Bactroban (Mupirocin Calcium) Ointment [Physicians Total Care, Inc.]

BACTROBAN NASAL is indicated for the eradication of nasal colonization with methicillin-resistant

S. aureus

in adult patients and health care workers as part of a comprehensive infection control program to reduce the risk of infection among patients at high risk of methicillin-resistant

S. aureus

infection during institutional outbreaks of infections with this pathogen.

NOTE:
• 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

S. aureus

.

• There are insufficient data at this time to recommend use of BACTROBAN NASAL for general prophylaxis of any infection in any patient population.

• Greater than 90% of subjects/patients in clinical trials had eradication of nasal colonization 2 to 4 days after therapy was completed. Approximately 30% recolonization was reported in 1 domestic study within 4 weeks after completion of therapy. These eradication rates were clinically and statistically superior to those reported in subjects/patients in the vehicle-treated arms of the adequate and well-controlled studies. 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.

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 at this time.

Clinical Trials

In clinical trials, 210 domestic and 2,130 foreign adult subjects/patients received BACTROBAN NASAL ointment. Less than 1% of domestic or foreign subjects and patients in clinical trials were withdrawn due to adverse events.

The most frequently reported adverse events in foreign clinical trials were as follows: Rhinitis (1.0%), taste perversion (0.8%), pharyngitis (0.5%).

In domestic clinical trials, 17% (36/210) of adults treated with BACTROBAN NASAL ointment reported adverse events thought to be at least possibly drug-related. The incidence of adverse events that were reported in at least 1% of adults enrolled in domestic clinical trials were as follows:

ADVERSE EVENTS (≥1% INCIDENCE)-ADULTS IN US TRIALS

% of Subjects/Patients Experiencing Event

BACTROBAN NASAL

(n=210)

Headache

9%

Rhinitis

6%

Respiratory disorder, including

upper respiratory tract congestion

5%

Pharyngitis

4%

Taste perversion

3%

Burning/stinging

2%

Cough

2%

Pruritus

1%

The following events thought possibly drug-related were reported in less than 1% of adults enrolled in domestic clinical trials: Blepharitis, diarrhea, dry mouth, ear pain, epistaxis, nausea, and rash.

All adequate and well-controlled clinical trials have been performed using BACTROBAN NASAL ointment, 2% in 1 arm and the vehicle ointment in the other arm of the study. No adequate and well-controlled safety data are available from direct, head-to-head comparative studies of this product and other products for this indication.

AVOID CONTACT WITH THE EYES.

Application of BACTROBAN NASAL to the eye under testing conditions has caused severe symptoms such as burning and tearing. These symptoms resolved within days to weeks after discontinuation of the ointment.

In the event of a sensitization or severe local irritation from BACTROBAN NASAL, usage should be discontinued.

General

As with other antibacterial products, prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (See DOSAGE AND ADMINISTRATION.) Information for Patients

Patients should be given the following instructions:
• Apply approximately one-half of the ointment from the single-use tube directly into 1 nostril and the other half into the other nostril;

• Avoid contact of the medication with the eyes;

• Discard the tube after using, do not re-use;

• Press the sides of the nose together and gently massage after application to spread the ointment throughout the inside of the nostrils; and

• Discontinue usage of the medication and call your healthcare practitioner if sensitization or severe local irritation occurs. Drug Interactions

The effect of the concurrent application of intranasal mupirocin calcium and other intranasal products has not been studied. Until further information is known, mupirocin calcium ointment, 2% should not be applied concurrently with any other intranasal products. Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals to evaluate carcinogenic potential of mupirocin calcium 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 mutagenicity: 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.

Reproduction studies were performed in rats with mupirocin administered subcutaneously at doses up to

40

times the human intranasal dose (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of impaired fertility from mupirocin sodium. Pregnancy

Teratogenic Effects: Pregnancy Category B

Reproduction studies have been performed in rats and rabbits with mupirocin administered subcutaneously at doses up to 65 and 130 times, respectively, the human intranasal dose (approximately 20 mg mupirocin per day) on a mg/m2 basis and revealed no evidence of harm to the fetus due to mupirocin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BACTROBAN NASAL is administered to a nursing woman. Pediatric Use

Safety in children under the age of 12 years has not been established. (See CLINICAL PHARMACOLOGY.)

(See INDICATIONS AND USAGE.)

Adults (12 years of age and older):
Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.

After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares.

The single-use 1.0 gram tube will deliver a total of approximately 0.5 grams of the ointment (approximately 0.25 grams/nostril).

The tube should be discarded after usage; it should not be re-used.

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 package insert.

Until further information is known, BACTROBAN NASAL should not be applied concurrently with any other intranasal products.