Respiratory tract infections caused by β-haemolytic streptococci of group A. Middle ear inflammation caused by staphylococci and β-haemolytic streptococci. Infections of bones and joints caused by staphylococci. Infections of the skin and soft tissues caused by staphylococci and / or β-haemolytic streptococci. Uncomplicated urinary tract infections caused byEscherichia coli, Proteus mirabilis andKlebsiella spp. The cultures and antibiogram should be performed before and during treatment. If indicated, check the kidney function. Inflammation of the paranasal sinuses caused by β-haemolytic streptococci andStaphylococcus aureus (only methicillin sensitive strains).
Composition:
1 capsule contains 250 mg or 500 mg cephalexin as a monohydrate; capsules contain patent blue. After dissolving in water - 5 ml of suspension contains 250 mg of Cefalexin in the form of a monohydrate; the suspension contains sucrose.
Action:
Β-lactam antibiotic, 1st generation cephalosporin for oral administration. Species usually sensitive - Gram-positive aerobic bacteria:Staphylococcus aureus (sensitive to methicillin),Streptococcus agalactiae Streptococcus pyogenes; Gram-negative aerobic bacteria:Escherichia coli; anaerobic bacteria:Peptostreptococcus spp. Species among which a resistance problem may occur:Citrobacter spp., Enterobacter spp., Morganella morganii. Species with innate resistance:Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis. Cefalexin after oral administration is absorbed quickly and almost completely. Cmax is achieved within 1 h after administration and the therapeutic concentrations are maintained for 6-8 h. It is excreted in the urine by glomerular filtration and tubular secretion, in an unchanged form. Hemodialysis and peritoneal dialysis remove cefalexin from the body. T0,5 it is about 60 min; may be longer in newborns due to immaturity of the kidneys.
Contraindications:
Hypersensitivity to cephalosporins or to any of the excipients.
Precautions:
Cefalexin should not be used in infections caused byHaemophilus influenzae or if it is probable that these bacteria will be involved in the infection. Before administering an antibiotic, an accurate medical history should be conducted regarding the patient's tendency to hypersensitivity reactions to penicillins, cephalosporins or other allergens due to the possibility of anaphylactic reactions. Exercise caution in patients allergic to penicillin (risk of cross-allergy between penicillins and cephalosporins). If an allergic reaction occurs, treatment should be discontinued and appropriate medical treatment should be instituted. Use with caution in patients with markedly impaired renal function (slower elimination and increased risk of toxicity) - perform appropriate diagnostic and laboratory tests. During the treatment, the patient should be monitored for superinfection (eg fungal or resistant strains of bacteria) - in the case of superinfection, appropriate treatment should be implemented. For any patient with diarrhea associated with antibiotic use, the possibility of pseudomembranous colitis should be considered; after determining the diagnosis of this disease, the antibiotic should be discontinued and appropriate treatment instituted. Capsules contain patent blue - a dye that can cause allergic reactions. The suspension contains sucrose - it should not be used in patients with disorders related to fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency; sucrose content (2.97 g in 5 ml suspension) should be taken into account in patients with diabetes or a low calorie diet.
Pregnancy and lactation:
Take caution when using cefalexin during pregnancy or breast-feeding (cefalexin is excreted in human milk).
Side effects:
Common: diarrhea, nausea. Uncommon: eosinophilia, rash, urticaria, pruritus, transient increase in ALT and AST.Rare: neutropenia, thrombocytopenia, haemolytic anemia, headache, dizziness, abdominal pain, vomiting, dyspepsia, pseudomembranous colitis, transient interstitial nephritis, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, angioneurotic edema, pruritus of the organs sexual and anal, vaginitis, fatigue, anaphylactic reaction, hepatitis, jaundiced congestion. Not known: joint pain, arthritis, vaginal candidiasis, fever, hallucinations, agitation, confusion, positive results of direct Coombs tests, false positives in urine Glucose tests.
Dosage:
Orally. Adults: 1-4 g / day in divided doses. In uncomplicated urinary tract infections, streptococcal angina and skin and soft tissue infections: 250 mg every 6 hours or 500 mg every 12 hours; in severe infections or those caused by more resistant microorganisms, it may be necessary to increase the dose (if a dose of> 4 g / day is needed, parenteral cephalosporin should be considered). Children and adolescents (appropriate for the child's age, pharmaceutical form of the drug): 25-50 mg / kg / day in divided doses; in uncomplicated urinary tract infections, the drug is administered every 12 hours; in severe infections, the dose can be doubled; in otitis media: 75-100 mg / kg / day in 4 divided doses. In infants, use in case of absolute necessity and under strict control. In infections caused by β-haemolytic streptococci, the drug is administered for at least 10 days.Special groups of patients. Do not exceed the 500 mg / day dose in dialysis patients.
(C)
