Cefixime Trihydrate is an orally active cephalosporin antibiotic with strong in-vitro bactericidal activity against a wide range of Gram-positive and Gram-negative bacteria. It is indicated for the treatment of the following acute infections caused by susceptible microorganisms:

Upper Respiratory Tract Infections (URTI): Examples include otitis media and other URTIs where the causative organism is known or suspected to be resistant to commonly used antibiotics, or where treatment failure could pose significant risk. Lower Respiratory Tract Infections: Examples include bronchitis.

Urinary Tract Infections (UTI): Examples include cystitis, cystourethritis, and pyelonephritis. Clinical efficacy has been demonstrated against commonly occurring pathogens such as Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (both beta-lactamase positive and negative), Moraxella catarrhalis (both beta-lactamase positive and negative), and Enterobacter species. Cefixime is highly stable in the presence of beta-lactamase enzymes.

Cefixime is a third-generation semisynthetic cephalosporin antibiotic for oral use. It is bactericidal against a broad spectrum of Gram-positive and Gram-negative bacteria at achievable plasma concentrations. It works by inhibiting bacterial cell wall synthesis. Cefixime is highly stable in the presence of beta-lactamase enzymes, making it effective against many organisms resistant to penicillins and some other cephalosporins. Oral absorption is about 40% to 50%, and it can be administered with or without food.

Absorption of Cefixime is not significantly affected by food. The usual course of treatment is 7 days, which may be extended up to 14 days if required.

Adults and children over 10 years: The recommended dosage is 200–400 mg daily, depending on infection severity, given as a single dose or in two divided doses.

Elderly: Same dose as adults may be used. Renal function should be assessed and dosage adjusted in severe renal impairment.

Children: Recommended dose is 8 mg/kg/day, either as a single dose or in two divided doses. Daily doses in terms of suspension volume:

• 6 months up to 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 >50 kg or older than 10 years: Treat with adult dose 200–400 mg/day depending on infection severity.

Children <6 months: Safety and efficacy not established.

Dosage in Renal Impairment: Cefixime can be given in renal impairment. Normal dosing may be used if creatinine clearance ≥20 ml/min. For clearance <20 ml/min, do not exceed 200 mg once daily. Same recommendation applies for patients on chronic ambulatory peritoneal dialysis or hemodialysis.

Like other cephalosporins, Cefixime may cause slight increases in prothrombin time in some patients. Care should be taken in patients receiving anticoagulant therapy.

Patients with known hypersensitivity to cephalosporin antibiotics.

Cefixime is generally well tolerated. Most adverse reactions are mild and self-limiting. Gastrointestinal: Diarrhea and changes in stool consistency are the most common, especially at higher doses. Less frequent effects include nausea, abdominal pain, dyspepsia, vomiting, flatulence, and rarely pseudomembranous colitis. Central Nervous System: Headache and dizziness. Hypersensitivity: Rash, pruritus, urticaria, drug fever, and arthralgia. These usually subside after discontinuation. Hematological & Clinical Chemistry: Thrombocytopenia, leukopenia, eosinophilia, and mild transient changes in liver or renal function tests. These are infrequent and reversible. Miscellaneous: Genital pruritus and vaginitis may occur.

There are no adequate well-controlled studies in pregnant women. Use only if clearly necessary. It is unknown if Cefixime is excreted in human milk; caution is advised when administered to nursing women.

Use with caution in patients with known drug hypersensitivity, especially penicillin-sensitive patients, due to potential cross-allergenicity. Discontinue Cefixime if allergic reactions occur and provide appropriate treatment. Administer carefully in patients with severe renal impairment. Broad-spectrum antibiotics may alter normal gut flora and allow Clostridium difficile overgrowth, which can cause antibiotic-associated diarrhea.

Gastric lavage may be performed; no specific antidote exists. Hemodialysis or peritoneal dialysis does not significantly remove Cefixime. Adverse effects in healthy volunteers receiving up to 2 g single dose were similar to those at recommended doses.

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