- Approval Id
- 814a7dd012fc071a
- Drug Name
- TRACRIUM INJECTION 10 mg/ml
- Product Name
- TRACRIUM INJECTION 10 mg/ml
- Approval Number
- SIN06058P
- Approval Date
- 1991-05-22
- Registrant
- DCH AURIGA SINGAPORE
- Licence Holder
- DCH AURIGA SINGAPORE
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>In common with all neuromuscular blocking agents monitoring of neuromuscular function is recommended during the use of <em>TRACRIUM</em> in order to individualise dosage requirements.</p>
<ul>
<li><p><strong>Use by injection in adults</strong></p>
<p><em>TRACRIUM </em>is administered by intravenous (i.v.) injection. The dosage range for adults is 0.3 to 0.6 mg/kg (depending on the duration of full block required) and will provide adequate relaxation for 15 to 35 minutes.</p>
<p>Endotracheal intubation can usually be accomplished within 90 seconds from the i.v. injection of 0.5 to 0.6 mg/kg.</p>
<p>Full block can be prolonged with supplementary doses of 0.1 to 0.2 mg/kg as required. Successive supplementary dosing does not give rise to accumulation of neuromuscular blocking effect.</p>
<p>Spontaneous recovery from the end of full block occurs in about 35 minutes as measured by the restoration of the tetanic response to 95% of normal neuromuscular function.</p>
<p>The neuromuscular block produced by <em>TRACRIUM</em> can be rapidly reversed by standard doses of anticholinesterase agents, such as neostigmine and edrophonium, accompanied or preceded by atropine, with no evidence of recurarisation.</p></li>
<li><p><strong>Use as an infusion in adults</strong></p>
<p>After an initial bolus dose of 0.3 to 0.6 mg/kg, <em>TRACRIUM</em> can be used to maintain neuromuscular block during long surgical procedures by administration as a continuous infusion at rates of 0.3 to 0.6 mg/kg/h.</p>
<p><em>TRACRIUM</em> can be administered by infusion during cardiopulmonary bypass surgery at the recommended infusion rates. Induced hypothermia to a body temperature of 25°C to 26°C reduces the rate of inactivation of <em>TRACRIUM</em>, therefore full neuromuscular block may be maintained by approximately half the original infusion rate at these low temperatures.</p>
<p><em>TRACRIUM </em>(multi-dose vials and injection) is compatible with the following infusion solutions for the times stated below:</p>
<table class="borderless-100">
<tbody>
<tr>
<td>Infusion Solution </td>
<td>Period of Stability<br><br></td>
</tr>
<tr>
<td>Sodium Chloride i.v. Infusion British Pharmacopoeia (BP)(0.9% w/v)<br><br></td>
<td>24 hours</td>
</tr>
<tr>
<td>Glucose i.v. Infusion BP (5% w/v)<br><br></td>
<td>8 hours</td>
</tr>
<tr>
<td>Ringer's Injection United States Pharmacopoeia (USP)<br><br></td>
<td>8 hours</td>
</tr>
<tr>
<td>Sodium Chloride (0.18% w/v) and Glucose (4% w/v) i.v. Infusion BP<br><br></td>
<td>8 hours</td>
</tr>
<tr>
<td>Compound Sodium Lactate i.v. Infusion BP (Hartmann’s Solution for Injection)<br><br></td>
<td>4 hours</td>
</tr>
</tbody>
</table>
<p>When diluted in these solutions to give <em>TRACRIUM</em> concentrations of 0.5 mg/ml and above, the resultant solutions will be stable in daylight for the stated periods at temperatures of up to 30°C.</p></li>
<li><p><strong>Use in children</strong></p>
<p>The dosage in children over the age of 1 month is the same as that in adults on a bodyweight basis.</p></li>
<li><p><strong>Use in the elderly</strong></p>
<p><em>TRACRIUM</em> may be used at standard dosage in elderly patients. It is recommended, however, that the initial dose be at the lower end of the range and that it be administered slowly.</p></li>
<li><p><strong>Use in patients with reduced renal and/or hepatic function</strong></p>
<p><em>TRACRIUM</em> may be used at standard dosage at all levels of renal or hepatic function, including end-stage failure.</p></li>
<li><p><strong>Use in patients with cardiovascular disease</strong></p>
<p>In patients with clinically significant cardiovascular disease, the initial dose of <em>TRACRIUM</em> should be administered over a period of 60 seconds.</p></li>
</ul>
- Route Of Administration
- INTRAVENOUS
- Indication Info
- <p><strong>Indications</strong></p>
<p><em>TRACRIUM</em> is a highly selective, competitive or non-depolarising neuromuscular blocking agent which is used as an adjunct to general anaesthesia to enable tracheal intubation to be performed and to relax skeletal muscles during surgery or controlled ventilation during a wide range of medical procedures.</p>
<p>The multi-dose vial contains benzyl alcohol 0.9% w/v as an antimicrobial preservative and is intended for multiple use in one or more patients.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p><strong><em>Injection:</em></strong></p>
<ul class="dash">
<li><em>TRACRIUM</em> is contraindicated in patients known to be hypersensitive to atracurium, cisatracurium or benzenesulfonic acid.</li>
</ul>
<p><em><strong>Multi-dose vial:</strong></em></p>
<ul class="dash">
<li><em>TRACRIUM</em> (multi-dose vial) is contraindicated in patients known to be hypersensitive to atracurium, cisatracurium, benzenesulfonic acid or benzyl alcohol.</li>
</ul>
- Atc Code
- M03AC04
- Atc Item Name
- atracurium
- Pharma Manufacturer Name
- DCH AURIGA SINGAPORE
