Cillinox Suspension

Therapeutic Class

Antibacterial, Penicillins

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Suspension (NRN: 04-2428): Each 5 mL contains: Ampicillin Trihydrate USP equiv. to Ampicillin USP 125 mg, Cloxacillin Sodium USP equiv. to Cloxacillin USP 125 mg; powder for reconstitution.

Pack size: White PE bottle of 100 mL.

Oral drops (NRN: 04-7472): Each 0.6 mL contains: Ampicillin Trihydrate USP equiv. to Ampicillin USP 60 mg, Cloxacillin Sodium USP equiv. to Cloxacillin USP 30 mg; powder for reconstitution.

Pack size: Amber glass bottle of 12 mL.

Pharmacology

Ampicillin is bactericidal at low concentrations and is clinically effective not only against the gram-positive organisms usually susceptible to penicillin G but also against a variety of gram-negative organisms. Ampicillin and Cloxacillin are semi-synthetic bactericidal penicillin derived antibiotics. Ampicillin has bactericidal action against gram-positive microorganisms e.g Streptococcus pneumoniae, Enterococcus faecalis. It also has bactericidal action against gram-negative Bacilli including some strains of Bordetella pertusis, Haemophilus influenzae and some Enterbacteriaceae such as E. coli, Proteus mirabilis.

Cloxacillin is effective against penicillinase in beta-lactamase producing organisms e.g., Staphylococci, Pseudomonas aeruginosa, P. vulgaris, Klebsiella pneumoniae.

The combination of Ampicillin and Cloxacillin in Cillinox therefore provides bactericidal activity against a wide range of microorganisms including mixed infections of Ampicillin-susceptible gram-negative bacteria and penicillin-resistantStaphylococci.

Indications

Cillinox is indicated in the treatment of infections of the respiratory tract, ear, nose and throat, Urinary tract, skin and soft tisssues; Septicaemia, Pelvic infections, Endocarditis and Orthopaedic infections.

Cillinox Neonatal drops is indicated for the prophylaxis or treatment of bacterial infections in premature babies or neonates, such as following amniotic fluid infection in delayed or complicated delivery.

Contra-indications

History or previous hypersensitivity reaction, glandular fever and lymphatic lymphoma and causes of obvious resistance.

Precautions/Warnings

Cillinox should be given with caution to patients with a history of allergy to other drugs, care in administering high doses to patients with renal impairment, to be used strictly under medical supervision during pregnancy.

Interactions

When administered concurrently, the following drugs may interact with Ampicillin:

Allopurinol – Increased possibility of skin rash; particularly in hyperuricemic patients may occur.

Bacteriostatic antibiotics– Chloramphenicol, erythromycins, sulfonamides, or tetracyclines may interfere with the bactericidal effect of penicillins.

This has been demonstrated in vitro; however, the clinical significance of this interaction is not well-documented.

Oral contraceptives – May be less effective and increased breakthrough bleeding may occur.

Probenecid – May decrease renal tubular secretion of Ampicillin resulting in increased blood levels and/or Ampicillin toxicity.

Adverse Effects

Common side effects include skin rash, diarrhoea, nausea and vomiting.

Dosage & Administration

Storage/Handling Recommendations

Keep all medicine in a cool dry place and out of the reach of children.