Mupirocin Ointment USP, 2% is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus)and Streptococcus pyogenes (S. pyogenes).

• For Topical Use Only.
• Apply a small amount of Mupirocin Ointment USP, 2%, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 10 days.
• Cover the treated area with gauze dressing if desired.
• Re-evaluate patients not showing a clinical response within 3 to 5 days.
• Mupirocin Ointment USP, 2% is not for intranasal, ophthalmic, or other mucosal use [ see Warnings and Precautions (5.2, 5.6)].
• Do not apply Mupirocin Ointment USP, 2% concurrently with any other lotions, creams, or ointments [ see Clinical Pharmacology (12.3)].

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base supplied in 15-gram and 22-gram tubes.

Mupirocin Ointment USP, 2% is contraindicated in patients with known hypersensitivity to mupirocin or any of the excipients of Mupirocin Ointment USP, 2%.

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)]

Mupirocin Ointment USP, 2% contains the RNA synthetase inhibitor antibacterial, mupirocin.

The chemical name is ( E)-(2 S,3 R,4 R,5 S)-5-[(2 S,3 S,4 S,5 S)-2,3-epoxy-5-hydroxy-4-methylhexyl] tetrahydro-3,4-dihydroxy-β-methyl-2 H-pyran-2-crotonic acid, ester with 9-hydroxynonanoic acid. The molecular formula of mupirocin is C 26H 44O 9, and the molecular weight is 500.6.

The structural formula of mupirocin is:

Figure 1. Structure of Murpirocin

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base (polyethylene glycol ointment, NF) consisting of polyethylene glycol 400 and polyethylene glycol 3350.

The efficacy of topical mupirocin ointment in impetigo was tested in 2 trials. In the first, subjects with impetigo were randomized to receive either mupirocin ointment 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 (n = 49) and 35% for vehicle placebo (n = 51). Pathogen eradication rates in the evaluable populations were 94% for mupirocin ointment and 62% for vehicle placebo.

In the second trial, subjects with impetigo were randomized to receive either mupirocin ointment 3 times daily or 30 to 40 mg per 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 (n = 29) and 78.5% for erythromycin (n = 28). Pathogen eradication rates in the evaluable populations were 100% for both test groups.

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 (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. The age range of the pediatric subjects was 7 months to 13 years. The clinical efficacy rate for mupirocin ointment (n = 27) was 96%, and for erythromycin it was unchanged (78.5%).

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.

Each gram of Mupirocin Ointment USP, 2% contains 20 mg mupirocin in a water-miscible ointment base.

Mupirocin Ointment USP, 2% is supplied in

NDC 60760-960-22 (22-gram tube)

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

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

Advise the patient to administer Mupirocin Ointment USP, 2% as follows:

• Use Mupirocin Ointment USP, 2% only as directed by the healthcare provider. It is for external use only. Avoid contact of Mupirocin Ointment USP, 2% with the eyes. If Mupirocin Ointment USP, 2% gets in the eyes, rinse thoroughly with water.
• Do not use Mupirocin Ointment USP, 2% in the nose.
• Wash your hands before and after applying Mupirocin Ointment USP, 2%.
• Use a gauze pad or cotton swab to apply a small amount of Mupirocin Ointment USP, 2% 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. Mupirocin Ointment USP, 2% 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 impetigo has not improved in 3 to 5 days, contact the healthcare provider.

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

Made in Israel

Manufactured By Padagis

Yeruham, Israel

Distributed By

Padagis

Allegan, MI 49010 • www.padagis.com

Rev 01-22

1N200 RC J10

Mupirocin Ointment USP, 2%

What is Mupirocin Ointment USP, 2%?

Mupirocin Ointment USP, 2% is a prescription medicine used on the skin (topical use) to treat a skin infection called impetigo that is caused by bacteria called Staphylococcus aureusand Streptococcus pyogenes.

It is not known if Mupirocin Ointment USP, 2% is safe and effective in children under 2 months of age.

Who should not use Mupirocin Ointment USP, 2%?

Do not use Mupirocin Ointment USP, 2% if:

• you are allergic to mupirocin or any of the ingredients in Mupirocin Ointment USP, 2%. See the end of this Patient Information leaflet for a complete list of the ingredients in Mupirocin Ointment USP, 2%.

What should I tell my healthcare provider before using Mupirocin Ointment USP, 2%?

Before using Mupirocin Ointment USP, 2%, tell your healthcare provider about all of your medical conditions including if you:

• have kidney problems
• are pregnant or plan to become pregnant. It is not known if Mupirocin Ointment USP, 2% will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Mupirocin Ointment USP, 2% passes into your breast milk. You and your healthcare provider should decide if you can use Mupirocin Ointment USP, 2% 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 Mupirocin Ointment USP, 2% with other lotions, creams, or ointments.

How should I use Mupirocin Ointment USP, 2%?

• Mupirocin Ointment USP, 2% is for use on the skin (topical).Do not get Mupirocin Ointment USP, 2% in your eyes, nose, mouth, or vagina (mucosal surfaces).
• Use Mupirocin Ointment USP, 2% exactly as your healthcare provider tells you to use it.
• Apply a small amount of Mupirocin Ointment USP, 2%, with a cotton swab or gauze pad, to the affected area 3 times each day.
• It is important that you take the full course of Mupirocin Ointment USP, 2%. Do not stop early because your symptoms may disappear before the infection is fully cleared.
• Wash your hands before and after applying Mupirocin Ointment USP, 2%.
• After applying Mupirocin Ointment USP, 2%, 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 Mupirocin Ointment USP, 2%.
• If you are breastfeeding and use Mupirocin Ointment USP, 2% on your breast or nipple, wash the area well before breastfeeding your child.

What are the possible side effects of Mupirocin Ointment USP, 2%?

Mupirocin Ointment USP, 2% may cause serious side effects, including:

• severe allergic reactions. Stop using Mupirocin Ointment USP, 2% 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
  • swelling of your face, lips, mouth, or tongue
  • a rash over your whole body
  • trouble breathing or wheezing
  • dizziness, fast heartbeat or pounding in your chest
• eye irritation. Do not get Mupirocin Ointment USP, 2% in your eyes. If Mupirocin Ointment USP, 2% gets in your eyes, rinse your eyes well with water.
• irritation in the area Mupirocin Ointment USP, 2% is used. Stop using Mupirocin Ointment USP, 2% and call your healthcare provider if you develop an irritation, severe itching, or a rash while using Mupirocin Ointment USP, 2%.
• 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 Mupirocin Ointment USP, 2%.
• risk of absorption of polyethylene glycol through the skin. Mupirocin Ointment USP, 2% contains polyethylene glycol, which in large amounts can cause kidney damage. You should not apply Mupirocin Ointment USP, 2% to open skin wounds or damaged skin, especially if you have kidney problems.
• increased risk of infection at IV (intravenous) sites. Mupirocin Ointment USP, 2% should not be used on skin that is near an IV (intravenous) site.

The most common side effects of Mupirocin Ointment USP, 2% include:

• burning
• stinging or pain
• itching

These are not all the possible side effects of Mupirocin Ointment USP, 2%. 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 Mupirocin Ointment USP, 2%?

• Store Mupirocin Ointment USP, 2% at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep Mupirocin Ointment USP, 2% and all medicines out of the reach of children.

General information about the safe and effective use of Mupirocin Ointment USP, 2%

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet.

Do not use Mupirocin Ointment USP, 2% for a condition for which it was not prescribed. Do not give Mupirocin Ointment USP, 2% 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 Mupirocin Ointment USP, 2% that is written for health professionals.

What are the ingredients in Mupirocin Ointment USP, 2%?

Active Ingredient:mupirocin

Inactive Ingredients:polyethylene glycol 400 and polyethylene glycol 3350

This Patient Information has been approved by the U.S. Food and Drug Administration.

Made in Israel

Manufactured By Padagis

Yeruham, Israel

Distributed By

Padagis

Allegan, MI 49010 • www.padagis.com

Rev 01-22

1N200 RC J10

For more information call Padagis at 1-866-634-9120