Cefamax DS

Indications

Cefamax DS is prescribed for the treatment of mild to moderate infections caused by specific, susceptible microorganisms, in the following conditions:

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

Consult a registered healthcare professional for appropriate dosage and treatment advice.

Pharmacology

Ceftibuten, the active component in Cefamax DS, is a semi-synthetic, oral Cephalosporin antibiotic. As a dihydrate salt, it exerts its bactericidal effect by binding to vital proteins in the bacterial cell wall, inhibiting the synthesis of the cell wall, and leading to bacterial death.

Dosage & Administration

• Otitis Media
  • Adults: 400 mg orally once daily for 10 days
  • Children (over 6 months): 9 mg/kg/day (up to 400 mg) once daily for 10 days
• Tonsillitis/Pharyngitis
  • Adults: 400 mg orally once daily for 10 days
  • Children (over 6 months): 9 mg/kg/day (up to 400 mg) once daily for 10 days
• Acute Bronchitis
  • Adults: 400 mg orally once daily for 10 days
  • Children (over 12 years): 400 mg orally once daily for 10 days
• Cystitis (Urinary Tract Infection)
  • Adults: 400 mg orally once daily for 7 days
  • Children (over 12 years): 400 mg orally once daily for 7 days
• Pneumonia
  • Adults: 200 mg orally every 12 hours for 7 to 14 days
  • Children (over 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
  • Children (over 12 years): 400 mg orally once daily for 10 to 14 days
• Urinary Tract Infections
  • Adults: 400 mg orally once daily for 10 days
  • Children (over 6 months): 9 mg/kg/day (up to 400 mg) once daily for 10 days

Follow the dosage instructions provided by your healthcare provider.

Drug Interactions

The pharmacokinetic profile of Cefamax DS is unaffected by Theophylline or Antacids. However, Ranitidine may increase both the Cmax and AUC of Cefamax DS.

Contraindications

Cefamax DS is not recommended for individuals with a known allergy to cephalosporin antibiotics.

Possible Side Effects

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

Pregnancy & Lactation

Cefamax DS is classified as Pregnancy Category B. There are no controlled studies in pregnant women, so it should only be used during pregnancy when the benefits clearly outweigh the risks. It is not confirmed whether Ceftibuten is excreted in human milk. Caution is advised when administering Cefamax DS to breastfeeding women.

Precautions & Warnings

Prolonged use of Cefamax DS may lead to the development of antibiotic-resistant organisms. Patients should be monitored closely for signs of infection. For those with renal insufficiency, the dosage of Cefamax DS may need to be adjusted. Caution is required when prescribing Cefamax DS to individuals with a history of gastrointestinal diseases, especially colitis.

Use in Special Populations

• Renal Impairment:
  • CrCl 5-29 ml/min: 100 mg orally once daily
  • CrCl 30-49 ml/min: 200 mg orally once daily
• Hepatic Impairment: No dose adjustment is required for patients with liver dysfunction.

Therapeutic Class

Third-Generation Cephalosporins

Reconstitution Instructions

• The small bottle contains purified water, and the large bottle contains granules.
• Pour the purified water into the large bottle, tighten the cap, and shake for at least 1 minute.
• Use the reconstituted suspension with a measuring cup or dropper.

After preparation, the suspension should be consumed within 14 days if stored in a refrigerator. Shake well before each use.

Storage Recommendations

Store at temperatures below 25°C, away from light and moisture. After reconstitution, store the suspension between 2°C and 8°C for up to 14 days. Keep out of reach of children.