- Approval Id
- 6ff055be33eb398a
- Drug Name
- TRACIDOL INJECTION 50mg/ml
- Product Name
- TRACIDOL INJECTION 50mg/ml
- Approval Number
- SIN15303P
- Approval Date
- 2017-07-24
- Registrant
- YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
- Licence Holder
- YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INJECTION, SOLUTION
- Dosage
- <p><strong>Dosage and Administration:</strong><br>
Intravenous, Subcutaneous, Intramuscular.<br>
The dose should be adjusted to the intensity of the pain and the sensitiveness of each patient.</p>
<p><strong>Adults and children over 14 years old:</strong><br>
IV: 50–100mg or up to 400mg daily, to be administered by slow injection or diluted in solution for administration by infusion. Infusion solutions that can be prepared with TRACIDOL Injection 50mg/ml are mentioned as below:-</p>
<ul class="dash">
<li>5% Glucose</li>
<li>0.9% Sodium Chloride</li>
<li>4.2% & 8.4% Sodium Bicarbonate</li>
</ul>
<p>The mixture should be prepared the same day the solution is to be used</p>
<p>IM/SC: 50–100mg<br>
Total daily dose: up to 400mg/day</p>
<p>If the pain relief is still insufficient 30–60 min after administration of 50–100 mg, a 2nd single dose of 50 mg may be used. If the required amount for analgesic is expected to be higher, in cases of severe pain conditions, the initial dose can be increased based on clinical experience. The lowest effective analgesic dose should generally be chosen. The total daily dose of 400 mg should not be exceeded, except in special circumstances.</p>
<p><strong>Special dosage:</strong><br>
Children >1 year: Individual dose of 1–2 mg/kg body weight.</p>
<p>In general, the daily dose should not exceed 400mg of tramadol. The duration of action of tramadol may be prolonged in patients with impaired renal or hepatic function. In patients with creatinine clearance less than 30ml/min, the dosing interval of tramadol should be increased to 12 hours. The maximum recommended daily dose is 200mg. Since less than 10% of a dose of tramadol hydrochloride is removed by hemodialysis, patients undergoing dialysis may receive their usual dosage on the day of dialysis. Adults and children 14 years of age and older with hepatic cirrhosis may receive a dosage of 50mg every 12 hours. There is some evidence that elderly patients require lower doses of tramadol than younger patients. Creatinine clearance should be monitored and used as a determining factor for dosage adjustment. Age alone is not sufficient criteria for dosage adjustment.</p>
<p>Duration of treatment: Tramadol should not in any circumstances be used longer than therapeutically absolutely necessary. If the nature and severity of the disease makes more prolonged analgesic treatment with tramadol necessary, a regular, careful and frequent check should be carried out possibly by the use of treatment-free intervals to determine whether and to what extent a medical requirement still exists. In case of long term treatment with tramadol the possibility of dependence cannot be excluded.</p>
- Route Of Administration
- INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR
- Indication Info
- <p><strong>Indication:</strong><br>
Moderate to severe pain.</p>
- Contraindications
- <p><strong>Contraindication(s):</strong></p>
<ol>
<li>Hypersensitivity to tramadol.</li>
<li>Acute intoxication by alcohol, hypnotics, analgesics, opioid or psychotropic drugs</li>
<li>Patients who are receiving MAO inhibitors (including selegiline) or have used them during the last 14 days.</li>
<li>Patients suffering from epilepsy, in case it is not sufficiently controlled by treatment.</li>
<li>Tramadol must not be used as a substitute in opioid-dependent patients. Although Tramadol is an opioid, it does not suppress morphine withdrawal symptoms.</li>
</ol>
- Atc Code
- N02AX02
- Atc Item Name
- tramadol
- Pharma Manufacturer Name
- YUNG SHIN PHARMACEUTICAL (SINGAPORE) PTE LTD
