Suprax, 100 mg/5 ml 60 ml

Pharmacological action – broad spectrum antibacterial, bactericidal.

Pharmacodynamics

Inhibits the synthesis of the cell membrane of the pathogen. Cefixime is resistant to 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, E. 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

In oral administration the bioavailability of cefixime is 40-50% regardless of meals, but Cmax of cefixime in serum is reached 0.8 hours faster when the drug is taken with food.

When taking the drug in the form of capsules in a dose of 200 mg, Cmax in the serum is reached after 4 hours and is 2 mcg/ml, when taking in a dose of 400 mg – 3.5 mcg/ml. When taking the preparation in suspension form in a dose of 200 mg, Cmax in serum is reached after 4 hours and is 2.8 µg/ml, when taken in a dose of 400 mg – 4.4 µg/ml. Binding with plasma proteins, mainly with albumin, is 65%.

About 50% of the dose is excreted unchanged in the urine within 24 hours, about 10% of the dose is excreted in the bile. T1/2 depends on the dose and is 3-4 hours.

In patients with kidney dysfunction in creatinine Cl 20-40 ml/min T1/2 is increased to 6.4 hours, in creatinine Cl 5-10 ml/min – to 11.5 hours.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

– pharyngitis;

– tonsillitis;

– sinusitis;

– acute and chronic bronchitis;

– otitis media;

– uncomplicated urinary tract infections;

– uncomplicated gonorrhea.

Active ingredient

Composition

5 ml of ready-to-use suspension: – cefixime 100 mg

Excipients:

sodium benzoate,

sucrose,

yellow resin,

strawberry flavoring.

How to take, the dosage

Ingestion. For adults and children over 12 years of age with body weight over 50 kg an average daily dose is 400 mg (once daily or 200 mg twice daily). The average duration of the course of treatment is 7-10 days.

In uncomplicated gonorrhea it is 400 mg once daily.

In children under 12 years of age it is prescribed as a suspension in a dose of 8 mg/kg once or in 2 doses (4 mg/kg every 12 hours). For children aged 6 months to 1 year the daily dose of suspension is 2.5-4 ml, 2-4 years – 5 ml, 5-11 years – 6-10 ml. In diseases caused by Streptococcus pyogenes, the course of treatment is at least 10 days.

In case of kidney dysfunction the dose is adjusted depending on creatinine clearance index in serum: in creatinine Cl 21-60 ml/min or in patients on hemodialysis the daily dose should be reduced by 25%. In creatinine Cl less than or equal to 20 ml/min or in patients on peritoneal dialysis, the daily dose should be reduced by half.

How to prepare the suspension: invert the bottle and shake the powder. Add 40 ml of cooled to room temperature boiled water in 2 steps and shake after each addition until a homogeneous suspension is formed. After that, let the suspension stand for 5 min to ensure complete dissolution of the powder. The ready to use suspension should be shaken before use.

Interaction

Blockers of tubular secretion (allopurinol, diuretics, etc.) delay renal excretion of cefixime, which may lead to increased toxicity.

Decreases prothrombin index, increases the effect of indirect anticoagulants.

The antacids containing magnesium or aluminum hydroxide slow the absorption of the drug.

Special Instructions

Patients with a history of allergic reactions to penicillins may have hypersensitivity to cephalosporin antibiotics.

In prolonged use of the drug it is possible to disrupt normal intestinal microflora, which may lead to growth of Clostridium difficile, cause severe diarrhea and pseudomembranous colitis. During treatment, a positive direct Coombs reaction and a false positive urine glucose reaction are possible.

Contraindications

Hypersensitivity to cephalosporins and penicillins.

With caution: Elderly age;

Chronic renal failure;

Pseudomembranous colitis (history);

Childhood (under 6 months).

Side effects

Allergic reactions: skin itching, urticaria, skin hyperemia, eosinophilia, fever, erythema multiforme, toxic epidermal necrolysis, anaphylactic shock.

Digestive system disorders: Dry mouth, anorexia, nausea, vomiting, diarrhea, flatulence, abdominal pain, dysbacteriosis, disorders of liver function (increased activity of hepatic transaminases, alkalinases, hyperbilirubinemia, jaundice), GI candidiasis; rarely – stomatitis, glossitis, pseudomembranous enterocolitis.

Hematopoietic organs: leukopenia, neutropenia, thrombocytopenia, hemolytic anemia.

Urinary system disorders: interstitial nephritis.

Nervous system disorders: dizziness, headache.

Overdose

Symptoms: increased risk of adverse reactions.

Treatment: gastric lavage; symptomatic and supportive therapy, which if necessary includes the use of antihistamines, GCS, pressor amines, oxygen therapy, transfusion of infusion solutions, IVH. It is not excreted in significant amounts by hemo- or peritoneal dialysis.

Pregnancy use

Pregnant use is possible only when the estimated benefit to the mother exceeds the potential risk to the fetus.

Breastfeeding should be stopped if it is necessary to use during lactation.

Similarities