Bactroban Nasal

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Contraindications

Hypersensitivity

Cautions

Anaphylaxis, urticaria, angioedema, and generalized rash reported

Manufacturer cautions against use of mupirocin ointment in burn patients, particularly those with extensive burns, since potentially toxic amounts of polyethylene glycol (PEG) contained in the vehicle may be absorbed percutaneously

Avoid contact with eyes; in case of accidental contact, rinse well with water

Discontinue use in event of sensitization or severe local irritation from ointment

Clostridium difficile-associated diarrhea (CDAD) reported with use; if CDAD suspected or confirmed, discontinue ongoing antibacterial drug use not directed against C. difficile; institute appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation, as clinically indicated

Prolonged use may result in overgrowth of nonsusceptible organisms, including fungi

Not formulated for use on mucosal surfaces; intranasal use has been associated with isolated reports of stinging and drying

Not for use in conditions where absorption of large quantities of polyethylene glycol possible, especially if there is evidence of moderate or severe renal impairment; polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys

Ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance

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.

In the U.S.

• Bactroban

Available Dosage Forms:

• Ointment

Therapeutic Class: Antibiotic

Along with its needed effects, a medicine 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:

• Bloody nose
• rash

• 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 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
• ear pain

• Burning or stinging in the nose
• change in taste
• itching
• sore throat
• stuffy or runny nose

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Burning.
• Itching.
• Stinging.
• Headache.
• Stuffy nose.
• Sore throat.
• Cough.
• Change in taste.
• Runny nose.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

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.

Mupirocin is an antibiotic that treats or prevents infection caused by bacteria.

Mupirocin nasal (for the nose) is used to treat bacteria in the nostrils of patients and healthcare workers during an outbreak of severe staph infection within a hospital or other medical setting. This can help prevent the growth of staph bacteria in patients with a high risk of infection.

Mupirocin nasal may also be used for purposes not listed in this medication guide.

• Impetigo
• Rash

It is not likely that other drugs you take orally or inject will have an effect on topically applied mupirocin. But many drugs can interact with each other. Tell each of your health care providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.