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

Excipients: carmellose sodium (sodium carboxymethylcellulose purified), citric acid (citric acid), vanillin, raspberry flavor (aromatic food essence [raspberry]), sucrose (sugar refined sugar).

Description:

White or white with a slightly yellowish tint powder, sweet taste, with a specific smell. The finished suspension is a homogeneous suspension with a greyish or yellowish hue.

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.

Has a wide range of activities. It is active against gram-positive microorganisms: Staphylococcus spp., (Including penicillinase-producing and non-producing penicillinase strains Staphylococcus aureus, penicillin-sensitive strains of Staphylococcus epidermidis), Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus pyogenes), Corynebacterium diphtheriae; Clostridium spp., Bacillis anthracis, Actinomyces israelii; 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 fungi.

It does not act 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:

After ingestion quickly and well absorbed. Bioavailability is 90-95%, food intake slows down absorption, but does not affect its completeness. Time to reach the maximum concentration (TCmax) after ingestion of 0.25, 0.5 or 1 g - 1 hour, the value of Cmax - 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 - by glomerular filtration, 1/3 -

by tubular secretion); with bile - 0.5%. Kidney clearance - 210 ml / min. When

violation of the excretory function of the kidneys 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:

Infections of the upper and lower respiratory tract (bronchitis, acute and exacerbation of chronic pneumonia, bronchopneumonia, empyema and abscess of the lungs);

urogenital system (pyelonephritis, cystitis, urethritis, prostatitis, epididymitis, endometritis, gonorrhea, vulvovaginitis, etc.);

LOP-organs (pharyngitis, otitis media, sinusitis, tonsillitis, etc.);

skin and soft tissues (furunculosis, abscess, phlegmon, pyoderma, lymphadenitis, lymphangitis, etc.); bones and joints (including osteomyelitis).

Contraindications:

Hypersensitivity (including to other beta-lactams).

Carefully:Renal failure, pseudomembranous colitis (in the anamnesis), pregnancy, lactation, breast age (up to 6 months).

Pregnancy and lactation:

The use of the drug during pregnancy 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. It is recommended to take 30-60 minutes before eating with water.

Adults.

In the average dose for adults - 0.25-0.5 g 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.

Adult patients with renal dysfunction daily dose reduced depending on the clearance of creatinine (CC): with KK 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 4 divided doses.

Children.

Children up to 10 years of age, the drug is 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; the frequency of administration is 4 times a day. With an 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 in adults, adolescents, children older than 1 year, the frequency of intake is 2 times a day. In severe infections, the daily dose can be increased to 100 mg / kg, and the frequency of administration - up to 6 times a day.

Preparation of the suspension.

Single dose package:

A small amount of boiled and cooled water or distilled water is poured into a clean glass, then the contents of one packet are poured and mixed until a uniform suspension is obtained.

After taking the glass, rinse with water, dry and store in a dry and clean place. Bottle:

In a vial containing 2.5 g of active substance, add 80 ml of boiled and cooled water or distilled water. In 1 ml of the finished suspension contains 25 mg of cephalexin. Suspension before use is shaken.

Dosage the suspension with a double-spoon: a large spoon contains 5 ml (125 mg), a small spoon contains 2.5 ml (62.5 mg) or a spoon with two labels: the lower one corresponds to 2.5 ml (62.5 mg) and the upper spoon contains 5 ml (125 mg).

Multiplicity of drug intake - 4 times / day. For infectious diseases caused by streptococci, the course of treatment should be at least 10 days.

Side effects:

Allergic reactions: rash, hives, Quincke's edema, erythema, rarely - eosinophilia, toxic epidermal necrolysis (Lyell's syndrome), anaphylactic shock, malignant exudative erythema (Stevens-Johnson syndrome).

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

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

From the musculoskeletal system: arthralgia, arthritis.

From the digestive system: abdominal pain, dry mouth, anorexia, nausea, vomiting, diarrhea, toxic hepatitis, cholestatic jaundice, intestinal candidiasis, oral cavity, rarely - pseudomembranous enterocolitis.

From the hematopoiesis: neutropenia, thrombocytopenia, and leukopenia.

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 (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), the risk of kidney damage increases.

Salicylates and indomethacin slow the excretion of cephalexin.

Reduces the prothrombin index, increases the effect of indirect anticoagulants.

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.

Form release / dosage:

Powder for the preparation of a suspension for ingestion 125 mg / 5 ml.

Packaging:

35 g of powder (2.5 g of active substance) into bottles of polyethylene. Each bottle with instructions for use, with a plastic cup and a spoon for taking medicines, or a spoon of a dispensing chemist, is placed in a pack of cardboard.

Powder for the preparation of a suspension for ingestion 125 mg, 250 mg and 500 mg.

1.75 g, 3.5 g or 7 g (125 mg, 250 mg or 500 mg of active ingredient, respectively) of the powder into single-dose packages. 5, 10 or 20 bags with instructions for use are placed in a pack of cardboard.

Storage conditions:List B. In a dry, the dark place at a temperature of 15 to 25 ° C. The suspension is stored at a temperature of 15 to 25 ° C for no more than 6 days or in a refrigerator for no more than 14 days. Keep out of the reach of children.

Shelf life:2 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:P N000563 / 01

Date of registration:09.04.2013

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

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp19.10.2015

Illustrated instructions

Instructions

Cephalexin (Cefalexin)