Active substanceCephalexinCephalexin
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  • Dosage form: & nbspCapsules.
    Composition:

    Active substance cephalexin (in terms of the active substance) 250 mg,

    Excipients:

    lactulose 300.0 mg

    magnesium stearate 6.0 mg

    sodium lauryl sulfate 6.0 mg

    hypromellose 3.1 mg

    cellulose microcrystalline to obtain the contents of a capsule with a mass of 610.0 mg

    capsules are hard gelatinous [gelatin (up to 100%), water (14-15%), titanium dioxide (0.9740%), dye quinoline yellow (0.5833%), dye sunset yellow (0.0025%)].

    Description:Hard gelatin capsules No. 00 yellow. The contents of the capsules are a granular white powder with a yellowish tint, with a characteristic odor.
    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.It is sufficiently resistant to penicillinases of gram-positive microorganisms, is destroyed by beta-lactamases of gram-negative microorganisms. Wide spectrum of action: active against gram-positive microorganisms: Staphylococcus spp., Not producing and producing penicillinase, Staphylococcus epidermidis (penicillin-resistant strains); Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), Corynebacterium diphtheriae; Clostridium spp., Bacillus anthracis, Actinomyces israelii; Gram-negative microorganisms: Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella (Branhamella) catarrhalis, Proteus mirabilis, Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Treponema spp.
    It acts on Pseudomonas aeruginosa, pseudomonas of other species, Proteus spp. (indolpositive strains), Mycobacterium tuberculosis, anaerobic microorganisms, Enterococcus faecalis, Haemophilus spp., Enterobacter spp., Serratia spp., Aeromonas spp., Acinetobacter spp., methicillin-resistant strains of staphylococci.
    Pharmacokinetics:
    Absorption - 90%, acid-fast, food intake slows down absorption, but does not affect its completeness. Bioavailability is 95%. The maximum concentration in the blood is achieved after 1-2 hours, after ingestion of 250 mg, 500 mg, 1 g, the maximum concentration - 9, 18, and 32 μg / ml, respectively. It is distributed relatively evenly in various tissues and body fluids: lungs, bronchial mucosa, liver, heart, kidneys. The blood-brain barrier does not pass, it penetrates into the placenta, in small amounts it is excreted in breast milk.The volume of distribution is 0.26 l / kg.
    Connection with plasma proteins - 5-15%. Half-life: 1.5 hours 90% is excreted by the kidneys unchanged (2/3 by glomerular filtration, 1/3 by tubular secretion); with bile - 0.5%. The total clearance is 380 ml / min, the renal clearance is 210 ml / min. The maximum concentration in the urine after ingestion of 250 mg, 500 mg, 1 g, respectively - 1000, 2200, 5000 μg / ml. If there is a violation of kidney function, the concentration in the blood increases, and the elimination time is prolonged.
    Indications:
    Infectious-inflammatory diseases caused by microorganisms sensitive to cephalexin:
    Infections of the upper and lower respiratory tract (bronchitis, acute pneumonia, empyema of the pleura and lung abscess); genitourinary system (pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis); ENT organs (pharyngitis, otitis media, sinusitis, tonsillitis); skin and soft tissues (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis), bones and joints (including osteomyelitis).
    Contraindications:
    Hypersensitivity to cephalexin (including other beta-lactams), to other components of the drug.
    Children under 12 years of age with a body weight of less than 40 kg (for this dosage form).


    Carefully:Renal failure, pseudomembranous colitis (in the anamnesis), pregnancy.
    Pregnancy and lactation:The use of the drug during pregnancy is possible only if the intended benefit for 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. In the average dose for adults - 0.25-0.5 g every 6 hours. If necessary, the daily dose - 4 g. Duration of treatment - 7-14 days. Children - preferably in the form of a suspension. With streptococcal pharyngitis, infections of the skin and soft tissues in adults, adolescents, children over 12 years of age, the frequency of intake is 2 times a day. For infections caused by group A beta-hemolytic streptococcus, the minimum duration of treatment is 10 days. Adult patients with impaired renal function, daily dose are set taking into account the value of creatinine clearance: at a value of 5-20 ml / min the maximum daily dose is 1.5 g / day; at a value of less than 5 ml / min - 0.5 g / day.
    Side effects:

    Allergic reactions: urticaria, angioedema, erythema,skin eruptions, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), anaphylaxis, arthralgia, arthritis, eosinophilia, fever.

    From the nervous system: dizziness, weakness, headache, agitation, hallucinations, convulsions, confusion.

    From the genitourinary and urinary system: vaginitis, vaginal discharge, genital candidamycosis, genital and anus itching, interstitial nephritis, renal dysfunction, toxic nephropathy, increased creatinine, urea nitrogen.

    From the digestive system: pain in the abdomen, dryness of the oral mucosa, anorexia, nausea, vomiting, dyspepsia, diarrhea, toxic hepatitis, cholestatic jaundice, hyperbilirubinemia, candidamycosis of the intestine, oral cavity, rarely pseudomembranous colitis.

    On the part of the organs of hematopoiesis: neutropenia, thrombocytopenia, leukopenia, hemolytic anemia, aplastic anemia, pancytopenia, agranulocytosis, neutropenia, leukopenia, thrombocytopenia, bleeding. Laboratory indicators: increased activity of "liver" transaminases and alkaline phosphatase, an increase in prothrombin time.

    Overdose:Symptoms: Vomiting, nausea, epigastric pain, diarrhea, hematuria. Treatment: Activated carbon, maintenance of airway patency, monitoring of vital functions, gas composition of blood, electrolyte balance.
    Interaction:
    Strengthens the effect of indirect anticoagulants. Enhances the nephrotoxicity of aminoglycosides, polymyxins, phenylbutazone, furosemide. Salicylates and indomethacin slow down the excretion of cephalexin. Drugs that reduce tubular secretion, increase the concentration of cephalexin in the blood and slow its elimination.
    When used simultaneously with metformin, a dose adjustment of the latter may be required.
    Special instructions:In patients with impaired renal function, the drug is administered with caution in reduced doses, because of possible cumulation. During the period of treatment is not recommended to use ethanol. During treatment, a positive direct Coombs reaction is possible, as well as a false positive urine reaction to glucose.
    With staphylococcal infection, there is a cross-resistance between cephalosporins and isoxazolylpenicillins. When using the drug, both on the background of taking and 2-3 weeks after stopping treatment, it is possible to develop diarrhea caused by Clostridium difficile (pseudomembranous colitis). In mild cases, it is sufficient to discontinue treatment and apply ion-exchange resins (colestramine, colestipol), in severe cases, compensation for loss of fluid, electrolytes and protein, the appointment of vancomycin, bacitracin or metronidazole. Do not use drugs that inhibit the intestinal motility.
    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, confusion.
    Form release / dosage:
    Capsules 250 mg.


    Packaging:
    5 capsules per circuit cell packaging made of polyvinylchloride film and aluminum foil printed lacquered.
    30 capsules in bottles for medicines made of plastic with screw caps.
    Each vial, 2, 4, 6 contour mesh packages together with instructions for use are placed in a pack of cardboard.
    Storage conditions:Store in a dry place, protected from light and out of reach of children, at a temperature of no higher than 25 ° C.
    Shelf life:2 years. Do not use after the expiration date.
    Terms of leave from pharmacies:On prescription
    Registration number:LS-002617
    Date of registration:30.12.2011
    The owner of the registration certificate:AVVA RUS, OJSC AVVA RUS, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp19.10.2015
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