Suprax (Cefixim) 400 mg, 6 pcs.

Astellas Pharma Europe BV, Netherlands

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Product Overview

Structure

Cefixime (in the form of trihydrate) 

Excipients:

silica colloidal

magnesium stearate,

carmellose calcium.

pharmachologic effect

SUPRAX is a semi-synthetic cephalosporin broad-spectrum antibiotic of the third generation for oral administration. It is bactericidal. The mechanism of action is due to inhibition of the synthesis of the cell membrane of the pathogen. Cefixime is resistant to β-lactamases produced by most gram-positive and gram-negative bacteria.

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.

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 marcesens.

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

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.

Pregnancy and lactation

The use of Suprax during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

If necessary, the use of Suprax during lactation should stop breastfeeding.

Contraindications

- impaired renal function with CC less than 60 ml / min (for capsules);

- children's age up to 12 years (for capsules);

- Hypersensitivity to cephalosporins and penicillins.

With caution, Suprax should be prescribed to elderly patients, patients with chronic renal failure or pseudomembranous colitis (in the anamnesis), in the form of granules for the preparation of a suspension - for children under 6 months of age.

Side effects

From the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, constipation, abdominal pain, flatulence, a transient increase in liver transaminases and alkaline phosphatase activity, hyperbilirubinemia, jaundice, gastrointestinal candidiasis, dysbiosis; rarely - stomatitis, glossitis, pseudomembranous enterocolitis.

From the hemopoietic system: leukopenia, thrombocytopenia, neutropenia, hemolytic anemia, pancytopenia, aplastic anemia, bleeding.

From the side of the central nervous system: dizziness, headache.

From the urinary system: interstitial nephritis, impaired renal function, acute renal failure.

Allergic reactions: pruritus, urticaria, flushing, eosinophilia, fever, erythema multiforme, toxic epidermal necrolysis, anaphylactic shock.

On the part of laboratory parameters: an increase in urea nitrogen, hypercreatininemia, an increase in prothrombin time.

Other: candidiasis, shortness of breath, development of B. hypovitaminosis

Interaction

Tubular secretion blockers (allopurinol, diuretics) delay the excretion of cefixime by the kidneys, which can lead to an increase in the concentration of the drug in the blood plasma.

With the simultaneous use of cefixime and carbamazepine, the concentration of carbamazepine in the blood plasma increases.

Reduces the prothrombin index, enhances the effect of indirect anticoagulants.

Antacids containing magnesium or aluminum hydroxide slow down the absorption of the drug, so the drug should be used 1-2 hours before or 4 hours after taking these drugs.

How to take, course of administration and dosage

For adults and children over 12 years old with a body weight of more than 50 kg, the daily dose is 400 mg 1 time / day. The duration of treatment is 7-10 days.

With uncomplicated gonorrhea, 400 mg is prescribed once.

For children under 12 years of age, the drug is prescribed in the form of a suspension in a dose of 8 mg / kg body weight 1 time / day or 4 mg / kg every 12 hours.

For children aged 5-11 years, the daily dose is 6-10 ml of suspension, 2-4 years old - 5 ml, from 6 months to 1 year old - 2.5-4 ml.

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 undergoing peritoneal dialysis, the daily dose should be reduced by 2 times.

Patients with impaired renal function with CC less than 60 ml / min, on hemodialysis or peritoneal dialysis, the drug should be prescribed in the form of a suspension.

Rules for the preparation of the suspension

Turn the bottle over and shake the granules. Add 40 ml of boiled water chilled to room temperature in 2 stages and shake after each addition until a homogeneous suspension is formed. After this, it is necessary to allow the suspension to settle for 5 minutes to ensure complete disintegration of the granules. Before use, the prepared suspension should be shaken.

Overdose

Symptoms: increased manifestations of the described side effects, with the exception of allergic reactions.

Treatment: gastric lavage; conduct symptomatic and supportive therapy, which, if necessary, includes the use of antihistamines, GCS, epinephrine, norepinephrine, dopamine, oxygen therapy, transfusion of infusion solutions, mechanical ventilation. Cefixime is not excreted in large quantities from circulating blood by hemo - or peritoneal dialysis.

Storage conditions

At a temperature of 15–25 ° C

Shelf life

3 years

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