Cephalexin (Cephalexin)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceCephalexinCephalexin
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    • Dosage form: & nbspGranules for the preparation of a suspension for oral administration.
    Composition:

    In 5 ml of the suspension is contained active substance cephalexin 250 mg (in the form of cephalexin monohydrate); Excipients: sodium saccharinate 2,920 mg, citric acid anhydrous 5,270 mg, dye Iron oxide yellow E 172-1.750 mg, guar gum 16,000 mg, sodium benzoate 25,000 mg, simethicone S 184-2,500 mg, sucrose 1667.390 mg, strawberry flavor 5.830 mg, apple flavor 6.670 mg, raspberry flavor 6,670 mg, tutti-frutti flavoring 10,000 mg.

    Description:
    Granular powder of yellow-orange color.
    When adding water, a yellow-orange suspension with a characteristic fruity smell is formed.
    Pharmacotherapeutic group:Antibiotic-cephalosporin.
    ATX: & nbsp

    J.01.D.B.01   Cephalexin

    Pharmacodynamics:
    Cephalosporin antibiotic of the first generation.It acts bactericidal, disrupts the synthesis of the cell wall of microorganisms. Sufficiently resistant to penicillinases
    gram-positive microorganisms, collapses beta-lactamases of gram-negative microorganisms.
    It is active against gram-positive microorganisms - Staphylococcus spp. (including coagulase-positive S. aureus, S. hyicus, S.intermedius, S. schleiferi, coagulase negative S.epidermidis, S. haemolyticus, S. hominis, S.capitis, S.warneri, S.auricularis, S. saprophyticus, S.cohnii, S.xylosus, S.equorum), Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes),
    Gram-negative microorganisms - Escherichia coli, Proteus mirabilis, Klebsiella spp. (including Klebsiella pneumoniae), Haemophilus influenzae, Moxarella (Branhamela) catarrhalis. Cephalexin is active against Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., however, the clinical significance of this fact is limited. Ineffective against Enterococcus spp. (Enterococcus faecalis), Morganella morganii, Proteus vulgaris, Pseudomonas or Herellea spp. (Pseudomonas aeruginosa) or Acinetobacter calcoaceticus, Serratia marcescens, Clostridium spp., Bacteroides fragilis. Not sensitive to cephalexin methicillin-resistant staphylococci (in vitro), i.e. there is cross-resistance.
    Pharmacokinetics:
    After ingestion quickly and well absorbed. Bioavailability is 90-95%, food intake slows down absorption, but does not affect its completeness. The time to reach the maximum concentration (TCmax) after ingestion of 0.25, 0.5 or 1 g -1 hour, the maximum concentration (Cmax) is 9, 18 and 32 μg / ml, respectively. The therapeutic concentration persists for 4-6 hours. The connection with plasma proteins is 10-15%.The volume of distribution is 0.26 l / kg.
    It is distributed relatively evenly in various tissues and body fluids: lungs, liver, heart, kidneys, bile, gall bladder, bones, joints, respiratory tract. Poorly penetrates the unchanged blood-brain barrier (BBB). Passes through the placenta, in small amounts excreted in breast milk, is found in the amniotic fluid. It is not metabolized. The half-life (T1 / 2) is 0.9-1.2 hours. The total clearance is 380 ml / min. It is excreted by the kidneys - 70-89% unchanged (2/3 - glomerular filtration, 1/3 -cannot secretion); with bile - 0.5%. Kidney clearance - 210 ml / min. If the excretory function of the kidneys is violated, the concentration in the blood increases, and the time of excretion by the kidneys is prolonged, T1 / 2 after oral administration - 5-30 hours.
    Moderately withdrawn by hemodialysis, well - with peritoneal dialysis.

    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to cephalexin:
    Infections of the upper and lower respiratory tract (bronchitis, pneumonia, bronchopneumonia, empyema of the pleura and lung abscess); LOP-organs (pharyngitis, otitis media, sinusitis,angina); genitourinary system (pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis); skin and soft tissues (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis); bones and joints (including osteomyelitis).
    Contraindications:Hypersensitivity (including to other beta-lactam antibiotics), sugarase / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
    Carefully:
    Renal failure, pseudomembranous colitis (in the anamnesis), pregnancy, lactation, children up to 6 months.

    Pregnancy and lactation:The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus. If it is necessary to prescribe the drug during lactation, breastfeeding should be stopped.
    Dosing and Administration:
    Inside, 30-60 minutes before meals, washed down with water.
    The average dose for adults and children over 10 years is 250-500 mg every 6 hours. The daily dose of the drug should be at least 1-2 g, if necessary, can be increased to 4 g. The duration of the course of treatment is 7-14 days.For infections caused by group A beta-hemolytic streptococcus, the minimum duration of treatment is 10 days.
    For adult patients with impaired renal function, the daily dose is reduced taking into account the value of creatinine clearance (QC): with QC 5-20 ml / min maximum daily dose -1.5 g / day; with SC less than 5 ml / min - 0.5 g / day. The daily dose is divided into 2-4 admission.
    Children up to 10 years of age, the drug is recommended to be administered in the form of a suspension for oral administration. With a body weight of less than 40 kg, the average daily dose is 25-100 mg / kg body weight; the frequency of reception is 4 times a day. With average otitis - a dose of 75 mg / kg / day, the frequency of reception - 4 times a day. With streptococcal pharyngitis, infections of the skin and soft tissues, the frequency of reception is 2 times a day. In severe infections, the daily dose of 100 mg / kg of body weight is applied, the frequency of intake is up to 6 times a day.
    Preparation of the suspension: in the vial add water to the risks and shake well. The prepared suspension is stable at room temperature for 14 days. Before each use, the suspension must be shaken. 5 ml of the finished suspension contains 250 mg of cephalexin.
    Side effects:
    Allergic reactions: rash, hives, Quincke's edema, erythema, rarely - eosinophilia, toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactic shock.
    On the part of the digestive system: abdominal pain, dry mouth, anorexia, nausea, vomiting, diarrhea, gastritis, toxic hepatitis, cholestatic jaundice, increased activity of "liver" transaminases and alkaline phosphatase, increased bilirubin concentration, candidiasis of the intestine, oral cavity, pseudomembranous colitis.
    From the nervous system: dizziness, weakness, headache, agitation, hallucinations, convulsions.
    On the part of the genitourinary system: interstitial nephritis, genital and anal itching, vaginitis, vaginal discharge, candidiasis of genital organs.
    On the part of the hematopoiesis: leukopenia, neutropenia, thrombocytopenia, pancytopenia, agranulocytosis, aplastic anemia, hemolytic anemia.
    From the musculoskeletal system: arthralgia, arthritis.
    Laboratory indicators: increased prothrombin time.
    Other: fever.
    Overdose:
    Symptoms: Vomiting, nausea, epigastric pain, diarrhea, hematuria.
    Treatment: Activated carbon (more effective than lavage), maintenance of airway patency, monitoring of vital functions, blood gases, electrolyte balance.
    Interaction:
    When used simultaneously with furosemide, ethacrynic acid, nephrotoxic antibiotics (eg, aminoglycosides, polymyxins), phenylbutazone, the risk of kidney damage increases.
    Drugs that reduce tubular secretion, increase the concentration of the drug in the blood and slow its elimination.
    When used simultaneously with metformin, a dose adjustment of the latter may be required.
    Salicylates and indomethacin slow the excretion of cephalexin.
    Reduces the prothrombin index, increases the effect of indirect anticoagulants.
    Special instructions:
    Patients with allergic reactions to penicillins and carbapenems in history may have increased sensitivity to cephalosporin antibiotics. During treatment with cephalexin, a positive direct Coombs reaction is possible, as well as a false positive urine reaction to glucose. During the period of treatment is not recommended to use ethanol.
    In patients with impaired renal function, cumulation is possible (correction of the dosing regimen is required).
    With staphylococcal infection, there is a cross-resistance between cephalosporins and isoxazolylpenicillins.
    Patients with diabetes should take into account that 5 ml of the finished suspension contains 1.65 g of sucrose (or 0.14 bread units, XE), respectively, the maximum daily dose of cephalexin contains 2.24 XE.
    Effect on the ability to drive transp. cf. and fur:During the use of the drug, patients should be very careful to drive and engage in other potentially dangerous activities due to possible side effects from the central nervous system, such as dizziness, agitation, convulsions, hallucinations.
    Form release / dosage:Granules for the preparation of a suspension for oral administration 250 mg / 5 ml.
    Packaging:For 40 g of granules for the preparation of 100 ml of suspension in a bottle of dark glass with a risk, sealed with a plastic or metal cover with the control of the first opening. 1 bottle with a measuring spoon (volume 5 ml, with a risk for volume of 2.5 ml) and instructions for use in a pack of cardboard.
    Storage conditions:
    In a dry, dark place at a temperature of 15 to 25 ° C. Keep out of the reach of children.
    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:П N011645 / 02
    Date of registration:02.09.2011
    The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia
    Manufacturer: & nbsp
    Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia
    Information update date: & nbsp19.10.2015
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