Mupirocin

1 INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Mupirocin Cream USP, 2% is indicated for the treatment of secondarily infected traumatic skin lesions (up to 10 cm in length or 100 cm 2 in area) due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).

2 DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

For Topical Use Only. Apply a small amount of mupirocin 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. Mupirocin cream is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions ( 5.2 , 5.6 )] . Do not apply mupirocin cream concurrently with any other lotions, creams, or ointments [see Clinical Pharmacology ( 12.3 )].

3 DOSAGE FORMS AND STRENGTHS

DOSAGE FORMS & STRENGTHS SECTION

Mupirocin Cream USP, 2% m is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and water-based emulsion, supplied in 15-gram and 30-gram tubes.

4 CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

5 WARNINGS AND PRECAUTIONS

WARNINGS AND PRECAUTIONS SECTION

6 ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

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 )]

8 USE IN SPECIFIC POPULATIONS

USE IN SPECIFIC POPULATIONS SECTION

11 DESCRIPTION

DESCRIPTION SECTION

Mupirocin Cream USP, 2% contains the dihydrate crystalline calcium hemi-salt of the RNA synthetase inhibitor antibacterial, mupirocin. Chemically, it is (α 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, calcium salt (2:1), dihydrate. The molecular formula of mupirocin calcium, USP is (C 26 H 43 O 9 ) 2 Ca•2H 2 O, and the molecular weight is 1075.3 g/mol. The molecular weight of mupirocin free acid is 500.6 g/mol. The structural formula of mupirocin calcium, USP is: Each gram of mupirocin cream contains 20 mg (2% w/w) of mupirocin equivalent to 21.5 mg (2.15% w/w) of mupirocin calcium. The inactive ingredients are benzyl alcohol, polyoxyl 20 cetostearyl ether, mono and di-glycerides, mineral oil, phenoxyethanol, purified water and xanthan gum.

12 CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

NONCLINICAL TOXICOLOGY SECTION

14 CLINICAL STUDIES

CLINICAL STUDIES SECTION

The efficacy of topical mupirocin 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 cm 2 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 mupirocin 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 mupirocin 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 mupirocin cream. Subjects were randomized to either 10 days of topical mupirocin 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 mupirocin cream and 93.9% (46 of 49) for cephalexin.

15 REFERENCES

REFERENCES SECTION

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

HOW SUPPLIED SECTION

Mupirocin Cream USP, 2% is a white cream that contains 20 mg (2% w/w) of mupirocin per gram in an oil- and water-based emulsion. Mupirocin Cream USP, 2% is supplied in 15-gram and 30-gram tubes. NDC 21922-029-04 (15-gram tube) NDC 21922-029-05 (30-gram tube) Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Do not freeze.

17 PATIENT COUNSELING INFORMATION

INFORMATION FOR PATIENTS SECTION

dvise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient to administer mupirocin cream as follows: Use mupirocin cream only as directed by the healthcare provider. It is for external use only. Avoid contact of mupirocin cream with the eyes. If mupirocin cream gets in the eyes, rinse thoroughly with water. Do not use mupirocin cream in the nose. Wash your hands before and after applying mupirocin cream. Use a gauze pad or cotton swab to apply a small amount of mupirocin 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. Mupirocin 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. Manufactured by: Encube Ethicals Private Limited Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev. 11/2021 PHARMACIST-DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT ---------------------------------------------------------------------------------------------------------------------------------------------------------------

Patient Information

PATIENT MEDICATION INFORMATION SECTION

PATIENT INFORMATION MUPIROCIN (mue pir'oh sin) CREAM, for topical us e What is mupirocin cream? Mupirocin 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 mupirocin cream is safe and effective in children under 3 months of age. Who should not use mupirocin cream? Do not use mupirocin cream if: you are allergic to mupirocin or any of the ingredients in mupirocin cream. See the end of this Patient Information leaflet for a complete list of the ingredients in mupirocin cream. What should I tell my healthcare provider before using mupirocin cream? Before using mupirocin 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 mupirocin cream will harm your unborn baby.•are breastfeeding or plan to breastfeed. It is not known if mupirocin passes into your breast milk. You and your healthcare provider should decide if you can use mupirocin 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 mupirocin cream with other lotions, creams, or ointments. How should I use mupirocin cream? Mupirocin cream is for use on the skin (topical). Do not get mupirocin cream in your eyes, nose, mouth, or vagina (mucosal surfaces). Use mupirocin cream exactly as your healthcare provider tells you to use it. Apply a small amount of mupirocin cream, with a cotton swab or gauze pad, to the affected area 3 times each day. Apply mupirocin cream for 10 days. It is important that you take the full course of mupirocin cream. Do not stop early because your symptoms may disappear before the infection is fully cleared. Wash your hands before and after applying mupirocin cream. After applying mupirocin 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 mupirocin cream. If you are breastfeeding and use mupirocin cream on your breast or nipple, wash the area well before breastfeeding your child. What are the possible side effects of mupirocin cream? Mupirocin cream may cause serious side effects, including: severe allergic reactions. Stop using mupirocin 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 mupirocin cream in your eyes. If mupirocin cream gets in your eyes, rinse your eyes well with water . irritation in the area mupirocin cream is used . A rash may occur after using mupirocin cream and can be severe. Stop using mupirocin cream and call your healthcare provider if you develop an irritation, severe itching, or a rash while using mupirocin 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 mupirocin cream. The most common side effects of mupirocin cream include: headache rash nausea These are not all the possible side effects of mupirocin 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 mupirocin cream? Store mupirocin cream at room temperature between 68°F to 77°F (20°C to 25°C). Do not freeze mupirocin cream. Keep mupirocin cream and all medicines out of the reach of children. General information about the safe and effective use of mupirocin cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use mupirocin cream for a condition for which it was not prescribed. Do not give mupirocin 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 mupirocin cream that is written for health professionals. What are the ingredients in mupirocin cream? Active Ingredient: mupirocin calcium Inactive Ingredients: benzyl alcohol, polyoxyl 20 cetostearyl ether, mono- and di-glycerides, mineral oil, phenoxyethanol, purified water and xanthan gum. Manufactured by: Encube Ethicals Private Limited Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA This Patient Information has been approved by the U.S. Food and Drug Administration Revised: 11/2021

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label NDC 21922-029-04 ( Mupirocin Cream USP, 2% - Tube-15 g) NDC 21922-029-04 Mupirocin Cream USP, 2% For topical use 15 g (Net Wt.) Rx only Carton Label NDC 21922-029-04 (Mupirocin Cream USP, 2% - Tube-15 g) NDC 21922-029-04 Mupirocin Cream USP, 2% For topical use 15 g (Net Wt.) Rx only

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ube Label NDC 21922-029-05 ( Mupirocin Cream USP, 2% - Tube-30 g) NDC 21922-029-05 Mupirocin Cream USP, 2% For topical use 30 g (Net Wt.) Rx only Carton Label NDC 21922-029-05 (Mupirocin Cream USP, 2% - Tube-30 g) NDC 21922-029-05 Mupirocin Cream USP, 2% For topical use 30 g (Net Wt.) Rx only