A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Bactroban Indications, Dosage, Storage, Stability - Mupirocin
Bactroban Indications, Dosage, Storage, Stability - Mupirocin
INDICATIONS
AND USES
Bactroban Nasal (mupirocin calcium ointment), 2% is indicated for the eradication
of nasal colonization with methicillin-resistant Staphylococcus aureus in
adult patients and health care workers as part of a comprehensive infection
control program to reduce the risk of infection among patients at high risk
of methicillin-resistant S. aureus infection during institutional outbreaks
of infections with this pathogen.
NOTE:
- There are insufficient data at this time to establish that this product
is safe and effective as part of an intervention program to prevent autoinfection
of high-risk patients from their own nasal colonization with S. aureus
.
- There are insufficient data at this time to recommend use of Bactroban
Nasal for general prophylaxis of any infection in any patient population.
- Greater than 90% of subjects/patients in clinical trials had eradication
of nasal colonization 2 to 4 days after therapy was completed. Approximately
30% recolonization was reported in one domestic study within 4 weeks after
completion of therapy. These eradication rates were clinically and statistically
superior to those reported in subjects/patients in the vehicle-treated arms
of the adequate and well-controlled studies. Those treated with vehicle had
eradication rates of 5% to 30% at 2 to 4 days post-therapy with 85% to 100%
recolonization within 4 weeks.
All adequate and well-controlled trials of this product were vehicle-controlled;
therefore, no data from direct, head-to-head comparisons with other products
are available at this time.
DOSAGE AND ADMINISTRATION
(See INDICATIONS
AND USAGE.)
Adults (12 years of age and older): Approximately one-half
of the ointment from the single-use tube should be applied into one nostril
and the other half into the other nostril twice daily (morning and evening)
for 5 days.
After application, the nostrils should be closed by pressing together and releasing
the sides of the nose repetitively for approximately 1 minute. This will spread
the ointment throughout the nares.
The single-use 1.0 gram tube will deliver a total of approximately 0.5 grams
of the ointment (approximately 0.25 grams/nostril).
The tube should be discarded after usage; it should not be re-used.
The safety and effectiveness of applications of this medication for greater
than 5 days have not been established. There are no human clinical or pre-clinical
animal data to support the use of this product in a chronic manner or in manners
other than those described in this package insert.
Until further information is known, Bactroban Nasal should not be applied
concurrently with any other intranasal products.
HOW SUPPLIED
Bactroban Nasal (mupirocin calcium ointment), 2% is supplied in 1.0 gram tubes
packaged in cartons of 10.
NDC 0029-1526-11 (1.0 gram tubes in packages of 10).
Store at or below 25°C (77°F).
REFERENCE
- National Committee for Clinical Laboratory Standards. Methods for Dilution
Antimicrobial Susceptibility Tests for Bacteria That Grow Aerobically Third
Edition; Approved Standard NCCLS Document M7-A3. Vol. 12, No. 25, NCCLS, Villanova,
PA, December 1993.
Manufactured by DPT Laboratories
San Antonio, TX 78215
Distributed by SmithKline Beecham Pharmaceuticals
Philadelphia, PA 19101
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