Suprax Solutab pills dispersible 400 mg 7 pcs.
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Active ingredients
Cefixime
Release form
Pills
Composition
1 tablet contains: active substance: cefixime trihydrate - 447.0 mg (equivalent to cefixime 400.0 mg) excipients: microcrystalline cellulose, low substituted hyprolosis, anhydrous silicon dioxide colloid, povidone K-30, strawberry flavor (FA 15757 and PV 4284), magnesium stearate , dye orange yellow S (E 110)
Pharmacological effect
Semisynthetic antibiotic from the group of cephalosporins III generation for oral administration. It has a bactericidal effect. The mechanism of action is associated with inhibition of the synthesis of the bacterial cell wall. Cefixime is resistant to a wide spectrum of β-lactamase produced by many gram-positive and gram-negative bacteria. In clinical practice and in vitro, the efficacy of cefixime was confirmed in infections caused by Streptococcus pneumoniae, Streptococcus pyogenes, Haemophilus influenzae, Moraxella catarrhalis, Escherichia coli, Proteus mirabilis, Neisseria gonorrhoeae. Cefixime is also active in vitro against Gram-positive — Streptococcus agalactiae and Gram-negative bacteria — the liver, the haemophilus parainfluenzae, Proteus vulgaris, Klebsiella pneumoniae, the Klebsiella oxytoca, Pasteurella multocida, Providencia spp., The salmon, which is the age for the means of the word for the means of the day, which is the age for the means of the word, which is the means for the means of the man, which is the means that the man, akin to the means of the Pseudomonas spp., Enterococcus spp., Listeria monocytogenes, most strains of Enterobacter spp., Staphylococcus spp. Are resistant to the drug. (including methicillin-resistant strains), Bacteroides fragilis, Clostridium spp.
Pharmacokinetics
Absorption When ingested, bioavailability is 40-50% and does not depend on food intake. Cmax in the blood plasma in adults after oral administration at a dose of 400 mg is reached in 3-4 hours and is 2.5-4.9 mcg / ml, after administration at a dose of 200 mg - 1.49-3.25 mcg / ml. Food intake on the absorption of the drug from the gastrointestinal tract has no significant effect. Distribution: Vd with the introduction of 200 mg of cefixime was 6.7 liters, while reaching Css - 16.8 liters. About 65% of cefixime binds to plasma proteins. Cefixime creates the highest concentrations in urine and bile. Cefixime penetrates the placenta. The concentration of cefixime in the blood of the umbilical cord reached 1 / 6-1 / 2 of the drug concentration in the blood plasma of the mother; in breast milk, the drug is not determined. Metabolism and excretion: T1 / 2 in adults and children is 3-4 hours. Cefixime is not metabolized in the liver; 50-55% of the accepted dose is excreted in the urine in unchanged form within 24 hours. About 10% of cefixime is excreted in the bile. Pharmacokinetics in special clinical situations: In renal failure, an increase in T1 / 2 and, accordingly, a higher plasma concentration of the drug and a slowing down of its elimination by the kidneys can be expected.In patients with CC 30 ml / min, when receiving 400 mg of cefixime T1 / 2 increases to 7-8 hours, plasma Cmax averages 7.53 μg / ml, and excretion in the urine in 24 hours - 5.5%. In patients with cirrhosis of the liver T1 / 2 increases to 6.4 h, the time to reach Cmax - 5.2 h; at the same time, the proportion of the drug eliminated by the kidneys increases. Cmax and AUC do not change.
Indications
Tonsillitis, pharyngitis, sinusitis, acute otitis media, acute bronchitis, exacerbation of chronic bronchitis, pneumonia, uncomplicated urinary tract infections, uncomplicated gonorrhea.
Contraindications
Hypersensitivity to cephalosporins or penicillins. hypersensitivity to cefixime or components of the drug. Not recommended for use in children with chronic renal failure and in children weighing less than 25 kg in this dosage form. Precautions should be prescribed the drug for renal failure, colitis (in history), during pregnancy, as well as elderly patients.
Precautionary measures
On the part of the hemopoietic system: very rarely - transient leukopenia, agranulocytosis, pancytopenia, thrombocytopenia or eosinophilia; in some cases - a violation of blood coagulation. Allergic reactions: rarely - urticaria, pruritus; very rarely - Lyell's syndrome (in this case, the drug should be immediately canceled), drug fever, serum sickness syndrome, hemolytic anemia and interstitial nephritis (epinephrine (adrenaline), systemic GCS and antihistamines are administered during the development of anaphylactic shock). From the side of the central nervous system: infrequently - headaches, dizziness, dysphoria. On the part of the digestive system: often - abdominal pain, digestive disorders, nausea, vomiting and diarrhea; rarely, transient increases in alkaline phosphatase and transaminase levels; very rarely - pseudomembranous colitis; in some cases - hepatitis and cholestatic jaundice. On the part of the urinary system: very rarely - a small increase in the concentration of creatinine in the blood, hematuria.
Use during pregnancy and lactation
Use of the drug Suprax Solutab during pregnancy is possible in the case when the intended benefits to the mother outweigh the potential risk to the fetus. If necessary, the use of the drug during lactation breastfeeding should be temporarily discontinued.
Dosage and administration
For adults and children weighing more than 50 kg, the daily dose is 400 mg in 1 or 2 doses. For children with a body weight of 25-50 kg, the drug is administered at a dose of 200 mg / day in 1 dose. The tablet can be swallowed with a sufficient amount of water, or diluted in water and drink the resulting suspension immediately after preparation. The drug can be taken regardless of the meal. The duration of treatment depends on the nature of the course of the disease and the type of infection. After the disappearance of symptoms of infection and / or fever, it is advisable to continue taking the drug for at least 48-72 hours. The course of treatment for infections of the respiratory tract and ENT organs is 7-14 days. For tonsillopharyngitis caused by Streptococcus pyogenes, the treatment should be at least 10 days. With uncomplicated gonorrhea, the drug is prescribed in a dose of 400 mg once. For uncomplicated infections of the lower urinary tract in women, a drug is prescribed for 3-7 days, for uncomplicated infections of the upper urinary tract infections in women for 14 days. With uncomplicated infections of the upper and lower urinary tract in men, the duration of treatment is 7-14 days.
Side effects
From the side of the hemopoietic system it is very rare - transient leukopenia, agranulocytosis, pancytopenia, thrombocytopenia or eosinophilia. in some cases - a violation of blood coagulation. Allergic reactions rarely - urticaria, pruritus. very rarely - Lyell's syndrome (in this case, the drug should be immediately canceled), drug fever, serum sickness syndrome, hemolytic anemia and interstitial nephritis (epinephrine (adrenaline), systemic GCS and antihistamines are administered during the development of anaphylactic shock). From the side of the central nervous system infrequently - headaches, dizziness, dysphoria. On the part of the digestive system often - abdominal pain, digestive disorders, nausea, vomiting and diarrhea. rarely, transient increases in alkaline phosphatase and transaminase levels. very rarely - pseudomembranous colitis. in some cases - hepatitis and cholestatic jaundice. From the urinary system is very rare - a slight increase in the concentration of creatinine in the blood, hematuria.
Overdose
When taken in a dose exceeding the maximum daily, it is possible to increase the frequency of the above dose-dependent side effects. Treatment: gastric lavage; conduct symptomatic and supportive therapy. Hemodialysis and peritoneal dialysis are not effective.
Interaction with other drugs
Tubular secretion blockers (including probenecid) slow down the excretion of cefixime in the urine, which can lead to overdose symptoms. Cefixime reduces the prothrombin index, enhances the effect of indirect anticoagulants. With simultaneous use of cefixime with carbamazepine, an increase in plasma concentration of the latter was observed; in such cases it is advisable to conduct therapeutic drug monitoring.
special instructions
Due to the possibility of cross-allergic reactions with penicillins, it is recommended to carefully evaluate the history of patients. In the event of an allergic reaction, the use of the drug should be immediately discontinued. With long-term use of the drug may disrupt the normal intestinal microflora, which can lead to excessive reproduction of Clostridium difficile and the development of pseudomembranous colitis. With the appearance of mild forms of antibiotic-associated diarrhea, as a rule, it is enough to stop taking the drug. In more severe forms, corrective treatment is recommended (for example, oral administration of vancomycin 250 mg 4 times / day). Antidiarrheal drugs that inhibit the motility of the gastrointestinal tract, with the development of pseudomembranous colitis are contraindicated. In the case of the use of the drug Suprax Soljutab simultaneously with aminoglycosides, polymyxin B, sodium colysymetatum, loop diuretics (furosemide, ethacrynic acid) in high doses, it is necessary to carefully monitor the function of the kidneys. After prolonged treatment with Suprax Solutab, the state of hemopoiesis function should be checked. Dispersible pills should be dissolved only in water. During treatment, a false-positive direct Coombs reaction and a false-positive reaction of urine to glucose are possible when using some test systems for rapid diagnosis. Impact on the ability to drive vehicles and control mechanisms Research on the effects of the drug Suprax Solutab on the ability to drive vehicles and mechanisms was not conducted. Due to possible adverse effects (eg, dizziness), caution should be exercised.