Cefim-3, Powder For Suspension - (100mg/5ml) is a preparation that, after reconstitution, contains Cefixime Trihydrate equivalent to Cefixime 100mg per 5ml. It is manufactured by ACI Limited. It is available in a 50ml bottle. 

Indications:

Cefim-3 is an orally active, third-generation cephalosporin antibiotic. It is indicated for the treatment of acute infections caused by susceptible microorganisms, including: 

• Upper Respiratory Tract Infections (URTIs): Such as otitis media (ear infections), pharyngitis, tonsillitis, and sinusitis, especially when the causative organism is known or suspected to be resistant to other common antibiotics. 
• Lower Respiratory Tract Infections (LRTIs): Such as bronchitis and acute exacerbations of chronic bronchitis. 
• Urinary Tract Infections (UTIs): Including uncomplicated cystitis, cystourethritis, and pyelonephritis. 
• Uncomplicated Gonorrhea (cervical/urethral) caused by Neisseria gonorrhoeae. 
• Typhoid Fever.

Clinical efficacy has been demonstrated against common pathogens including Streptococcus pneumoniae, Streptococcus pyogenes, Escherichia coli, Proteus mirabilis, Klebsiella species, Haemophilus influenzae (beta-lactamase positive and negative), and Moraxella catarrhalis (beta-lactamase positive and negative). 

Pharmacology:

Cefixime is a bactericidal antibiotic that acts by interfering with the synthesis of the bacterial cell wall. It is highly stable in the presence of beta-lactamase enzymes, making it effective against many organisms resistant to penicillins and some other cephalosporins. Approximately 40%-50% of an oral dose is absorbed from the gastrointestinal tract. 

Dosage and Administration:

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

• Children (6 months or older): The recommended dosage is 8 mg/kg/day, administered as a single dose or in two divided doses (every 12 hours). 
  • 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: Dosage should be 10 mg/kg/day for 14 days. 
• Adults and children over 12 years: 200-400 mg daily, given as a single dose or in two divided doses. 
• Uncomplicated gonococcal infections: A single oral dose of 400 mg. 

Reconstitution Instructions for 50ml Suspension: To prepare 50 ml suspension, add 35 ml (7 teaspoonfuls) of boiled and cooled water in two portions to the bottle. Shake well after each addition until the powder is completely mixed with water. Keep the prepared suspension in a cool place and consume within 14 days of preparation. 

Contraindications:

Cefim-3 is contraindicated in patients with known hypersensitivity to cefixime or other cephalosporin antibiotics. 

Side Effects:

Cefim-3 is generally well tolerated. Most adverse reactions are mild and self-limiting. 

• Gastrointestinal: Diarrhea and changes in stool consistency are most frequent (more common with higher doses). Other less frequent side effects include nausea, abdominal pain, dyspepsia, vomiting, and flatulence. Pseudomembranous colitis has been reported. 
• Central Nervous System: Headache and dizziness. 
• Hypersensitivity reactions: Rash, pruritus (itching), urticaria (hives), drug fever, and arthralgia (joint pain) have been observed. These usually subside upon discontinuation of therapy. 
• Hematological: Rarely, thrombocytopenia, leukopenia, and eosinophilia have been reported. 

Precautions and Warnings:

• Use with caution in patients with a history of gastrointestinal diseases, particularly colitis. 
• Exercise caution in patients with markedly impaired renal function; dose adjustment is necessary if creatinine clearance is less than 20 ml/min (maximum 200 mg daily for adults and children over 12 years). 
• Cephalosporins should be given with caution to penicillin-sensitive patients due to potential cross-allergenicity. 
• 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. Cefim-3 should be used during pregnancy only if clearly needed. 
• Lactation: It is not known if cefixime is excreted in human milk. Caution should be exercised, and consideration given to discontinuing nursing temporarily if essential. 

Drug Interactions:

• Concomitant use with Carbamazepine may elevate carbamazepine levels. 
• Concurrent use with Warfarin and other anticoagulants may increase prothrombin time; monitor INR closely. 

Storage Conditions:

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