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HSA Approval

ROYCE RIFAMPICIN CAPSULE 300MG

SIN16653P

ROYCE RIFAMPICIN CAPSULE 300MG

ROYCE RIFAMPICIN CAPSULE 300MG

December 7, 2022

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Regulatory Information

GOLDPLUS UNIVERSAL PTE LTD

GOLDPLUS UNIVERSAL PTE LTD

Therapeutic

Prescription Only

Formulation Information

CAPSULE

**Dosage and Administration :** 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. **Adults :** 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. **Children:** Up to 20mg per kg body weight daily to a maximum of 600mg as a single dose. **Premature and newborn infants :** 10mg/kg once daily. Royce Rifampicin should be given with other effective antituberculosis drugs to prevent the possible emergence of rifampicin-resistant strains of mycobacteria.

ORAL

Medical Information

**Indication :** 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.

**Contraindication :** Jaundice; hypersensitivity to Rifampicin antibiotics; first trimester of pregnancy; premature and newborn infants; are concurrently receiving saquinavir/ritonavir therapy.

J04AB02

rifampicin

Manufacturer Information

GOLDPLUS UNIVERSAL PTE LTD

Royce Pharma Manufacturing Sdn. Bhd.

Active Ingredients

Rifampicin

300mg

Rifampicin

Documents

Package Inserts

1.4.3_PI Portrait_17112022.pdf

Approved: December 7, 2022

Download

Patient Information Leaflets

1.4.4_PIL-RifaC (SG)_01092022.pdf

Approved: December 7, 2022

Download
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