Cefamax 400

Indications

Cefamax is designed to treat mild-to-moderate infections caused by susceptible microorganisms, specifically in the following conditions:

• Acute Bacterial Exacerbations of Chronic Bronchitis: Effective against Haemophilus influenzae (including beta-lactamase producing strains), Moraxella catarrhalis (including beta-lactamase producing strains), and penicillin-susceptible strains of Streptococcus pneumoniae.
• Acute Bacterial Otitis Media: Targeting infections due to Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.
• Pharyngitis and Tonsillitis: Primarily caused by Streptococcus pyogenes.

Pharmacology

Ceftibuten, the active component of Cefamax, is a semi-synthetic cephalosporin antibiotic formulated for oral use. It exerts its bactericidal effects by binding to essential proteins in the bacterial cell wall, inhibiting cell wall synthesis.

Dosage & Administration

Otitis Media:

• Adults: 400 mg orally once daily for 10 days
• Pediatrics (>6 months): 9 mg/kg/day (maximum 400 mg) for 10 days

Tonsillitis/Pharyngitis:

• Adults: 400 mg orally once daily for 10 days
• Pediatrics (>6 months): 9 mg/kg/day (maximum 400 mg) for 10 days

Bronchitis:

• Adults: 400 mg orally once daily for 10 days
• Pediatrics (>12 years): 400 mg orally once daily for 10 days

Cystitis:

• Adults: 400 mg orally once daily for 7 days
• Pediatrics (>12 years): 400 mg orally once daily for 7 days

Pneumonia:

• Adults: 200 mg orally every 12 hours for 7 to 14 days
• Pediatrics (>12 years): 200 mg orally every 12 hours for 7 to 14 days

Sinusitis:

• Adults: 400 mg orally once daily for 10 to 14 days
• Pediatrics (>12 years): 400 mg orally once daily for 10 to 14 days

Urinary Tract Infection:

• Adults: 400 mg orally once daily for 10 days
• Pediatrics (>6 months): 9 mg/kg/day (maximum 400 mg) for 10 days

Always follow your doctor’s advice when taking medication.

Interactions

Theophylline and antacids do not affect the pharmacokinetics of Cefamax, while ranitidine increases its Cmax and AUC.

Contraindications

Ceftibuten is not recommended for patients with a known allergy to cephalosporin antibiotics.

Side Effects

Common side effects may include nausea, headache, diarrhea, dyspepsia, dizziness, abdominal pain, and vomiting.

Pregnancy & Lactation

Ceftibuten is classified as Pregnancy Category B. Controlled studies in pregnant women are lacking, so it should be used only if the benefits outweigh the risks. The excretion of Ceftibuten in breast milk is unknown, so caution is advised during breastfeeding.

Precautions & Warnings

Prolonged use of broad-spectrum antibiotics like Cefamax may lead to the development of resistant organisms. Close monitoring of the patient is crucial. Dose adjustments may be necessary for patients with renal impairment, and caution should be exercised in individuals with a history of gastrointestinal disorders, particularly colitis.

Use in Special Populations

Renal Impairment:

• CrCl 5 to 29 ml/min: 2.25 mg/kg or 100 mg orally once daily
• CrCl 30 to 49 ml/min: 4.5 mg/kg or 200 mg orally once daily

Hepatic Impairment: No dose adjustment is needed.

Therapeutic Class

Third-generation cephalosporins.

Reconstitution

• The small bottle contains purified water; the large bottle contains granules.
• Pour the purified water completely into the large bottle.
• Secure the cap and shake for at least one minute.
• Use a measuring cup or dropper for the reconstituted suspension.

The prepared suspension should be consumed within 14 days if stored in the refrigerator. Shake well before each use.

Storage Conditions

Store below 25°C, away from light and moisture. After reconstitution, the suspension can be used for 14 days when stored at 2° to 8°C. Keep out of reach of children.