- Approval Id
- 152af6e957b239ca
- Drug Name
- CURAM 1000MG+200MG POWDER FOR INTRAVENOUS SOLUTION
- Product Name
- CURAM 1000MG+200MG POWDER FOR INTRAVENOUS SOLUTION
- Approval Number
- SIN13390P
- Approval Date
- 2007-12-10
- Registrant
- SANDOZ SINGAPORE PTE. LTD.
- Licence Holder
- SANDOZ SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- INJECTION, POWDER, FOR SOLUTION
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><strong>Dosage</strong><br>The duration of treatment is dependent on the indication and the severity of the infection. Curam 1000mg + 200mg Powder for intravenous solution may not be used for more than 14 days without monitoring of the patient’s liver function.</p>
<p><u>Adults and children over 12 years</u><br>
<u><em>Normal renal function</em></u><br>
Non-serious infections: Amoxicillin/Clavulanic acid 1000/200 mg 8 hourly by intravenous injection. In more serious infections, increase frequency to six hourly intervals, If possible, preference should be given to the oral form of Amoxicillin/Clavulanic acid.</p>
<p><u>Children (3 months – 12 years)</u></p>
<table class="borderless-100">
<tbody>
<tr>
<td>- Serious infections</td>
<td>Usually 25/5 mg/kg per slow intravenous injection or infusion (infusion time at least 30 minutes) every six hours.</td>
</tr>
<tr>
<td>- Non-serious infections</td>
<td>Up to a maximum 25/5 mg/kg per slow intravenous injection or infusion (infusion time at least 30 minutes), every eight hours. If possible the oral form of Amoxicillin/Clavulanic acid is preferable.<br><br></td>
</tr>
<tr>
<td><u>Children (0 – 3 months)</u></td>
<td>25/5 mg/kg per infusion every 12 hours in premature infants and full term infants during the perinatal period, increasing to eight hours thereafter.</td>
</tr>
</tbody>
</table>
<p><em><u>Dosage in the case of renal impairment</u></em><br>
Elimination of clavulanic acid and amoxicillin via the kidneys is delayed in patients with renal impairment. Depending on the degree of renal impairment, the total daily dose of Curam 1000mg + 200mg Powder for intravenous solution (expressed in quantities of amoxicillin) should not exceed that indicated in following table.</p>
<img src="/TGIF/CuramIV-Table1.png" alt="Curam IV Dosage Table 1" /><br><br>
<p>Similar reduction in dosage should be made for children.</p>
<p><u><em>Adult dose for surgical prophylaxis</em></u><br>
Amoxicillin/Clavulanic acid 1000/200 mg Powder for solution for injection/infusion at the induction of anaesthesia. Operations where there is an increased risk of infection, e.g. colorectal surgery, may require 3 up to 4 doses in a 24-hour period 8 hourly.</p>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Curam 1000mg + 200mg Powder for intravenous solution may be administered for the short-term treatment of primarily serious infections due to micro-organisms that are resistant to amoxicillin and other B-lactam antibiotics as a result of the formation of a clavulanic acid-susceptible ß-lactamase, such as:</p>
<ul>
<li>Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.</li>
<li>Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.</li>
<li>Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.</li>
<li>Skin and soft tissue infections e.g. boils, abscesses, cellulites, wound infections.</li>
<li>Bone and joint infections e.g. osteomyelitis.</li>
<li>Other infections e.g. intra-abdominal sepsis.</li>
</ul>
<p>Curam 1000mg + 200mg Powder for intravenous solution can be used for prophylaxis against infections in major surgery such as gastrointestinal, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<ul class="dash">
<li>Hypersensitivity to the active substances, to any of the penicillins or to any of the excipients</li>
<li>History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another beta-lactam agent (e.g. a cephalosporin, carbapenem or monobactam)</li>
<li>History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8 Undesirable effects – <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
- SANDOZ SINGAPORE PTE. LTD.
- Company Detail Path
- /organization/sandoz-singapore-pte-ltd
