- Approval Id
- e10312ba87538c6c
- Drug Name
- ULTRADOL F.C. TABLETS 37.5MG/325MG
- Product Name
- ULTRADOL F.C. TABLETS 37.5MG/325MG
- Approval Number
- SIN16498P
- Approval Date
- 2022-05-19
- Registrant
- MIRACO NUTRIPHARM PTE. LTD.
- Licence Holder
- MIRACO NUTRIPHARM PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and administration</strong><br>
The tablets should be taken orally, whole, not divided or chewed, with sufficient liquid, without regard to food. ULTRADOL should under no circumstances be administered for longer than absolutely necessary. If long-term pain treatment with ULTRADOL is necessary in view of the nature and severity of the illness, then careful and regular monitoring should be carried out (if necessary, with breaks in treatment) to establish whether and to what extent further treatment is necessary.</p>
<p><strong>Dosage – adults and children 16 years of age and over</strong><br>
The maximum single dose of ULTRADOL is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to a maximum of 8 tablets per day. The lowest effective dose should be used for the shortest period of time.</p>
<p><strong>Treatment withdrawal</strong><br>
Do not stop use of ULTRADOL abruptly. Withdrawal symptoms may be relieved by tapering the medication (see <em>Warnings and Precautions – Treatment Withdrawal</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Children below 16 years of age</strong><br>
The use of ULTRADOL is contraindicated in children below 12 years of age (see <em>Contraindications</em>).</p>
<p>The safety and effectiveness of ULTRADOL in children aged 12 to below 16 years of age has not been established (see <em>Contraindications and Warnings and Precautions – Other Risk Factors for Life-threatening Respiratory Depression in Children</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>). Therefore, treatment is not recommended in this population.</p>
<p><strong>Elderly (75 years of age and older)</strong><br>
Elimination of the active components may be prolonged in elderly patients over 75 years of age. Therefore, if necessary, the dosage interval may be extended according to the patients requirements.</p>
<p><strong>Renal insufficiency/Dialysis/Hepatic Insufficiency</strong><br>
The pharmacokinetics of the tramadol/paracetamol combination in patients with renal impairment has not been studied. Experience with tramadol suggests that impaired renal function results in a decreased rate and extent of excretion of tramadol. In patients with creatinine clearances of less than 30mL/min, it is recommended that the dosing interval of ULTRADOL be increased not to exceed 2 tablets every 12 hours. The pharmacokinetics and tolerability of Tramadol Hydrochloride/Paracetamol in patients with impaired hepatic function has not been studied. Tramadol and paracetamol are both extensively metabolized by the liver. The use of ULTRADOL in patients with severe hepatic impairment is not recommended.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong><br>
ULTRADOL is indicated for the treatment of moderate to severe pain.</p>
- Contraindications
- <p><strong>Contraindications</strong><br>
ULTRADOL is contraindicated:</p>
<ul>
<li>in all children younger than 12 years of age.</li>
<li>in post-operative management in children younger than 18 years of age following tonsillectomy and/or adenoidectomy.</li>
<li>in patients who have previously demonstrated hypersensitivity to tramadol, paracetamol or any other components (see <em>List of Excipients</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>) of this product or opioids.</li>
<li>in cases of acute intoxication with alcohol, hypnotics, centrally acting analgesics, opioids or psychotropic drugs.</li>
<li>in patients using monoamine oxidase inhibitors (MAOI) concurrently or within the last 14 days (see <em>Interactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>in patients with significant respiratory depression (see <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Atc Code
- N02AJ13
- Atc Item Name
- tramadol and paracetamol
- Pharma Manufacturer Name
- MIRACO NUTRIPHARM PTE. LTD.
