Zoventa 400 mg

Description

Indications
Zoventa is indicated for the treatment of mild-to-moderate infections caused by susceptible strains of microorganisms, including:

• Acute Bacterial Exacerbations of Chronic Bronchitis: Caused by Haemophilus influenzae (including β-lactamase producing strains), Moraxella catarrhalis (including β-lactamase producing strains), and penicillin-susceptible Streptococcus pneumoniae.
• Acute Bacterial Otitis Media: Caused by Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pyogenes.
• Pharyngitis and Tonsillitis: Caused by Streptococcus pyogenes.

Pharmacology
Ceftibuten is a semi-synthetic third-generation cephalosporin that inhibits bacterial cell wall synthesis by binding to essential target proteins, leading to bactericidal action.

Dosage & Administration

• Otitis Media:
  • Adults: 400 mg once daily for 10 days.
  • Pediatrics (>6 months): 9 mg/kg/day (max 400 mg) once daily for 10 days.
• Tonsillitis/Pharyngitis:
  • Adults: 400 mg once daily for 10 days.
  • Pediatrics (>6 months): 9 mg/kg/day (max 400 mg) once daily for 10 days.
• Bronchitis:
  • Adults: 400 mg once daily for 10 days.
  • Pediatrics (>12 years): 400 mg once daily for 10 days.
• Cystitis:
  • Adults and Pediatrics (>12 years): 400 mg once daily for 7 days.
• Pneumonia:
  • Adults: 200 mg every 12 hours for 7-14 days.
  • Pediatrics (>12 years): 200 mg every 12 hours for 7-14 days.
• Sinusitis:
  • Adults and Pediatrics (>12 years): 400 mg once daily for 10-14 days.
• Urinary Tract Infection:
  • Adults: 400 mg once daily for 10 days.
  • Pediatrics (>6 months): 9 mg/kg/day (max 400 mg) once daily for 10 days.

Interaction

• Theophylline and antacids do not alter the pharmacokinetics of Zoventa.
• Ranitidine increases the Cmax and AUC of Zoventa.

Contraindications
Ceftibuten is contraindicated in patients allergic to cephalosporins.

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

Pregnancy & Lactation

• Pregnancy: Category B. Use only if clearly needed.
• Lactation: Unknown if Ceftibuten is excreted in human milk; caution is advised.

Precautions & Warnings

• Prolonged use may lead to resistant organisms.
• Dose adjustments may be needed in patients with renal insufficiency.
• Caution should be exercised in patients with gastrointestinal diseases (especially colitis).

Use in Special Populations

• Renal Impairment:
  • CrCl 5-29 ml/min: 2.25 mg/kg or 100 mg once daily.
  • CrCl 30-49 ml/min: 4.5 mg/kg or 200 mg once daily.
• Hepatic Impairment: No dose adjustment is necessary.

Therapeutic Class
Third-generation Cephalosporins

Reconstitution Instructions

1. Pour the purified water from the small bottle into the large bottle containing granules.
2. Tighten the cap and shake for at least one minute.
3. Use a measuring cup or dropper for dosing.
4. Store the prepared suspension in a refrigerator (2°-8°C) and consume within 14 days. Shake well before use.

Storage Conditions
Store below 25°C, protected from light and moisture. Keep out of reach of children.