- Approval Id
- bcceb737bd9a095f
- Drug Name
- TROLATE CAPSULE 300MG
- Product Name
- TROLATE CAPSULE 300MG
- Approval Number
- SIN16946P
- Approval Date
- 2024-02-15
- Registrant
- GLORIOUS DEXA SINGAPORE PTE. LTD.
- Licence Holder
- GLORIOUS DEXA SINGAPORE PTE. LTD.
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- CAPSULE
- Dosage
- <p><strong>Recommended Dosage:</strong><br>
<u>Adults:</u><br>
Initial dose: 100 mg 3 times a day or 300 mg/day as a single dose, should be given with meals thereby optimizing the absorption of the medication.<br>
If after strict cholesterol diet the concentration of cholesterol stays at >4 g/l, dose can be increased to 100 mg 4 times daily.<br>
Initial dose should be maintained until cholesterol level gets back to normal. If cholesterol level is stabilized, dosage of 100 mg twice daily can be given provided that cholesterol level is checked every 3 months. If there is a new increase in the plasma cholesterol concentration, dose should go back to initial dose of 100 mg 3 times daily.</p>
<p><u>Children:</u><br>
Over 10 years: maximum 5 mg/kg daily.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications:</strong><br>
TROLATE is indicated to treatment:</p>
<ul class="dash">
<li>Hypercholesterolemia (type IIa).</li>
<li>Hypertriglyceridemia (type IV).</li>
<li>Mix hyperlipidemia (type IIb and III).</li>
</ul>
- Contraindications
- <p><strong>Contraindications:</strong></p>
<ul class="dash">
<li>Pregnancy and lactation.</li>
<li>Hepatic insufficiency (including biliary cirrhosis and unexplained persistent liver function abnormality).</li>
<li>Known gallbladder disease.</li>
<li>Severe chronic kidney disease.</li>
<li>Chronic or acute pancreatitis with the exception of acute pancreatitis due to severe hypertriglyceridemia.</li>
<li>Known photoallergy or phototoxic reaction during treatment with fibrates or ketoprofen.</li>
<li>Hypersensitivity to the active substance or to any of the excipients listed.</li>
</ul>
- Atc Code
- C10AB05
- Atc Item Name
- fenofibrate
- Pharma Manufacturer Name
- GLORIOUS DEXA SINGAPORE PTE. LTD.
