Bactroban Cream

Name: Bactroban Cream

Indications

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).

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.

Warnings and Precautions

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)].

Eye Irritation

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

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.

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.

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)].

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.

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)]

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.

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)].

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.

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.

Patient Counseling 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 [see Warnings and Precautions (5.1)]. • If no improvement is seen in 3 to 5 days, contact the healthcare provider.

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

GlaxoSmithKline

Research Triangle Park, NC 27709

©2017 the GSK group of companies. All rights reserved.

BBC:4PI

PHARMACIST‑DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PATIENT INFORMATION

BACTROBAN® (BACK-troh-ban)

(mupirocin calcium)

cream

What is Bactroban Cream?

Bactroban Cream is a prescription medicine used on the skin (topical use) to treat certain skin infections caused by bacteria called Staphylococcus aureus and Streptococcus pyogenes.

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

Who should not use Bactroban Cream?

Do not use Bactroban Cream if:

• you are allergic to mupirocin or any of the ingredients in Bactroban Cream. See the end of this Patient Information leaflet for a complete list of the ingredients in Bactroban Cream.

What should I tell my healthcare provider before using 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 hands before and after applying 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.

What are the possible side effects of Bactroban Cream?

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 called clostridium 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.

What are the ingredients in Bactroban Cream?

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

BACTROBAN® Cream

(mupirocin calcium cream, 2%)

15 grams(Net Wt.)

Rx only

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 LABEL Item Code (Source) NDC:0029-1527
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MUPIROCIN CALCIUM (MUPIROCIN) MUPIROCIN 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL  
CETETH-20  
CETYL ALCOHOL  
MINERAL OIL  
PHENOXYETHANOL  
WATER  
STEARYL ALCOHOL  
XANTHAN GUM  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:0029-1527-22 1 TUBE in 1 CARTON
1 15 g in 1 TUBE
2 NDC:0029-1527-25 1 TUBE 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 01/23/1998
Labeler - GlaxoSmithKline LLC (167380711)
Revised: 05/2017   GlaxoSmithKline LLC
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Read the Bactroban Cream User Reviews »

© Bactroban Cream Patient Information is supplied by Cerner Multum, Inc. and Bactroban Cream Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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