Suprax granules for suspension preparation 100mg / 5ml, 60ml

Infectious and inflammatory diseases caused by sensitive microorganisms:

• pharyngitis,

• tonsillitis,

• sinusitis,

• acute and chronic bronchitis,

• otitis media,

• uncomplicated urinary tract infections,

• uncomplicated gonorrhea.

Suprax is taken orally. For adults and children over 12 years old weighing more than 50 kg, the average daily dose is 400 mg (1 time per day or 200 mg 2 times a day). The average duration of the course of treatment is 7-10 days.

With uncomplicated gonorrhea - 400 mg once a day.

Children under the age of 12 are prescribed as a suspension at a dose of 8 mg / kg once or in 2 divided doses (4 mg / kg every 12 hours). For children aged 6 months to 1 year, the daily dose of the suspension is 2.5Ц4 ml, at the age of 2Ц4 years - 5 ml, at the age of 5Ц11 years - 6Ц10 ml.

For diseases caused by Streptococcus pyogenes, the course of treatment is at least 10 days.

In case of impaired renal function, the dose is set depending on the serum creatinine clearance rate: with Cl creatinine 21-60 ml / min or in patients on hemodialysis, the daily dose should be reduced by 25%. When Cl creatinine is less than or equal to 20 ml / min or in patients on peritoneal dialysis, the daily dose should be halved. FROM

suspension preparation method: turn the bottle over and shake the powder. Add 40 ml of boiled water cooled to room temperature in 2 steps and shake after each addition until a homogeneous suspension is formed. After that, it is necessary to allow the suspension to settle for 5 minutes to ensure complete dissolution of the powder. Shake the finished suspension before use.

Granules for oral suspension from almost white to cream color, small; after mixing, an almost white to cream slurry with a sweet strawberry aroma forms.

cefixime

Excipients: sodium benzoate - 0.03 g, sucrose - 30.225 g, xanthan gum - 0.155 g, strawberry flavor - 0.048 g.

• Hypersensitivity to cephalosporins and penicillins.

• Precautions: advanced age; chronic renal failure; pseudomembranous colitis (in history); children's age (up to 6 months).

pharmachologic effect

Semi-synthetic cephalosporin antibiotic of the third generation for oral administration of a wide spectrum of action. It has a bactericidal effect. The mechanism of action is due to the inhibition of the synthesis of the cell membrane of the pathogen. Cefixime is resistant to the action of ?-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 diversceus. Serratia marcesceus. 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. Are resistant to cefixime. (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 Cmax of cefixime in serum is reached 0.8 hours faster when taking the drug with food. Plasma protein binding, mainly 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. T1 / 2 depends on the dose and is 3-4 hours. In patients with impaired renal function with CC from 20 to 40 ml / min, T1 / 2 increases to 6.4 hours, with CC 5-10 ml / min - up to 11.5 hours.

Side effect

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, dysbiosis; rarely - stomatitis, glossitis, pseudomembranous enterocolitis. From the hematopoietic system: leukopenia, thrombocytopenia, neutropenia, hemolytic anemia. From the side of the central nervous system: dizziness, headache. From the urinary system: interstitial nephritis. Allergic reactions: pruritus, urticaria, flushing of the skin, eosinophilia, fever.

Application during pregnancy and lactation

Use during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, use during lactation should stop breastfeeding.

Application for impaired renal function

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%. When CC is 20 ml / min, the daily dose should be reduced by 2 times.

Application in children

Use with caution in children under 6 months of age.

Use in elderly patients

It should be used with caution in elderly patients.

special instructions

It should be used with caution in elderly patients, patients with chronic renal failure or pseudomembranous colitis (in history), in children under 6 months of age. With prolonged use, it is possible to disrupt the normal intestinal microflora, 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, hypersensitivity to cephalosporin antibiotics is possible. During treatment, a positive direct Coombs' reaction and a false positive urine glucose reaction are possible.