Cef-3 DS

Indications

Cef-3 DS is an orally active third generation cephalosporin antibiotic with bactericidal activity against a wide range of gram-positive and gram-negative organisms. It is indicated for acute infections caused by susceptible organisms, including upper respiratory tract infections such as otitis media and other URTI where resistance to commonly used antibiotics is suspected or treatment failure carries significant risk, lower respiratory tract infections such as bronchitis, and urinary tract infections including cystitis, cystourethritis and pyelonephritis. Clinical efficacy has been demonstrated in infections caused by pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), Moraxella catarrhalis (beta-lactamase positive and negative) and Enterobacter species. Cef-3 DS is highly stable in the presence of beta-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 usual plasma concentrations by interfering with bacterial cell wall synthesis. It is highly stable to beta-lactamase enzymes, so many organisms resistant to penicillins and some cephalosporins may be susceptible to cefixime. Oral absorption is about 40% to 50% and is not significantly altered by food.

Dosage & Administration

• Adults and children over 10 years: 200-400 mg daily according to severity of infection, given as a single dose or in two divided doses.
• Elderly: Same dose as adults; assess renal function and adjust dose in severe renal impairment.
• Children: 8 mg/kg/day as a single dose or in two divided doses. As a guide when using suspension: 6 months to under 1 year: 3.75 ml daily; 1-4 years: 5 ml daily; 5-10 years: 10 ml daily.
• In typhoid (children): 5 mg/kg body weight twice daily for 10-14 days.
• Children over 10 years or weighing more than 50 kg: Use the recommended adult dose of 200-400 mg daily depending on severity of infection.
• Children under 6 months: Safety and efficacy have not been established.
• Renal impairment: For creatinine clearance 20 ml/min or greater, use normal dose and schedule. For creatinine clearance less than 20 ml/min, do not exceed 200 mg once daily. Patients on chronic ambulatory peritoneal dialysis or haemodialysis should follow the same recommendation as for creatinine clearance less than 20 ml/min.

Interaction

As with other cephalosporins, increases in prothrombin time have been reported in a few patients; use with caution in patients receiving anticoagulant therapy.

Contraindications

Known hypersensitivity to cefixime or other cephalosporin antibiotics.

Side Effects

Cef-3 DS is generally well tolerated and most adverse reactions are mild and self-limiting. Gastrointestinal: diarrhoea and stool changes are the most frequent, especially with higher doses; less frequent effects include nausea, abdominal pain, dyspepsia, vomiting and flatulence. Pseudomembranous colitis has been reported. Central nervous system: headache and dizziness. Hypersensitivity reactions: rash, pruritus, urticaria, drug fever and arthralgia, usually resolving after discontinuation. Hematological and clinical chemistry: thrombocytopenia, leukopenia and eosinophilia, usually infrequent and reversible; mild transient changes in liver and renal function tests have been observed. Other: genital pruritus and vaginitis.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women, so cefixime should be used during pregnancy only if clearly needed. It is not known whether cefixime is excreted in human milk; caution is advised when administering to nursing women.

Precautions & Warnings

Use with caution in patients with a history of hypersensitivity to any drugs. Cephalosporins should be used with caution in penicillin-sensitive patients because of partial cross-allergenicity; severe reactions including anaphylaxis have occurred with both classes. If an allergic reaction occurs, discontinue Cef-3 DS and treat appropriately. Use with caution in patients with markedly impaired renal function. Broad-spectrum antibiotics can alter normal colonic flora and permit overgrowth of Clostridium difficile; a toxin produced by C. difficile is a primary cause of antibiotic-associated diarrhoea. In pregnancy and lactation, Cef-3 DS should not be used unless considered essential by the physician.

Overdose Effects

In overdose, gastric lavage may be considered. There is no specific antidote. Cef-3 DS is not significantly removed from the circulation by haemodialysis or peritoneal dialysis. In healthy adult volunteers, single doses up to 2 g produced an adverse reaction profile similar to that seen at recommended doses.

Storage Conditions

Store below 30°C, protected from light and moisture, and keep out of the reach of children.