Tuesday, May 18, 2010

Acetylcholine

U.S. BRAND NAMES — Miochol®-E

PHARMACOLOGIC CATEGORY
Cholinergic Agonist
Ophthalmic Agent, Miotic

DOSING: ADULTS — To produce miosis: Intraocular: 0.5-2 mL of 1% injection (5-20 mg) instilled into anterior chamber before or after securing one or more sutures

DOSING: ELDERLY — Refer to adult dosing.

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

Powder for solution, intraocular, as chloride:
Miochol®-E: 1:100 [20 mg; packaged with diluent (2 mL)]

DOSAGE FORMS: CONCISE
Powder for intraocular solution:
Miochol®-E: 1:100 [20 mg; packaged with diluent (2 mL)]

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Open under aseptic conditions only. Attach filter before irrigating eye.

USE — Produces complete miosis in cataract surgery, keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis is required

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Bradycardia, flushing, hypotension

Central nervous system: Headache

Ocular: Clouding, corneal edema, decompensation

Respiratory: Dyspnea

Miscellaneous: Diaphoresis

CONTRAINDICATIONS — Hypersensitivity to acetylcholine chloride or any component of the formulation; acute iritis and acute inflammatory disease of the anterior chamber

WARNINGS / PRECAUTIONS
Disease-related concerns: Diseases affected by systemic effects: Systemic effects rarely occur but can cause problems for patients with asthma, GI spasm, acute heart failure, hyperthyroidism, Parkinson's disease, peptic ulcer disease, and or urinary tract obstruction.

Special populations: Pediatrics: Safety and efficacy have not been established in children.

Other warnings/precautions: Aseptic conditions: Open under aseptic conditions only. Cataract surgery: During cataract surgery, use only after lens is in place.

DRUG INTERACTIONS
Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. Risk C: Monitor therapy

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Acetylcholine is used primarily in the eye and there are no reports of its use in pregnancy. Because it is ionized at physiologic pH, transplacental passage would not be expected.

CANADIAN BRAND NAMES — Miochol®-E

INTERNATIONAL BRAND NAMES — Acetilcolina Colirio (AR); Acetilcolina Cusi (ES); Miochol (FI, GR, LU, NL, NZ); Miochol-E (AU, BE, CH, CN, DE, DK, FI, GB, HK, ID, IE, IL, IT, KP, NL, NO, SE, ZA); Miochole (FR); Miovisin (IT); OQ-Miot (CO)

MECHANISM OF ACTION — Causes contraction of the sphincter muscles of the iris, resulting in miosis and contraction of the ciliary muscle, leading to accommodation spasm

PHARMACODYNAMICS / KINETICS
Onset of action: Rapid

Duration: ~10 minutes

PATIENT INFORMATION — Do not touch dropper to eye. May sting on instillation. Use caution while driving at night or performing hazardous tasks.

Acetylcholine

U.S. BRAND NAMES — Miochol®-E

PHARMACOLOGIC CATEGORY
Cholinergic Agonist
Ophthalmic Agent, Miotic

DOSING: ADULTS — To produce miosis: Intraocular: 0.5-2 mL of 1% injection (5-20 mg) instilled into anterior chamber before or after securing one or more sutures

DOSING: ELDERLY — Refer to adult dosing.

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

Powder for solution, intraocular, as chloride:
Miochol®-E: 1:100 [20 mg; packaged with diluent (2 mL)]

DOSAGE FORMS: CONCISE
Powder for intraocular solution:
Miochol®-E: 1:100 [20 mg; packaged with diluent (2 mL)]

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Open under aseptic conditions only. Attach filter before irrigating eye.

USE — Produces complete miosis in cataract surgery, keratoplasty, iridectomy, and other anterior segment surgery where rapid miosis is required

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Bradycardia, flushing, hypotension

Central nervous system: Headache

Ocular: Clouding, corneal edema, decompensation

Respiratory: Dyspnea

Miscellaneous: Diaphoresis

CONTRAINDICATIONS — Hypersensitivity to acetylcholine chloride or any component of the formulation; acute iritis and acute inflammatory disease of the anterior chamber

WARNINGS / PRECAUTIONS
Disease-related concerns: Diseases affected by systemic effects: Systemic effects rarely occur but can cause problems for patients with asthma, GI spasm, acute heart failure, hyperthyroidism, Parkinson's disease, peptic ulcer disease, and or urinary tract obstruction.

Special populations: Pediatrics: Safety and efficacy have not been established in children.

Other warnings/precautions: Aseptic conditions: Open under aseptic conditions only. Cataract surgery: During cataract surgery, use only after lens is in place.

DRUG INTERACTIONS
Acetylcholinesterase Inhibitors: May enhance the adverse/toxic effect of Cholinergic Agonists. Risk C: Monitor therapy

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Acetylcholine is used primarily in the eye and there are no reports of its use in pregnancy. Because it is ionized at physiologic pH, transplacental passage would not be expected.

CANADIAN BRAND NAMES — Miochol®-E

INTERNATIONAL BRAND NAMES — Acetilcolina Colirio (AR); Acetilcolina Cusi (ES); Miochol (FI, GR, LU, NL, NZ); Miochol-E (AU, BE, CH, CN, DE, DK, FI, GB, HK, ID, IE, IL, IT, KP, NL, NO, SE, ZA); Miochole (FR); Miovisin (IT); OQ-Miot (CO)

MECHANISM OF ACTION — Causes contraction of the sphincter muscles of the iris, resulting in miosis and contraction of the ciliary muscle, leading to accommodation spasm

PHARMACODYNAMICS / KINETICS
Onset of action: Rapid

Duration: ~10 minutes

PATIENT INFORMATION — Do not touch dropper to eye. May sting on instillation. Use caution while driving at night or performing hazardous tasks.

Acetohydroxamic acid

U.S. BRAND NAMES — Lithostat®

PHARMACOLOGIC CATEGORY
Urinary Tract Product

DOSING: ADULTS — Susceptible infections: Oral: 250 mg 3-4 times/day for a total daily dose of 10-15 mg/kg/day

DOSING: PEDIATRIC — Susceptible infections: Oral: Initial: 10 mg/kg/day

DOSING: ELDERLY — Refer to adult dosing.

DOSING: RENAL IMPAIRMENT — Not recommended for use in significant renal impairment (Srcr >2.5 mg/dL).

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

Tablet:
Lithostat®: 250 mg

DOSAGE FORMS: CONCISE
Tablet:
Lithostat®: 250 mg

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Should be administered on an empty stomach.

USE — Adjunctive therapy in chronic urea-splitting urinary infection

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Deep vein thrombosis (rare), embolism, palpitation, phlebitis

Central nervous system: Anorexia, anxiety, depression, headache, malaise, nervousness, tremor

Dermatologic: Flushing (with ethanol consumption), rash (nonpruritic, macular)

Gastrointestinal: Nausea, vomiting

Hematologic: Hemolytic anemia (15% with laboratory evidence; ~3% severe requiring discontinuation; may be accompanied by GI symptoms or systemic complaints of malaise and/or fatigue); hyperbilirubinemia

Respiratory: Pulmonary embolism (rare)

CONTRAINDICATIONS — Hypersensitivity to acetohydroxamic acid or any component of the formulation; pregnancy

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Bone marrow suppression: May suppress bone marrow function; use with caution in patients with prior bone marrow depression. Close monitoring of hematologic function is recommended. Hemolytic anemia: Has been associated with hemolytic anemia (Coombs' negative), which may be associated with gastrointestinal distress and systemic symptoms; use with caution in patients with anemia. Monitor hematologic parameters during extended therapy. Hepatotoxicity: May cause hepatic injury; close monitoring of hepatic function is recommended.

Disease-related concerns: Psychiatric disorders: Use with caution in patients with pre-existing psychiatric disorders; may be associated with nervousness, anxiety, and/or depression.

DRUG INTERACTIONS — There are no known significant interactions.

ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Avoid ethanol (may increase incidence of rash and/or flushing).

Food: May decrease absorption of acetohydroxamic acid.

PREGNANCY RISK FACTOR — X (show table)

LACTATION — Excretion in breast milk unknown/not recommended

DIETARY CONSIDERATIONS — Should be taken on an empty stomach, 1 hour before or 2 hours after meals.

PRICING — (data from drugstore.com)
Tablets (Lithostat)
250 mg (100): $172.79

MONITORING PARAMETERS — In patients receiving therapy >2 weeks, monitor CBC with reticulocytes at 3-month intervals during the duration of treatment.

CANADIAN BRAND NAMES — Lithostat®

INTERNATIONAL BRAND NAMES — Uronefrex (BE, ES, FR, LU)

MECHANISM OF ACTION — Acetohydroxamic acid inhibits bacterial urease enzymes, decreasing the formation of ammonia in the urine by urea-splitting organisms. A reduction in urinary ammonia may increase the antibacterial activity of some antibiotic agents.

Acetohydroxamic acid

U.S. BRAND NAMES — Lithostat®

PHARMACOLOGIC CATEGORY
Urinary Tract Product

DOSING: ADULTS — Susceptible infections: Oral: 250 mg 3-4 times/day for a total daily dose of 10-15 mg/kg/day

DOSING: PEDIATRIC — Susceptible infections: Oral: Initial: 10 mg/kg/day

DOSING: ELDERLY — Refer to adult dosing.

DOSING: RENAL IMPAIRMENT — Not recommended for use in significant renal impairment (Srcr >2.5 mg/dL).

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

Tablet:
Lithostat®: 250 mg

DOSAGE FORMS: CONCISE
Tablet:
Lithostat®: 250 mg

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Should be administered on an empty stomach.

USE — Adjunctive therapy in chronic urea-splitting urinary infection

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: Deep vein thrombosis (rare), embolism, palpitation, phlebitis

Central nervous system: Anorexia, anxiety, depression, headache, malaise, nervousness, tremor

Dermatologic: Flushing (with ethanol consumption), rash (nonpruritic, macular)

Gastrointestinal: Nausea, vomiting

Hematologic: Hemolytic anemia (15% with laboratory evidence; ~3% severe requiring discontinuation; may be accompanied by GI symptoms or systemic complaints of malaise and/or fatigue); hyperbilirubinemia

Respiratory: Pulmonary embolism (rare)

CONTRAINDICATIONS — Hypersensitivity to acetohydroxamic acid or any component of the formulation; pregnancy

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Bone marrow suppression: May suppress bone marrow function; use with caution in patients with prior bone marrow depression. Close monitoring of hematologic function is recommended. Hemolytic anemia: Has been associated with hemolytic anemia (Coombs' negative), which may be associated with gastrointestinal distress and systemic symptoms; use with caution in patients with anemia. Monitor hematologic parameters during extended therapy. Hepatotoxicity: May cause hepatic injury; close monitoring of hepatic function is recommended.

Disease-related concerns: Psychiatric disorders: Use with caution in patients with pre-existing psychiatric disorders; may be associated with nervousness, anxiety, and/or depression.

DRUG INTERACTIONS — There are no known significant interactions.

ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Avoid ethanol (may increase incidence of rash and/or flushing).

Food: May decrease absorption of acetohydroxamic acid.

PREGNANCY RISK FACTOR — X (show table)

LACTATION — Excretion in breast milk unknown/not recommended

DIETARY CONSIDERATIONS — Should be taken on an empty stomach, 1 hour before or 2 hours after meals.

PRICING — (data from drugstore.com)
Tablets (Lithostat)
250 mg (100): $172.79

MONITORING PARAMETERS — In patients receiving therapy >2 weeks, monitor CBC with reticulocytes at 3-month intervals during the duration of treatment.

CANADIAN BRAND NAMES — Lithostat®

INTERNATIONAL BRAND NAMES — Uronefrex (BE, ES, FR, LU)

MECHANISM OF ACTION — Acetohydroxamic acid inhibits bacterial urease enzymes, decreasing the formation of ammonia in the urine by urea-splitting organisms. A reduction in urinary ammonia may increase the antibacterial activity of some antibiotic agents.

Monday, May 17, 2010

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.

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.

Acetic acid

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Acetic acid for irrigation may be confused with glacial acetic acid
VoSol® may be confused with Vexol®

PHARMACOLOGIC CATEGORY
Otic Agent, Anti-infective
Topical Skin Product

DOSING: ADULTS
Irrigation (Note: Dosage of an irrigating solution depends on the capacity or surface area of the structure being irrigated):
For continuous irrigation of the urinary bladder with 0.25% acetic acid irrigation, the rate of administration will approximate the rate of urine flow; usually 500-1500 mL/24 hours
For periodic irrigation of an indwelling urinary catheter to maintain patency, about 50 mL of 0.25% acetic acid irrigation is required

Otitis externa: Otic: Insert saturated wick; keep moist 24 hours; remove wick and instill 5 drops 3-4 times/day

DOSING: ELDERLY — Refer to adult dosing.

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

Solution for irrigation: 0.25% (250 mL, 500 mL, 1000 mL)

Solution, otic: 2% (15 mL)

DOSAGE FORMS: CONCISE
Solution for irrigation: 0.25% (250 mL, 500 mL, 1000 mL)

Solution, otic: 2% (15 mL)

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — Not for internal intake or I.V. infusion; topical use or irrigation use only.

USE — Irrigation of the bladder; treatment of superficial bacterial infections of the external auditory canal

ADVERSE REACTIONS SIGNIFICANT — <1% (Limited to important or life-threatening): Hematuria, systemic acidosis, urologic pain

CONTRAINDICATIONS — Hypersensitivity to acetic acid or any component of the formulation; during transurethral procedures

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Acidosis: Systemic acidosis may result from absorption. Bladder irritation: Use of irrigation in patients with mucosal lesions of urinary bladder may cause irritation.

Other warnings/precautions: Administration: Not for internal intake or I.V. infusion; topical use or irrigation use only.

DRUG INTERACTIONS — There are no known significant interactions.

PREGNANCY RISK FACTOR — C (show table)

INTERNATIONAL BRAND NAMES — Aquaear (AU); Earcalm (GB, IE); Suym Otico (PE)