Indications

Zemicef is an orally active cephalosporin antibiotic with marked in-vitro bactericidal activity against a wide variety of Gram-positive and Gram-negative organisms. It is indicated for the treatment of the following acute infections caused by susceptible microorganisms:

Upper Respiratory Tract Infections (URTI): e.g. otitis media and other URTIs resistant to commonly used antibiotics or where treatment failure may carry significant risk.
Lower Respiratory Tract Infections: e.g. bronchitis.
Urinary Tract Infections (UTI): e.g. cystitis, cystourethritis, pyelonephritis.

Clinical efficacy has been demonstrated against Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella spp., Haemophilus influenzae (β-lactamase positive and negative), Moraxella catarrhalis (β-lactamase positive and negative), and Enterobacter spp. Zemicef is highly stable in the presence of β-lactamase enzymes.

Pharmacology

Cefixime is a third-generation semisynthetic cephalosporin antibiotic for oral administration. It is bactericidal against a broad spectrum of Gram-positive and Gram-negative bacteria at achievable plasma concentrations. It kills bacteria by interfering with bacterial cell wall synthesis. It is highly stable in the presence of β-lactamase enzymes, making many organisms resistant to penicillins and some cephalosporins susceptible to Cefixime. Absorption is about 40–50%, whether administered with or without food.

Dosage & Administration

General course: 7 days, extendable up to 14 days if required.
Adults & children >10 years: 200–400 mg daily depending on severity, as a single dose or in two divided doses.
Elderly: Same as adults; adjust dose in severe renal impairment.
Children: 8 mg/kg/day as a single dose or in two divided doses.
- 6 months–1 year: 3.75 ml daily
- 1–4 years: 5 ml daily
- 5–10 years: 10 ml daily
- Typhoid: 5 mg/kg twice daily for 10–14 days
Children >50 kg or >10 years: Adult dose (200–400 mg daily).
Children <6 months: Safety and efficacy not established.
Renal impairment:
- Creatinine clearance ≥20 ml/min: normal dose.
- Creatinine clearance <20 ml/min: max 200 mg once daily.
- Hemodialysis/peritoneal dialysis: same as clearance <20 ml/min.

Interaction

Prothrombin time increases noted in some patients. Caution with anticoagulant therapy.

Contraindications

Hypersensitivity to cephalosporin antibiotics.

Side Effects

Generally well tolerated. Most adverse reactions are mild and self-limiting.

Gastrointestinal: Diarrhea, stool changes, nausea, abdominal pain, dyspepsia, vomiting, flatulence, pseudomembranous colitis.
CNS: Headache, dizziness.
Hypersensitivity: Rash, pruritus, urticaria, drug fever, arthralgia.
Hematology: Thrombocytopenia, leukopenia, eosinophilia (rare, reversible).
Liver/Renal: Mild transient changes in function tests.
Miscellaneous: Genital pruritus, vaginitis.

Pregnancy & Lactation

No adequate controlled studies in pregnant women. Use only if clearly needed. Unknown if excreted in human milk; caution advised in nursing mothers.

Precautions & Warnings

Use cautiously in patients hypersensitive to other drugs.
Cross-allergenicity possible with penicillins. Severe reactions (including anaphylaxis) reported.
Discontinue if allergic reaction occurs.
Use cautiously in patients with impaired renal function.
Broad-spectrum antibiotics may cause Clostridium difficile-associated diarrhea.
Avoid use in pregnancy and lactation unless essential.

Overdose Effects

No specific antidote. Gastric lavage may be indicated. Not significantly removed by dialysis. Single doses up to 2 g in healthy adults produced no adverse effects beyond those seen at recommended doses.