action

Semi-synthetic cephalosporin antibiotic of III generation for oral administration of a broad spectrum of action. It has a bactericidal effect. The mechanism of action is caused by inhibition of synthesis of the pathogen cell membrane. Cefixime is resistant to β-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.

Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes, most Staphylococcus spp. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.

Pharmacokinetics

Bioavailability of cefixime in per oral administration is 40-50 % regardless of meals, however Cmax in serum is reached quicker in 0.8 hour while taking the preparation with meal. Binding to plasma proteins, mainly to albumin, is 65%. About 50% of the dose is excreted unchanged in the urine within 24 hours, about 10% of the dose is excreted with the bile. T1/2 is dose-dependent and is 3-4 hours. In patients with kidney dysfunction with CKR from 20 to 40 ml/min, T1/2 is increased to 6.4 hours, with CKR from 5 to 10 ml/min - to 11.5 hours.

Contraindications to use

Hypersensitivity to cephalosporins and penicillins.

Administration during pregnancy and lactation

Administration during pregnancy is possible only in case when the assumed benefit for a mother exceeds the potential risk for a fetus.

In case of necessity of application during lactation period breast feeding should be discontinued.

Administration in renal impairment

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

Administration in children

Caution should be exercised when using in children under 6 months of age.

Administration in elderly patients

Caution should be exercised when using in elderly patients.

Indications of active substances of the drug Suprax

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

Dosing regimen

The method of use and dosing regimen of a particular drug depend on its form of release and other factors. The optimal dosing regimen is determined by the doctor. It should be strictly adhered to in accordance with the dosage form used for the particular drug indications and the dosing regimen.

For adults and children over 12 years of age with body mass over 50 kg a daily dose is 400 mg (1 time per day or 200 mg 2 times per day). The duration of the treatment course is 7-10 days. In uncomplicated gonorrhea - 400 mg once.

In children under 12 years of age - 8 mg/kg of body weight once daily or 4 mg/kg every 12 hours.

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

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

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