Bacitracin, neomycin, polymyxin B, and hydrocortisone

U.S. BRAND NAMES — Cortisporin® Ointment

PHARMACOLOGIC CATEGORY
Antibiotic, Ophthalmic
Antibiotic, Topical
Corticosteroid, Ophthalmic
Corticosteroid, Topical

DOSING: ADULTS
Ophthalmic infection: Ophthalmic ointment: Instill 1/2 inch ribbon to inside of lower lid every 3-4 hours until improvement occurs.

Superficial dermal infection: Topical: Apply sparingly 2-4 times/day. Therapy should be discontinued when control is achieved; if no improvement is seen, reassessment of diagnosis may be necessary.

DOSING: PEDIATRIC — Refer to adult dosing.

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Ointment, ophthalmic: Bacitracin 400 units, neomycin 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 10 mg per g (3.5 g)

Ointment, topical:
Cortisporin®: Bacitracin 400 units, neomycin 3.5 mg, polymyxin B 5000 units, and hydrocortisone 10 mg per g (15 g)

DOSAGE FORMS: CONCISE
Ointment, ophthalmic: Bacitracin 400 units, neomycin sulfate 3.5 mg, polymyxin B 10,000 units, and hydrocortisone 10 mg per g (3.5 g)

Ointment, topical:
Cortisporin®: Bacitracin 400 units, neomycin 3.5 mg, polymyxin B 5000 units, and hydrocortisone 10 mg per g (15 g)

GENERIC EQUIVALENT AVAILABLE — Yes: Ophthalmic ointment

USE — Prevention and treatment of susceptible inflammatory conditions where bacterial infection (or risk of infection) is present

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined. For additional information, see individual agents.

Ophthalmic ointment:
Dermatologic: Delayed wound healing, rash
Ocular: Cataracts, corneal thinning, glaucoma, irritation, keratitis (bacterial), intraocular pressure increase, optic nerve damage, scleral thinning
Miscellaneous: Hypersensitivity (including anaphylaxis), secondary infection, sensitization to kanamycin, paromomycin, streptomycin, and gentamicin

Topical ointment:
Dermatologic: Acneiform eruptions, allergic contact dermatitis, burning skin, dryness, folliculitis, hypertrichosis, hypopigmentation, irritation, maceration of skin, miliaria, ocular hypertension, perioral dermatitis, pruritus, skin atrophy, striae
Otic: Ototoxicity
Renal: Nephrotoxicity
Miscellaneous: Hypersensitivity (including anaphylaxis), secondary infection, sensitization to karamycin, paromycin, streptomycin, and gentamicin

CONTRAINDICATIONS — Hypersensitivity to bacitracin, neomycin, polymyxin B, hydrocortisone, or any component of the formulation; not for use in viral infections, fungal diseases, mycobacterial infections

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible) particularly in younger children. HPA axis suppression may lead to adrenal crisis. Risk is increased when used over large surface areas, for prolonged periods, or with occlusive dressings. Immunosuppression: Prolonged use of corticosteroids may also increase the incidence of secondary infection, mask acute infection (including fungal infections), prolong or exacerbate viral infections, or limit response to vaccines. Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered. Neomycin sensitization: Symptoms of neomycin sensitization include itching, reddening, edema, and failure to heal. Discontinuation of product and avoidance of similar products should be considered. Systemic effects: Adverse systemic effects including hyperglycemia, glycosuria, and fluid and electrolyte changes.

Dosage form specific issues: Ophthalmic ointment: Should never be directly introduced into the anterior chamber. May retard corneal healing. Prolonged use may result in ocular hypertension/glaucoma, corneal and scleral thinning, potentially resulting in perforation. Use with caution in glaucoma. Avoid use following ocular cataract surgery. Inadvertent contamination of multiple-dose ophthalmic solutions, has caused bacterial keratitis.

METABOLISM / TRANSPORT EFFECTS — Hydrocortisone: Substrate of CYP3A4 (minor); Induces CYP3A4 (weak)

DRUG INTERACTIONS
Acetylcholinesterase Inhibitors: Corticosteroids (Systemic) may enhance the adverse/toxic effect of Acetylcholinesterase Inhibitors. Increased muscular weakness may occur. Risk C: Monitor therapy

Aminoglutethimide: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy

Amphotericin B: Corticosteroids (Systemic) may enhance the hypokalemic effect of Amphotericin B. Risk C: Monitor therapy

Antacids: May decrease the bioavailability of Corticosteroids (Oral). Risk D: Consider therapy modification

Antidiabetic Agents: Corticosteroids (Systemic) may diminish the hypoglycemic effect of Antidiabetic Agents. In some instances, corticosteroid-mediated HPA axis suppression has led to episodes of acute adrenal crisis, which may manifest as enhanced hypoglycemia, particularly in the setting of insulin or other antidiabetic agent use. Risk C: Monitor therapy

Antifungal Agents (Azole Derivatives, Systemic): May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Aprepitant: May increase the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification

Barbiturates: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Bile Acid Sequestrants: May decrease the absorption of Corticosteroids (Oral). Risk C: Monitor therapy

Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy

Calcitriol: Corticosteroids (Systemic) may diminish the therapeutic effect of Calcitriol. Risk C: Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Capreomycin: May enhance the neuromuscular-blocking effect of Polymyxin B. Risk C: Monitor therapy

Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Risk C: Monitor therapy

CARBOplatin: Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Risk C: Monitor therapy

Cardiac Glycosides: Aminoglycosides may decrease the absorption of Cardiac Glycosides. Risk C: Monitor therapy

CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy

Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect of Colistimethate. Risk D: Consider therapy modification

Colistimethate: Polymyxin B may enhance the neuromuscular-blocking effect of Colistimethate. Risk C: Monitor therapy

Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

CycloSPORINE: Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE. Risk C: Monitor therapy

CycloSPORINE: Corticosteroids (Systemic) may increase the serum concentration of CycloSPORINE. CycloSPORINE may increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Echinacea: May diminish the therapeutic effect of Immunosuppressants. Risk D: Consider therapy modification

Estrogen Derivatives: May increase the serum concentration of Corticosteroids (Systemic). Risk C: Monitor therapy

Fluconazole: May decrease the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Fosaprepitant: May increase the serum concentration of Corticosteroids (Systemic). The active metabolite aprepitant is likely responsible for this effect. Risk D: Consider therapy modification

Gallium Nitrate: Aminoglycosides may enhance the nephrotoxic effect of Gallium Nitrate. Risk X: Avoid combination

Isoniazid: Corticosteroids (Systemic) may decrease the serum concentration of Isoniazid. Risk C: Monitor therapy

Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Risk D: Consider therapy modification

Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Risk C: Monitor therapy

Loop Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Loop Diuretics. Risk C: Monitor therapy

Macrolide Antibiotics: May decrease the metabolism of Corticosteroids (Systemic). Exceptions: Azithromycin; Dirithromycin [Off Market]; Spiramycin. Risk D: Consider therapy modification

Mitotane: May decrease the serum concentration of Corticosteroids (Systemic). Risk D: Consider therapy modification

Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Risk X: Avoid combination

Neuromuscular-Blocking Agents: Polymyxin B may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Risk D: Consider therapy modification

Neuromuscular-Blocking Agents: Aminoglycosides may enhance the respiratory depressant effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy

Neuromuscular-Blocking Agents (Nondepolarizing): May enhance the adverse neuromuscular effect of Corticosteroids (Systemic). Increased muscle weakness, possibly progressing to polyneuropathies and myopathies, may occur. Risk D: Consider therapy modification

NSAID (COX-2 Inhibitor): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (COX-2 Inhibitor). Risk C: Monitor therapy

NSAID (Nonselective): Corticosteroids (Systemic) may enhance the adverse/toxic effect of NSAID (Nonselective). Risk C: Monitor therapy

OnabotulinumtoxinA: Aminoglycosides may enhance the neuromuscular-blocking effect of OnabotulinumtoxinA. Risk C: Monitor therapy

Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Exceptions: Amoxicillin; Ampicillin; Cloxacillin; Dicloxacillin; Methicillin; Nafcillin; Oxacillin; Penicillin G (Parenteral/Aqueous); Penicillin G Benzathine; Penicillin G Procaine; Penicillin V Potassium. Risk D: Consider therapy modification

P-Glycoprotein Inducers: May decrease the serum concentration of P-Glycoprotein Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

P-Glycoprotein Inhibitors: May increase the serum concentration of P-Glycoprotein Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Risk C: Monitor therapy

Primidone: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

Quinolone Antibiotics: May enhance the adverse/toxic effect of Corticosteroids (Systemic). Risk of tendon-related side effects, including tendonitis and rupture, may be enhanced. Risk C: Monitor therapy

Rifamycin Derivatives: May increase the metabolism of Corticosteroids (Systemic). Risk C: Monitor therapy

RimabotulinumtoxinB: Aminoglycosides may enhance the neuromuscular-blocking effect of RimabotulinumtoxinB. Risk C: Monitor therapy

Salicylates: May enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy

Thiazide Diuretics: Corticosteroids (Systemic) may enhance the hypokalemic effect of Thiazide Diuretics. Risk C: Monitor therapy

Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Risk C: Monitor therapy

Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Risk C: Monitor therapy

Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Vaccinial infections may develop. Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination

Vancomycin: May enhance the nephrotoxic effect of Aminoglycosides. Risk C: Monitor therapy

Warfarin: Corticosteroids (Systemic) may enhance the anticoagulant effect of Warfarin. Risk C: Monitor therapy

PREGNANCY RISK FACTOR — C (show table)

LACTATION — Excretion in breast milk unknown/use caution

PRICING — (data from drugstore.com)
Ointment (Bacitra-Neomycin-Polymyxin-HC)
1% (3.5): $13.93

Ointment (Cortisporin)
1% (15): $70.84

MONITORING PARAMETERS — If ophthalmic ointment is used >10 days or in patients with glaucoma, monitor intraocular pressure (IOP).

CANADIAN BRAND NAMES — Cortisporin® Topical Ointment

INTERNATIONAL BRAND NAMES — Cortisporin Topical Ointment (CA); Polybamycin (SG)

MECHANISM OF ACTION — See individual agents.

PHARMACODYNAMICS / KINETICS — See individual agents.