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Pharmacological action

Generation of the cephalosporin antibiotic I. Broad spectrum of activity: active against gram-positive microorganisms: Staphylococcus spp., Non-producing and non-penicillinase producing, 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 mirabilis, Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Treponema spp. It acts on Pseudomonas aeruginosa, pseudomonas of other species, Proteus spp. (indole positive strains), Mycobacterium tuberculosis, anaerobic microorganisms, Enterococcus faecalis, Haemophilus spp., Enterobacter spp., Serratia spp., Aeromonas spp., Acinetobacter spp., staphylococcus strains resistant to methicillin.

Directions for use

Infectious diseases of various localizations caused by microorganisms sensitive to cephalexin: upper and lower respiratory tract infections (bronchitis, acute pneumonia and exacerbation of chronic bronchitis); genitourinary system (acute and chronic pyelonephritis, cystitis, prostatitis, endometritis, gonorrhea, vulvovaginitis and others in the acute stage); ENT organs (tonsillitis, acute otitis media, sinusitis, etc.); purulent infections of the skin and soft tissues (furunculosis, abscess, pyoderma, etc.); bone and joint infections.

Formal national guidelines for the appropriate use of antibacterial agents should be considered.

Dosage and administration

Inside, whatever the food intake, watered with water.

The daily intake usually recommended for adults is 1 to 4 g.

Many infections respond to doses of 1 g to 2 g per day, divided into single doses of 250 mg or 500 mg.

The following additional information should also be taken into account:

adults:

Most infections respond well to a dose of 500 mg every 8 hours or 1 g every 12 hours. For the treatment of skin and soft tissue infections, streptococcal pharyngitis and lungs, uncomplicated urinary tract infections, a dose of 250 mg every 6 hours or 500 mg every 12 hours is usually required.

In severe infections, especially those caused by less sensitive microorganisms, the dose should be increased to 1 g three times a day or 3 g twice a day.

If daily doses of cephalexin greater than 4 g are required, the use of cephalosporins for parenteral administration at appropriate doses should be considered.

The maximum daily dose for adults is 4000 mg.

Duration of treatment:

For most acute infections, treatment should continue for at least two days after the symptoms have subsided, but in the event of chronic, recurrent or complicated urinary tract infection, it is recommended to continue treatment for two weeks (1 g twice a day).

For the treatment of gonorrhea, as a rule, a single dose of 3 g with 1 g of probenecid for men or 2 g with 0.5 g of probenecid for women is sufficient. Co-administration of probenecid delays the elimination of cephalexin and increases serum concentrations by 50 to 100%.

Elderly patients:

The usual dose for adults. Keep in mind a possible decrease in kidney.

function. Patients with renal insufficiency:

Cephalexin is used with caution in kidney failure. A dose reduction is necessary if the kidney function is markedly impaired. In this case, extensive clinical and laboratory studies should be conducted, as a safe dose may be less than the usual recommended one.

As with other antibiotics, which are mainly excreted by the kidneys, the accumulation of cephalexin in the body can occur when kidney function is roughly half normal. Therefore, the maximum recommended doses should be proportionally reduced in these patients.

Clinical practice shows that due to the wide therapeutic window of cephalexin, the recommended standard doses should only be halved in patients with creatinine clearance ≤ 50 ml / min. The maximum recommended dose (i.e. for adults - 4 g / day) should be reduced to 50% for light (40 - ≤ 50 ml / min), 25% for moderate (> 10 - < 40 ml / min) and 12.5% for severe renal failure (≤ 10 ml / min).

Dialysis patients:

Adult patients receiving intermittent peritoneal dialysis should also take 500 mg of cephalexin after each dialysis, i.e. in a total dose of up to 1 g that day.

Due to the presence of the dye E-110 in the gelatin capsule, the drug is contraindicated in children and adolescents under 18 years of age.

Allergic reactions: hives, rash, itching, angioneurotic edema, erythematous rashes, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), anaphylaxis, arthralgia, arthritis, eosinophilia and generalized pruritus pustulosis.

From the nervous system: dizziness, weakness, malaise, headache, sleep disturbance, restlessness, hallucinations, cramps.

From the genitourinary and urinary system: vaginitis, vaginal discharge, genital candidomycosis, interstitial nephritis, toxic nephritis, renal dysfunction, acute tubular necrosis.

From the digestive system: pain in the abdomen, dryness of the oral mucosa, decreased appetite, nausea, vomiting, dyspepsia, diarrhea, gastritis, toxic hepatitis, cholestatic jaundice, intestinal candidiasis, oral cavity, rarely pseudomembranous colitis.

From hemopoietic organs: pancytopenia, neutropenia, thrombocytopenia, leukopenia, aplastic anemia, hemolytic anemia.

Laboratory indicators: increased activity of "hepatic" transaminases and alkaline phosphatase; an increase in prothrombin time, an increase in the concentration of bilirubin, LDH in the serum.

Other: joint pain, fever, swollen lymph nodes, bleeding.

Adverse reaction reporting

If you experience any side effects, consult your doctor. This recommendation applies to all possible side effects, including those not listed in the package leaflet.

You can also report side effects to the Adverse Drug Reaction Information Database, including reports on the ineffectiveness of drugs detected in the state. By reporting side effects, you can help get more information about the safety of the drug.

Cons-indications

Hypersensitivity to cephalexin, any of the ingredients of the medication, or other cephalosporins.

Due to the presence of the dye E-110 in the gelatin capsule, the drug is contraindicated in children and adolescents under 18 years of age.

Precautions: renal insufficiency, severe hepatic insufficiency, pseudomembranous colitis (history).

Overdose

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

Treatment: activated carbon, maintenance of the airway permeability, monitoring of vital functions, blood gases, electrolyte balance.

Safety precautions

Before prescribing treatment with cephalexin, it is necessary to determine whether the patient has had allergic reactions to cephalosporins, penicillins, carbapenems and other drugs. Cephalexin should be used with caution in patients with some form of allergy, especially an allergy to medications.

With the development of an allergic reaction to cephalexin, it is necessary to stop taking the drug and take the appropriate measures.

The development of pseudomembranous colitis is reported when taking almost all broad-spectrum antibiotics, including penicillins and cephalosporins.

Colitis can range from mild to life-threatening. With the development of pseudomembranous colitis, it is necessary to stop taking cephalexin, in moderate and severe cases, it is necessary to take appropriate measures. Antibacterial treatment changes the normal intestinal flora, an increase in the number of clostridia occurs. Studies show that the toxin produced by clostridia is the main cause of the development of colitis associated with antibiotics.

Prolonged use of cephalexin can cause excessive growth of insensitive organisms. Careful observation of the patient during treatment is important. If secondary infection develops during treatment, appropriate measures should be taken.

During treatment with cephalexin, a direct positive Coombs reaction is possible, as well as a false positive urinary reaction to glucose. During treatment with cephalexin, a decrease in the activity of prothrombin is possible. The risk group includes patients with renal and hepatic insufficiency, with poor nutritional status, as well as patients receiving long-term antimicrobial treatment. Prothrombin time control is required. Ethanol should not be used during treatment.

In patients with renal impairment, cumulative cephalexin is possible (dosage adjustment is necessary).

In staph infections, there is cross resistance between the cephalosporins and the isoxazolylpenicillins.

Before using cephalexin, tell your doctor if you have developed severe rashes or scaling, blisters, and / or ulcers on the oral mucosa after taking cephalexin or other antibacterial drugs.

Cases of generalized acute exanthematic pustulosis with cephalexin have been reported. OGEP appears at the start of cephalexin administration in the form of a red, scaly, extensive rash with tubers under the skin and blisters and is accompanied by fever. Most frequent location: skin folds, trunk and upper limbs. The highest risk for this serious skin reaction is during the first week of use. If you have a rash or other skin symptoms, you should stop taking cephalexin and seek medical help immediately for medical help.

Cephalexin capsules contain auxiliary components - dyes (E-104 and E-110), which can cause allergic reactions.

Due to the presence of the dye E-110 in the gelatin capsule, the drug is contraindicated in children and adolescents under 18 years of age.

Use during pregnancy and lactation

The use of the drug during pregnancy and lactation is only justified in cases where the expected benefits to the mother outweigh the potential risk to the fetus. If necessary, the appointment of the drug during lactation should stop breastfeeding.

Impact on ability to drive vehicles and other potentially dangerous mechanisms

When using cephalexin, driving vehicles and other activities that require increased attention and speed of reaction are not recommended.

Interaction with other drugs

Cephalexin improves the effect of indirect anticoagulants. Improves the nephrotoxicity of aminoglycosides, polymyxins, phenylbutazone and 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 excretion.

In a study of 12 healthy people who took a single dose (500 mg) of cephalexin and metformin, the Cmax and AUC values increased, on average, by 34% and 24%, respectively. renal clearance value of metformin decreased by 14%. No adverse effects were noted in this study. No information on the interaction of cephalexin and metformin after repeated administration is available. The development of hypokalemia in patients treated with gentamicin and cephalexin simultaneously has been described.

Like other beta-lactam preparations, probenecid inhibits the renal excretion of cephalexin.

Simultaneous treatment with high doses of cephalosporins and nephrotoxic drugs such as aminoglycosides and potent diuretics can affect kidney function.

During treatment with cephalexin, and also within 7 days of treatment, it is necessary to refuse to take oral contraceptives and to use an alternative method of non-hormonal contraception.

While taking cephalexin, a false high concentration of creatinine is possible.

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