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Active ingredients
Cefixime
Release form
Capsules
Composition
1 capsule contains: cefixime (in the form of trihydrate) 400 mg Auxiliary substances: colloidal silicon dioxide, magnesium stearate, calcium carmellose. The composition of the shell of the capsules: titanium dioxide, dye azoruby (E122), dye indigo carmine (E132), gelatin. The composition of food ink: shellac, ethanol, isopropanol, butanol, propylene glycol, sodium hydroxide, povidone, titanium dioxide.
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
Renal dysfunction with CC less than 60 ml / min (for capsules), children under 12 years old, hypersensitivity to cephalosporins and penicillins. The drug should be prescribed with caution in elderly patients, with chronic renal failure, and pseudomembranous colitis (in history).
Precautionary measures
With care, the drug should be prescribed to patients of elderly age, with chronic renal failure, pseudomembranous colitis (in history).
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
Adults and children over 12 years old with a body weight of more than 50 kg of the drug is prescribed at a dose of 400 mg 1 time / day. For uncomplicated gonorrhea, 400 mg is administered once. The average duration of treatment is 7-10 days. For infections caused by Streptococcus pyogenes, the treatment should be at least 10 days. Patients with impaired renal function with a CC of less than 60 ml / min who are on hemodialysis or peritoneal dialysis, the drug should be prescribed in the form of a suspension to receive In.
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 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). Impact 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 high concentration of attention and speed of psychomotor reactions, taking into account the profile of side effects.