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Cefaclor

Description
Cefaclor 250: Capsule Purple opaque and white opaque capsule with "hovid" printed on one end and "CFC250" on the other end of the capsule.
Cefaclor 500 Capsule: Purple opaque and grey opaque capsule with "hovid" printed on one end and "CFC500" on the other end of the capsule.
Cefaclor 125 mg / 5 ml Granules: Pink, strawberry flavoured granules.

Composition
Cefaclor 250 Capsule: Cefaclor (as monohydrate) 250 mg / capsule

Cefaclor 500 Capsule: Cefaclor (as monohydrate) 500 mg / capsule

Cefaclor 125 mg / 5 ml Granules: Cefaclor (as monohydrate) 125 mg / 5 ml

Actions and Pharmacology
Bactericidal; its action depends on ability to reach and bind penicillin-binding proteins located in bacterial cytoplasmic membranes. Cefaclor inhibits bacterial septum and cell wall synthesis, probably by acylation of membrane-bound transpeptidase enzymes. This prevents cross-linkage of peptidoglycan chains, which is necessary for bacterial cell wall strength and rigidity. Also, cell devision and growth are inhibited, and elongation of susceptible bacteria and lysis frequently occur. Rapidly dividing bacteria are those most susceptible to the action of cefaclor.

Cefaclor has comparable activity in vitro against most Gram-positive cocci but is more active against Gram-negative bacteria including Escherichia coli, Klebsiella pneumoniae, Neisseria gonorrhoeae, Proteus mirabilis and Haemophilus influenzae.

Pharmacokinetics
Cefaclor is well absorbed from the gastro-intestinal tract. The presence of food may delay the absorption of cefaclor, but the total amount absorbed is unchanged. Oral administration of doses of 250, 500 and 1000 mg produce peak plasma concentrations of about 7, 13 and 23 pg per ml respectively at 0.5 to 1 hour. A plasma half-life of 0.5 to 1 hour has been reported; it may be slightly prolonged in patients with renal impairment. About 25% is bound to plasma proteins. Cefaclor appears to be widely distributed in the body; it crossed the placenta and low concentrations have been detected in breast milk. It is rapidly excreted by the kidneys; up to 85% of a dose appears unchanged in the urine within 8 hours; the greater part within 2 hours. High concentrations of cefaclor are achieved in the urine within 8 hours of a dose; peak concentrations of 600, 900, and 1900 pg per ml have been reported after doses of 250, 500 and 1000 mg respectively. Probenecid delays excretion. Some cefaclor is removed by haemodialysis.

Indications
Cefaclor is indicated for the treatments of the followings caused by susceptible organisms:
Bronchitis
Otitis media
Pharyngitis, bacterial
Tonsillitis
Pneumonia, bacterial
Skin and soft tissue infections
Urinary tract infections, bacterial

Contraindications
Contraindicated in patients with previous allergic reaction (anaphylaxis) to penicillins, penicillin derivatives, penicillamine, or cephalosporins.

Precautions
Caution should be exercised to patients with previous hypersensitivity reactions to cefaclor, cephalosporins, penicillins, penicillin derivatives, or penicillamine.
Risk-benefit should be considered when the following medical problems exist:
history of bleeding disorders
history of gastrointestinal disease, especially ulcerative colitis, regional enteritis, or antibiotic-associated colitis; pseudomembranous colitis has been reported with cephalosporins
hepatic function impairment
renal function impairment

Prolonged use of Cefaclor may result in the overgrowth of nonsusceptible organisms. If superinfection occurs during therapy, appropriate measures should be taken. Positive direct Coombs' tests have been reported during treatment with the cephalosporin antibiotics.

Use in pregnancy and lactation
Animal studies have shown no evidence of impaired fertility or teratogenicity. However, since there are no adequate or wellcontrolled studies in human, caution should be exercised when prescribing for the pregnant patient. Small amounts of cefaclor have been detected in breast milk. As the effect on nursing infants is not known, caution should be exercised when cefaclor is administered to a nursing woman.

Main Side/Adverse Effects
Incidence less frequent or rare include hypoprothrombinemia, pseudomembranous colitis, allergic reactions (anaphylaxis), erythema multiforme or Stevens-Johnson syndrome, hearing loss, haemolytic anemia, hypersensitivity reactions (symptoms including morbilliform eruptions, pruritus, urticaria, positive Coomb's tests), renal dysfunction, serum sickness-like reactions, seizures and thrombophlebitis.
Other incidences include:
Gastrointestinal reactions, headache, oral candidiasis and vaginal candidiasis.
Eosinophilia, genital pruritus, monoliasis or vaginitis, thrombocytopenia, reversible interstitial nephritis.
Central nervous system (CNS): reversible hyperactivity, agitation, nervousness, insomnia, confusion, hypertonia, dizziness, hallucinations and somnolence have been reported rarely.
Hepatic: slight elevations of ST (SGOT), ALT (SGPT) or alkaline phosphatase values.
Hematopoletic: transient lymphocytosis, leukopenia and rarely, haemolytic anemia, aplastic anemia, agranulocytosis and reversible neutropenia.
Increased prothrombin time.
Renal: slight elevations in blood urea (BUN) or serum creatinine or abnormal urinalysis.

Drug Interactions
The extent of absorption of cefaclor is decreased with concurrent use of aluminium hydroxide or magnesium-containing antacids.
Concurrent use of cefaclor and oral anticoagulants will increase the anticoagulant effect. There have been rare reports of increased prothrombin time in patients receiving cefaclor and warfarin concomitantly.
Renal excretion of cefaclor is inhibited by probenecid.
A false-positive reaction for glucose in the urine may occur with Benedict's of Fehling's solutions or with copper sulphate test tables.

Overdose
Symptoms of nausea, vomiting, epigastric distress and diarrhoea would be anticipated.

Treatment for overdosage
Activated charcoal may aid in decreasing the absorption of cefaclor. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.

Dosage and Administration
Cefaclor Capsule:
Usual adult and adolescent dose:
Oral, 250 mg to 500 mg every 8 hours up to 2 g per day; however, 4 g per day have been administered.
For the treatment of acute gonococcal urethritis, a single dose of 3 g combined with probenecid, 1 g, is given.

Usual paediatric dose: Refer to Cefaclor Granules.

Cefaclor Granules:
Usual adult and adolescent dose: Refer to Cefaclor Capsule.
Usual paediatric dose:
Oral,
Infants and children 1 month of age and older: 20 mg per kg of body weight daily in 3 divided doses. Doses up to 40 mg per kg of body weight per day have been used but maximum dose should not exceed 1 g per day.
Infants up to 1 month of age: Safety and efficacy have not been established.

Note: The information given here is limited. For further information, consult your doctor or pharmacist.

Storage

Store below 25C .

Protect from light and moisture.
Granules - After reconstitution, the suspension should be stored in refrigerator and be used within 10 days.

 

Presentation/Packing

Capsule - Bottle of 100's; blister packs of 10 x 10's
Granules - Bottle of 60 ml

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