Cefalexin - instructions for use, dose, side effects, contraindications

excipients: before the preparation of the core tablet Weight 0.3400 g: potato starch - 0.0566 g, methyl cellulose - 0.0272 g, sucrose - 0.0030 g, calcium stearate-0.0032 g;

Auxiliary substances for a film gastrointestinal membrane: methylcellulose 0.00540 g, titanium dioxide 0.00068 g, tropeoline O-0.00004 g, tween 80 (polysorbate 80) 0.00068 g, calcium stearate 0.00020 g; weight of the tablet with a coat - 0.347 g.

Description:Tablets are round, biconvex, covered with a film coating of yellow color, two layers are visible on a cross section. The color of the core without a shell is white or white with a slightly yellowish tinge.

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 in the relationship of 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 catarrhalis (Branhamella), Proteus mira-bilis, 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 time to reach the maximum concentration of the drug in the blood and other tissues is 1-2 hours. After oral administration at doses of 250,500 and 1000 mg, the maximum plasma concentration in the plasma is 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 the placenta and is released in small amounts with breast milk. The volume of distribution is 0.26 l / kg. Connection with plasma proteins - 5-15%. The half-life of the drug is 0.9-1.5 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 of the drug in the blood plasma is achieved 1-2 hours after oral administration at doses of 250, 500 and 1000 mg-1; 2.2 and 5 mg / ml, respectively. If the kidney function is disturbed, the concentration in the blood increases, and the elimination time is longer; the half-life of the drug is 20-40 h.

Indications:

Infections of the upper and lower respiratory tract (bronchitis, acute pneumonia and exacerbation of pneumonia, empyema of the pleura and lung abscess);

Infectious-inflammatory diseases caused by microorganisms sensitive to cephalexin;

genitourinary system (pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis);

LOP - organs, abscess of the lung (pharyngitis, otitis media, sinusitis, tonsillitis);

skin and soft tissues (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis);

bones and joints (including osteomyelitis).

Contraindications:Hypersensitivity to cephalexin, the drug, other beta-lactam antibiotics, given the possibility of cross-allergies, sucrose deficit / isomaltose, fructose intolerance, glucose-galactose malabsorption (the structure includes sucrose); Children under 3 years old (for this dosage form).

Carefully:Renal failure, pseudomembranous colitis (in the anamnesis), pregnancy.

Pregnancy and lactation:Despite the lack of data on the teratogenicity of cephalexin, prescribed during pregnancy is possible only when the intended benefits to the mother outweighs the potential risk to the fetus.

Perhaps, if the expected effect of therapy exceeds the potential risk to the fetus. For the duration of treatment, breastfeeding should be discontinued.

Dosing and Administration:

Inside, 30-60 minutes before meals, washed down with water. The dose is selected individually, taking into account the severity of the course, the localization of the infection, the sensitivity of the pathogen. The average dose for adults and children over 10 years is 250-500 mg every 6 hours. If necessary, the daily dose is 4000-6000 mg.

The duration of treatment is 7-14 days.With average otitis - a dose of 75 mg / kg / day, the frequency of reception - 4 times a day. In children with body weight less than 40 kg, the average daily dose is 25-50 mg / kg, the frequency of reception 4 times a day. In severe infections, the daily dose can be increased to 100 mg / kg, and the frequency of admission - up to 6 times a day. In infections caused by beta-hemolytic streptococcus group A, the minimum duration of treatment is 10 days.

With streptococcal pharyngitis, infections of the skin and soft tissues in adults, adolescents, the frequency of admission - 2 times a day.

In severe infections, the daily dose can be increased to 100 mg / kg, and the frequency of intake - up to 6 times a day .;

For infections caused by group A beta-hemolytic streptococcus, the minimum duration of treatment is 10 days. Adult patients with renal dysfunction daily dose are set taking into account the value of creatinine clearance: with creatinine clearance of 5-20 ml / min, the maximum daily dose is 1500 mg / day; with creatinine clearance less than 5 ml / min-500 mg / day.

Side effects:

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

- from the nervous system: dizziness, weakness, headache, excitement, hallucinations, convulsions;

- from the genitourinary and urinary system: vaginitis, vaginal discharge, candidamycosis of the genital organs, interstitial nephritis;

- from the digestive system: gastritis, abdominal pain, dry mouth, decreased appetite, nausea, vomiting, dyspepsia, diarrhea, toxic hepatitis, cholestatic jaundice, candidamycosis of the intestine, oral cavity, rarely - pseudomembranous KOLIT;

- from the hematopoiesis: hemolytic anemia, aplastic anemia, increased bilirubin concentration, pancytopenia, agranulocytosis, neutropenia, thrombocytopenia, leukopenia;

- from the musculoskeletal system: arthralgia, arthritis;

Laboratory indicators: increased activity of "liver" transaminases; increased prothrombin time;

These side effects occur after the drug is discontinued.

Serious side effects have not been observed so far. However, in case of adverse reactions, consult your doctor.

Overdose:Symptoms: vomiting, nausea, epigastric pain, diarrhea, hematuria.

Treatment: Activated carbon (more effective than lavage), maintenance of airway patency, control of vital functions, blood gases, electrolyte balance.

Interaction:

Strengthens the effect of indirect anticoagulants.

Enhances the nephrotoxicity of aminoglycosides, polymyxins, phenylbutazone, furosemide.

Salicylates and indomethacin slow the excretion of cephalexin by the kidneys. When used simultaneously with metformin, a dose adjustment of the latter may be required.

Drugs that reduce tubular secretion, increase the concentration of the drug in the blood and slow its elimination.

Special instructions:

There is a cross-allergy between penicillins and cephalosporins with increased sensitivity to penicillin in about 5-10% of patients. Treatment with cephalexin should be discontinued when allergic reactions occur, especially such as anaphylactic shock, and it is necessary to prescribe the usual anti-shock therapy in such cases. During treatment with cephalexin, a false positive urine reaction to glucose is possible.The Coombs test in patients receiving cephalosporins or penicillins sometimes gives a false positive result if Benedict or Felling solution, copper sulfate or "clinitis" tablets are used. In tests that are based on the action of enzymes, such as "Klinistiks," a pseudo-positive reaction to glycosuria does not occur.

In the tablet of the preparation - 0.003 g of sucrose or 0.00025 XE, with a maximum daily dose of the drug, the content of sucrose will be 0.006 XE. The simultaneous use of high doses of cephalosporins and nephrotoxic drugs (aminoglycosides, strong diuretics) sometimes leads to impairment of renal function, which is not noticed when using the usual doses.

In patients with impaired renal function, cumulation is possible (correction of the dosing regimen is required) - cephalexin appoint with caution in reduced doses.

With staphylococcal infection, there is a cross-resistance between cephalosporins and isoxazolylpenicillins.

During the treatment you can not drink alcohol.

Effect on the ability to drive transp. cf. and fur:During the treatment period, avoidance of potentially hazardous activities should be avoided,such as the management of vehicles and mechanisms that require increased attention and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets 250 mg.

Packaging:

10 tablets are placed in a contour mesh box made of a polyvinylchloride film and aluminum foil printed lacquered.

20 tablets are placed in cans of BPS type, sealed with lids tightened with a sealing element. Free space in the bank is filled with cotton hygroscopic cotton.

1.2 contour mesh packs or a jar along with the instruction for medical use are placed in a pack of cardboard.

Storage conditions:In dry, 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 expiry date.

Terms of leave from pharmacies:On prescription

Registration number:P N003669 / 01

Date of registration:31.08.2009

The owner of the registration certificate:BIOCHEMIST, OJSC BIOCHEMIST, OJSC Russia

Manufacturer: & nbsp

BIOCHEMIST, OJSC Russia

Information update date: & nbsp19.10.2015

Illustrated instructions

Instructions

Cephalexin (Cefalexin)