- Approval Id
- 89f4c84157b93820
- Drug Name
- MOXICLAV BIS DRY POWDER FOR ORAL SUSPENSION 457MG/5ML
- Product Name
- MOXICLAV BIS DRY POWDER FOR ORAL SUSPENSION 457MG/5ML
- Approval Number
- SIN16453P
- Approval Date
- 2022-03-29
- Registrant
- MEDOCHEMIE SINGAPORE PTE. LTD.
- Licence Holder
- MEDOCHEMIE SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- POWDER, FOR SUSPENSION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>Doses are expressed throughout in terms of amoxicillin/clavulanic acid content except when doses are stated in terms of an individual component.</p>
<p>The dose of Moxiclav Bis that is selected to treat an individual infection should take into account:</p>
<ul>
<li>The expected pathogens and their likely susceptibility to antibacterial agents (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>)</li>
<li>The severity and the site of the infection</li>
<li>The age, weight and renal function of the patient as shown below.</li>
</ul>
<p>The use of alternative presentations of Moxiclav (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 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>The usual recommended daily dosage is:</p>
<ul>
<li>25/3.6 mg/kg/day in mild to moderate infections (upper respiratory tract infections e.g. recurrent tonsillitis, lower respiratory infections and skin and soft tissue infections).</li>
<li>45/6.4 mg/kg/day for the treatment of more serious infections (upper respiratory tract infections e.g. otitis media and sinusitis, lower respiratory tract infections e.g. bronchopneumonia and urinary tract infections).</li>
</ul>
<p>No clinical data are available on doses above 45/6.4 mg/kg/day in children under 2 years.</p>
<p>There are no clinical data for Moxiclav Bis suspension 457 mg/5 mL to make dosage recommendations for children under 2 months old.</p>
<p>The tables below give dosage guidance for children.</p>
<table class="borderless-100">
<tbody>
<tr>
<td colspan="1" rowspan="2">25/3.6 mg/kg/day</td>
<td>2 – 6 years (13 – 21 kg)</td>
<td>2.5 ml Moxiclav Bis suspension 457 mg/5 mL twice daily.</td>
</tr>
<tr>
<td>7 – 12 years (22 – 40 kg)</td>
<td>5.0 ml Moxiclav Bis suspension 457 mg/5 mL twice daily.</td>
</tr>
<tr>
<td colspan="1" rowspan="2">45/6.4 mg/kg/day</td>
<td>2 – 6 years (13 – 21 kg)</td>
<td>5.0 ml Moxiclav Bis suspension 457 mg/5 mL twice daily.</td>
</tr>
<tr>
<td>7 – 12 years</td>
<td>10.0 ml Moxiclav Bis suspension 457 mg/5 ml twice daily.</td>
</tr>
</tbody>
</table>
<p>Children aged 2 months to under 2 years</p>
<p>Children under 2 years should be dosed according to body weight.</p>
<img src="/TGIF/MoxiclavBis-Table1.png" alt="Moxiclav Bis Dosage Table 1" /><br><br>
<p><u>Elderly</u></p>
<p>No dose adjustment is considered necessary.</p>
<p><u>Renal impairment</u></p>
<p>No dose adjustment is required in patients with creatinine clearance (CrCl) greater than 30 ml/min.<br>
In patients with creatinine clearance less than 30 ml/min, the use of Moxiclav Bis presentations with an amoxicillin to clavulanic acid ratio of 7:1 is not recommended, as no recommendations for dose adjustments are available.</p>
<p><u>Hepatic impairment</u></p>
<p>Dose with caution and monitor hepatic function at regular intervals (see sections 4.3 and 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). There is, as yet, insufficient evidence on which to base a dosage recommendation.</p>
<p><u>Method of administration</u></p>
<p>Moxiclav Bis is for oral use.<br>
Administer at the start of a meal to minimise potential gastrointestinal intolerance and optimise absorption of amoxicillin/clavulanic acid.<br>
Treatment should not exceed 14 days without review.<br>
Therapy can be started parenterally according to the SmPC of the IV-formulation and continued with an oral preparation.<br>
Shake to loosen powder, add water as directed, invert and shake.<br>
Shake the bottle before each dose (see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p>For instructions on reconstitution of the medicinal product before administration, see section 6.6 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Moxiclav Bis should be used in accordance with local official antibiotic prescribing guidelines and local susceptibility data.</p>
<p>Moxiclav Bis suspension for twice daily oral dosing, is indicated for short term treatment of bacterial infections at the following sites when amoxicillin resistant beta-lactamase producing strains are suspected as the cause. In other situations, amoxicillin alone should be considered.</p>
<p>Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.</p>
<p>Lower respiratory tract infections e.g. acute exacerbations of chronic bronchitis, lobar and bronchopneumonia.</p>
<p>Urinary tract infections e.g. cystitis, urethritis, pyelonephritis.</p>
<p>Skin and soft tissue infections e.g. cellulitis, animal bites.</p>
<p>Susceptibility to Moxiclav Bis will vary with geography and time. Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.</p>
<p>Mixed infections caused by amoxicillin-susceptible organisms in conjunction with Moxiclav Bis susceptible beta-lactamase producing organisms may be treated with Moxiclav Bis suspension 457 mg/5 ml. These infections should not require the addition of another antibiotic resistant to beta-lactamases.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul>
<li>Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</li>
<li><em>History of hypersensitivity to beta-lactams, e,g. cephalosporins</em></li>
<li>History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Atc Code
- J01CR02
- Atc Item Name
- amoxicillin and beta-lactamase inhibitor
- Pharma Manufacturer Name
- MEDOCHEMIE SINGAPORE PTE. LTD.
