Antibiotics

LABORATÓRIOS ATRAL, S.A., Portugal

560110431823

27/10/2023

TV TPI. LTD.

Amoxicillin, Clavulanic acid ( Clavulanite potassium)

Betamox Plus 400 is indicated for the treatment of the following infections in adults and children:
• Acute bacterial sinusitis (adequately diagnosed)
• Acute otitis media
• Acute exacerbations of chronic bronchitis (adequately diagnosed)
• Community acquired pneumonia
• Cystitis
• Pyelonephritis
• Skin and soft tissue infections in particular cellulitis, animal bites, severe dental abscess with spreading cellulitis.
• Bone and joint infections, in particular osteomyelitis.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.

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.
For adults and children ≥ 40 kg, this formulation of Augmentin provides a total daily dose of 1500 mg amoxicillin/375 mg clavulanic acid, when administered as recommended below.
For children < 40 kg, this formulation of Augmentin provides a maximum daily dose of 2400 mg amoxicillin/600 mg clavulanic acid, when administered as recommended below.
If it is considered that a higher daily dose of amoxicillin is required, it is recommended that another preparation of Augmentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections Special warnings and precautions for use and Pharmacodynamic properties).
Adults and children weighing 40 kg should be treated with another dosage form of Betamox.
The duration of therapy should be determined by the response of the patient. Some infections (e.g. osteomyelitis) require longer periods of treatment.
Treatment should not be extended beyond 14 days without review.
Adults and children ≥ 40 kg
Recommended dose:
- Standard dose (for all indications): 875 mg/125 mg twice daily.
- Higher dose (especially for infections such as otitis media, sinusitis, lower respiratory tract infections and urinary tract infections): 875 mg/125 mg taken three times per day.
Children < 40 kg
Children can be treated with Betamox/ Betamox Plus tablets or oral suspension.
Children 6 years of age and younger should be treated with Betamox/Betamox Plus oral suspension.
Recommended dose:
- From 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg twice daily.
- Up to 70 mg/10 mg/kg twice daily should be considered for some infections (eg: otitis media, sinusitis, lower respiratory tract infections).
There are no clinical data on Betamox Plus 400 in children under 2 months of age and no clinical data on doses higher than 45 mg/6.4 mg/kg/day in children under 2 years of age.
Elderly
No dose adjustment is required.
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, Betamox Plus with an amoxicillin to clavulanic acid ratio of 7:1 is not recommended, as no dose adjustment is recommended.
Hepatic impairment
Use caution when prescribing and periodically monitor liver function (see Contraindications and Special warnings and precautions for use).

400mg; 57 mg/5 ml

24

Powder for oral solution

Box of 1 bottle of 60, 100 ml