Bactroban Nasal

Topical Ointment:  2% (20 mg/g). Topical Cream:  2% (20 mg/g). Nasal ointment:  2% (20 mg/g).

Tablets should be stored at room temperature, 15 C-30 C (59 F-86 F).

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of mupirocin nasal ointment in children. Safety has not been established in children younger than 12 years of age.

Geriatric

No information is available on the relationship of age to the effects of mupirocin nasal ointment in the geriatric population. Safety and efficacy have not been established.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diarrhea—Use with caution. May make this condition worse.

• Tell all of your health care providers that you take Bactroban Nasal. This includes your doctors, nurses, pharmacists, and dentists.
• Do not use longer than you have been told. A second infection may happen.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Irritation where this medicine is used.
• Very bad itching.
• Dizziness.
• A fast heartbeat.
• A heartbeat that does not feel normal.
• A very bad and sometimes deadly form of diarrhea called Clostridium difficile (C diff)-associated diarrhea has happened with most antibiotics. This may happen while using the antibiotic or within a few months after you stop using it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Bactroban Nasal, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Bactroban Nasal. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Bactroban Nasal (mupirocin nasal ointment).

Review Date: October 4, 2017

Use Bactroban cream or ointment exactly as directed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not take by mouth. Bactroban is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

Wash your hands before and after applying Bactroban.

Clean and dry the affected skin area. Use a cotton swab or gauze pad to apply a small amount of Bactroban cream or ointment as directed.

Do not spread Bactroban over large areas of skin.

Bactroban is usually applied 3 times per day for 10 days. Use only a small amount of the cream or ointment.

Use only a sterile gauze pad to cover the treated skin. Do not cover treated areas with a bandage, plastic wrap, or other covering that does not allow air to circulate.

Call your doctor if your symptoms do not improve within 3 to 5 days, or if your skin condition gets worse.

Use this medicine for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Skipping doses may also increase your risk of further infection that is resistant to antibiotics.

Store at room temperature away from moisture and heat. Do not freeze. Keep the medicine tube tightly closed when not in use.

Summary of Use during Lactation

Because less than 1% is absorbed after topical application, mupirocin is considered a low risk to the nursing infant.[1] Ensure that the infant's skin does not come into direct contact with the areas of skin that have been treated. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[2] Mupirocin applied topically to the nipples appears to be relatively ineffective as a treatment for sore, cracked nipples.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

A mother who was exclusively nursing her 52-day-old infant developed a soft-tissue infection. She was treated with intravenous teicoplanin 400 mg every 12 hours for 3 doses, then 400 mg daily for 5 days total, intravenous ceftriaxone 1 gram daily, topical mupirocin cream twice daily. A careful follow-up indicated that her infant had no adverse effects.[3]

Effects on Lactation and Breastmilk

A small, randomized, unblinded trial of mothers with sore, cracked nipples was performed. Mupirocin 2% applied to the nipples after each feeding was much less effective (16% vs 79%) than an oral antibiotic (cloxacillin or erythromycin for 10 days) in resolving the problem. Additionally, more patients' condition worsened (28% vs 5%) with mupirocin than with an oral antibiotic.[4]

In a randomized, double-bind trial, lanolin was compared to an all-purpose nipple ointment containing mupirocin 1%, betamethasone 0.05%, and miconazole 2% for painful nipples while nursing in the first 2 weeks postpartum. The two treatments were equally effective in reducing nipple pain, nipple healing time, breastfeeding duration, breastfeeding exclusivity rate, mastitis and nipple symptoms, side effects or maternal satisfaction with treatment.[5]

Alternate Drugs to Consider

Bacitracin, Clindamycin

References

1. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006;24:167-97. PMID: 16677965

2. Noti A, Grob K, Biedermann M et al. Exposure of babies to C(15)-C(45) mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003;38:317-25. PMID: 14623482

3. Kaplan YC, Keskin-Arslan E, Acar S et al. Teicoplanin use during breastfeeding. Breastfeed Med. 2017. PMID: 28051878

4. Livingstone V, Stringer LJ. The treatment of Staphyloccocus aureus infected sore nipples: a randomized comparative study. J Hum Lact. 1999;15:241-6. PMID: 10578803

5. Dennis CL, Schottle N, Hodnett E, McQueen K. An all-purpose nipple ointment versus lanolin in treating painful damaged nipples in breastfeeding women: A randomized controlled trial. Breastfeed Med. 2012. PMID: 22428572

Substance Name

Mupirocin

CAS Registry Number

12650-69-0

Drug Class

Antiinfective Agents, Local

Antibacterial Agents

Applies to mupirocin topical: topical cream, topical ointment

Other dosage forms:

• nasal ointment

Along with its needed effects, mupirocin topical (the active ingredient contained in Bactroban Nasal) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking mupirocin topical:

• Burning, stinging, or pain on the application site

• Blistering, crusting, irritation, itching, or reddening of the skin
• canker sores
• cracked, dry, scaly skin
• pain, swelling, tenderness, warmth on the skin
• sores, ulcers, or white spots on the lips or tongue or inside the mouth

• Abdominal or stomach tenderness
• cough
• difficulty with swallowing
• dizziness
• fast heartbeat
• fever
• hives or welts, itching, or skin rash
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• redness of the skin
• severe abdominal or stomach cramps and pain
• tightness in the chest
• unusual tiredness or weakness
• watery and severe diarrhea, which may also be bloody

Some side effects of mupirocin topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Headache
• nausea