Bacidal ointment

Bacidal ointment is indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus (S. aureus) and Streptococcus pyogenes (S. pyogenes).

Mupirocinointment is an RNA synthetase inhibitor antibacterial indicated for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes. (1)

2 DOSAGE AND ADMINISTRATION

  • For Topical Use Only.
  • Apply a small amount of Bacidal 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.
  • Bacidal ointment is not for intranasal, ophthalmic, or other mucosal use [see Warnings and Precautions ( 5.2, 5.6)].
  • Do not apply Bacidal ointment concurrently with any other lotions, creams, or ointments [see Clinical Pharmacology ( 12.3)].
  • For Topical Use Only. (2)
  • Apply a small amount of Bacidal ointment, with a cotton swab or gauze pad, to the affected area 3 times daily for up to 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)

3 DOSAGE FORMS AND STRENGTHS

Each gram of Bacidal Ointment USP contains 20 mg Bacidal, USP in a water-miscible ointment base supplied in 22-gram tubes.

  • Ointment: Each gram contains 20 mg Bacidal, USP in a water-miscible ointment base supplied in 22-gram tubes. (3)

4 CONTRAINDICATIONS

Bacidal ointment is contraindicated in patients with known hypersensitivity to Bacidal or any of the excipients of Bacidal ointment.

  • Known hypersensitivity to Bacidal or any of the excipients of Bacidal ointment. (4)

5 WARNINGS AND PRECAUTIONS

Bacidal ointment is indicated for the topical treatment of impetigo
Bacidal ointment is indicated for the topical treatment of impetigo
  • Severe Allergic Reactions: Anaphylaxis, urticaria, angioedema, and generalized rash have been reported in patients treated with formulations of Bacidal, including Bacidal ointment.
  • Eye Irritation: Avoid contact with eyes. (5.2)
  • Local Irritation: Discontinue in the event of sensitization or severe local irritation. (5.3)
  • Clostridium difficile-Associated Diarrhea (CDAD): If diarrhea occurs, evaluate patients for CDAD. (5.4)
  • Potential for Microbial Overgrowth: Prolonged use may result in overgrowth of nonsusceptible microorganisms, including fungi. (5.5)
  • Risk Associated with Mucosal Use: Bacidal ointment is not formulated for use on mucosal surfaces. A separate formulation, BACTROBAN nasal ointment, is available for intranasal use. (5.6)
  • Risk of Polyethylene Glycol Absorption: Bacidal ointment should not be used where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment. (5.7)
  • Risk Associated with Use at Intravenous Sites: Bacidal ointment should not be used with intravenous cannulae or at central intravenous sites because of the potential to promote fungal infections and antimicrobial resistance. (5.8)

5.1 Severe Allergic Reactions

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash, have been reported in patients treated with formulations of Bacidal, including Bacidal ointment .

5.2 Eye Irritation

Avoid contact with the eyes. In case of accidental contact, rinse well with water.

5.3 Local Irritation

In the event of a sensitization or severe local irritation from Bacidal ointment, usage should be discontinued, and appropriate alternative therapy for the infection instituted.

5.4 Clostridium difficile-Associated Diarrhea

Clostridium difficile-associated diarrhea has been reported with use of nearly all antibacterial agents and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile.

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin-producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial drug use. Careful medical history is necessary since CDAD has been reported to occur over 2 months after the administration of antibacterial agents.

If CDAD is suspected or confirmed, ongoing antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile, and surgical evaluation should be instituted as clinically indicated.

5.5 Potential for Microbial Overgrowth

As with other antibacterial products, prolonged use of Bacidal ointment may result in overgrowth of nonsusceptible microorganisms, including fungi .

5.6 Risk Associated with Mucosal Use

Bacidal ointment is not formulated for use on mucosal surfaces. Intranasal use has been associated with isolated reports of stinging and drying. A separate formulation, BACTROBAN┬« nasal ointment, is available for intranasal use.

5.7 Risk of Polyethylene Glycol Absorption

Polyethylene glycol can be absorbed from open wounds and damaged skin and is excreted by the kidneys. In common with other polyethylene glycol-based ointments, Bacidal ointment should not be used in conditions where absorption of large quantities of polyethylene glycol is possible, especially if there is evidence of moderate or severe renal impairment.

6 ADVERSE REACTIONS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Severe Allergic Reactions
  • Eye Irritation
  • Local Irritation
  • Clostridium difficile-Associated Diarrhea
  • The most frequent adverse reactions (at least 1%) were burning, stinging or pain, and itching. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888)721-7115 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 Bacidal 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 Bacidal 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 Bacidal ointment.

Immune System Disorders

Systemic allergic reactions, including anaphylaxis, urticaria, angioedema, and generalized rash [see Warnings and Precautions ( 5.1)].

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