Home » Drug Information » FDA Approved Drugs » 1996
Medical Areas: Otolaryngology (Ear, Nose, Throat)
View By:YearCompanyConditionsTherapeutic AreasDrug Names
Bactroban Nasal 2% (mupirocin calcium ointment)
The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: SmithKline Beecham
Approval Status: Approved April 1996
Treatment Area: nasal bacteria
Bactroban Nasal has been approved as an intranasally
administered topical agent for the eradication of nasal
colonization with methicillin-resistant Staphylococcus aureus
(MRSA). This treatment has been approved for adult subjects and
health care workers as part of a comprehensive infection control
program to reduce the risk of MRSA infection during institutional
outbreaks of infections with this pathogen. A problem first
confined to tertiary care centers and large teaching hospitals,
MRSA outbreaks increasingly affect hospitals and other health care
institutions of all sizes and, once established, have proven
extremely difficult to eradicate.
Bactroban Nasal is available in a one-gram single-use applicator
tube and is formulated specifically for intranasal use. The
recommended course of therapy is twice daily application for five
Analysis of six U.S. clinical trials designed to evaluate the
effectiveness of Bactroban Nasal in eliminating S. aureus from the
nostrils in health care workers showed that of the volunteers
evaluated for efficacy, nasal carriage of S. aureus was eliminated
in 91% of volunteers receiving Bactroban Nasal, but only 6% of
volunteers receiving placebo. In addition, 74% of the volunteers
treated with Bactroban Nasal who were free of S. aureus at the end
of therapy (five days) remained free of the bacteria four weeks
after treatment compared with 12.5% of the placebo volunteers. No
serious side effects were reported. Only one of 339 participants
withdrew from the study due to a side effect.
The most frequently reported side effects associated with
Bactroban Nasal were headache (9%), rhinitis (6%), and respiratory
disorder including upper respiratory tract congestion (5%).
According to an estimate from the Centers for Disease Control
and Prevention (CDC), each year approximately two million patients
in the United States contract hospital-acquired infections. Further
complicating this problem is antibiotic resistance, which hampers
treatment of the infections.
Subjects at high risk of MRSA infection may include those
undergoing surgery and those being treated in intensive care units.
For this reason, it is important to contain nasal carriage of MRSA.
By eradicating MRSA from the nose, Bactroban Nasal interrupts the
transmission of the bacteria to a potential site of infection.