Product Dossier
RIMYCIN
Product Dossier for RIMYCIN (rifampicin, Alphapharm). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Alphapharm
- Active ingredient: rifampicin
- Therapeutic area: Infectious Disease
- Related brand: RIFADIN
- Same area: RETROVIR
- Same area: Savacol Antiseptic Mouth & Throat Rinse
What it is
Rifampicin is available as 150 mg and 300 mg capsules , syrup containing 100 mg per 5 mL , and intravenous infusion containing 600 mg per vial . Rifampicin is a semisynthetic antibiotic derivative of rifamycin B, specifically the hydrazone 3-(4-methylpiperazinyliminomethyl) rifamycin SV .
Approved indications
— Initial treatment and re-treatment of patients with tuberculosis, used in conjunction with at least one other antituberculosis drug . — Management of lepromatous leprosy and dimorphous leprosy to effect speedy conversion of the infectious state to the noninfectious state . — Alternative drug in lepromatous, dimorphous, indeterminate and tuberculoid leprosy resistant to sulfones and other antileprosy drugs . — Alternative drug in all those patients having true drug allergy to the more commonly used antileprosy drugs . — Prophylaxis of meningococcal disease in close contacts of known cases and in carriers . — Prophylaxis of household contacts of patients with H. influenzae type B .
Dosing overview
Oral Rifadin should be administered once daily, on an empty stomach either 30 minutes before or two hours after a meal . Serum concentrations following single daily administration of 600 mg rifampicin given intravenously over 1 to 3 hours are similar to those obtained after 600 mg by mouth .
Key safety warnings
Rifampicin has been shown to produce liver dysfunction, and there have been fatalities associated with jaundice in patients with liver disease or receiving rifampicin concomitantly with other hepatotoxic agents . Periodic liver function monitoring, especially ALT and AST, should be carried out prior to therapy and then every 2 to 4 weeks during therapy . Cases of drug-induced liver injury, including fatal cases especially when used in combination with other anti-tuberculosis drugs, have been reported with signs and symptoms including elevated serum hepatic enzymes, cholestatic jaundice, hepatitis, hepatotoxicity, hepatocellular injury, and mixed liver injury . Urine, faeces, saliva, sputum, sweat, tears and teeth may be coloured red-orange, yellow or brown by rifampicin and its metabolites, and soft contact lenses may be permanently stained . Rifampicin has been observed to increase the requirement for anticoagulant drugs of the coumarin type, and in patients receiving anticoagulants and rifampicin concurrently, the prothrombin time should be performed daily or as frequently as necessary to establish and maintain the required dose of anticoagulant . Rifadin is not recommended for intermittent therapy (less frequently than 2 to 3 times per week) because of the possibility of immunological reactions including anaphylaxis . The patient should be cautioned against intentional or accidental interruption of the daily dosage regimen, and if a patient develops thrombocytopenia, purpura, haemolytic anaemia or renal failure, treatment with Rifadin should be stopped at once and not reinstituted .
Contraindications
Jaundice is a contraindication . History of hypersensitivity to any of the rifamycins is a contraindication . Use is contraindicated when given concurrently with the combination of saquinavir/ritonavir . Cabotegravir, fostemsavir and lenacapavir are contraindicated with Rifadin . Concomitant administration with lurasidone is contraindicated as it markedly decreases the exposure of lurasidone .
PBS listing
The 300 mg capsule strength has 4 PBS items with authority required restriction, at an ex-manufacturer price of A$75.40, current to the 2026-05-01 schedule . The 150 mg capsule strength has 4 PBS items with authority required restriction, at an ex-manufacturer price of A$165.40, current to the 2026-05-01 schedule .
Regulatory history
Rimycin 150 mg and 300 mg capsules were first listed on the ARTG on 10 March 1994 . In September 2020, the PBAC recommended authority required listing of rifampicin for the treatment of Mycobacterium ulcerans infection (Buruli ulcer), with treatment to be used in combination with another antibiotic .