Pre and Post Sx Pouch (Page 2 of 2)

Carcinogenesis, Mutagenesis, Impairment of Fertility –

Long-term studies in animals to evaluate carcinogenic potential of mupirocin have not been conducted.

Results of the following studies performed with mupirocin calcium or mupirocin sodium in vitro and in vivo did not indicate a potential for genotoxicity: Rat primary hepatocyte unscheduled DNA synthesis, sediment analysis for DNA strand breaks, Salmonella reversion test (Ames), Escherichia coli mutation assay, metaphase analysis of human lymphocytes, mouse lymphoma assay, and bone marrow micronuclei assay in mice.

Reproduction studies were performed in male and female rats with mupirocin administered subcutaneously at doses up to 14 times a human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of impaired fertility and reproductive performance from mupirocin.

Pregnancy:

Teratogenic Effects:

Pregnancy Category B –

Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) on a mg/m 2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers –

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Mupirocin Ointment USP, 2% is administered to a nursing woman.

Pediatric Use –

The safety and effectiveness of Mupirocin Ointment USP, 2% have been established in the age range of 2 months to 16 years. Use of mupirocin ointment USP, 2% in these age groups is supported by evidence from adequate and well-controlled trials of mupirocin ointment USP, 2% in impetigo in pediatric subjects studied as part of the pivotal clinical trials (see CLINICAL STUDIES).

ADVERSE REACTIONS

The following local adverse reactions have been reported in connection with the use of mupirocin ointment USP, 2%: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects; rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate in less than 1% of subjects. Systemic allergic reactions, including anaphylaxis, urticaria, angioedema and generalized rash have been reported in patients treated with mupirocin formulations.

DOSAGE AND ADMINISTRATION

A small amount of Mupirocin Ointment USP, 2% should be applied to the affected area 3 times daily. The area treated may be covered with a gauze dressing if desired. Patients not showing a clinical response within 3 to 5 days should be re-evaluated.

CLINICAL STUDIES

The efficacy of topical mupirocin ointment USP, 2% in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% or vehicle placebo 3 times daily for 8 to 12 days. Clinical efficacy rates at end of therapy in the evaluable populations (adults and pediatric subjects included) were 71% for mupirocin ointment USP, 2% (n=49) and 35% for vehicle placebo (n=51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment USP, 2% and 62% for vehicle placebo. There were no side effects reported in the group receiving mupirocin ointment USP, 2%. In the second trial, subjects with impetigo were randomized to receive either mupirocin ointment USP, 2% 3 times daily or 30 to 40 mg/kg oral erythromycin ethylsuccinate per day (this was an unblinded trial) for 8 days. There was a follow-up visit 1 week after treatment ended. Clinical efficacy rates at the follow-up visit in the evaluable populations (adults and pediatric subjects included) were 93% for mupirocin ointment USP, 2% (n=29) and 78.5% for erythromycin (n=28). Pathogen eradication rates in the evaluable populations were 100% for both test groups. There were no side effects reported in the group receiving mupirocin ointment USP, 2%.

Pediatrics –

There were 91 pediatric subjects aged 2 months to 15 years in the first trial described above. Clinical efficacy rates at end of therapy in the evaluable populations were 78% for mupirocin ointment USP, 2% (n=42) and 36% for vehicle placebo (n=49). In the second trial described above, all subjects were pediatric except 2 adults in the group receiving mupirocin ointment USP, 2%. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment USP, 2% (n=27) was 96%, and for erythromycin it was unchanged (78.5%).

HOW SUPPLIED

Mupirocin Ointment USP, 2% is available as follows:

22 g tube (NDC 45802- 112 -22)

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].

*Bactroban Nasal® is a registered trademark of GlaxoSmithKline.

REFERENCES

1. Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard -Tenth Edition. CLSI document M07-A10 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.

2. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Diffusion Susceptibility Tests; Approved Standard – Twelfth Edition. CLSI document M02-A12 [2015], Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA.

3. Finlay JE, Miller LA, Poupard JA. Interpretive criteria for testing susceptibility of staphylococci to mupirocin. Antimicrob Agents Chemother 1997;41(5):1137-1139.

Made in Israel

Manufactured By Perrigo

Yeruham 80500, Israel

Distributed By

Perrigo®

Allegan, MI 49010 • www.perrigo.com

Rev 05-15

1N200 RC J6

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

Rx Only

Mupirocin Ointment USP, 2%

NET WT 22 g

Mupirocin Ointment
(click image for full-size original)

Dimethicone 5%

dimethicone
(click image for full-size original)

Chlorhexidine Gluconate 4%

chlor
(click image for full-size original)

Pre & Post Sx Pouch

Pre & Post Sx Pouch

Mupirocin 2%

Dimethicone 5%

Chlorhexidine Gluconate 4%

NDC 53225-5000-1

Lot #

Exp. Date

Terrain Pharmaceuticals

pouch
(click image for full-size original)
PRE AND POST SX POUCH
mupirocin 2%, dimethicone 5%, chlorhexidine gluconate 4% kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53225-5000
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53225-5000-1 1 KIT in 1 KIT None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 TUBE 22 g
Part 2 1 TUBE 118 mL
Part 3 1 BOTTLE, PLASTIC 118 mL
Part 1 of 3
MUPIROCIN
mupirocin ointment
Product Information
Item Code (Source) NDC:45802-112
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUPIROCIN (MUPIROCIN) MUPIROCIN 20 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYETHYLENE GLYCOL, UNSPECIFIED
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:45802-112-22 1 TUBE in 1 CARTON contains a TUBE
1 22 g in 1 TUBE This package is contained within the CARTON (45802-112-22)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA065123 10/30/2009
Part 2 of 3
REMEDY DIMETHICONE MOISTURE BARRIER
dimethicone cream
Product Information
Item Code (Source) NDC:53329-151
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
ASCORBYL PALMITATE
CITRIC ACID MONOHYDRATE
PROLINE
TAURINE
METHYLPARABEN
PROPYLPARABEN
VITAMIN A PALMITATE
ROSA CANINA FRUIT
STEARIC ACID
STEARYL ALCOHOL
EDETATE SODIUM (EDETIC ACID)
ALPHA-TOCOPHEROL
ALOE VERA LEAF
GLYCERYL MONOSTEARATE
GLYCINE
VANILLIN
GLYCERIN
DIMETHYL SULFONE
ACETYLCYSTEINE
POLYETHYLENE GLYCOL 400
POLYOXYL 100 STEARATE
PROPYLENE GLYCOL
PYRIDOXINE HYDROCHLORIDE
TROLAMINE
CORN OIL
NIACINAMIDE
WATER
ASCORBIC ACID
CETYL ALCOHOL
CHOLECALCIFEROL
DIAZOLIDINYL UREA
SUNFLOWER OIL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:53329-151-04 118 mL in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 08/07/2007
Part 3 of 3
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solution
Product Information
Item Code (Source) NDC:0116-1061
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 4 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
GLUCONOLACTONE
LAURAMINE OXIDE
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)
WATER
COCO DIETHANOLAMIDE
ISOPROPYL ALCOHOL
TRIDECYL ALCOHOL
PEG-75 LANOLIN
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0116-1061-04 118 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA019125 08/31/2011
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/19/2018
Labeler — Terrain Pharmaceuticals (078358750)

Revised: 10/2021 Terrain Pharmaceuticals

Page 2 of 2 1 2

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2021. All Rights Reserved.