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

Excipients: methylcellulose (metocel A15) 4.2 mg, calcium stearate monohydrate 3 mg, potato starch to the weight of the capsule content 300 mg; composition of the capsule: gelatin - 80,751 mg, glycerol - 0,122 mg, purified water - 13,92 mg, methyl

parahydroxybenzoate 0.35 mg, propyl parahydroxybenzoate 0.089 mg, titanium dioxide 0.644 mg, sodium lauryl sulfate 0.056 mg, dye sunset yellow E-110 0.013 mg, quinoline yellow E-104 dye 0.055 mg.

Description:Capsules number 0. Hard gelatin capsules of yellow color. Contents of capsules - a mixture of granules and white powder with a yellowish tint, with a characteristic odor. It is allowed to have capsule-shaped seals in the form of a column or tablet,which when pressed with a glass rod are scattered.

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. (at t.h. Streptococcus pneumoniae, Streptococcus pyogenes), Corynebacterium diphtherial, Clostridium spp., Bacillus anthracis, Actinomyces israelii; gram-negative microorganisms: Escherichia coli, Klebsiella spp. (at t.h. Klebsiella pneumoniae), Moraxella catarrhalis (Branhamella), Proteus mirabilis, Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Treponema spp.

He current on Pseudomonas aeruginosa, pseudomonads dr. species, Proteus spp. (indol-positive strains), Mycobacterium tuberculosis, anaerobic microorganisms, Enterococcus faecalis, Haemophilus spp., Enterobacter spp., Serratia spp., Aeromonas spp., Acinetobacter spp., methicillin-resistant strains staphylococci.

Pharmacokinetics:Absorption - 90%, acid-fast, food intake slows down absorption, but does not affect its completeness. Bioavailability is 95%. Time to reach the maximum concentration - 1-2 hours.After oral administration at doses of 250, 500 and 1000 mg, the maximum concentration 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%. Half-life 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. Maximum concentration in the urine after ingestion at doses of 250, 500 and 1000 mg - 1, 2.2 and 5 mg / ml, respectively. If there is a violation of kidney function, the concentration in the blood increases, and the elimination period is longer; the half-life is 20-40 hours.

Indications:Infectious-inflammatory diseases caused by microorganisms sensitive to cephalexin: upper and lower respiratory tract infections (bronchitis, acute pneumonia, empyema of the pleura and lung abscess); infection of the genitourinary system (pyelonephritis, cystitis, urethritis,prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis), infections of the LOP organs (pharyngitis, otitis media, sinusitis, tonsillitis), skin and soft tissue infections (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis), infections of bones and joints including osteomyelitis).

Contraindications:

Hypersensitivity (including other beta-lactam antibiotics), children under 12 years of age with a body weight of less than 40 kg.

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

Pregnancy and lactation:

The use of the drug during pregnancy and lactation is justified only when the intended benefit to the mother exceeds the potential risk to the fetus and the baby. 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.

Adults and children over 12 years of age with a body weight of more than 40 kg are given a dose of 250 mg 4 times a day (every 6 hours) or 500 mg twice a day (every 12 hours). The daily dose for adults and children over 12 years is 1000 mg, with a heavy infection, the daily dose can be increased to 4000 mg.

Patients with impaired renal function The daily dose is set taking into account the value of creatinine clearance: when creatinine clearance is 5-20 ml / min the maximum daily dose is 1500 mg / day; when creatinine clearance is less than 5 ml / min - 500 mg / day. The duration of treatment depends on the nature and severity of the pathological process and is determined by data from bacteriological studies. Usually the duration of treatment is 7-14 days, but with severe infectious diseases, longer therapy may be required. In most infectious diseases, treatment lasts at least another 48-72 hours after the disappearance of the symptoms of the disease and / or the results of bacteriological analysis. For infections caused by group A beta-hemolytic streptococcus, the minimum duration of treatment is 10 days.

Side effects:

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

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

On the part of the genitourinary and urinary system: vaginitis, vaginal discharge, candidamycosis of the genital organs, interstitial nephritis, genital itching.

From the digestive system: pain in the abdomen, dryness of the oral mucosa, decreased appetite, nausea, vomiting, dyspepsia, diarrhea, toxic hepatitis, cholestatic jaundice, candidamycosis of the intestine, oral cavity, pseudomembranous colitis, itching of the anus.

From the hematopoiesis: neutropenia, thrombocytopenia, and leukopenia.

Laboratory indicators: increased activity of "liver" transaminases and alkaline phosphatase; increased prothrombin time.

Overdose:

Symptoms: Vomiting, nausea, epigastric pain, diarrhea, hematuria.

Treatment: Activated carbon, maintenance of airway patency, control 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 the excretion of cephalexin by the kidneys. Drugs that reduce tubular secretion, increase the concentration of the drug in the blood and slow its elimination.

Special instructions:

Patients who had a history of allergic reactions to penicillins, carbapenems, 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.

Effect on the ability to drive transp. cf. and fur:When using cephalexin, driving and other activities that require increased attention and reaction speed are not recommended.

Form release / dosage:

Capsules 250 mg.

Packaging:10 capsules per contour cell packaging made of polyvinylchloride film and aluminum foil.By 3 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:In a dry, protected from light place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LS-000864

Date of registration:27.07.2010

Manufacturer: & nbsp

BELMEDPREPARATY, RUP Republic of Belarus

Information update date: & nbsp19.10.2015

Illustrated instructions

Instructions

Cephalexin (Cefalexin)