Ceclor^® (Capsules, Granules) Instructions for Use

ATC Code

J01DC04 (Cefaclor)

Active Substance

Cefaclor (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Second generation cephalosporin

Pharmacotherapeutic Group

Antibiotic-cephalosporin

Pharmacological Action

A broad-spectrum second-generation oral cephalosporin antibiotic. It exerts a bactericidal effect by inhibiting bacterial cell wall synthesis. It acetylates membrane-bound transpeptidases, thereby disrupting the cross-linking of peptidoglycans necessary for providing strength and rigidity to the cell wall.

It is active against Staphylococcus spp., Streptococcus pneumoniae, Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (including ampicillin-resistant strains), Neisseria gonorrhoeae (including penicillinase-producing strains), Bacteroides spp. (except for fragilis), Moraxella catarrhalis, Citrobacter diversus, Propionibacterium, Peptococcus spp., Peptostreptococcus spp.

It is not active against Listeria spp., Bordetella spp., Mycoplasma spp., Chlamydia spp., Enterococcus faecalis, Enterococcus faecium, Pseudomonas spp., Bacteroides fragilis spp., Campylobacter jejuni, most strains of Enterobacter, Morganella morganii, Proteus vulgaris, Providencia, Serratia, Acinetobacter.

Cefaclor is characterized by intermediate resistance to β-lactamases and is resistant to penicillinases.

Pharmacokinetics

Cefaclor is well absorbed from the gastrointestinal tract. Plasma protein binding is 25%. After a single oral dose of 250 mg, 500 mg, and 1000 mg taken on an empty stomach, the C_max in plasma was reached 60 minutes after administration and was about 7, 15, and 26 mg/L, respectively. Plasma protein binding is about 25%. Cefaclor is rapidly distributed in the body and reaches therapeutic concentration in most tissues and fluids. It crosses the placental barrier and is excreted in breast milk. 85% of the administered dose is excreted unchanged in the urine within 8 hours. The plasma T1/2 averages 45 minutes (29-60 minutes).

Indications

Infectious and inflammatory diseases caused by microorganisms sensitive to cefaclor: infections of the upper and lower respiratory tracts; ear, nose, and throat infections (e.g., otitis media, sinusitis, tonsillitis, pharyngitis); kidney and urinary tract infections (including gonorrhea); skin and soft tissue infections.

ICD codes

Dosage Regimen

Administer orally.

Set the dosage regimen individually based on infection severity, location, pathogen sensitivity, patient age, and dosage form.

For adults, the standard dosage for mild to moderate infections is 250 mg every 8 hours.

For more severe infections, infections caused by less susceptible organisms, or lower respiratory tract infections, increase the dosage to 500 mg every 8 hours.

The maximum daily dose for adults should not exceed 4 grams.

For the treatment of uncomplicated urinary tract infections, a dosage of 500 mg every 12 hours is sufficient.

For the treatment of uncomplicated gonorrhea, administer a single 3-gram dose.

For pediatric patients, the recommended daily dosage is 20 to 40 mg per kg of body weight, divided into two or three equal doses.

In more serious infections, such as otitis media, the higher dosage of 40 mg per kg per day is recommended.

The maximum pediatric daily dose should not exceed 1 gram.

For patients with renal impairment, adjust the dosage. If creatinine clearance is below 5 mL/min, administer 50% of the standard dose. For patients undergoing hemodialysis, administer a supplemental dose after the procedure.

Complete the full course of therapy, even if symptoms improve, to ensure eradication of the pathogen and prevent the development of resistance.

Adverse Reactions

Allergic reactions: skin rash, skin itching, genital itching, urticaria, eosinophilia, arthralgia, fever, shortness of breath, angioedema, conjunctivitis, fainting, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, anaphylaxis.

From the nervous system: agitation, anxiety, insomnia, dizziness, paresthesia, motor agitation, confusion, hallucinations, asthenia.

From the reproductive system: vaginitis.

From the urinary system: impaired renal function, interstitial nephritis, dysuria, nocturia.

From the digestive system: decreased appetite, diarrhea, nausea, vomiting, constipation, pseudomembranous enterocolitis, abdominal pain, hepatitis, cholestatic jaundice.

From the hematopoietic system: hypoplastic anemia, leukopenia, neutropenia, agranulocytosis, thrombocytopenia, hemolytic anemia.

From the cardiovascular system: increased blood pressure.

From laboratory parameters: hyperazotemia, increased urea concentration, hypercreatininemia, increased activity of hepatic transaminases, hyperbilirubinemia.

Other: candidiasis, superinfection, increased sweating, bleeding.

Contraindications

Hypersensitivity to cefaclor and other cephalosporins; pediatric age – depending on the dosage form.

With caution

In patients with a history of severe allergic diseases or bronchial asthma, chronic renal failure, leukopenia, hemorrhagic syndrome; pregnancy, lactation period.

Use in Pregnancy and Lactation

During pregnancy, it should be used only after consultation with a doctor, in cases where the intended benefit to the mother outweighs the potential risk to the fetus.

If it is necessary to use during lactation, breastfeeding should be discontinued.

Use in Renal Impairment

Use with caution in chronic renal failure.

Pediatric Use

It can be used in children of appropriate age categories strictly according to indications, in recommended doses and dosage forms. It is necessary to strictly follow the instructions in the cefaclor drug leaflets regarding contraindications for the use of specific cefaclor dosage forms in children of different ages.

Special Precautions

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

During the use of cefaclor, it is necessary to monitor prothrombin time and bleeding time.

During treatment, a positive direct Coombs test and a false-positive urine glucose reaction are possible.

Drug Interactions

Cefaclor, by suppressing the intestinal flora, inhibits the synthesis of vitamin K. Therefore, with simultaneous use with drugs that reduce platelet aggregation (NSAIDs, salicylates, sulfinpyrazone), the risk of bleeding increases. For the same reason, when co-administered with anticoagulants, an enhancement of the anticoagulant effect is noted.

With simultaneous use, probenecid slows down the excretion of cefaclor by reducing its tubular secretion.

With simultaneous use, Cefaclor enhances (mutually) the nephrotoxicity of aminoglycosides, polymyxins, phenylbutazone.

With simultaneous use, the antibacterial effect of cefaclor is enhanced by aminoglycosides, metronidazole, polymyxins, rifampicin, and weakened by chloramphenicol, tetracyclines.

With simultaneous use, antacids containing magnesium or aluminum hydroxide slow down the rate of absorption of cefaclor. Histamine H₂-receptor blockers (cimetidine, ranitidine, nizatidine, roxatidine, famotidine) do not affect the rate and extent of absorption.

With simultaneous use, tubular secretion blockers delay the renal excretion of cefaclor.

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.