Amoxicillin Clavulanate (Amoxgentin) - Everyday Health, an antibiotic that is available by prescription

Amoxicillin Clavulanate (Amoxgentin) - Everyday Health, an antibiotic that is available by prescription'



Each film-coated tablet contains amoxicillin trihydrate equivalent to 500 mg amoxicillin and potassium clavulanate equivalent to 125 mg of clavulanic acid.

Film-coated tablet

White to off-white, oval film-coated tablets debossed with 'AC' and a score line on one side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses.

4. Clinical particulars

4.1 Therapeutic indications

Amoxgentin is indicated for the treatment of the following infections in adults and children (see sections 4.2, 4.4 and 5.1):

• 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.

4.2 Posology and method of administration

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 Amoxgentin that is selected to treat an individual infection should take into account:

• The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4)

• 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 Amoxgentin (e.g. those that provide higher doses of amoxicillin and/or different ratios of amoxicillin to clavulanic acid) should be considered as necessary (see sections 4.4 and 5.1).

For adults and children ≥ 40 kg, this formulation of Amoxgentin 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 Amoxgentin 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 Amoxgentin is selected in order to avoid administration of unnecessarily high daily doses of clavulanic acid (see sections 4.4 and 5.1).

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 section 4.4 regarding prolonged therapy).

Amoxgentin ® Amoxicillin DT 250 / 500 mg ( dispersible tablets)
• Amoxicillin dispersible tablets are the equivalent of Amoxicillin OS, with each dose compacted into a
tablet, dispersible in 5-10 ml of water.
• Amoxgentin ® Amoxicillin DT is cheaper than its equivalent OS.
• It offers logistical and supply chain advantages in term of volume and weight.
• It is also designed to accommodate patients with difficulties in swallowing.
• Amoxgentin ® Amoxicillin DT facilitates and simplifies Community Case Management (CCM) and greater dosage
accuracy compared to OS which has to be manually measured and mixed.
• DT does not need refrigeration.
• The new protocols combined with clear and easy instructions for prescribing and administering
Amoxgentin ® Amoxicillin DT provides the most effective method of treatment for pneumonia.

Amoxgentin-OS ® Amoxicillin OS 

• Amoxicillin powder for oral suspension is at present the most commonly used paediatric formulation. 

• It is available in strengths of 125 mg/5mL and 250 mg/5mL. 

• It is administered as a liquid which facilitates the treatment of children and those with difficulties 

swallowing solid dosage forms like tablets or capsules. 

Antibiotics / 

Composition: Azithromycin 250 / 500mg Dispersible Tablet

& Amoxicillin powder for oral suspension.

6.1 List of excipients

Tablet core

Magnesium stearate

Sodium starch glycolate, Type A

Colloidal anhydrous silica

Microcrystalline cellulose

Tablet film-coat

Titanium dioxide (E171)

Hypromellose

Macrogol (4000, 6000)

Dimeticone

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

2 years in cold formed aluminium blisters (CFB) and desiccated pouch packs (DPP)

Tablets in desiccated pouch packs should be used within 30 days of opening.

6.4 Special precautions for storage

Store in the original package in order to protect from moisture.

Do not store above 25°C.

6.5 Nature and contents of container

PVC/Aluminium/Polyamide laminate with aluminium lidding foil referred to as a cold formed aluminium blister (CFB) containing 4, 10, 12, 14, 16, 20, 24, 30, 100 or 500 tablets.

Aluminium PVC/PVdC blister enclosed within an aluminium laminate pouch containing a desiccant sachet, referred to as a desiccated pouch (DPP) containing 14, 20 or 21 tablets.

Not all pack sizes may be marketed.

6.6 Special precautions for disposal and other handling'

No special requirements.

Administrative data

7. Marketing authorisation holder

Taj Pharmaceuticals Ltd

124 Great West Road, Brentford

Middlesex

TW8 9GS

www.tajpharma.com