Cephoral Powder for Suspension contains Cefixime Trihydrate. It is a widely used antibiotic in Bangladesh, manufactured by Labaid Pharmaceuticals Ltd. It comes in various strengths for suspension, including 100 mg/5 ml and 200 mg/5 ml, typically in 50 ml bottles.

Composition:

• Cephoral Powder for Suspension (100 mg/5 ml): After reconstitution, each 5 ml suspension contains Cefixime Trihydrate equivalent to Cefixime 100 mg.
• Cephoral Powder for Suspension (200 mg/5 ml) (also known as "DS" or "Double Strength"): After reconstitution, each 5 ml suspension contains Cefixime Trihydrate equivalent to Cefixime 200 mg.

Indications:

Cefixime is a third-generation cephalosporin antibiotic effective against a broad spectrum of Gram-positive and Gram-negative bacteria. It is indicated for the treatment of various bacterial infections, including:

• Upper Respiratory Tract Infections (URTIs): Such as otitis media (ear infections), pharyngitis, tonsillitis, and sinusitis.
• Lower Respiratory Tract Infections (LRTIs): Including bronchitis and acute exacerbations of chronic bronchitis.
• Urinary Tract Infections (UTIs): Such as uncomplicated cystitis, cystourethritis, and pyelonephritis.
• Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae.
• Typhoid Fever.
• Skin and Soft Tissue Infections (though less commonly highlighted for this specific formulation).

Pharmacology:

Cefixime is a bactericidal antibiotic that acts by inhibiting bacterial cell wall synthesis. It is highly stable in the presence of beta-lactamase enzymes, making it effective against many organisms that are resistant to other antibiotics. Approximately 40% to 50% of an oral dose is absorbed from the gastrointestinal tract, and its absorption is not significantly affected by food.

Dosage and Administration:

The usual course of treatment is 7 days, but it may be extended up to 14 days depending on the severity of the infection.

• Adults and children over 12 years:
  • For most infections: 200-400 mg daily, given as a single dose or in two divided doses.
  • For uncomplicated gonococcal infections: A single oral dose of 400 mg.
• Children (6 months or older): The general recommended dose is 8 mg/kg/day, administered as a single dose or in two divided doses (every 12 hours). Specific guidelines by age:
  • ½-1 year: 75 mg daily.
  • 1-4 years: 100 mg daily.
  • 5-10 years: 200 mg daily.
  • 11-12 years: 300 mg daily.
• Typhoid Fever in children: Dosage should be 10 mg/kg/day for 14 days.

Reconstitution Instructions: Always follow the specific instructions on the bottle. Typically, boiled and cooled water is added in portions, and the bottle is shaken well after each addition until the powder is fully dissolved. The prepared suspension usually needs to be stored in a cool place and consumed within 14 days.

Contraindications:

• Known hypersensitivity to cefixime or other cephalosporin antibiotics.
• History of allergy to penicillin antibiotics (due to potential cross-allergenicity).

Side Effects:

Cefixime is generally well tolerated, with most adverse reactions being mild and self-limiting.

• Gastrointestinal disturbances: The most frequent side effects are diarrhea and changes in stool consistency (more common with higher doses). Other gastrointestinal effects include nausea, abdominal pain, dyspepsia, vomiting, and flatulence. Pseudomembranous colitis is a rare but serious potential side effect.
• Central Nervous System: Headache and dizziness.
• Hypersensitivity reactions: Rash, pruritus (itching), urticaria (hives), drug fever, and arthralgia (joint pain) have been reported. These usually subside upon discontinuation of therapy.
• Hematological: Rarely, transient changes in blood counts like leukopenia, eosinophilia, or thrombocytopenia have been observed.
• Liver/Kidney: Mild transient changes in liver and renal function tests.

Precautions and Warnings:

• Use with caution in patients with a history of gastrointestinal diseases, particularly colitis.
• Use with caution in patients with markedly impaired renal function; dose adjustment is necessary if creatinine clearance is less than 20 ml/min (in such cases, a dose of 200 mg once daily for adults and children over 12 years should not be exceeded).
• Safety and efficacy have not been established in children aged less than 6 months.

Pregnancy and Lactation:  

• Pregnancy:There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
• Lactation: It is not known whether cefixime is excreted in human milk. Caution should be exercised when administered to a nursing woman.

Drug Interactions:

• Warfarin and other anticoagulants: Concomitant use may increase prothrombin time; INR should be monitored closely.
• Carbamazepine: Concomitant use may elevate carbamazepine levels.
• Probenecid: May increase cefixime concentrations.

Storage Conditions:

Store in a cool and dry place, below 30°C, protected from light and moisture. Keep out of the reach of children. The prepared suspension should be stored in a cool place and used within 14 days.

Note: This information is for general knowledge and informational purposes only and does not substitute professional medical advice. Always consult your doctor or pharmacist for specific instructions and guidance regarding your medication.