BACTROBAN- mupirocin calcium ointment

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5)

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

MUPIROCIN CALCIUM

הרכב:

MUPIROCIN 20 mg in 1 g

מסלול נתינה (של תרופות):

TOPICAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

BACTROBAN NASAL is indicated for the eradication of nasal colonization with methicillin-resistant S. 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 1 domestic study within 4 weeks after completion of therapy. These eradication r

leaflet_short:

BACTROBAN NASAL is supplied in 1.0-gram tubes. NDC 54868-4325-0 (package of 10 single-tube cartons). Store between 20° and 25°C (68° and 77°F); excursions permitted to 15°-30°C (59°-86°F). Do not refrigerate.

מצב אישור:

New Drug Application

מאפייני מוצר

BACTROBAN - MUPIROCIN CALCIUM OINTMENT
PHYSICIANS TOTAL CARE, INC.
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BACTROBAN NASAL
(MUPIROCIN CALCIUM OINTMENT, 2%)
FOR INTRANASAL USE ONLY
DESCRIPTION
BACTROBAN NASAL (mupirocin calcium ointment, 2%) contains the
dihydrate crystalline calcium
hemi-salt of the antibiotic mupirocin. Chemically, it is
(α_E_,2_S_,3_R_,4_R_,5_S_)-5-[(2_S_,3_S_,4_S_,5_S_)-2,3-Epoxy-5-
hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy-β-methyl-2_H_-pyran-2-crotonic
acid, ester with 9-
hydroxynonanoic acid, calcium salt (2:1), dihydrate.
The molecular formula of mupirocin calcium is (C
H O ) Ca•2H O, and the molecular weight is
1075.3. The molecular weight of mupirocin free acid is 500.6. The
structural formula of mupirocin
calcium is:
BACTROBAN NASAL is a white to off-white ointment that contains 2.15%
w/w mupirocin calcium
(equivalent to 2.0% pure mupirocin free acid) in a soft white ointment
base. The inactive ingredients are
paraffin and a mixture of glycerin esters (SOFTISAN 649).
CLINICAL PHARMACOLOGY
PHARMACOKINETICS
Following single or repeated intranasal applications of 0.2 gram of
BACTROBAN NASAL 3 times
daily for 3 days to 5 healthy adult male subjects, no evidence of
systemic absorption of mupirocin was
demonstrated. The dosage regimen used in this study was for
pharmacokinetic characterization only.
(See DOSAGE AND ADMINISTRATION for proper clinical dosing
information.)
In this study, the concentrations of mupirocin in urine and of monic
acid in urine and serum were below
the limit of determination of the assay for up to 72 hours after the
applications. The lowest levels of
determination of the assay used were 50 ng/mL of mupirocin in urine,
75 ng/mL of monic acid in urine,
and 10 ng/mL of monic acid in serum. Based on the detectable limit of
the urine assay for monic acid,
one can extrapolate that a mean of 3.3% (range: 1.2 to 5.1%) of the
applied dose could be systemically
absorbed from the nasal mucosa of ADULTS.
Data from a report of a pharmacokinetic study in neonates and
premature infants indicate that, un