Royce Pharma Manufacturing Sdn. Bhd. (MALAYSIA)🇸🇬 Health Sciences Authority
Approval Date
Dec 7, 2022
Approval ID
292e68c14936d641
Company
Royce Pharma Manufacturing Sdn. Bhd. (MALAYSIA)
Type
Therapeutic
Approval Details
Approval Id
292e68c14936d641
Drug Name
ROYCE RIFAMPICIN CAPSULE 150MG
Product Name
ROYCE RIFAMPICIN CAPSULE 150MG
Approval Number
SIN16652P
Approval Date
2022-12-07
Registrant
GOLDPLUS UNIVERSAL PTE LTD
Licence Holder
GOLDPLUS UNIVERSAL PTE LTD
Drug Type
Therapeutic
Forensic Classification
Prescription Only
Dosage Form
CAPSULE
Dosage
<p><strong>Dosage and Administration :</strong><br>
Royce Rifampicin should be given as a single dose before meals to ensure rapid and complete absorption. Dosage should be adjusted according to body weight of patients.<br>
<strong>Adults :</strong> 450 – 600mg daily as a single dose (based on approximately 10mg per kg body weight). Those patients 50 kg and over should take 600mg daily, whilst patients under 50 kg should take 450mg.<br>
<strong>Children: </strong>Up to 20mg per kg body weight daily to a maximum of 600mg as a single dose.<br>
<strong>Premature and newborn infants :</strong> 10mg/kg once daily.</p>
<p>Royce Rifampicin should be given with other effective antituberculosis drugs to prevent the possible emergence of rifampicin-resistant strains of mycobacteria.</p>
Route Of Administration
ORAL
Indication Info
<p><strong>Indication :</strong><br>
Royce Rifampicin Capsule used in combination with other active antituberculosis drugs is indicated in the treatment of all forms of tuberculosis. It is also effective against many atypical strains of mycobacteria.</p>
Contraindications
<p><strong>Contraindication :</strong><br>
Jaundice; hypersensitivity to Rifampicin antibiotics; first trimester of pregnancy; premature and newborn infants; are concurrently receiving saquinavir/ritonavir therapy.</p>
