MUPIROCIN OINTMENT 2% 22 G
Generic: Mupirocin
MUPIROCIN OINTMENT 2% 22 G
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Identification
Mupirocin
Mupirocin
Sun Pharmaceutical Industries, Inc.
HUMAN PRESCRIPTION DRUG
Administration
OINTMENT
TOPICAL
ANDA065170
Active Ingredients
| Ingredient | Strength |
|---|---|
| MUPIROCIN | 20 mg/g |
Pharmacological Class
Data sourced from openFDA / DailyMed. For full prescribing information, consult the drug label.
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Clinical Drug Information
Indications & Usage
1 INDICATIONS AND USAGE 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) . Mupirocin ointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes . ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION For Topical Use Only. Apply a small amount of mupirocin ointment, 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 is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions (5.2 , 5.6) ] . Do not apply mupirocin ointment concurrently with any other lotions, creams, or ointments [see Clinical Pharmacology (12.3) ] . For Topical Use Only. ( 2 ) Apply a small amount of mupirocin ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for 10 days. ( 2 ) Re-evaluate patients not showing a clinical response within 3 to 5 days. ( 2 ) Not for intranasal, ophthalmic, or other mucosal use. ( 2 )
Adverse Reactions
6 ADVERSE REACTIONS 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) ] The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following local adverse reactions were reported by at least 1% of subjects in connection with the use of mupirocin ointment in clinical trials: burning, stinging, or pain in 1.5% of subjects; itching in 1% of subjects. Rash, nausea, erythema, dry skin, tenderness, swelling, contact dermatitis, and increased exudate were reported in less than 1% of subjects. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials, the following reactions have been identified during postmarketing use of mupirocin ointment. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal relationship to mupirocin ointment. Immune System Disorders Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions (5.1) ] .
Information for Patients
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Advise the patient to administer mupirocin ointment as follows: Use mupirocin ointment only as directed by the healthcare provider. It is for external use only. Avoid contact of mupirocin ointment with the eyes. If mupirocin ointment gets in the eyes, rinse thoroughly with water. Do not use mupirocin ointment in the nose. Wash your hands before and after applying mupirocin ointment. Use a gauze pad or cotton swab to apply a small amount of mupirocin ointment 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 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.
Clinical data sourced from openFDA drug labeling. For complete prescribing information, consult the full drug label.