Indications

T-Cef (Cefixime) is an orally active cephalosporin antibiotic indicated for the treatment of acute infections caused by susceptible microorganisms. It is used for:

• Upper Respiratory Tract Infections (URTI): Such as otitis media and other URTI where the causative organism is known or suspected to be resistant to other commonly used antibiotics.
• Lower Respiratory Tract Infections: Such as bronchitis.
• Urinary Tract Infections (UTI): Such as cystitis, cystourethritis, and pyelonephritis. It is effective against a wide range of common pathogens, including Streptococcus pneumoniae, E. coli, and Haemophilus influenzae. T-Cef is highly stable in the presence of beta-lactamase enzymes.

Pharmacology

Cefixime is a third-generation semisynthetic cephalosporin antibiotic. It is bactericidal, meaning it kills bacteria by interfering with the synthesis of their cell walls. Its high stability against beta-lactamase enzymes makes it effective against many organisms that are resistant to penicillins and some other cephalosporins. Its absorption is about 40-50% and is not significantly affected by food.

Dosage & Administration

• Adults and Children over 10 years: 200-400 mg daily, given as a single dose or in two divided doses. The usual course of treatment is 7 days, which may be extended up to 14 days if needed.
• Elderly: Same as adult dosage, but renal function should be assessed and adjusted in cases of severe renal impairment.
• Children: 8 mg/kg/day, administered as a single dose or in two divided doses.
  • Children 6 months to 1 year: 3.75 ml daily.
  • Children 1-4 years: 5 ml daily.
  • Children 5-10 years: 10 ml daily.
• Typhoid in children: 5 mg/kg body weight twice daily for 10-14 days.
• Children less than 6 months: Safety and efficacy have not been established.
• Renal Impairment: No dose adjustment is needed for creatinine clearance of 20 ml/min or greater. For creatinine clearance less than 20 ml/min, the dose should not exceed 200 mg once daily.

Interaction

Like other cephalosporins, it may increase prothrombin times, so caution is advised for patients on anticoagulant therapy.

Contraindications

T-Cef is contraindicated in patients with a known hypersensitivity to cephalosporin antibiotics.

Side Effects

T-Cef is generally well-tolerated. The most common side effects are mild and self-limiting:

• Gastrointestinal: Diarrhea and stool changes (more common with higher doses), nausea, abdominal pain, vomiting, and flatulence. Pseudomembranous colitis has also been reported.
• Central Nervous System: Headache and dizziness.
• Hypersensitivity reactions: Rash, itching, urticaria, drug fever, and joint pain.
• Hematological: Rare, reversible thrombocytopenia, leukopenia, and eosinophilia.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if clearly needed. It is not known if Cefixime is excreted in human milk, so caution should be exercised when administering it to a nursing woman.

Precautions & Warnings

• Hypersensitivity: Use with caution in patients who have shown hypersensitivity to other drugs, particularly penicillin, due to the possibility of cross-allergenicity.
• Renal Impairment: Administer with caution in patients with significantly impaired renal function.
• Antibiotic-Associated Diarrhea: Treatment with broad-spectrum antibiotics can alter the normal flora of the colon and lead to Clostridium difficile overgrowth, which is a primary cause of antibiotic-associated diarrhea.

Overdose Effects

No specific antidote exists. Gastric lavage may be indicated. T-Cef is not removed in significant quantities by hemodialysis or peritoneal dialysis.

Storage Conditions

Keep below 30ºC, protected from light and moisture. Keep out of the reach of children.