BETAMOX ES
Product Range
Antibiotics
Manufacturer
LABORATÓRIOS ATRAL, S.A., Portugal
Visa Number
VN-22908-21
Applicant company
TV TPI. LTD.
Indication
Betamox ES is indicated for the treatment of the following infections in children at least 3 months of age and less than 40 kg of body weight, caused or expected to be caused by penicillin-resistant Streptococcus pneumoniae:
• Acute otitis media
• Community acquired pneumonia
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Composition
Amoxicillin, Clavulanic acid ( Clavulanite potassium)
Content
600mg, 42.9 mg/5 ml
Shelf life
24
Dosage Form
Powder for oral solution
Package
Box of 1 bottle of 50, 100 ml
Dosage
Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.
The dose of Betamox Plus 400 that is selected to treat an individual infection should take into account:
• The expected pathogens and their likely susceptibility to antibacterial agents.
• The severity and the site of the infection
• The age, weight and renal function of the patient as shown below.
Treatment should not be extended beyond 14 days without review.
Adults and children ≥ 40 kg:
There is no relevant experience using Betamox ES in adults and children ≥ 40 kg, therefore there are no dosage recommendations in these populations.
Children < 40 kg (≥ 3 months):
The recommended dose of Betamox ES oral suspension is 90 mg/6.4 mg/kg twice daily.
There are no clinical data on Betamox ES in children under 3 months of age.
Renal impairment
No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.
In patients with creatinine clearance less than 30 ml/min, the use of Betamox ES is not recommended, as no dose adjustment recommendations are available.
Hepatic impairment
Dosage cautiously and monitor liver function regularly.
Leaflet
NOT YET
