Cefalexin (Capsules) Instructions for Use

ATC Code

J01DB01 (Cefalexin)

Active Substance

Cefalexin (Rec.INN registered by WHO)

Clinical-Pharmacological Group

First generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A broad-spectrum first-generation cephalosporin antibiotic. It exerts a bactericidal effect.

It is active against gram-positive bacteria: Staphylococcus spp. (strains producing and not producing penicillinase), Streptococcus spp. (including Streptococcus pneumoniae), Corynebacterium diphtheriae; and gram-negative bacteria: Neisseria meningitidis, Neisseria gonorrhoeae, Shigella spp., Salmonella spp., Escherichia coli.

It is not active against Haemophilus influenzae, Proteus spp. (indole-positive strains), Mycobacterium tuberculosis, and anaerobic microorganisms.

Pharmacokinetics

After oral administration, it is well absorbed from the gastrointestinal tract. Absorption is 90%. Cefalexin is acid-stable; food intake slows down absorption but does not affect its completeness. Bioavailability is 95%.

C_max is reached in 1-2 hours. After oral administration of 250 mg, 500 mg, and 1 g, C_max is 9, 18, and 32 mcg/ml, respectively. It is distributed relatively evenly in various tissues and body fluids: lungs, bronchial mucosa, liver, heart, kidneys. It does not cross the blood-brain barrier, crosses the placental barrier, and is excreted in small amounts in breast milk.

V_d is 0.26 L/kg. Plasma protein binding is 5-15%.

T_1/2 is 0.9-1.5 hours. 90% is excreted by the kidneys unchanged (2/3 by glomerular filtration, 1/3 by tubular secretion); 0.5% is excreted in bile. Total clearance is 380 ml/min, renal clearance is 210 ml/min. C_max in urine after oral administration of 250 mg, 500 mg, and 1 g is 1000, 2200, and 5000 mcg/ml, respectively. In case of renal impairment, the concentration in the blood increases and the elimination time is prolonged. T_1/2 is 20-40 hours.

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to cefalexin, including diseases of the upper and lower respiratory tract, urinary tract, skin and soft tissues; otitis media, osteomyelitis, endometritis, gonorrhea.

ICD codes

Dosage Regimen

Capsules

The dosage is set individually, taking into account the severity and location of the infection, and the sensitivity of the pathogen. For oral administration, the average dose for adults is 250-500 mg every 6-12 hours. If necessary, the daily dose can be increased to 4-6 g. The duration of the treatment course is 7-14 days. For children weighing less than 40 kg, the average daily dose is 25-50 mg/kg, with a frequency of administration of 4 times/day. In severe infections, the daily dose may be increased to 100 mg/kg, and the frequency of administration to 6 times/day. For infections caused by group A beta-hemolytic streptococcus, the minimum duration of treatment is 10 days.

Adverse Reactions

From the nervous system: weakness, agitation, hallucinations, convulsions, headache, dizziness, drowsiness, in isolated cases – hallucinations.

From the urinary system: interstitial nephritis.

From the reproductive system: vaginitis, vaginal discharge, genital candidiasis.

From the digestive system: nausea, vomiting, dry mouth, loss of appetite, diarrhea, abdominal pain, dyspepsia, intestinal candidiasis, oral candidiasis; rarely – pseudomembranous enterocolitis; in isolated cases – cholestatic jaundice, hepatitis.

From the hematopoietic system: in isolated cases – changes in peripheral blood picture (reversible leukopenia, neutropenia, thrombocytopenia).

From laboratory parameters: increased activity of hepatic transaminases and alkaline phosphatase, increased prothrombin time.

Allergic reactions: urticaria, erythema, malignant exudative erythema (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell’s syndrome), anaphylaxis, arthritis, eosinophilia, itching of the genitals and anus, skin rash, itching, dermatitis, eosinophilia; rarely – angioedema, arthralgia.

Contraindications

Hypersensitivity to cephalosporins.

Use in Pregnancy and Lactation

Use during pregnancy and lactation (breastfeeding) is possible only in cases where the intended benefit to the mother outweighs the potential risk to the fetus or child.

Use in Renal Impairment

Use with caution in renal insufficiency.

Pediatric Use

Use with caution in children under 6 months of age.

Special Precautions

Use with caution in renal insufficiency, history of pseudomembranous colitis.

In patients with hypersensitivity to penicillins, allergic reactions to cephalosporin antibiotics are possible.

During treatment, a positive direct Coombs test, as well as a false-positive urine glucose reaction, may occur.

During therapy, alcohol should not be consumed.

Use with caution in children under 6 months of age.

Drug Interactions

With simultaneous use, Cefalexin enhances the effect of indirect anticoagulants.

With simultaneous use, Cefalexin enhances the nephrotoxicity of aminoglycosides, polymyxins, phenylbutazone, furosemide.

Salicylates and indomethacin slow down the excretion of cefalexin.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.