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Amphotericin B (Conventional)

Pronunciation

Pronunciation

(am foe TER i sin bee con VEN sha nal)

Index Terms

  • Amphotericin B Deoxycholate
  • Amphotericin B Desoxycholate
  • Conventional Amphotericin B

Dosage Forms

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

Solution Reconstituted, Injection, as desoxycholate:

Generic: 50 mg (1 ea)

Pharmacologic Category

  • Antifungal Agent, Parenteral

Pharmacology

Binds to ergosterol altering cell membrane permeability in susceptible fungi and causing leakage of cell components with subsequent cell death. Proposed mechanism suggests that amphotericin causes an oxidation-dependent stimulation of macrophages (Lyman 1992).

Absorption

Poor oral absorption

Distribution

Minimal amounts enter the aqueous humor, bile, pericardial fluid, pleural fluid, and synovial fluid

CNS penetration:

Preterm neonates (GA: 27.4 ± 5 weeks): High interpatient variability; 40% to 90% of serum concentrations (Baley 1990)

Adults: Poor (inflamed or noninflamed meninges)

Excretion

Urine (2% to 5% as biologically active form); ~40% eliminated over a 7-day period and may be detected in urine for at least 7 weeks after discontinued use

Clearance (Benson 1989):

Infants and Children (8 months to 9 years): 0.57 ± 0.152 mL/minute/kg

Children and Adolescents (10-14 years): 0.24 ± 0.02 mL/minute/kg

Time to Peak

Within 1 hour following a 4- to 6-hour dose

Half-Life Elimination

Premature neonates (GA: 27.4 ± 5 weeks): 14.8 hours (range: 5 to 82 hours) (Baley 1990)

Infants and Children (4 months to 14 years): 18.1 ± 6.6 hours (range: 11.9 to 40.3 hours) (Benson 1989)

Adults: Biphasic: Initial: 15 to 48 hours; Terminal: 15 days

Protein Binding

Plasma: 90%

Use: Labeled Indications

Life-threatening fungal infections: Treatment of patients with progressive, potentially life-threatening fungal infections: Aspergillosis, cryptococcosis (torulosis), North American blastomycosis, systemic candidiasis, coccidioidomycosis, histoplasmosis, zygomycosis (including mucormycosis due to susceptible species of the genera Absidia, Mucor, and Rhizopus), and infections due to related susceptible species of Conidiobolus, Basidiobolus, and sporotrichosis.

Leishmaniasis: May be useful in the treatment of American mucocutaneous leishmaniasis, but it is not the drug of choice as primary therapy.

Use: Unlabeled

Treatment of fungal endophthalmitis, symptomatic candidal cystitis (bladder irrigation)

Contraindications

Hypersensitivity to amphotericin or any component of the formulation

Dosing: Adult

Note: Conventional amphotericin formulations (desoxycholate [Amphocin, Fungizone]) may be confused with lipid-based formulations (AmBisome, Abelcet, Amphotec). Lipid-based and conventional formulations are not interchangeable and have different dosage recommendations. Overdoses have occurred when conventional formulations were dispensed inadvertently for lipid-based products.

Note: Premedication: For patients who experience infusion-related immediate reactions, premedicate with the following drugs 30 to 60 minutes prior to drug administration: NSAID and/or diphenhydramine or acetaminophen with diphenhydramine or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered.

Test dose: IV: 1 mg infused over 20 to 30 minutes. Many clinicians believe a test dose is unnecessary.

Susceptible fungal infections: IV: Adults: 0.3 to 1.5 mg/kg/day; 1 to 1.5 mg/kg over 4 to 6 hours every other day may be given once therapy is established; aspergillosis, rhinocerebral mucormycosis, often require 1 to 1.5 mg/kg/day; do not exceed 1.5 mg/kg/day

Aspergillosis, disseminated: IV: 0.6 to 0.7 mg/kg/day for 3 to 6 months

Aspergillosis (invasive) in HIV-infected patients (off-label use): IV: 1 mg/kg once daily until infection resolution and CD4 count >200 cells/mm3 (HHS [OI adult 2015])

Bone marrow transplantation (prophylaxis): IV: Low-dose amphotericin B 0.1 to 0.25 mg/kg/day has been administered after bone marrow transplantation to reduce the risk of invasive fungal disease.

Candidemia (neutropenic or non-neutropenic): IV: 0.5 to 1 mg/kg/day until 14 days after first negative blood culture and resolution of signs and symptoms (Pappas, 2009)

Candidiasis, chronic, disseminated: IV: 0.5 to 0.7 mg/kg/day for 3 to 6 months and resolution of radiologic lesions (Pappas, 2009)

Coccidioidomycosis in HIV-infected patients with severe, non-meningeal infection (ie, diffuse pulmonary or severely ill with extrathoracic disseminated disease) (off-label use): IV: 0.7 to 1 mg/kg/day until clinical improvement, then initiate triazole therapy (eg, fluconazole or itraconazole) (HHS [OI adult 2015])

Dematiaceous fungi: IV: 0.7 mg/kg/day in combination with an azole

Endocarditis: IV: 0.6 to 1 mg/kg/day (with or without flucytosine) for 6 weeks after valve replacement; Note: If isolates susceptible and/or clearance demonstrated, guidelines recommend step-down to fluconazole; also for long-term suppression therapy if valve replacement is not possible (Pappas, 2009)

Endophthalmitis, fungal (off-label use):

Intravitreal: 5 to 12.5 mcg (with or without concomitant systemic therapy) (Brod, 1990)

IV: 0.7 to 1 mg/kg/day (with flucytosine) for at least 4 to 6 weeks (Pappas, 2009)

Esophageal candidiasis: IV: 0.3 to 0.7 mg/kg/day for 14 to 21 days after clinical improvement (Pappas, 2009)

Histoplasmosis: Chronic, severe pulmonary or disseminated: IV: 0.5 to 1 mg/kg/day for 7 days, then 0.8 mg/kg every other day (or 3 times/week) until total dose of 10 to 15 mg/kg; may continue itraconazole as suppressive therapy (lifelong for immunocompromised patients)

Meningitis:

Candidal: IV: 0.7 to 1 mg/kg/day (with or without flucytosine) for at least 4 weeks; Note: Liposomal amphotericin favored by IDSA guidelines based on decreased risk of nephrotoxicity and potentially better CNS penetration (Pappas, 2009)

Cryptococcal or Coccidioides: Intrathecal: Initial: 0.01 to 0.05 mg as single daily dose; may increase daily in increments of 0.025 to 0.1 mg as tolerated (maximum: 1.5 mg/day; most patients will tolerate a maximum dose of ~0.5 mg/treatment). Once titration to a maximum tolerated dose is achieved, that dose is administered daily. Once CSF improvement noted, may decrease frequency on a weekly basis (eg, 5 times/week, then 3 times/week, then 2 times/week, then once weekly, then once every other week, then once every 2 weeks, etc) until administration occurs once every 6 weeks. Typically, concurrent oral azole therapy is maintained (Stevens, 2001). Note: IDSA notes that the use of intrathecal amphotericin for cryptococcal meningitis is generally discouraged and rarely necessary (Perfect, 2010).

Histoplasma: IV: 0.5 to 1 mg/kg/day for 7 days, then 0.8 mg/kg every other day (or 3 times/week) for 3 months total duration; follow with fluconazole suppressive therapy for up to 12 months

Meningoencephalitis, cryptococcal (Perfect, 2010): IV:

HIV positive: Induction: 0.7 to 1 mg/kg/day (plus flucytosine 100 mg/kg/day) for 2 weeks, then change to oral fluconazole for at least 8 weeks; alternatively, amphotericin (0.7 to 1 mg/kg/day) may be continued uninterrupted for 4 to 6 weeks; maintenance: amphotericin 1 mg/kg/week for ≥1 year may be considered, but inferior to use of azoles

HIV negative: Induction: 0.7 to 1 mg/kg/day (plus flucytosine 100 mg/kg/day) for 2 weeks (low-risk patients), ≥4 weeks (non-low-risk, but without neurologic complication, immunosuppression, underlying disease, and negative CSF culture at 2 weeks), >6 weeks (neurologic complication or patients intolerant of flucytosine) Follow with azole consolidation/maintenance treatment.

Oropharyngeal candidiasis: IV: 0.3 mg/kg/day for 7 to 14 days (Pappas, 2009)

Osteoarticular candidiasis: IV: 0.5 to 1 mg/kg/day for several weeks, followed by fluconazole for 6 to 12 months (osteomyelitis) or 6 weeks (septic arthritis) (Pappas, 2009)

Penicillium marneffei: IV: 0.6 mg/kg/day for 2 weeks

Pneumonia: Cryptococcal (mild to moderate): IV:

HIV positive: 0.5 to 1 mg/kg/day

HIV negative: 0.5 to 0.7 mg/kg/day (plus flucytosine) for 2 weeks

Sporotrichosis: Pulmonary, meningeal, osteoarticular or disseminated: IV: Total dose of 1 to 2 g, then change to oral itraconazole or fluconazole for suppressive therapy

Urinary tract candidiasis (IDSA [Pappas, 2009]):

Fungus balls: IV: 0.5 to 0.7 mg/kg/day with or without flucytosine 25 mg/kg 4 times daily

Pyelonephritis: IV: 0.5 to 0.7 mg/kg/day with or without flucytosine 25 mg/kg 4 times daily for 2 weeks

Symptomatic cystitis: IV: 0.3 to 0.6 mg/kg/day for 1 to 7 days

Bladder irrigation in patients with C. krusei or fluconazole-resistant C. glabrata: Irrigate with 50 mcg/mL solution instilled periodically or continuously for 5 to 7 days or until cultures are clear. Note: Recommended for use in conjunction with other treatment modalities (Fisher, 2011).

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Note: Conventional amphotericin formulations (desoxycholate [Amphocin, Fungizone]) may be confused with lipid-based formulations (AmBisome, Abelcet, Amphotec). Lipid-based and conventional formulations are not interchangeable and have different dosage recommendations. Overdoses have occurred when conventional formulations were dispensed inadvertently for lipid-based products.

Note: Premedication: For patients who experience infusion-related immediate reactions, premedicate with the following drugs 30 to 60 minutes prior to drug administration: NSAID and/or diphenhydramine or acetaminophen with diphenhydramine or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered.

Test dose: IV: Infants and Children: 0.1 mg/kg/dose to a maximum of 1 mg; infuse over 30 to 60 minutes. Many clinicians believe a test dose is unnecessary.

Susceptible fungal infections: IV: Infants and Children: Maintenance dose: 0.25 to 1 mg/kg/day given once daily; infuse over 2 to 6 hours. Once therapy has been established, amphotericin B can be administered on an every-other-day basis at 1 to 1.5 mg/kg/dose; cumulative dose: 1.5 to 2 g over 6 to 10 weeks

Note: Duration of therapy varies with nature of infection: Usual duration is 4 to 12 weeks or cumulative dose of 1 to 4 g.

Indication-specific dosing:

Infants and Children:

Aspergillosis (HIV-exposed/-positive): IV: 1 to 1.5 mg/kg/day once daily (CDC, 2009)

Candidiasis (HIV-exposed/-positive):

Invasive: IV: 0.5 to 1.5 mg/kg/day once daily (CDC, 2009)

Esophageal: IV: 0.3 to 0.5 mg/kg/day once daily (CDC, 2009)

Oropharyngeal, refractory: IV: 0.3 to 0.5 mg/kg/day (CDC, 2009)

Coccidioidomycosis (HIV-exposed/-positive): IV: 0.5 to 1 mg/kg/day (CDC, 2009)

Cryptococcus, CNS disease (HIV-exposed/-positive): IV: 0.7 to 1 mg/kg/day plus flucytosine; Note: Minimum 2 week induction followed by consolidation and chronic suppressive therapy; may increase amphotericin dose to 1.5 mg/kg/day if flucytosine is not tolerated.

Cryptococcus, disseminated (non-CNS disease) or severe pulmonary disease (HIV-exposed/-positive): IV: 0.7 to 1 mg/kg/day once daily with or without flucytosine

Histoplasma, CNS or severe disseminated: IV: 1 mg/kg/day once daily (CDC, 2009)

Adolescents:

Aspergillosis (invasive) in HIV-infected patients (off-label use): IV: Refer to adult dosing.

Coccidioidomycosis in HIV-infected patients with severe, non-meningeal infection (ie, diffuse pulmonary or severely ill with extrathoracic disseminated disease) (off-label use): IV: Refer to adult dosing.

Dosing: Renal Impairment

If renal dysfunction is due to the drug, the daily total can be decreased by 50% or the dose can be given every other day. IV therapy may take several months.

Renal replacement therapy: Poorly dialyzed; no supplemental dose or dosage adjustment necessary, including patients on intermittent hemodialysis or CRRT.

Peritoneal dialysis (PD): Administration in dialysate: 1 to 2 mg/L of peritoneal dialysis fluid either with or without low-dose IV amphotericin B (a total dose of 2 to 10 mg/kg given over 7 to 14 days). Precipitate may form in ionic dialysate solutions.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Reconstitution

Add 10 mL of SWFI (without a bacteriostatic agent) to each vial of amphotericin B. Further dilute with 250 to 500 mL D5W; final concentration should not exceed 0.1 mg/mL (peripheral infusion) or 0.25 mg/mL (central infusion). For bladder irrigation (off-label use), reconstituted solution is further diluted with 1,000 mL SWFI for a final concentration of 50 mcg/mL (Fisher 2011).

Administration

IV: May be infused over 4 to 6 hours. For a patient who experiences chills, fever, hypotension, nausea, or other nonanaphylactic infusion-related reactions, premedicate with the following drugs 30 to 60 minutes prior to drug administration: A nonsteroidal (eg, ibuprofen, choline magnesium trisalicylate) ± diphenhydramine or acetaminophen with diphenhydramine or hydrocortisone. If the patient experiences rigors during the infusion, meperidine may be administered. Bolus infusion of normal saline immediately preceding, or immediately preceding and following amphotericin B may reduce drug-induced nephrotoxicity. Risk of nephrotoxicity increases with amphotericin B doses >1 mg/kg/day. Infusion of admixtures more concentrated than 0.25 mg/mL should be limited to patients absolutely requiring volume contraction.

Intravitreal (off-label use/route): Administer amphotericin intravitreally with a final concentration of 5 mcg/0.1 mL NS (John 2007).

Irrigation: (via urinary catheter) (off-label use/route): Administer via three way urinary catheter at a rate of 42 mL/hour (Nesbit 1999).

Compatibility

Solution: Stable in D5W; incompatible with D5LR, D51/4NS, D51/2NS, D5NS, D5R, LR, R, NS.

Y-site administration: Incompatible with allopurinol, amifostine, Aminosyn® II, amsacrine, anidulafungin, aztreonam, bivalirudin, caspofungin, cefepime, dexmedetomidine, docetaxel, doxorubicin liposomal, enalaprilat, etoposide phosphate, fenoldopam, filgrastim, fludarabine, FreAmine® III, gemcitabine, granisetron, hetastarch in lactate electrolyte injection (Hextend®), linezolid, melphalan, meropenem, ondansetron, paclitaxel, pantoprazole, pemetrexed, piperacillin/tazobactam, propofol, tigecycline, vinorelbine.

Storage

Store intact vials under refrigeration. Protect from light. Reconstituted vials are stable, protected from light, for 24 hours at room temperature and 1 week when refrigerated. Parenteral admixtures in D5W are stable, protected from light, for 24 hours at room temperature and 2 days under refrigeration. Short-term exposure (<24 hours) to light during IV infusion does not appreciably affect potency.

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Aminoglycosides: Amphotericin B may enhance the nephrotoxic effect of Aminoglycosides. Monitor therapy

Antifungal Agents (Azole Derivatives, Systemic): May diminish the therapeutic effect of Amphotericin B. Monitor therapy

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Cardiac Glycosides: Amphotericin B may enhance the adverse/toxic effect of Cardiac Glycosides. Monitor therapy

Colistimethate: Amphotericin B may enhance the nephrotoxic effect of Colistimethate. Consider therapy modification

Corticosteroids (Orally Inhaled): May enhance the hypokalemic effect of Amphotericin B. Monitor therapy

Corticosteroids (Systemic): May enhance the hypokalemic effect of Amphotericin B. Monitor therapy

CycloSPORINE (Systemic): Amphotericin B may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Monitor therapy

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Dronabinol: May increase the serum concentration of Amphotericin B. Specifically, dronabinol may displace amphotericin B from its protein-binding sites, leading to an increased concentration of active, unbound drug. Monitor therapy

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Flucytosine: Amphotericin B may enhance the adverse/toxic effect of Flucytosine. This may be related to the adverse effects of amphotericin B on renal function. Monitor therapy

Foscarnet: May enhance the nephrotoxic effect of Amphotericin B. Avoid combination

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Hypotension-Associated Agents: Blood Pressure Lowering Agents may enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Monitor therapy

Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination

Sodium Stibogluconate [INT]: Amphotericin B (Conventional) may enhance the cardiotoxic effect of Sodium Stibogluconate [INT]. Specifically, arrhythmia and sudden cardiac death risks may be increased. Consider therapy modification

Adverse Reactions

Systemic:

>10%:

Cardiovascular: Hypotension

Central nervous system: Chills, headache (less frequent with I.T), malaise, pain (less frequent with I.T)

Endocrine & metabolic: Hypokalemia, hypomagnesemia

Gastrointestinal: Anorexia, diarrhea, epigastric pain, heartburn, nausea (less frequent with I.T), stomach cramps, vomiting (less frequent with I.T)

Hematologic & oncologic: Anemia (normochromic-normocytic)

Local: Pain at injection site (with or without phlebitis or thrombophlebitis [incidence may increase with peripheral infusion of admixtures])

Renal: Renal function abnormality (including azotemia, renal tubular acidosis, nephrocalcinosis [>0.1 mg/ml]), renal insufficiency

Respiratory: Tachypnea

Miscellaneous: Fever

1% to 10%:

Cardiovascular: Flushing, hypertension

Central nervous system: Arachnoiditis, delirium, neuralgia (lumbar; especially with intrathecal therapy), paresthesia (especially with intrathecal therapy)

Genitourinary: Urinary retention

Hematologic & oncologic: Leukocytosis

<1% (Limited to important or life-threatening): Acute hepatic failure, agranulocytosis, anuria, blood coagulation disorder, bone marrow depression, bronchospasm, cardiac arrest, cardiac arrhythmia, cardiac failure, convulsions, diplopia, dyspnea, eosinophilia, exfoliation of skin, hearing loss, hemorrhagic gastroenteritis, hepatitis, hypersensitivity pneumonitis, increased liver enzymes, jaundice, leukoencephalopathy, leukopenia, maculopapular rash, melena, nephrogenic diabetes insipidus, oliguria, peripheral neuropathy, pruritus, pulmonary edema, renal failure, renal tubular acidosis, shock, Stevens-Johnson syndrome, thrombocytopenia, tinnitus, toxic epidermal necrolysis, ventricular fibrillation, vertigo (transient), visual disturbance, wheezing

ALERT: U.S. Boxed Warning

Appropriate use:

This drug should be used primarily for treatment of patients with progressive and potentially life-threatening fungal infections; it should not be used to treat noninvasive forms of fungal disease such as oral thrush, vaginal candidiasis, and esophageal candidiasis in patients with normal neutrophil counts.

Error prevention:

Exercise caution to prevent inadvertent overdose with amphotericin B. Verify the product name and dosage if dose exceeds 1.5 mg/kg.

Warnings/Precautions

Concerns related to adverse effects:

• Anaphylaxis: Has been reported with amphotericin B-containing drugs; facilities for cardiopulmonary resuscitation should be available during administration due to the possibility of anaphylactic reaction. If severe respiratory distress occurs, the infusion should be immediately discontinued; during the initial dosing, the drug should be administered under close clinical observation.

• Infusion reactions: Acute reactions (eg, fever, shaking chills, hypotension, anorexia, nausea, vomiting, headache, tachypnea) may occur 1 to 3 hours after starting an intravenous infusion. These reactions are usually more common with the first few doses and generally diminish with subsequent doses. Avoid rapid infusion to prevent hypotension, hypokalemia, arrhythmias, and shock.

• Leukoencephalopathy: Has been reported following administration of amphotericin. Total body irradiation has been reported to be a possible predisposition.

• Nephrotoxicity: May cause nephrotoxicity; usual risk factors include underlying renal disease, concomitant nephrotoxic medications and daily and/or cumulative dosing of amphotericin. Avoid use with other nephrotoxic drugs; drug-induced renal toxicity usually improves with interrupting therapy, decreasing dosage, or increasing dosing interval. However permanent impairment may occur, especially in patients receiving large cumulative dose (eg, >5 g) and in those also receiving other nephrotoxic drugs. Hydration and sodium repletion prior to administration may reduce the risk of developing nephrotoxicity. Frequent monitoring of renal function is recommended.

Disease-related concerns:

• Fungal infections: [US Boxed Warning]: Should be used primarily for treatment of progressive, potentially life-threatening fungal infections, not noninvasive forms of infection.

• Renal impairment: Use with caution in patients with renal impairment.

Special populations:

• Neutropenic patients: Pulmonary reactions may occur in neutropenic patients receiving leukocyte transfusions; separation of the infusions as much as possible is advised.

Other warnings/precautions:

• Error prevention: [US Boxed warning]: Verify the product name and dosage if dose exceeds 1.5 mg/kg.

• Therapy interruption: If therapy is stopped for >7 days, restart at the lowest dose recommended and increase gradually.

Monitoring Parameters

BUN and serum creatinine levels should be determined every other day when therapy is increased and at least weekly thereafter. Renal function (monitor frequently during therapy), electrolytes (especially potassium and magnesium), liver function tests, temperature, PT/PTT, CBC; monitor input and output; monitor for signs of hypokalemia (muscle weakness, cramping, drowsiness, ECG changes, etc)

Pregnancy Risk Factor

B

Pregnancy Considerations

Adverse events were not observed in animal reproduction studies. Amphotericin crosses the placenta and enters the fetal circulation. No teratogenic or undue systemic toxicity (electrolyte imbalance or renal dysfunction) has been reported in the mother or fetus. Toxic maternal effects are to be expected and must be monitored (Perfect 2010). Amphotericin B is recommended for the treatment of serious systemic fungal diseases in pregnant women. Refer to current guidelines (King 1998).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience heartburn, nausea, vomiting, diarrhea, lack of appetite, muscle pain, or joint pain. Have patient report immediately to prescriber signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice); signs of kidney problems (urinary retention, hematuria, change in amount of urine passed, or weight gain); signs of fluid and electrolyte problems (mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness or passing out, tachycardia, increased thirst, seizures, loss of strength and energy, lack of appetite, urinary retention or change in amount of urine passed, dry mouth, dry eyes, nausea or vomiting); chills; severe dizziness; passing out; fast breathing; signs of breathing problems (shortness of breath, wheezing, coughing, or breathing gets worse); excessive weight gain; swelling of arm or leg; seizures, black, tarry, or bloody stools; hearing impairment; loss of strength and energy; vision changes; burning or numbness feeling; bruising; bleeding; severe headache; angina; or injection site pain or irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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