Suprax granules for suspension for oral administration 100 mg 5 ml vial 60 ml
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Active ingredients
Cefixime
Release form
Granules
Composition
1 dose contains: cefixime trihydrate (micronized) 1.402 g (100 mg / 5 ml of the prepared suspension) (equivalent to 1.2 g cefixime + 4% repacking) Excipients: sodium benzoate - 0.03 g, sucrose - 30.225 g, gum xanthan gum - 0.155 g , strawberry flavoring - 0.048 g.
Pharmacological effect
Semisynthetic cephalosporin antibiotic of a broad spectrum of action of the III generation for intake. Bactericidal effect. The mechanism of action is due to inhibition of the synthesis of the cell membrane of the pathogen. Cefixime is resistant to β-lactamase 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-synsus, an example, Syro. Pseudomonas spp., Enterococcus (Streptococcus) serogroup D, Listeria monocytogenes, Staphylococcus spp. Are resistant to cefexim. (including methicillin-resistant strains), Enterobacter spp., Bacteroides fragilis, Clostridium spp.
Pharmacokinetics
Absorption and distribution When taken orally, the bioavailability of cefixime is 40-50% regardless of food intake, however, Cmax cefixime in serum is achieved faster by 0.8 h when taking the drug with food. When taking the drug in the form of capsules Cmax in the serum is reached after 4 hours and is 3.5 μg / ml. When taking the drug in the form of a suspension in a dose of 200 mg Cmax in serum is reached after 4 hours and is 2.8 mcg / ml, when taken in a dose of 400 mg - 4.4 mcg / ml. Binding to plasma proteins, mainly albumin, is 65%. Withdrawal 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. Pharmacokinetics in special clinical situations In patients with impaired renal function, with CK from 20 to 40 ml / min, T1 / 2 increases to 6.4 h, with CK 5–10 ml / min up to 11.5 hours
Indications
Infectious and inflammatory diseases caused by microorganisms sensitive to the drug: Pharyngitis, tonsillitis, sinusitis. Acute and chronic bronchitis. Middle otitis. Uncomplicated urinary tract infections. Uncomplicated gonorrhea.
Contraindications
Impaired renal function with a CC of less than 60 ml / min (for capsules). Children up to 12 years old (for capsules). Children up to 6 months (for suspension). Increased sensitivity to cephalosporins and penicillins. You should use the drug with care in elderly patients. , in chronic renal failure, pseudomembranous colitis (in history).
Precautionary measures
From the nervous system: headache, dizziness, tinnitus, convulsions. On the part of the digestive system: dry mouth, anorexia, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, dysbiosis, abnormal liver function, cholestasis, cholestatic jaundice, candidiasis, stomatitis, glossitis, pseudomembranous enterocolitis. On the part of the hemopoietic system: pancytopenia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, bleeding. On the part of the urinary system: interstitial nephritis, impaired renal function, acute renal failure. On the part of the reproductive system: vaginitis, genital itching. From the laboratory indicators: an increase in the activity of hepatic transaminases and alkaline phosphatase, hyperbilirubinemia, an increase in urea nitrogen, hypercreatininemia, an increase in prothrombin time.
Use during pregnancy and lactation
Use of Supraksa during pregnancy is possible only when the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, use Supraksa during lactation should stop breastfeeding.
Dosage and administration
For children aged 6 months to 12 years, the drug is prescribed at 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; at the age of 6 months to 1 year - 2.5-4 ml. Adults and children over 12 years old with a body weight of more than 50 kg are prescribed the drug at a dose of 400 mg 1 time / day or 200 mg 2 times / day. The average duration of treatment is 7-10 days. For infections caused by Streptococcus pyogenes, the treatment should be at least 10 days. In case of impaired renal function (with CC 21-60 ml / min) or in patients on hemodialysis, the daily dose should be reduced by 25%. With QC ≤ 20 ml / min or in patients on peritoneal dialysis, the daily dose should be reduced by 2 times. Terms of preparation of the suspension Turn the bottle and shake its contents.Add 40 ml of boiled water cooled to room temperature in 2 stages and shake after each addition to form a homogeneous suspension. After that, it is necessary to allow the suspension to settle for 5 minutes to ensure complete dissolution of the granules. Before use, the finished suspension should be shaken.
Side effects
Allergic reactions urticaria, skin hyperemia, pruritus, eosinophilia, fever, multiforme exudative erythema (including Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock, reactions reminiscent of serum sickness. headache, dizziness, tinnitus, convulsions. On the part of the digestive system, dry mouth, anorexia, nausea, vomiting, diarrhea, constipation, flatulence, abdominal pain, dysbiosis, abnormal liver function, cholestasis, cholestatic yellow ha, candidiasis, stomatitis, glossitis, pseudomembranous enterocolitis. From the side of the hemopoietic system, there are people, there are people in the center of the cystrophy, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia, aplastic anemia, hemorrhage. vaginitis of the reproductive system, genital itching. From laboratory indicators, increased activity of hepatic transaminases and alkaline phosphatases, hyperbilirubinemia, increased urea nitrogen, g perkreatininemiya, increased prothrombin vremeni.Prochie candidiasis, shortness of breath.
Overdose
Symptoms: increased manifestations of the described side effects, especially of the digestive system, with the exception of allergic reactions. Treatment: gastric lavage; carry out 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 the circulating blood by hemo-or peritoneal dialysis.
Interaction with other drugs
The tubular secretion blockers (allopurinol, diuretics) delay the excretion of cefixime by the kidneys, which can lead to an increase in drug concentration in the blood plasma.With 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 medicines.
special instructions
With long-term use of the drug may disrupt the normal intestinal microflora, which can lead to an increase in Clostridium difficile and cause the development of severe diarrhea and pseudomembranous colitis. Patients with a history of allergic reactions to penicillins, may show increased sensitivity to cephalosporin antibiotics. During treatment, a positive direct Coombs reaction and a false-positive reaction of urine to glucose are possible. Patients with diabetes should take into account that the suspension contains sucrose: 15 g in 20 ml (400 mg). Influence on the ability to drive vehicles and control mechanisms Patients taking cefixime, should be careful when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions, taking into account the side effects profile.