Bactroban Ointment

BACTROBAN® nasal ointment is indicated for the eradication of nasal colonization with methicillin‑resistant Staphylococcus aureus (MRSA) in adult and pediatric patients (aged 12 years and older) and healthcare workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of MRSA infection during institutional outbreaks of infections with this microorganism.

Limitations of Use

• 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 Staphylococcus aureus (S. aureus). • There are insufficient data at this time to recommend use of BACTROBAN nasal ointment for general prophylaxis of any infection in any patient population.

• For Intranasal Use Only. • Apply approximately one-half of the ointment from the single-use tube into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days. • After application, close the nostrils by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares. • Do not apply BACTROBAN nasal ointment concurrently with any other intranasal products [see Clinical Pharmacology (12.3)]. • The single-use 1-gram tube will deliver a total of approximately 0.5 grams of the ointment (approximately 0.25 grams per nostril). • Discard the tube after usage. Do not re-use.

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.

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 41 times the human intranasal dose (approximately 20 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.

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. 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 prescribing information.

In clinical trials, 210 domestic (US) and 2,130 foreign adult subjects received BACTROBAN nasal ointment. Greater than 90% of subjects in clinical trials had eradication of nasal colonization 2 to 4 days after therapy was completed. Approximately 30% recolonization was reported in 1 domestic trial within 4 weeks after completion of therapy. These eradication rates were clinically and statistically superior to those reported in subjects in the vehicle-treated arms of the adequate and well-controlled trials. 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.

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

Advise the patient to administer BACTROBAN nasal ointment as follows:

• Use BACTROBAN nasal ointment only as directed by the healthcare provider. Avoid contact of BACTROBAN nasal ointment with the eyes. If BACTROBAN nasal ointment gets in or near the eyes, rinse thoroughly with water. • Wash your hands before and after applying BACTROBAN nasal ointment. • Apply approximately one‑half of the BACTROBAN nasal ointment from the single‑use tube directly into 1 nostril and the other half into the other nostril. • Press the sides of the nose together and gently massage after application to spread the ointment throughout the inside of the nostrils. • Discard the tube after using. Do not re-use. • Report to the healthcare provider any signs of local adverse reactions. BACTROBAN nasal ointment 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)]. • It is important that you take the full course of BACTROBAN nasal ointment. Do not stop early because the amount of bacteria in your nose may not be reduced.

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

SOFTISAN is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

GlaxoSmithKline

Research Triangle Park, NC 27709

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

BBN:7PI

PHARMACIST‑DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT

PAtient Information BACTROBAN® (BACK-troh-ban) (mupirocin calcium) nasal ointment

What is BACTROBAN nasal ointment? BACTROBAN nasal ointment is a prescription medicine used to reduce the amount of methicillin-resistant Staphylococcus aureus (MRSA) bacteria in your nose. It is not known if BACTROBAN nasal ointment is safe and effective in children under 12 years of age.

Who should not use BACTROBAN nasal ointment? Do not use BACTROBAN nasal ointment if: • you are allergic to mupirocin or any of the ingredients in BACTROBAN nasal ointment. See the end of this Patient Information leaflet for a complete list of the ingredients in BACTROBAN nasal ointment.

What should I tell my healthcare provider before using BACTROBAN nasal ointment? Before using BACTROBAN nasal ointment, 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 nasal ointment will harm your unborn baby. • are breastfeeding or plan to breastfeed. It is not known if BACTROBAN nasal ointment passes into your breast milk. You and your healthcare provider should decide if you can use BACTROBAN nasal ointment 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 nasal ointment with other intranasal products.

How should I use BACTROBAN nasal ointment? • BACTROBAN nasal ointment is for use in the nose (intranasal). Do not get BACTROBAN in your eyes or mouth. • Use BACTROBAN nasal ointment exactly as your healthcare provider tells you to use it. • Apply approximately one-half of the BACTROBAN nasal ointment from a single-use tube to the inside surface at the front of each nostril 2 times a day for 5 days. • Press the sides of your nose together and gently rub between your finger and thumb for about 1 minute. This spreads the BACTROBAN nasal ointment around the nose. • It is important that you take the full course of BACTROBAN nasal ointment. Do not stop early because the amount of bacteria in your nose may not be reduced. • Wash your hands before and after applying BACTROBAN nasal ointment.

What are the possible side effects of BACTROBAN nasal ointment? BACTROBAN nasal ointment may cause serious side effects, including: • severe allergic reactions. Stop using BACTROBAN nasal ointment 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 nasal ointment in your eyes. If BACTROBAN nasal ointment gets in your eyes, rinse your eyes well with water. • irritation in the area BACTROBAN nasal ointment is used. Stop using BACTROBAN nasal ointment and call your healthcare provider if you develop an irritation, severe itching, or a rash while using BACTROBAN nasal ointment. • 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 nasal ointment.   The most common side effects of BACTROBAN nasal ointment include: These are not all the possible side effects of BACTROBAN nasal ointment. 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 nasal ointment? • Store BACTROBAN nasal ointment at room temperature up to 25ºC (77ºF). • Do not refrigerate BACTROBAN nasal ointment. • Keep BACTROBAN nasal ointment and all medicines out of the reach of children.

General information about the safe and effective use of BACTROBAN nasal ointment. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use BACTROBAN nasal ointment for a condition for which it was not prescribed. Do not give BACTROBAN nasal ointment 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 nasal ointment that is written for health professionals.

What are the ingredients in BACTROBAN nasal ointment? Active Ingredient: mupirocin calcium Inactive Ingredients: paraffin and SOFTISAN® 649 BACTROBAN is a registered trademark of the GSK group of companies. SOFTISAN is a trademark of its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products. ©2017 the GSK group of companies. All rights reserved. GlaxoSmithKline, Research Triangle Park, NC 27709 BBN:3PIL For more information, call 1-888-825-5249.

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

PRINCIPAL DISPLAY PANEL

NDC 0029-1526-11

BACTROBAN® (mupirocin calcium)

Nasal Ointment, 2%

10 x 1.0 gram Single-Use Tubes

This shrink-wrapped unit represents one 5-day course of therapy.

Store at 20o - 25oC (68o – 77oF); excursions permitted 15o - 30oC (59o – 86oF).. Do not refrigerate.

Do not use if seal on tube nozzle is broken.

Usual Dosage: For intranasal use only. Apply one-half the contents of a tube in one nostril. Apply other half of tube contents in other nostril. See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

  10000000136205 Rev. 8/15

BACTROBAN  mupirocin calcium ointment

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0029-1526 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 PARAFFIN

Product Characteristics Color WHITE (white to off-white) Score      Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description 1 NDC:0029-1526-11 10 CARTON in 1 PACKAGE 1 NDC:0029-1526-03 1 TUBE in 1 CARTON 1 1 g in 1 TUBE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA050703 04/10/1996

Labeler - GlaxoSmithKline LLC (167380711)

Revised: 05/2017   GlaxoSmithKline LLC

Mupirocin is an antibiotic. Mupirocin topical prevents bacteria from growing on your skin.

Mupirocin topical is used to treat infections of the skin such as impetigo.

Mupirocin topical may also be used for purposes other than those listed in this medication guide.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Avoid your eyes, nose, mouth, and lips when applying mupirocin topical. If medication gets in any of these areas, wash with water.

Watch for signs of improvement in 3 to 5 days. If your condition gets worse or does not improve, see your doctor.

Apply the missed dose as soon as you remember. However, if it is almost time for your next dose, skip the dose you missed and apply only the regular amount of mupirocin topical. Do not use a double dose of this medication unless otherwise directed by your doctor.