Laboratórios Atral, S.A. – Portugal

TV Pharmaceutical Trade Promotion and Investment Co., Ltd.

Amoxicillin trihydrate 1006 mg (equivalent to amoxicillin) and potassium clavulanate 148.75 mg (equivalent to clavulanic acid)

875 mg / 125 mg

24 months

Film-coated tablets

Box of 1 blister x 16 tablets; Box of 2 blisters x 8 tablets; Box of 4 blisters x 4 tablets

560110330925

July 17, 2025

July 17, 2030

Antibiotics

Betamox Plus is an antibacterial agent with a broad spectrum of activity, notably against pathogens commonly encountered in both community and hospital settings. The beta-lactamase inhibitory action of clavulanate extends the antibacterial spectrum of amoxicillin to encompass a wide range of micro-organisms, including strains resistant to other beta-lactam antibiotics.
Betamox Plus should be used in accordance with official local antibacterial prescribing guidelines and local susceptibility patterns.
Betamox Plus oral formulation, administered twice daily, is indicated for the short-term treatment of bacterial infections at the following sites:
Upper respiratory tract infections: Tonsillitis, sinusitis, otitis media.
Lower respiratory tract infections: Acute exacerbations of chronic bronchitis, lobar pneumonia, and bronchopneumonia.
Genitourinary tract infections: Cystitis, urethritis, pyelonephritis.
Skin and soft tissue infections: Furuncles, abscesses, cellulitis, wound infections.
Bone and joint infections: Osteomyelitis.
Dental infections: Dentoalveolar abscess.
Other infections: Septic abortion, puerperal sepsis, intra-abdominal sepsis.
Bacterial susceptibility to Betamox Plus varies with geography and time (see Pharmacodynamic Properties and Pharmacokinetic Properties). Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing should be performed when necessary.

Doses are expressed throughout in terms of both amoxicillin/clavulanic acid content, except when doses are stated in terms of an individual component.
The dose of Betamox Plus that is selected to treat an individual infection should take into account:
- The expected pathogens and their likely susceptibility to antibacterial agents (see Special Warnings and Precautions for Use).
- The severity and the site of the infection.
- The age, weight, and renal function of the patient, as shown below.
The use of alternative presentations of amoxicillin/clavulanic acid (e.g., those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see Special Warnings and Precautions for Use and Pharmacodynamic Properties).
For adults and children weighing ≥ 40 kg, this formulation provides a total daily dose of 1,750 mg amoxicillin/250 mg clavulanic acid with twice-daily administration, and 2,625 mg amoxicillin/375 mg clavulanic acid with three-times-daily dosing, when administered as recommended below. For children weighing < 40 kg, the maximum daily dose of Betamox Plus is 1,000–2,800 mg amoxicillin/143–400 mg clavulanic acid when administered as recommended below. If a higher daily dose of amoxicillin is considered necessary, it is recommended that another presentation of amoxicillin/clavulanic acid be selected to avoid administration of unnecessarily high daily doses of clavulanic acid (see Special Warnings and Precautions for Use and Pharmacodynamic Properties).
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 (see Special Warnings and Precautions for Use regarding prolonged therapy).
Adults and Children Weighing ≥ 40 kg:
Recommended doses:
- Standard dose (for all indications): 875 mg/125 mg twice daily;
- Higher dose (particularly for infections such as otitis media, sinusitis, lower respiratory tract infections, and urinary tract infections): 875 mg/125 mg three times daily.
Children Weighing < 40 kg:
Children may be treated with amoxicillin/clavulanic acid tablets, suspensions, or pediatric sachets.
Recommended doses:
- 25 mg/3.6 mg/kg/day to 45 mg/6.4 mg/kg/day divided into 2 doses;
- Up to 70 mg/10 mg/kg/day divided into 2 doses may be considered for some infections such as otitis media, sinusitis, and lower respiratory tract infections.
Because the tablets cannot be divided, children weighing less than 25 kg must not be treated with Betamox Plus tablets.
The table below presents the received dose (mg/kg body weight) in children weighing 25 kg to 40 kg upon administration of a single 875 mg/125 mg tablet: