Acetic acid, propylene glycol diacetate, and hydrocortisone

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
VoSol® may be confused with Vexol®

U.S. BRAND NAMES — Acetasol® HC; VoSol® HC

PHARMACOLOGIC CATEGORY
Otic Agent, Anti-infective

DOSING: ADULTS — Otitis externa (superficial): Otic: Instill 3-5 drops in ear(s) every 4-6 hours

DOSING: PEDIATRIC — Children ≥ 3 years: 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.

Solution, otic [drops]:
Acetasol® HC: Acetic acid 2%, propylene glycol diacetate 3%, and hydrocortisone 1% (10 mL) [contains benzethonium chloride]
VoSol® HC: Acetic acid 2%, propylene glycol diacetate 3%, and hydrocortisone 1% (10 mL) [contains benzethonium chloride]

DOSAGE FORMS: CONCISE
Solution, otic [drops]:
Acetasol® HC, VoSol® HC: Acetic acid 2%, propylene glycol diacetate 3%, and hydrocortisone 1% (10 mL)

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — After removing cerumen and debris, solution may be applied by inserting a cotton wick into the ear canal and saturating with the solution. Wick may remain in place for 24 hours and then removed; however, drops should continue to be instilled into ear canal as long as indicated.

USE — Treatment of superficial infections of the external auditory canal caused by organisms susceptible to the action of the antimicrobial, complicated by swelling

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined: Otic: Transient burning or stinging may be noticed occasionally when the solution is first instilled into the acutely inflamed ear

CONTRAINDICATIONS — Hypersensitivity to acetic acid, propylene glycol, hydrocortisone, or any component of the formulation; perforated tympanic membrane; herpes simplex; vaccinia, and varicella

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: 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

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

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: 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

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: 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 (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

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

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

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

PRICING — (data from drugstore.com)
Solution (Acetasol HC)
2-1% (10): $209.97

PATIENT INFORMATION — See individual agent for Hydrocortisone.