Description
Composition:
CLAVENEN Tablets
Each film coated tablet contains:
- CLAVENEN 375:
- Amoxicillin 250 mg (as Amoxicillin trihydrate)
- Clavulanic Acid 125 mg (As Clavulanate Potassium)
- CLAVENEN 625:
- Amoxicillin 500 mg (as Amoxicillin trihydrate)
- Clavulanic Acid 125 mg (As Clavulanate Potassium)
- CLAVENEN 1000:
- Amoxicillin 875 mg (as Amoxicillin trihydrate)
- Clavulanic Acid 125 mg (As Clavulanate Potassium)
CLAVENEN Powder for Oral Suspension
Each 5 ml when reconstituted contains:
- CLAVENEN 156.25:
- Amoxicillin 125 mg (As Amoxicillin trihydrate)
- Clavulanic Acid 31.25 mg (As Clavulanate Potassium)
- CLAVENEN 312.5:
- Amoxicillin 250 mg (As Amoxicillin trihydrate)
- Clavulanic Acid 62.5 mg (As Clavulanate Potassium)
- CLAVENEN 457:
- Amoxicillin 400 mg (As Amoxicillin Trihydrate)
- Clavulanic Acid 57 mg (As Clavulanate Potassium)
- CLAVENEN 228.5:
- Amoxicillin 200 mg (As Amoxicillin Trihydrate)
- Clavulanic Acid 28.5 mg (As Clavulanate Potassium)
- CLAVENEN 600:
- Amoxicillin 600 mg (As Amoxicillin Trihydrate)
- Clavulanic Acid 42.9 mg (As Clavulanate Potassium
Indications:
- Treatment of infections due to susceptible isolates of bacteria, including those producing beta lactamase: Haemophilus influenza, Moraxella catarrhalis, Staphylococcus aureus, Escherichia coli, Klebsiella species and Enterobacter species.
- Lower Respiratory Tract Infections
- Acute Bacterial Otitis Media
- Sinusitis
- Skin and Skin Structure Infections
- Urinary Tract Infections
For CLAVENEN-600 only:
Treatment of pediatric patients with recurrent or persistent acute otitis media due to S. pneumoniae, H. influenzae or M. catarrhalis.
Contraindication:
- History of serious hypersensitivity reactions (e.g., anaphylaxis or Stevens- Johnson syndrome) to amoxicillin, clavulanate or to other beta lactam antibacterial drugs (e.g., penicillins and cephalosporins).
- History of cholestatic jaundice/hepatic dysfunction associated with this drug.
Side Effects:
Diarrhea, nausea, vomiting, dermatitis and vaginitis.
Dosage and Administration:
Adults:
- one 500 mg tablet every 12 hours or one 250 mg every 8 hours
- for more severe infections and infections of the respiratory tract, the dose should be one 875 mg tablet every 12 hours or one 500 mg tablet every 8 hours.
pediatric patients:
- Neonates and infants aged > 3 months: The recommended dose is 30 mg/kg/day divided every 12 hours.
- Patients aged 3 months and older:
| Infection | 200/5 OR 400/5 ORAL SUSPENSION | 125/5 OR 250/5 ORAL SUSPENSION |
| Otitis media (Duration of therapy studied and recommended for acute otitis media is 10 days.), sinusitis, lower respiratory tract infections, and more severe infections
|
45 mg/kg/day every 12 hours
|
40 mg/kg/day every 8 hours
|
|
Less severe infections
|
25 mg/kg/day every 12 hours
|
20 mg/kg/day every 8 hours
|
- Pediatric patients weighing 40 kg or more should be dosed according to adult recommendations.
For Clavenen 600:
The recommended dose is 90 mg/kg/day divided every 12 hours, administered for 10 days.
| Body weight kg | Volume providing 90mg/kg/day |
| 8 | 3 ml twice daily |
| 12 | 4.5 ml twice daily |
| 16 | 6 ml twice daily |
| 20 | 7.5 ml twice daily |
| 24 | 9 ml twice daily |
| 28 | 10.5 ml twice daily |
| 32 | 12 ml twice daily |
| 36 | 13.5 ml twice daily |
How Supplied:
Tablets:
- CLAVENEN 375: Box of 10 tablets.
- CLAVENEN 625: Box of 6 or 10 or 15 tablets.
- CLAVENEN 1000: Box of 6 or 10 or 14 tablets.
Powder for Oral Suspension:
- CLAVENEN 156.25: Bottle of 60 mL or 100 mL.
- CLAVENEN 312.5: Bottle of 60 mL or 100 mL.
- CLAVENEN 457: Bottle of 60 mL or 100 mL.
- CLAVENEN 228.5: Bottle of 60 mL or 100 mL.
- CLAVENEN 600: Bottle of 75 mL or 100 mL.
