Cephalexin capsules 500mg, No. 16

• Infections of the upper and lower respiratory tract (pharyngitis, otitis media, sinusitis, tonsillitis, bronchitis, acute and exacerbation of chronic pneumonia, bronchopneumonia, empyema and lung abscess);

• infections of the genitourinary system (pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis);

• infections of the skin and soft tissues (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis);

• infections of bones and joints (including osteomyelitis).

Inside, 30-60 minutes before meals with water.

The average dose for adults and children over 10 years old is 250-500 mg every 6 hours. The daily dose of the drug should be at least 1-2 g, if necessary, it 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 CC value: with CC 5-20 ml / min, the maximum daily dose is 1.5 g / day; with CC less than 5 ml / min - 0.5 g / day. The daily dose is divided into 4 doses. For children under the age of 10, the drug is recommended to be prescribed 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 of body weight; frequency of admission - 4 times / day. With otitis media - the dose is 75 mg / kg / day, the frequency of administration is 4 times / day. With streptococcal pharyngitis, infections of the skin and soft tissues, the frequency of administration is 2 times / day. In severe infections, the daily dose can be increased to 100 mg / kg of body weight, and the frequency of administration - up to 6 times / day.

Capsules

1 caps.

cephalexin

Excipients: magnesium stearate, microcrystalline cellulose PH 102

• Children under 3 years of age (for the dosage form - capsules);

• hypersensitivity (including to other beta-lactam antibiotics).

  With caution - renal failure, pseudomembranous colitis (in history), pregnancy, lactation, breast age (up to 6 months - for suspension).

pharmachologic effect

1st generation cephalosporin antibiotic. Acts bactericidal, disrupts the synthesis of the cell wall of microorganisms. Resistant to lactamases. Has a wide range of effects. It is active against gram-positive microorganisms - Staphylococcus spp., (Including strains of Staphylococcus aureus producing and not producing penicillinase, penicillin-sensitive strains of Staphylococcus epidermidis), Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), Corynebacterium diphtheriae; gram-negative microorganisms - Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Escherichia coli, Klebsiella spp. (including Klebsiella pneumoniae), Moraxella catarrhalis, Proteus mirabilis; Treponema spp., Radiant mushrooms. Ineffective against Pseudomonas aeruginosa, Proteus spp. (indole-positive strains),Morganella morganii, Mycobacterium tuberculosis, Enterococcus faecalis, Haemophilus spp., Enterobacter spp., Serratia spp., Pseudomonas spp., Aeromonas spp., Acinetobacter spp., Methicillin-resistant strains, anaerobic microorganisms. It is resistant to penicillinase of staphylococci, but is destroyed by cephalosporinase of gram-negative microorganisms.

Pharmacokinetics

After oral administration, it is rapidly and well absorbed. Bioavailability - 90-95%, food intake slows down absorption, but does not affect its completeness. The time to reach Cmax after oral administration of 0.25, 0.5 or 1 g is 1 hour, the value of Cmax is 9, 18 and 32 ?g / ml, respectively. The therapeutic concentration lasts for 4-6 hours. The connection with plasma proteins is 10-15%. Vd - 0.26 l / kg. It is distributed relatively evenly in various tissues and body fluids: lungs, liver, heart, kidneys, bile, gallbladder, bones, joints, respiratory tract. Poorly penetrates the unchanged BBB. Passes through the placenta, in a small amount excreted in breast milk, found in amniotic fluid. Not metabolized. T1 / 2 - 0.9-1.2 hours. Total clearance - 380 ml / min. Excreted by the kidneys - 70-89% unchanged (2/3 - by glomerular filtration,1/3 - tubular secretion); with bile - 0.5%. Renal clearance - 210 ml / min. In case of impaired renal excretory function, the concentration in the blood increases, and the time of excretion by the kidneys is lengthened, T1 / 2 after ingestion - 5-30 hours. Moderately excreted using hemodialysis, well - using peritoneal dialysis.

Side effect

Allergic reactions: rash, urticaria, Quincke's edema, erythema, rarely - eosinophilia, toxic epidermal necrolysis, Stevens-Johnson syndrome, anaphylactic shock.

From the digestive system: abdominal pain, dry mouth, anorexia, nausea, vomiting, diarrhea, toxic hepatitis, cholestatic jaundice, increased activity of hepatic transaminases and alkaline phosphatase, intestinal candidiasis, oral cavity, pseudomembranous enterocolitis.

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

From the genitourinary system: interstitial nephritis, itching of the genitals and anus, vaginitis, vaginal discharge, genital candidiasis.

From the side of hematopoietic organs: leukopenia, neutropenia, thrombocytopenia.

From the musculoskeletal system: arthralgia, arthritis. Laboratory indicators: increase in prothrombin time.

Application during pregnancy and lactation

The use of the drug during pregnancy and lactation is possible only if the intended benefit to the mother outweighs the potential risk to the fetus. If necessary, the appointment of the drug during lactation should stop breastfeeding.

Application for impaired renal function

For adult patients with impaired renal function, the daily dose is reduced taking into account the CC value: with CC 5-20 ml / min, the maximum daily dose is 1.5 g / day; with CC less than 5 ml / min - 0.5 g / day. The daily dose is divided into 4 doses.

Application in children

Contraindication: children under 3 years of age (for the dosage form - capsules). For children under the age of 10, the drug is recommended to be prescribed in the form of a suspension for oral administration.

special instructions

Patients with a history of allergic reactions to penicillins and carbapenems may be hypersensitive to cephalosporin antibiotics. During treatment with cephalexin, a positive direct Coombs' reaction is possible, as well as a false positive urine reaction to glucose. It is not recommended to consume ethanol during the treatment period. In patients with impaired renal function, cumulation is possible (correction of the dosage regimen is required). In staphylococcal infections, there is cross-resistance between cephalosporins and isoxazolylpenicillins.

Overdose

Symptoms: vomiting, nausea, epigastric pain, diarrhea, hematuria. Treatment: activated carbon (more effective than lavage), maintaining airway patency, monitoring vital functions, blood gases, electrolyte balance.

Drug interactions

With simultaneous use with furosemide, ethacrynic acid, nephrotoxic antibiotics (for example, aminoglycosides), the risk of kidney damage increases. Salicylates and indomethacin slow down the excretion of cephalexin. Cephalexin reduces the prothrombin index, enhances the effect of indirect anticoagulants.