- Approval Id
- bb8d3aebbfbb6d40
- Drug Name
- KOACT 1000 FILM-COATED TABLETS 875MG/125MG
- Product Name
- KOACT 1000 FILM-COATED TABLETS 875MG/125MG
- Approval Number
- SIN16676P
- Approval Date
- 2023-01-11
- Registrant
- APOTHECA MARKETING PTE LTD
- Licence Holder
- APOTHECA MARKETING PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong><br>
Pharmaceutical form: Film-coated tablets<br>
Dosage depends on the age and renal function of the patient and the severity of the infection.<br>
To minimise potential gastrointestinal intolerance, administer at the start of a meal. The absorption of Co-amoxiclav Tablets 875-125 mg is optimised when taken at the start of a meal.<br>
Treatment should not be extended beyond 14 days without review.<br>
Therapy can be started parenterally and continued with an oral preparation.<br>
Tablets should be swallowed whole without chewing. If required, tablets may be broken in half and swallowed without chewing.<br>
Co-amoxiclav Tablets 875-125 mg tablets are not recommended in children of 12 years and under.</p>
<p><strong>Adults and Children over 12 years</strong><br>
The usual recommended daily dosage is:</p>
<img src="/TGIF/Koact-Table1.png" alt="Koact Dosage Table 1" /><br><br>
<p><strong>Renal Impairment</strong><br>
No adjustment in dose is required in patients with creatinine clearance (CrCl) greater than 30 mL/min. The <em>Co-amoxiclav Tablets 875-125 mg</em> tablet should only be used in patients with a creatinine clearance (CrCl) rate of more than 30 mL/min.</p>
<img src="/TGIF/Koact-Table2.png" alt="Koact Dosage Table 2" /><br><br>
<p><strong>Hepatic Impairment</strong><br>
Dose with caution; monitor hepatic function at regular intervals.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong><br>
Co-amoxiclav Tablets 875-125 mg is an antibiotic agent with a notably broad spectrum of activity against the commonly occurring bacterial pathogens in general practice and hospital. The beta-lactamase inhibitory action of clavulanate extends the spectrum of amoxicillin to embrace a wider range of organisms, including many resistant to other beta-lactam antibiotics.<br>
Co-amoxiclav Tablets 875-125 mg should be used in accordance with local official antibiotic-prescribing guidelines and local susceptibility data.<br>
Co-amoxiclav Tablets 875-125 mg oral presentations for twice daily dosing, are indicated for short-term treatment of bacterial infections at the following sites:<br>
<em>Upper respiratory tract infections (including ENT)</em> e.g. recurrent tonsillitis, sinusitis, otitis media.<br>
<em>Lower respiratory tract infections</em> e.g. acute exacerbation of chronic bronchitis (AECB), lobar and bronchopneumonia.<br>
<em>Genito-urinary tract infections</em> e.g. cystitis, urethritis, pyelonephritis.<br>
<em>Skin and soft tissue infections</em> e.g. boils, abscesses, cellulitis, wound infections.<br>
<em>Bone and joint infections</em> e.g. osteomyelitis.<br>
<em>Dental infections</em> e.g. dentoalveolar abscess, pericoronitis, acute periodontitis.<br>
<em>Other infections</em> e.g. septic abortion, puerperal sepsis, intra-abdominal sepsis.<br>
Susceptibility to <em>Co-amoxiclav</em> will vary with geography and time (see <em>Pharmacological Properties, Pharmacodynamics</em> for further information – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
Co-amoxiclav Tablets 875-125 mg is contraindicated in patients with a history of hypersensitivity to betalactams, e.g. penicillins and cephalosporins.</p>
<p>Co-amoxiclav Tablets 875-125 mg is contraindicated in patients with a previous history of Co-amoxiclav Tablets 875-125 mg associated jaundice/hepatic dysfunction.</p>
- Atc Code
- J01CR02
- Atc Item Name
- amoxicillin and beta-lactamase inhibitor
- Pharma Manufacturer Name
- APOTHECA MARKETING PTE LTD
