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Basic Drug Info
Drug Name:Mycobutin
Manufacturer:Pharmacia and Upjohn Company
Other Info:Rx onlyLAB-0217-3.0October 2007



Clinical Trials:


Indications and Usage
MYCOBUTIN Capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
Disease -- A definite pathologic process with a characteristic set of signs and symptoms. It may affect the whole body or any of its parts, and its etiology, pathology, and prognosis may be known or unknown.

HIV Infections -- any state of infection accompanied by evidence of HIV in the body (positive test for HIV genome, cDNA, proteins, antigens, or antibodies); may be medically asymptomatic or symptomatic; use AIDS when appropriate.

Contraindications
MYCOBUTIN Capsules are contraindicated in patients who have had clinically significant hypersensitivity to rifabutin or to any other rifamycins.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

Warnings

MYCOBUTIN Capsules must not be administered for MAC prophylaxis to patients with active tuberculosis.

Tuberculosis in HIV-positive patients is common and may present with atypical or extrapulmonary findings.

Patients are likely to have a nonreactive purified protein derivative (PPD) despite active disease.

In addition to chest X-ray and sputum culture, the following studies may be useful in the diagnosis of tuberculosis in the HIV-positive patient: blood culture, urine culture, or biopsy of a suspicious lymph node.Patients who develop complaints consistent with active tuberculosis while on prophylaxis with MYCOBUTIN should be evaluated immediately, so that those with active disease may be given an effective combination regimen of antituberculosis medications.

Administration of MYCOBUTIN as a single agent to patients with active tuberculosis is likely to lead to the development of tuberculosis that is resistant both to MYCOBUTIN and to rifampin.There is no evidence that MYCOBUTIN is effective prophylaxis against M.

tuberculosis.

Patients requiring prophylaxis against both M.

tuberculosis and Mycobacterium avium complex may be given isoniazid and MYCOBUTIN concurrently.Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including MYCOBUTIN (rifabutin capsules, USP), and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C.

difficile.

C.

difficile produces toxins A and B which contribute to the development of CDAD.

Hypertoxin producing strains of C.

difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C.

difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C.

difficile, and surgical evaluation should be instituted as clinically indicated.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.