MYCOBUTIN 150 MG

What is MYCOBUTIN?

MYCOBUTIN 150 MG contains RIFABUTIN : 150 MG. It is listed in the Health Canada Drug Product Database under DIN 02063786, held by PFIZER CANADA ULC, supplied as CAPSULE for ORAL administration. Health Canada currently lists it as marketed, status dated 16-Feb-2005. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.

What is MYCOBUTIN used for?

MYCOBUTIN (rifabutin) is indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection (CD4+ cell count ≤200/mm³ with an AIDS defining diagnosis, or CD4+ cell count ≤ 100/mm³ without an AIDS defining diagnosis). To reduce the development of drug-resistant bacteria and maintain the effectiveness of MYCOBUTIN and other antibacterial drugs, MYCOBUTIN should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.

Product details and regulatory record

How is it administered?

It is recommended that MYCOBUTIN (rifabutin) 300 mg be administered once daily with or without food. For those patients who experience nausea, vomiting or other gastrointestinal upsets, it may be useful to split the MYCOBUTIN dose in half (one 150 mg capsule) twice a day with food. The capsule(s) should be swallowed whole with a drink of water. If a dose is missed, the patient should take the dose as soon as remembered. If it is almost time for the next dose, the patient should skip the missed dose and take the next dose at the regularly scheduled time. Do not double the dose.

Included because it drives pack selection and wastage. Consult the monograph.

How is it stored and handled?

Store at controlled room temperature, 15°C-30 °C. Keep container tightly closed. Keep out of reach and sight of children.

How is it supplied?

MYCOBUTIN (rifabutin) is supplied as hard gelatin capsules having an opaque red-brown cap and body, imprinted with PHARMACIA & UPJOHN/ MYCOBUTIN, in white ink, each containing 150 mg rifabutin.

Contraindications

Concomitant use with rilpivirine containing prolonged-release suspension for injection is contraindicated. MYCOBUTIN is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.

Warnings and precautions

MYCOBUTIN (rifabutin) prophylaxis must not be administered to patients with active tuberculosis. Patients who develop signs and symptoms consistent with active tuberculosis while on MYCOBUTIN prophylaxis should be evaluated immediately. Administration of MYCOBUTIN, as a single-agent, to patients with active tuberculosis is likely to lead to the development of tuberculosis which is resistant both to MYCOBUTIN and to rifampin. There is no evidence that MYCOBUTIN provides effective prophylaxis against M. tuberculosis infections. Patients requiring prophylaxis against both M. tuberculosis and Mycobacterium avium complex may be given isoniazid and MYCOBUTIN concurrently. Significant drug-drug interactions between rifabutin and protease inhibitors, among many other drugs, requires careful consideration. Patients should be carefully monitored to avoid uveitis. If uveitis is suspected, the patient should be referred to an ophthalmologist and, if considered necessary, treatment with MYCOBUTIN should be suspended. Rifabutin is a CYP450 3A inducer. Therefore, co-administration with antiretroviral products including but not limited to bictegravir, elvitegravir/Cobicistat, oral rilpivirine, or doravirine and anti-HCV products including but not limited to sofosbuvir (alone or in combination) is not recommended due to the expected decrease in plasma concentrations of the antiretrovirals and anti-HCV products which may lead to loss of virologic response and possible development of resistance. Anaphylactic shock has occurred with other antibiotics of the same class. Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including MYCOBUTIN (rifabutin). CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Severe cutaneous adverse reactions (SCARs), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported with anti-tuberculosis drugs. If patients develop a skin rash they should be monitored closely and suspect drug(s) discontinued if lesions progress.

Who else supplies RIFABUTIN worldwide?

Nexara tracks national medicine registries and published price lists across multiple markets. RIFABUTIN appears in 5 registered pack listings across 4 markets, published on 4 different national price bases. Where a Canadian route is closed, that is where an alternative route of supply starts — subject to the import rules in both countries.

Registered listings are not stock. Ask us to confirm what can actually be sourced for your order.