BACTROBAN- mupirocin calcium cream
For Healthcare Providers >

1. Patient Information
2. Advise The Patient To Administer Bactroban Cream As Follows:
3. Do Not Use Bactroban Cream If:
4. Before Using Bactroban Cream, Tell Your Healthcare Provider About All Of Your Medical Conditions Including If You:
5. How Should I Use Bactroban Cream?
6. Bactroban Cream May Cause Serious Side Effects, Including:
7. The Most Common Side Effects Of Bactroban Cream Include:
8. How Should I Store Bactroban Cream?
9. Active Ingredient:
10. Inactive Ingredients:
11. Revised: 5/2017document Id:

Patient Information ⮝

Advise the patient to read the FDA-approved patient labeling (Patient Information).

Advise The Patient To Administer Bactroban Cream As Follows: ⮝

Use BACTROBAN cream only as directed by the healthcare provider. It is for external use only. Avoid contact of BACTROBAN cream with the eyes. If BACTROBAN cream gets in the eyes, rinse thoroughly with water.

Do not use BACTROBAN cream in the nose.

Wash your hands before and after applying BACTROBAN cream.

Use a gauze pad or cotton swab to apply a small amount of BACTROBAN cream to the affected area. The treated area may be covered by gauze dressing if desired.

Report to the healthcare provider any signs of local adverse reactions. BACTROBAN cream should be stopped and the healthcare provider contacted if irritation, severe itching, or rash occurs.

Report to the healthcare provider or go to the nearest emergency room if severe allergic reactions, such as swelling of the lips, face, or tongue, or wheezing occur[

BACTROBAN cream is a prescription medicine used on the skin (topical use) to treat certain skin infections caused by bacteria calledStaphylococcus aureusandStreptococcus pyogenes.

It is not known if BACTROBAN cream is safe and effective in children under 3 months of age.

Do Not Use Bactroban Cream If: ⮝

you are allergic to mupirocin or any of the ingredients in BACTROBAN cream.

Before Using Bactroban Cream, Tell Your Healthcare Provider About All Of Your Medical Conditions Including If You: ⮝

are pregnant or plan to become pregnant. It is not known if BACTROBAN cream will harm your unborn baby.

are breastfeeding or plan to breastfeed. It is not known if BACTROBAN cream passes into your breast milk. You and your healthcare provider should decide if you can use BACTROBAN cream while breastfeeding.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Do not mix BACTROBAN cream with other lotions, creams, or ointments.

How Should I Use Bactroban Cream? ⮝

BACTROBAN cream is for use on the skin (topical).Do not get BACTROBAN cream in your eyes, nose, mouth, or vagina (mucosal surfaces).

Use BACTROBAN cream exactly as your healthcare provider tells you to use it.

Apply a small amount of BACTROBAN cream, with a cotton swab or gauze pad, to the affected area 3 times each day. Apply BACTROBAN cream for 10 days.

It is important that you take the full course of BACTROBAN cream. Do not stop early because your symptoms may disappear before the infection is fully cleared.

Wash your handsbefore and afterapplying BACTROBAN cream.

After applying BACTROBAN cream, you may cover the treated area with a clean gauze pad, unless your healthcare provider has told you to leave it uncovered.

Talk to your healthcare provider if your skin does not improve after 3 to 5 days of treatment with BACTROBAN cream.

If you are breastfeeding and use BACTROBAN cream on your breast or nipple, wash the area well before breastfeeding your child.

Bactroban Cream May Cause Serious Side Effects, Including: ⮝

severe allergic reactions.Stop using BACTROBAN cream and call your healthcare provider or go to the nearest emergency room right away if you have any of the following signs or symptoms of a severe allergic reaction:

hives trouble breathing or wheezing

swelling of your face, lips, mouth, or tongue dizziness, fast heartbeat, or pounding in your chest

a rash over your whole body

eye irritation. Do not get BACTROBAN cream in your eyes. If BACTROBAN cream gets in your eyes, rinse your eyes well with water.

irritation in the area BACTROBAN cream is used. A rash may occur after using BACTROBAN cream and can be severe. Stop using BACTROBAN cream and call your healthcare provider if you develop an irritation, severe itching, or a rash while using BACTROBAN cream.

a type of diarrhea calledclostridium difficile-associated diarrhea (CDAD).CDAD may happen in people who use or have used medicine to treat bacterial infections. The severity of CDAD can range from mild diarrhea to severe diarrhea that may cause death (fatal colitis). Call your healthcare provider or go to the nearest emergency room right away if you have diarrhea while using or after you stop using BACTROBAN cream.

The Most Common Side Effects Of Bactroban Cream Include: ⮝

headache

rash

nausea

These are not all the possible side effects of BACTROBAN cream. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How Should I Store Bactroban Cream? ⮝

Store BACTROBAN cream at room temperature between 68 F to 77 F (20 C to 25 C).

Do not freeze BACTROBAN cream.

Keep BACTROBAN cream and all medicines out of the reach of children.

General information about the safe and effective use of BACTROBAN cream.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BACTROBAN cream for a condition for which it was not prescribed. Do not give BACTROBAN cream to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about BACTROBAN cream that is written for health professionals.

Active Ingredient: ⮝

mupirocin calcium

Inactive Ingredients: ⮝

benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum

BACTROBAN is a registered trademark of the GSK group of companies.

2017 the GSK group of companies. All rights reserved.

GlaxoSmithKline, Research Triangle Park, NC 27709

BBC:2PIL

For more information, call 1-888-825-5249.

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: May 2017

PRINCIPAL DISPLAY PANEL

NDC 0029-1527-22

BACTROBANCream

(mupirocin calcium cream, 2%)

15 grams(Net Wt.)

Rxonly

Do not use if seal on tube nozzle is broken

Made in England

2015 the GSK group of companies

10000000136830 Rev. 9/15

BACTROBAN mupirocin calcium cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0029-1527 Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUPIROCIN CALCIUM(UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5) MUPIROCIN 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL(UNII: LKG8494WBH) CETETH-20(UNII: I835H2IHHX) CETYL ALCOHOL(UNII: 936JST6JCN) MINERAL OIL(UNII: T5L8T28FGP) PHENOXYETHANOL(UNII: HIE492ZZ3T) WATER(UNII: 059QF0KO0R) STEARYL ALCOHOL(UNII: 2KR89I4H1Y) XANTHAN GUM(UNII: TTV12P4NEE)

Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0029-1527-22 1 in 1 CARTON 01/23/1998 1 15 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0029-1527-25 1 in 1 CARTON 01/23/1998 2 30 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050746 01/23/1998

Labeler -GlaxoSmithKline LLC (167380711)

Revised: 5/2017document Id: ⮝

7fbf9ae2-228b-4e60-8867-d5cf9b31893934391-3Set id: 9257f9cd-abaf-4bb2-d9ac-4bc8f65ae558Version: 16Effective Time: 20170508GlaxoSmithKline LLC

1. No Title 1572554874
2. Bactroban Cream Mupirocin Calcium Cream 2% - Package Label
3. Highlights Of Prescribing Information
4. Dosage Forms And Strengths
5. Warnings And Precautions
6. 1 Indications And Usage
7. 2 Dosage And Administration
8. 3 Dosage Forms And Strengths
9. 4 Contraindications
10. 5 Warnings And Precautions
11. 6 Adverse Reactions
12. 8 Use In Specific Populations
13. 11 Description
14. 12 Clinical Pharmacology
15. 13 Nonclinical Toxicology
16. 14 Clinical Studies
17. 15 References
18. 16 How Supplied/storage And Handling
19. Description
20. Clinical Pharmacology
21. Indications And Usage
22. Contraindications
23. Warnings
24. Precautions
25. Adverse Reactions
26. Overdosage
27. Dosage And Administration
28. Clinical Studies
29. How Supplied
30. No Title 1572448797

No Title 1572554874 ⮝

Principal Display Panel

BACTROBAN CREAM

MUPIROCIN CALCIUM CREAM 2%

15 grams (Net Wt.)

Rx only

Store at or below 25oC (77oF). Do not freeze.

Each gram contains 21.5 mg mupirocin calcium in a mineral oil cream base.

Dosage: For dermatologic use only. Apply a small amount of cream to the affected area three times daily for 10 days. Patients not showing clinical response within 3 to 5 days should be re-evaluated.

See accompanying prescribing information.

Bactroban Cream

Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1 What Bactroban is and what it is used for
2 Before you use Bactroban
3 How to use Bactroban
4 Possible side effects
5 How to store Bactroban
6 Further information

1 What Bactroban is and what it is used for
Bactroban Cream (called Bactroban in this leaflet) contains a medicine called mupirocin calcium. Bactroban is an antibiotic cream.
It is used:
to treat infections on your skin in small cuts, wounds or on scraped skin.
to kill bacteria causing infections on your skin called Staphylococcus aureus and Streptococcus pyogens
this cream is for external use on your skin only.

2 Before you use Bactroban
Do not use Bactroban if:
you are allergic (hypersensitive) to mupirocin calcium, mupirocin or any of the other ingredients of Bactroban (listed in Section 6)
the patient is less than 1 year old.
If you are not sure if this applies to you, do not use this medicine. Talk to your doctor, nurse or pharmacist before using Bactroban.

Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

Pregnancy and breast-feeding
Do not use Bactroban if you are pregnant, might become pregnant or are breast-feeding. Talk to your doctor, nurse or pharmacist for advice before using any medicine, if you are pregnant or breastfeeding.

Important information about some of the ingredients of Bactroban
Bactroban contains cetyl alcohol and stearyl alcohol. These ingredients may cause skin reactions where you apply the cream. See also Section 4.

3 How to use Bactroban
Always use Bactroban exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.
Take special care with Bactroban
Do not use Bactroban in your eyes. If you are using Bactroban on your face, be careful not to use it in or near your eyes or nose.
Do not put Bactroban into your mouth or swallow it.
If a cracked nipple is being treated, the cream must be thoroughly washed off prior to breast-feeding.

Using this medicine
Do not mix Bactroban with any other external cream or ointment medicines on the infected area of your skin as this may reduce the effectiveness of Bactroban.
You usually apply Bactroban on your skin up to 3 times a day.
1. Wash and dry your hands.
2. Place a small amount of Bactroban on a clean cotton wool pad or gauze swab.
3. Apply the cream to the infected area of your skin.
4. You can cover the treated area with a plaster or other suitable dressing, unless your doctor has told you to leave it uncovered.
5. Replace the cap on the tube and wash your hands.

How long should you use Bactroban for?
Use Bactroban for as long as your doctor has told you. If you are not sure, ask your doctor, nurse or pharmacist. The bacteria are normally cleared from your skin within 10
days of starting treatment. Do not use for more than 10 days.
If your skin condition does not improve within 3 to 5 days, see your doctor.
A yeast infection of moist areas of the body may develop if Bactroban is used for a long time. On the skin this looks like bright red spots which may be very itchy. On occasion small pustules may be present in the middle.
If this occurs, tell your doctor, pharmacist or nurse.

If you use more Bactroban than you should
If you use more Bactroban than you should, speak to your doctor, nurse or pharmacist for advice.
If you swallow Bactroban, contact your doctor immediately and indicate what and how much you have swallowed.

If you forget to use Bactroban
If you forget to apply Bactroban, apply it as soon as you remember.
If your next dose is due within an hour, skip the missed dose.
Do not use a double dose to make up for a forgotten dose.
If you stop using Bactroban too early, not all the bacteria may have been killed or they may continue to grow. Ask your doctor, nurse or pharmacist when to stop using the
cream.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

4 Possible side effects
Like all medicines, Bactroban can cause side effects, not everybody gets them. The following side effects may happen with this medicine:
Common (these may affect between 1 and 100 people)
Itching, redness, burning, rash, swelling, pain on your skin where Bactroban is applied.
Dryness and redness of the skin can also occur on other parts of your body.

If you develop a severe skin reaction or allergy:
wipe off the cream
stop using it and
tell your doctor as soon as possible.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5 How to store Bactroban\
Keep out of the reach and sight of children.
Do not store above 25 C. Do not freeze.
Do not use Bactroban after the expiry date which is stated on the tube. The expiry date refers to the last day of that month.
Do not use Bactroban if it looks different to normal.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6 Further information6 Further information
What Bactroban contains
1 g of cream contains 21.5 mg mupirocin calcium equivalent to 20 mg mupirocin.
The other ingredients are xanthan gum, liquid paraffin, cetomacrogol 1000, stearyl alcohol, cetyl alcohol, phenoxyethanol, benzyl alcohol and purified water. See also section 2.

What Bactroban looks like and contents of the pack
Bactroban is a smooth white cream.
Bactroban is available in a 15 g tube.
Each tube comes in a carton.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Beecham Group plc
Trading as GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

Manufacturer
Glaxo Wellcome Operations
Harmire Road
Barnard Castle
Co Durham
DL12 8DT

Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name Bactroban Cream
Reference number 00038/0372
This is a service provided by the Royal
National Institute for the Blind.
Leaflet date: October 2007

Bactroban is a registered trademark of the GlaxoSmithKline group of companies

2007 GlaxoSmithKline group of companies

BACTROBAN mupirocin calcium cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4642(NDC:0029-1527) Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5) MUPIROCIN CALCIUM 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETETH-20 (UNII: I835H2IHHX) CETYL ALCOHOL (UNII: 936JST6JCN) MINERAL OIL (UNII: T5L8T28FGP) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-4642-1 1 in 1 CARTON 1 15 g in 1 TUBE 2 NDC:54868-4642-0 1 in 1 CARTON 2 30 g in 1 TUBE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050746 07/12/2002

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 2/2007 Document Id: 76d3c42c-12e8-4135-8ccf-3f3cb2d49de0 34391-3 Set id: 87734c71-a574-465d-b941-f993f9ae8b2b Version: 1 Effective Time: 20070213 Physicians Total Care, Inc.

Bactroban Cream Mupirocin Calcium Cream 2% - Package Label ⮝

BACTROBAN mupirocin calcium cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-028(NDC:0029-1527) Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5) MUPIROCIN CALCIUM 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETETH-20 (UNII: I835H2IHHX) CETYL ALCOHOL (UNII: 936JST6JCN) MINERAL OIL (UNII: T5L8T28FGP) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:16590-028-30 30 g in 1 TUBE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050746 01/23/1998

Labeler - STAT RX USA LLC (786036330)

Establishment
Name	Address	ID/FEI	Business Operations
STAT RX USA LLC		786036330	relabel, repack

Revised: 1/2011 Document Id: ca5af146-331e-458e-8558-eb2418897ae0 34391-3 Set id: 76bdab9d-9153-4db6-9b9a-ff376374a8ea Version: 1 Effective Time: 20110106 STAT RX USA LLC

Highlights Of Prescribing Information ⮝

These highlights do not include all the information needed to use BACTROBAN Cream safely and effectively. See full prescribing information for BACTROBAN Cream.
BACTROBAN (mupirocin calcium) cream, for topical use

Initial U.S. Approval: 1997

Dosage Forms And Strengths ⮝

Cream: 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in 15-gram and 30-gram tubes. (3)

Warnings And Precautions ⮝

Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of BACTROBAN, including BACTROBAN cream. (5.1)

Eye Irritation: Avoid contact with eyes. (5.2)

Local Irritation: Discontinue in the event of sensitization or severe local irritation. (5.3)

Clostridium difficile-Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. (5.4)

Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (5.5)

Risk Associated with Mucosal Use: BACTROBAN cream is not formulated for use on mucosal surfaces. A separate formulation, BACTROBAN nasal ointment, is available for intranasal use. (5.6)

1 Indications And Usage  ⮝

BACTROBAN cream is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).

2 Dosage And Administration  ⮝

For Topical Use Only.

Apply a small amount of BACTROBAN cream, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days.

Cover the treated area with gauze dressing if desired.

Re-evaluate patients not showing a clinical response within 3 to 5 days.

BACTROBAN cream is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions (5.2, 5.6)].

Do not apply BACTROBAN cream concurrently with any other lotions, creams or ointments [see Clinical Pharmacology (12.3)].

3 Dosage Forms And Strengths  ⮝

BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water based emulsion supplied in 15-gram and 30-gram tubes.

4 Contraindications  ⮝

BACTROBAN cream is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of BACTROBAN cream.

5 Warnings And Precautions  ⮝

5.1 Severe Allergic Reactions

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of BACTROBAN, including BACTROBAN cream [see Adverse Reactions (6.2)].

5.2 Eye Irritation

Avoid contact with the eyes. In case of accidental contact, rinse well with water.

5.3 Local Irritation

In the event of a sensitization or severe local irritation from BACTROBAN cream, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

5.4 Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents 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 antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.5 Potential for Microbial Overgrowth

As with other antibacterial products, prolonged use of BACTROBAN cream may result in overgrowth of nonsusceptible microorganisms, including fungi [see Dosage and Administration (2)].

5.6 Risk Associated with Mucosal Use

BACTROBAN cream is not formulated for use on mucosal surfaces. A separate formulation, BACTROBAN (mupirocin calcium) nasal ointment, is available for intranasal use.

6 Adverse Reactions  ⮝

The following adverse reactions are discussed in more detail in other sections of the labeling:

Severe Allergic Reactions [see Warnings and Precautions (5.1)]

Eye Irritation [see Warnings and Precautions (5.2)]

Local Irritation [see Warnings and Precautions (5.3)]

Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.4)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

In 2 randomized, double blind, double dummy trials, 339 subjects were treated with topical BACTROBAN cream plus oral placebo. Adverse reactions occurred in 28 (8.3%) subjects. The following adverse reactions were reported by at least 1% of subjects in connection with the use of BACTROBAN cream in clinical trials: headache (1.7%), rash (1.1%), and nausea (1.1%).

Other adverse reactions which occurred in less than 1% of subjects were: abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.

In a supportive trial in the treatment of secondarily infected eczema, 82 subjects were treated with BACTROBAN cream. The incidence of adverse reactions was as follows: nausea (4.9%), headache and burning at application site (3.6% each), pruritus (2.4%), and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

6.2 Postmarketing Experience

In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of BACTROBAN cream. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to BACTROBAN cream.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions (5.1)].

8 Use In Specific Populations  ⮝

8.1 Pregnancy

Risk Summary

There are insufficient human data to establish whether there is a drug-associated risk with BACTROBAN cream in pregnant women. Systemic absorption of mupirocin through intact human skin is minimal following topical administration of BACROBAN cream [see Clinical Pharmacology (12.3)]. No developmental toxicity was observed in rats or rabbits treated with mupirocin subcutaneously during organogenesis at doses of 160 or 40 mg per kg per day, respectively (22 and 11 times the human topical dose based on calculations of dose divided by the entire body surface area).

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies.

Data

Animal Data: Developmental toxicity studies have been performed with mupirocin administered subcutaneously to rats and rabbits at doses up to 160 mg per kg per day during organogenesis. This dose is 22 and 43 times, respectively, the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area. Maternal toxicity was observed (body weight loss/decreased body weight gain and reduced feeding) in both species with no evidence of developmental toxicity in rats. In rabbits, excessive maternal toxicity at the high dose precluded the evaluation of fetal outcomes. There was no developmental toxicity in rabbits at 40 mg per kg per day, 11 times the human topical dose based on calculations of dose divided by the entire body surface area.

Mupirocin administered subcutaneously to rats in a pre- and postnatal development study (dosed during late gestation through lactation) was associated with reduced offspring viability in the early postnatal period at a dose of 106.7 mg per kg, in the presence of injection site irritation and/or subcutaneous hemorrhaging. This dose is 14 times the human topical dose based on calculations of dose divided by the entire body surface area. The no-observed adverse effect level in this study was 44.2 mg per kg per day, which is 6 times the human topical dose.

8.2 Lactation

Risk Summary

It is not known whether mupirocin is present in human milk, has effects on the breastfed child, or has effects on milk production. However, breastfeeding is not expected to result in exposure of the child to the drug due to the minimal systemic absorption of mupirocin in humans following topical administration of BACTROBAN cream [see Clinical Pharmacology (12.3)]. The developmental and health benefits of breastfeeding should be considered along with the mother s clinical need for BACTROBAN cream and any potential adverse effects on the breastfed child from BACTROBAN cream or from the underlying maternal condition.

Clinical Considerations

To minimize oral exposure of the drug to children, a breast and/or nipple being treated with BACTROBAN cream should be thoroughly washed prior to breastfeeding.

8.4 Pediatric Use

The safety and effectiveness of BACTROBAN cream have been established in the age-groups 3 months to 16 years. Use of BACTROBAN cream in these age-groups is supported by evidence from adequate and well controlled trials of BACTROBAN cream in adults with additional data from 93 pediatric subjects studied as part of the pivotal trials in adults [see Clinical Studies (14)].

8.5 Geriatric Use

In 2 adequate and well controlled trials, 30 subjects older than 65 years were treated with BACTROBAN cream. No overall difference in the efficacy or safety of BACTROBAN cream was observed in this patient population when compared with that observed in younger patients.

11 Description  ⮝

BACTROBAN (mupirocin calcium) cream, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is ( E,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy- -methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate.

The molecular formula of mupirocin calcium is (C26H43O9)2Ca 2H2O, and the molecular weight is 1075.3. The molecular weight of mupirocin free acid is 500.6. The structural formula of mupirocin calcium is:

Figure 1. Structure of Mupirocin Calcium

BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water based emulsion. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.

12 Clinical Pharmacology  ⮝

12.1 Mechanism of Action

Mupirocin is an RNA synthetase inhibitor antibacterial [see Microbiology (12.4)].

12.3 Pharmacokinetics

Absorption

Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of BACTROBAN cream 3 times daily for 5 days to various skin lesions greater than 10 cm in length or 100 cm2 in area in 16 adults (aged 29 to 60 years) and 10 children (aged 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, in urine. Data from this trial indicated more frequent occurrence of percutaneous absorption in children (90% of subjects) compared with adults (44% of subjects); however, the observed urinary concentrations in children (0.07 to 1.3 mcg per mL [1 pediatric subject had no detectable level]) are within the observed range (0.08 to 10.03 mcg per mL [9 adults had no detectable level]) in the adult population. In general, the degree of percutaneous absorption following multiple dosing appears to be minimal in adults and children.

The effect of the concurrent application of BACTROBAN cream with other topical products has not been studied [see Dosage and Administration (2)].

Elimination

In a trial conducted in 7 healthy adult male subjects, the elimination half-life after intravenous administration of mupirocin was 20 to 40 minutes for mupirocin and 30 to 80 minutes for monic acid.

Metabolism: Following intravenous or oral administration, mupirocin is rapidly metabolized. The principal metabolite, monic acid, demonstrates no antibacterial activity.

Excretion: Monic acid is predominantly eliminated by renal excretion.

12.4 Microbiology

Mupirocin is an RNA synthetase inhibitor antibacterial produced by fermentation using the organism Pseudomonas fluorescens.

Mechanism of Action

Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl-transfer RNA (tRNA) synthetase.

Mupirocin is bactericidal at concentrations achieved by topical administration Mupirocin is highly protein bound (greater than 97%) and the effect of wound secretions on the minimum inhibitory concentrations (MICs) of mupirocin has not been determined.

Resistance

When mupirocin resistance occurs, it results from the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC 512 mcg/mL) has been reported in increasing numbers of isolates of S. aureus and with higher frequency in coagulase-negative staphylococci. Mupirocin resistance occurs with greater frequency in methicillin-resistant than methicillin-susceptible staphylococci.

Cross Resistance

Due to its mode of action, mupirocin does not demonstrate cross resistance with other classes of antimicrobial agents.

Antimicrobial Activity

Mupirocin has been shown to be active against susceptible isolates of S. aureus and S. pyogenes, both in vitro and in clinical trials [see Indications and Usage (1)]. The following in vitro data are available, but their clinical significance is unknown. Mupirocin is active against most isolates of Staphylococcus epidermidis.

Susceptibility Test Methods

High-level mupirocin resistance ( 512 mcg/mL) may be determined using standard disk diffusion or broth microdilution tests.1,2 Because of the occurrence of mupirocin resistance in methicillin-resistant S. aureus (MRSA), it is appropriate to test MRSA populations for mupirocin susceptibility prior to the use of mupirocin using a standardized method.3,4,5

13 Nonclinical Toxicology  ⮝

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long term studies in animals to evaluate carcinogenic potential of mupirocin calcium 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.

In a fertility/reproductive performance study (with dosing through lactation), mupirocin administered subcutaneously to male and female rats at doses up to 100 mg per kg per day which is 14 times the human topical dose (approximately 60 mg mupirocin per day) based on calculations of dose divided by the entire body surface area, did not result in impaired fertility or impaired reproductive performance attributable to mupirocin.

14 Clinical Studies  ⮝

The efficacy of topical BACTROBAN cream for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10 cm in length or 100 cm2 in total area) was compared with that of oral cephalexin in 2 randomized, double blind, double dummy clinical trials. Clinical efficacy rates at follow up in the per-protocol populations (adults and pediatric subjects included) were 96.1% for BACTROBAN cream (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow up in the per-protocol populations were 100% for both BACTROBAN cream and oral cephalexin.

Pediatrics

There were 93 pediatric subjects aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion trials, although only 3 were younger than 2 years of age in the population treated with BACTROBAN cream. Subjects were randomized to either 10 days of topical BACTROBAN cream 3 times daily or 10 days of oral cephalexin (250 mg 4 times daily for subjects greater than 40 kg or 25 mg per kg per day oral suspension in 4 divided doses for subjects less than or equal to 40 kg). Clinical efficacy at follow up (7 to 12 days post-therapy) in the per-protocol populations was 97.7% (43 of 44) for BACTROBAN cream and 93.9% (46 of 49) for cephalexin.

15 References  ⮝

1.

Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Susceptibility Testing;Twenty-sixth Informational Supplement. CLSI document M100-S26. Clinical and Laboratory Standards Institute, 950 West Valley Rd., Suite 2500, Wayne, PA 19087, USA, 2016.

2.

Patel J, Gorwitz RJ, et al. Mupirocin Resistance. Clinical Infectious Diseases. 2009; 49(6): 935-41.

3.

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. Clinical and Laboratory Standards Institute, 950 West Valley Road, Suite 2500, Wayne, Pennsylvania 19087, USA, 2015.

4.

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

5.

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

16 How Supplied/storage And Handling  ⮝

BACTROBAN cream is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2% mupirocin free acid) in an oil- and water-based emulsion.

BACTROBAN cream, 2% is supplied in 15 gram and 30 gram tubes.

NDC 0029-1527-22 (15-gram tube)

NDC 0029-1527-25 (30-gram tube)

Store at or below 25 C (77 F). Do not freeze.

Description ⮝

BACTROBAN CREAM (mupirocin calcium cream, 2%) contains the dihydrate crystalline calcium hemi-salt of the antibiotic mupirocin. Chemically, it is ( E,2S,3R,4R,5S)-5-[(2S,3S,4S,5S)-2,3-Epoxy-5-hydroxy-4-methylhexyl]tetrahydro-3,4-dihydroxy- -methyl-2H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid, calcium salt (2:1), dihydrate.

The molecular formula of mupirocin calcium is (C26H43O9)2Ca 2H2O, 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 CREAM is a white cream that contains 2.15% w/w mupirocin calcium (equivalent to 2.0% mupirocin free acid) in an oil and water-based emulsion. The inactive ingredients are benzyl alcohol, cetomacrogol 1000, cetyl alcohol, mineral oil, phenoxyethanol, purified water, stearyl alcohol, and xanthan gum.

Clinical Pharmacology ⮝

Pharmacokinetics

Systemic absorption of mupirocin through intact human skin is minimal. The systemic absorption of mupirocin was studied following application of BACTROBAN CREAM 3 times daily for 5 days to various skin lesions (>10 cm in length or 100 cm2 in area) in 16 adults (aged 29 to 60 years) and 10 children (aged 3 to 12 years). Some systemic absorption was observed as evidenced by the detection of the metabolite, monic acid, in urine. Data from this study indicated more frequent occurrence of percutaneous absorption in children (90% of patients) compared to adults (44% of patients); however, the observed urinary concentrations in children (0.07 - 1.3 mcg/mL [1 pediatric patient had no detectable level]) are within the observed range (0.08 - 10.03 mcg/mL [9 adults had no detectable level]) in the adult population. In general, the degree of percutaneous absorption following multiple dosing appears to be minimal in adults and children. Any mupirocin reaching the systemic circulation is rapidly metabolized, predominantly to inactive monic acid, which is eliminated by renal excretion.

Microbiology

Mupirocin is an antibacterial agent produced by fermentation using the organism Pseudomonas fluorescens. It is active against a wide range of gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). It is also active against certain gram-negative bacteria. Mupirocin inhibits bacterial protein synthesis by reversibly and specifically binding to bacterial isoleucyl transfer-RNA synthetase. Due to this unique mode of action, mupirocin demonstrates no in vitro cross-resistance with other classes of antimicrobial agents.

Resistance occurs rarely; however, when mupirocin resistance does occur, it appears to result from the production of a modified isoleucyl-tRNA synthetase. High-level plasmid-mediated resistance (MIC >1024 mcg/mL) has been reported in some strains of Staphylococcus aureus and coagulase-negative staphylococci.

Mupirocin is bactericidal at concentrations achieved by topical application. The minimum bactericidal concentration (MBC) against relevant pathogens is generally 8-fold to 30-fold higher than the minimum inhibitory concentration (MIC). In addition, mupirocin is highly protein bound (>97%), and the effect of wound secretions on the MICs of mupirocin has not been determined.

Mupirocin has been shown to be active against most strains of S. aureus and Streptococcus pyogenes, both in vitro and in clinical studies. (See INDICATIONS AND USAGE.) The following in vitro data are available, BUT THEIR CLINICAL SIGNIFICANCE IS UNKNOWN. Mupirocin is active against most strains of Staphylococcus epidermidis and Staphylococcus saprophyticus.

Indications And Usage ⮝

BACTROBAN CREAM is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm2 in area) due to susceptible strains of S. aureus and S. pyogenes.

Contraindications ⮝

BACTROBAN CREAM is contraindicated in patients with known hypersensitivity to any of the constituents of the product.

Warnings ⮝

Avoid contact with the eyes.

In the event of a sensitization or severe local irritation from BACTROBAN CREAM, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

Precautions ⮝

General

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (See DOSAGE AND ADMINISTRATION.)

BACTROBAN CREAM is not formulated for use on mucosal surfaces.

Information for Patients

Use this medication only as directed by your healthcare provider. It is for external use only. Avoid contact with the eyes.

The treated area may be covered by gauze dressing if desired.

Report to your healthcare provider any signs of local adverse reactions. The medication should be stopped and your healthcare provider contacted if irritation, severe itching, or rash occurs.

If no improvement is seen in 3 to 5 days, contact your healthcare provider.

Drug Interactions

The effect of the concurrent application of topical mupirocin calcium cream and other topical products has not been studied.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium 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 mutagenicity: 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.

Fertility studies were performed in rats with mupirocin administered subcutaneously at doses up to 49 times a human topical dose of 1 gram/day (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of impaired fertility from mupirocin sodium.

Pregnancy

Teratogenic Effects: Pregnancy Category B. Teratology studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 78 and 154 times, respectively, a human topical dose of 1 gram/day (approximately 20 mg mupirocin per day) on a mg/m2 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 reproduction 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 BACTROBAN CREAM is administered to a nursing woman.

Pediatric Use

The safety and effectiveness of BACTROBAN CREAM have been established in the age groups 3 months to 16 years. Use of BACTROBAN CREAM in these age groups is supported by evidence from adequate and well-controlled studies of BACTROBAN CREAM in adults with additional data from 93 pediatric patients studied as part of the pivotal trials in adults. (See CLINICAL STUDIES.)

Geriatric Use

In 2 well-controlled studies, 30 patients older than 65 years were treated with BACTROBAN CREAM. No overall difference in the efficacy or safety of BACTROBAN CREAM was observed in this patient population when compared to that observed in younger patients.

Adverse Reactions ⮝

In 2 randomized, double-blind, double-dummy trials, 339 patients were treated with topical BACTROBAN CREAM plus oral placebo. Adverse events thought to be possibly or probably drug-related occurred in 28 (8.3%) patients. The incidence of those events that were reported in at least 1% of patients enrolled in these trials were: Headache (1.7%), rash, and nausea (1.1% each).

Other adverse events thought to be possibly or probably drug-related which occurred in less than 1% of patients were: Abdominal pain, burning at application site, cellulitis, dermatitis, dizziness, pruritus, secondary wound infection, and ulcerative stomatitis.

In a supportive study in the treatment of secondarily infected eczema, 82 patients were treated with BACTROBAN CREAM. The incidence of adverse events thought to be possibly or probably drug-related was as follows: Nausea (4.9%), headache, and burning at application site (3.6% each), pruritus (2.4%) and 1 report each of abdominal pain, bleeding secondary to eczema, pain secondary to eczema, hives, dry skin, and rash.

Overdosage ⮝

Intravenous infusions of 252 mg, as well as single oral doses of 500 mg of mupirocin, have been well tolerated in healthy adult subjects. There is no information regarding overdose of BACTROBAN CREAM.

Dosage And Administration ⮝

A small amount of BACTROBAN CREAM should be applied to the affected area 3 times daily for 10 days. The area treated may be covered with 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 BACTROBAN CREAM for the treatment of secondarily infected traumatic skin lesions (e.g., lacerations, sutured wounds, and abrasions not more than 10 cm in length or 100 cm2 in total area) was compared to that of oral cephalexin in 2 randomized, double-blind, double-dummy clinical trials. Clinical efficacy rates at follow-up in the per protocol populations (adults and pediatric patients included) were 96.1% for BACTROBAN CREAM (n = 231) and 93.1% for oral cephalexin (n = 219). Pathogen eradication rates at follow-up in the per protocol populations were 100% for both BACTROBAN CREAM and oral cephalexin.

Pediatrics: There were 93 pediatric patients aged 2 weeks to 16 years enrolled per protocol in the secondarily infected skin lesion studies, although only 3 were less than 2 years of age in the population treated with BACTROBAN CREAM. Patients were randomized to either 10 days of topical BACTROBAN CREAM 3 times daily or 10 days of oral cephalexin (250 mg 4 times daily for patients >40 kg or 25 mg/kg/day oral suspension in 4 divided doses for patients 40 kg). Clinical efficacy at follow-up (7 to 12 days post-therapy) in the per protocol populations was 97.7% (43/44) for BACTROBAN CREAM and 93.9% (46/49) for cephalexin. Only 1 adverse event (headache) was thought to be possibly or probably related to drug therapy with BACTROBAN CREAM in the intent-to-treat pediatric population of 70 children (1.4%).

How Supplied ⮝

BACTROBAN CREAM is supplied in 15-gram and 30-gram tubes.

NDC 0029-1527-22 (15-gram tube)

NDC 0029-1527-25 (30-gram tube)

Store at or below 25 C (77 F). Do not freeze.

GlaxoSmithKline

Research Triangle Park, NC 27709

BACTROBAN CREAM is a registered trademark of GlaxoSmithKline.

2005, GlaxoSmithKline. All rights reserved.

May 2005 BB:L7B

No Title 1572448797 ⮝

Principal Display Panel

BACTROBAN CREAM

MUPIROCIN CALCIUM CREAM 2%

15 grams (Net Wt.)

Rx only

Store at or below 25oC (77oF). Do not freeze.

Each gram contains 21.5 mg mupirocin calcium in a mineral oil cream base.

Dosage: For dermatologic use only. Apply a small amount of cream to the affected area three times daily for 10 days. Patients not showing clinical response within 3 to 5 days should be re-evaluated.

See accompanying prescribing information.

Bactroban Cream

Read all of this leaflet carefully before you start using this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor, nurse or pharmacist.
This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

In this leaflet:

1 What Bactroban is and what it is used for
2 Before you use Bactroban
3 How to use Bactroban
4 Possible side effects
5 How to store Bactroban
6 Further information

1 What Bactroban is and what it is used for
Bactroban Cream (called Bactroban in this leaflet) contains a medicine called mupirocin calcium. Bactroban is an antibiotic cream.
It is used:
to treat infections on your skin in small cuts, wounds or on scraped skin.
to kill bacteria causing infections on your skin called Staphylococcus aureus and Streptococcus pyogens
this cream is for external use on your skin only.

2 Before you use Bactroban
Do not use Bactroban if:
you are allergic (hypersensitive) to mupirocin calcium, mupirocin or any of the other ingredients of Bactroban (listed in Section 6)
the patient is less than 1 year old.
If you are not sure if this applies to you, do not use this medicine. Talk to your doctor, nurse or pharmacist before using Bactroban.

Using other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. This includes medicines obtained without a prescription, including herbal medicines.

Pregnancy and breast-feeding
Do not use Bactroban if you are pregnant, might become pregnant or are breast-feeding. Talk to your doctor, nurse or pharmacist for advice before using any medicine, if you are pregnant or breastfeeding.

Important information about some of the ingredients of Bactroban
Bactroban contains cetyl alcohol and stearyl alcohol. These ingredients may cause skin reactions where you apply the cream. See also Section 4.

3 How to use Bactroban
Always use Bactroban exactly as your doctor has told you. You should check with your doctor, nurse or pharmacist if you are not sure.
Take special care with Bactroban
Do not use Bactroban in your eyes. If you are using Bactroban on your face, be careful not to use it in or near your eyes or nose.
Do not put Bactroban into your mouth or swallow it.
If a cracked nipple is being treated, the cream must be thoroughly washed off prior to breast-feeding.

Using this medicine
Do not mix Bactroban with any other external cream or ointment medicines on the infected area of your skin as this may reduce the effectiveness of Bactroban.
You usually apply Bactroban on your skin up to 3 times a day.
1. Wash and dry your hands.
2. Place a small amount of Bactroban on a clean cotton wool pad or gauze swab.
3. Apply the cream to the infected area of your skin.
4. You can cover the treated area with a plaster or other suitable dressing, unless your doctor has told you to leave it uncovered.
5. Replace the cap on the tube and wash your hands.

How long should you use Bactroban for?
Use Bactroban for as long as your doctor has told you. If you are not sure, ask your doctor, nurse or pharmacist. The bacteria are normally cleared from your skin within 10
days of starting treatment. Do not use for more than 10 days.
If your skin condition does not improve within 3 to 5 days, see your doctor.
A yeast infection of moist areas of the body may develop if Bactroban is used for a long time. On the skin this looks like bright red spots which may be very itchy. On occasion small pustules may be present in the middle.
If this occurs, tell your doctor, pharmacist or nurse.

If you use more Bactroban than you should
If you use more Bactroban than you should, speak to your doctor, nurse or pharmacist for advice.
If you swallow Bactroban, contact your doctor immediately and indicate what and how much you have swallowed.

If you forget to use Bactroban
If you forget to apply Bactroban, apply it as soon as you remember.
If your next dose is due within an hour, skip the missed dose.
Do not use a double dose to make up for a forgotten dose.
If you stop using Bactroban too early, not all the bacteria may have been killed or they may continue to grow. Ask your doctor, nurse or pharmacist when to stop using the
cream.
If you have any further questions on the use of this product, ask your doctor, nurse or pharmacist.

4 Possible side effects
Like all medicines, Bactroban can cause side effects, not everybody gets them. The following side effects may happen with this medicine:
Common (these may affect between 1 and 100 people)
Itching, redness, burning, rash, swelling, pain on your skin where Bactroban is applied.
Dryness and redness of the skin can also occur on other parts of your body.

If you develop a severe skin reaction or allergy:
wipe off the cream
stop using it and
tell your doctor as soon as possible.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

5 How to store Bactroban\
Keep out of the reach and sight of children.
Do not store above 25 C. Do not freeze.
Do not use Bactroban after the expiry date which is stated on the tube. The expiry date refers to the last day of that month.
Do not use Bactroban if it looks different to normal.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will
help to protect the environment.

6 Further information6 Further information
What Bactroban contains
1 g of cream contains 21.5 mg mupirocin calcium equivalent to 20 mg mupirocin.
The other ingredients are xanthan gum, liquid paraffin, cetomacrogol 1000, stearyl alcohol, cetyl alcohol, phenoxyethanol, benzyl alcohol and purified water. See also section 2.

What Bactroban looks like and contents of the pack
Bactroban is a smooth white cream.
Bactroban is available in a 15 g tube.
Each tube comes in a carton.

Marketing Authorisation Holder and Manufacturer
Marketing authorisation holder
Beecham Group plc
Trading as GlaxoSmithKline UK
Stockley Park West
Uxbridge
Middlesex
UB11 1BT

Manufacturer
Glaxo Wellcome Operations
Harmire Road
Barnard Castle
Co Durham
DL12 8DT

Other formats
To listen to or request a copy of this leaflet in Braille, large print or audio please call, free of charge:
0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name Bactroban Cream
Reference number 00038/0372
This is a service provided by the Royal
National Institute for the Blind.
Leaflet date: October 2007

Bactroban is a registered trademark of the GlaxoSmithKline group of companies

2007 GlaxoSmithKline group of companies

BACTROBAN mupirocin calcium cream

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-4642(NDC:0029-1527) Route of Administration TOPICAL

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUPIROCIN CALCIUM (UNII: RG38I2P540) (MUPIROCIN - UNII:D0GX863OA5) MUPIROCIN CALCIUM 20 mg in 1 g

Inactive Ingredients Ingredient Name Strength BENZYL ALCOHOL (UNII: LKG8494WBH) CETETH-20 (UNII: I835H2IHHX) CETYL ALCOHOL (UNII: 936JST6JCN) MINERAL OIL (UNII: T5L8T28FGP) PHENOXYETHANOL (UNII: HIE492ZZ3T) WATER (UNII: 059QF0KO0R) STEARYL ALCOHOL (UNII: 2KR89I4H1Y) XANTHAN GUM (UNII: TTV12P4NEE)

Product Characteristics Color white Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54868-4642-1 1 in 1 CARTON 1 15 g in 1 TUBE 2 NDC:54868-4642-0 1 in 1 CARTON 2 30 g in 1 TUBE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050746 07/12/2002

Labeler - Physicians Total Care, Inc. (194123980)

Establishment
Name	Address	ID/FEI	Business Operations
Physicians Total Care, Inc.		194123980	relabel

Revised: 2/2007 Document Id: 76d3c42c-12e8-4135-8ccf-3f3cb2d49de0 34391-3 Set id: 87734c71-a574-465d-b941-f993f9ae8b2b Version: 1 Effective Time: 20070213 Physicians Total Care, Inc.