OPTICEF SUSPENSION
OPTICEF GRANULES FOR ORAL SUSPENSION 100 mg/5 mL per 60 mL (32 g) in a bottle and OPTICEF GRANULES FOR ORAL SUSPENSION 100 mg/5 mL per 100 mL (53 g) in a bottle
Instructions Normative documentsComposition
Active ingredient: cefixime;
Each 5 mL of the preparation contains cefixime 100 mg (as cefixime trihydrate – 111.9 mg);
Excipients: sucrose, xanthan gum, sodium benzoate (E 211), orange flavor.
Dosage form
Granules for oral suspension.
Main physicochemical properties:
Granules: granules ranging from nearly white to light yellow in color;
Suspension: viscous liquid ranging from nearly white to light yellow in color.
Pharmacological group
Systemic antibacterial agents.
Beta-lactam antibiotics. Third-generation cephalosporins. ATC code J01DD08.
Pharmacological properties
Pharmacodynamics:
Cefixime is a third-generation cephalosporin antibiotic for oral administration. It exhibits significant bactericidal activity against a broad spectrum of gram-positive and gram-negative microorganisms in vitro. Clinically effective in treating infections caused by common pathogens, including Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, Proteus mirabilis, Klebsiella species, beta-lactamase-positive and -negative Haemophilus influenzae, beta-lactamase-positive and -negative Branhamella catarrhalis, and Enterobacter species. It maintains high stability in the presence of beta-lactamases.
Most enterococci strains (Streptococcus faecalis, Group D streptococci) and Staphylococci (including coagulase-positive, coagulase-negative, and methicillin-resistant strains) are resistant to cefixime. Additionally, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes, and Clostridia are also resistant to cefixime.
Pharmacokinetics:
Absorption: The absolute bioavailability of cefixime after oral administration ranges from 22% to 54%. Since food intake has minimal effect on absorption, cefixime can be administered regardless of food consumption. Peak serum levels after recommended doses for adults or children range from 1.5 to 3 mcg/mL. With repeated dosing, there may be slight accumulation of cefixime.
Distribution: Cefixime is almost entirely bound to albumin, with an average free fraction of approximately 30%.
Metabolism: Metabolites of cefixime have not been isolated from human serum or urine.
Excretion: Cefixime is primarily excreted unchanged in the urine, predominantly via glomerular filtration. There is no data available regarding the penetration of cefixime into breast milk.
Indications
Infectious-inflammatory diseases caused by microorganisms susceptible to the drug include:
Upper respiratory tract infections (including otitis media) and other upper respiratory tract infections (sinusitis, pharyngitis, bacterial tonsillitis) in cases of known or suspected resistance of the pathogen to other commonly used antibiotics, or in case of risk of treatment ineffectiveness;
Lower respiratory tract infections (including acute bronchitis and exacerbations of chronic bronchitis);
Urinary tract infections (including cystitis, cystourethritis, uncomplicated pyelonephritis).
Clinically effective in treating infections caused by common pathogens, including Streptococcus pneumoniae, Streptococcus pyogenes, E. coli, Proteus mirabilis, Klebsiella species, beta-lactamase-positive and -negative Haemophilus influenzae, beta-lactamase-positive and -negative Branhamella catarrhalis, and Enterobacter species. It maintains high stability in the presence of beta-lactamases.
Most enterococci strains (Streptococcus faecalis, Group D streptococci) and Staphylococci (including coagulase-positive, coagulase-negative, and methicillin-resistant strains) are resistant to cefixime. Additionally, most strains of Pseudomonas, Bacteroides fragilis, Listeria monocytogenes, and Clostridia are also resistant to cefixime.
SIDE EFFECTS
Confirmed hypersensitivity to cephalosporin antibiotics or other components of the drug; hypersensitivity to penicillins; porphyria.