- Approval Id
- b27904a1a6ec4972
- Drug Name
- Custodiol Solution
- Product Name
- Custodiol Solution
- Approval Number
- SIN17327P
- Approval Date
- 2025-09-16
- Registrant
- KOEHLER PHARMACEUTICALS ASIA PTE LTD
- Licence Holder
- KOEHLER PHARMACEUTICALS ASIA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- SOLUTION
- Dosage
- <p><strong>RECOMMENDED DOSAGE:</strong></p>
<ol type="A">
<li><p><strong>Heart</strong></p>
<p><strong>Cardioplegia</strong></p>
<p>Perfusion volume:<br>
The perfusion rate is 1 ml/minute/gram heart weight. The normal weight of the heart accounts for approximately 0.5% of body weight in an adult, leading to a total volume of Custodiol between 1.5 and 2 litres.</p>
<p>Temperature of the solution:<br>
6 °C – 10 °C in open heart procedure</p>
<p>Perfusion pressure (= pressure in the aortic root):<br>
In adults, initially 110 to 140 cm hydrostatic pressure, equivalent to 80 to 110 mmHg is used. The surgeon has to make sure, that the aortic valve is closing properly. After onset of cardiac arrest, the pressure is reduced by half to 50 – 70 cm hydrostatic pressure, equivalent to 40 – 60 mmHg. In case of severe coronary stenosis, a higher pressure should be used (approx. 50 mmHg).</p>
<p>Perfusion time:<br>
Using this dosing and pressure regimen, the perfusion time must be 6 – 8 minutes in order to achieve myocardial homogeneous equilibration and this time should not be shorter under any circumstances.</p>
<p>Perfusion technique:<br>
After clamping the aorta and simultaneous “venting” of the left ventricle, the solution will be administered antegrade. Cardioplegic perfusion can be performed by either a roller pump with constant volume or by gravity (after cardiac arrest, the solution bag must be kept at 40–50 cm above the level of the heart).</p>
<p>Administration guidelines for additional cardioplegic perfusion:<br>
If cardioplegic reperfusions gets necessary, perfusion time should be 1 – 2 minutes (equivalent to 200 – 400 ml); the perfusion pressure should correspond to the pressure in the last minute of the initial cardioplegic coronary perfusion.</p>
<p>In most cases, the patient is placed in moderate systemic hypothermia.</p>
<p>Usually, Custodiol is given via the aortic root. In case of aortic insufficiency and of dissection of thoracic aortic surgery, the solution must be administered by selective coronary perfusion into the coronary ostia.</p>
<p>Administration guidelines for retrograde perfusion on coronary sinus:<br>
Do not exceed 30 mmHg infusion pressure (usually about 250 ml/min) for a retrograde infusion of the same duration as an antegrade infusion (6–8 minutes minimum).</p>
<p><strong>Paediatric population</strong></p>
<p>There is only a limited amount of data regarding the use in children and adolescents.</p>
<p>Heart<br>
Perfusion pressure:<br>
In neonates and infants, initially 110 to 120 cm water column above the level of the heart, equivalent to 80 to 90 mmHg; after the onset of cardiac arrest, reduction to 40 to 50 cm water column, equivalent to 30 to 40 mmHg. In patients with severe coronary sclerosis, higher pressures over a longer period of time should be maintained. The right atrium should be opened and the cardioplegia completely aspirated outside the bypass circuit to avoid haemodilution.</p>
<p>The perfusion volume depends on the age of the children: 50 ml/kg (first month of life), 30 ml/kg (2nd month-1st year), 20 ml/kg (>1st year), while perfusion time is 4–6 minutes in all cases. For example, an estimated heart weight of 50 g would require approximately 350 ml.</p></li>
</ol>
- Route Of Administration
- OTHERS
- Indication Info
- <p><strong>INDICATION:</strong></p>
<ul>
<li>Cardioplegia in heart surgery</li>
</ul>
- Contraindications
- <p><strong>CONTRAINDICATIONS:</strong></p>
<p>Hypersensitivity to the active substances or to any of the excipients.</p>
