Details About Generic Salt ::  Amphote1

Main Medicine Class:: Anti-infective,antifungal   

(am-foe-TER-ih-sin B)
Amphotericin B Deoxycholate
Fungizone
Amphotericin B Lipid-Based
Abelcet
Amphotericin B Cholesteryl
Amphotec
Class: Anti-infective/antifungal

 

Drugs Class ::

 Action Alters fungal cell membrane permeability.

Indications for Drugs ::

 Indications Treatment of progressive, potentially fatal infections caused by certain fungal species. Amphotericin B Desoxycholate: Treatment of American mucocutaneous leishmaniasis. Amphotericin B Lipid-Based: Treatment of invasive fungal infections in patients refractory to conventional amphotericin B desoxycholate or when renal impairment or unacceptable toxicity precludes use of the desoxycholate formulation (lipid complex); treatment of infections caused by Candida, or Cryptococcus species (liposomal); empirical treatment of febrile, neutropenic patients with presumed fungal infections (liposomal); treatment of visceral leishmaniasis (liposomal). Amphotericin B Cholesteryl: Treatment of invasive aspergillosis. Amphotericin B (Topical): Treatment of cutaneous and mucocutaneous mycotic infections caused by Candida sp. Unlabeled use(s): Prophylaxis of fungal infections in patients with bone marrow transplantation; treatment of primary amoebic meningoencephalitis caused by Naegleria fowleri; subconjunctival or intravitreal treatment of ocular aspergillosis; bladder irrigation for candidal cystitis; chemoprophylaxis of aspergillosis; intrathecal treatment of severe meningitis unresponsive to IV therapy; intra-articular or IM treatment of coccidioidal arthritis.

Drug Dose ::

 Route/Dosage

AMPHOTERICIN B DESOXYCHOLATE

ADULTS: IV Test dose of 0.05 mg/mL infused slowly over 20 to 30 min. Record patient’s temperature, pulse, respiration, and blood pressure q 30 min for 2 to 4 hr.

Systemic Fungal Infections

ADULTS: IV Initial recommended dose is 0.25 to 0.3 mg/kg/day infused slowly over 2 to 6 hr. Dose is increased gradually up to 0.5 to 0.7 mg/kg/day and up to 1.5 mg/kg/day for some mycoses (maximum daily dose 1.5 mg/kg). Daily dose varies with type of infection, ranging from 0.5 to 1.5 mg/kg/day for 4 to 12 weeks. However, aspergillosis regimen is 1 to 1.5 mg/kg/day up to a total treatment dose of 3.6 g; rhinocerebral phycomycosis regimen is 0.25 to 1.5 mg/kg/day to a total treatment dose of 3 to 4 g; sporotrichosis regimen is 0.5 mg/kg/day up to a total treatment dose of 2.5 g.

Leishmaniasis

ADULTS: IV 0.5 mg/kg/day on alternate days for 14 doses.

Amphotericin B Liposomal

Empirical Fungal Infection

ADULTS: IV 3 mg/kg/day.

Systemic Fungal Infection

ADULTS: IV 3 to 5 mg/kg/day as a 1 to 2 mg/mL dilution. CHILDREN: IV 3 to 5 mg/kg/day as a 0.2 to 0.5 mg/mL dilution.

Leishmaniasis

ADULTS: IV 3 mg/kg/day on days 1 through 5, and days 14 and 21 to immunocompetent patients; administer 4 mg/kg/day on days 1 through 5, and days 10, 17, 24, 31, and 38 to immunosuppressed patients.

Amphotericin B Lipid Complex

Systemic Fungal Infection

ADULTS: IV 5 mg/kg/day as a 1 mg/mL dilution; patients with cardiovascular disease dilute to 2 mg/mL. CHILDREN: IV 5 mg/kg/day as a 2 mg/mL dilution.

AMPHOTERICIN B CHOLESTERYL

Systemic Fungal Infection

ADULTS: IV Test dose advisable (eg, 10 mL containing 1.6 to 8.3 mg infused over 15 to 30 min); recommended treatment dose is 3 to 4 mg/kg/day.

Amphotericin B

Topical

2 to 4 times/day for 1 to 4 wk.

Contraindication ::

 Contraindications Standard considerations.

Drug Precautions ::

 Precautions

Pregnancy: Category B. Lactation: Undetermined. Children: Amphotericin B desoxycholate: Safety and efficacy not established. Amphotericin B, lipid-based (ie, cholesteryl, lipid complex, liposomal): Safety and efficacy in children < 1 mo not established. Nephrotoxicity: Drug is toxic and should be used with caution under close supervision. Renal damage is most important toxic effect. Despite its dangerous side effects, amphotericin B frequently is the only effective treatment for potentially fatal fungal diseases. Topical use: Avoid contact with eyes. Pulmonary reactions: Acute dyspnea, hypoxemia, and interstitial infiltrates can occur in neutropenic patients receiving amphotericin B and leukocyte transfusions.

PATIENT CARE CONSIDERATIONS


Drug Side Effects ::

 Adverse Reactions

CV: Arrhythmias; ventricular fibrillation; cardiac arrest; hypotension; chest pain; hypertension; tachycardia. CNS: Headache; convulsions; peripheral neuropathy; anxiety; confusion. DERM: Topical preparations may cause local irritation (eg, erythema, pruritis, burning sensation) or dryness; pruritus; rash; sweating. EENT: Hearing loss. GI: Anorexia; nausea; vomiting; dyspepsia; diarrhea; cramping; epigastric pain; hemorrhagic gastroenteritis. GU: Hypokalemia; azotemia; hyposthenuria; nephrocalcinosis; renal tubular acidosis; anuria; oliguria; permanent renal damage; kidney failure; hematuria. HEMA: Normochromic, normocytic anemia; thrombocytopenia; leukopenia; agranulocytosis; eosinophilia; leukocytosis. META: Increased ALT and AST; bilirubinemia. RESP: Respiratory failure; dyspena; respiratory disorder; increased cough; epistaxis; hypoxia; lung disorder; pleural effusion; rhinitis. OTHER: Fever (sometimes with shaking chills); malaise; generalized pain, including muscle and joint pain; venous pain at injection site with phlebitis and thrombophlebitis; weight loss; anaphylactoid reactions; sepsis.

Drug Mode of Action ::  

 Action Alters fungal cell membrane permeability.

Drug Interactions ::

 Interactions

Corticosteroids: Increased potential for hypokalemia. Cyclosporine: May increase nephrotoxic effects. Nephrotoxic agents (eg, aminoglycosides): Possible synergistic nephrotoxicity. INCOMPATIBILITIES: Do not mix with other IV medications.

Drug Assesment ::

 Assessment/Interventions

  • Obtain patient history, including drug history and any allergies.
  • Ensure that fungal culture (blood or urine, as appropriate) of organism has been obtained before beginning therapy.
  • Monitor pulse and BP every 15 min during test dose.
  • Monitor IV injection site closely during administration for signs of infiltration.
  • Monitor laboratory values, including liver function tests, CBC, renal function tests, and magnesium levels during therapy.
  • Monitor I&O during therapy.
  • Monitor temperature 4 hr after administration; may be elevated.
  • Assess for symptoms of hypokalemia, especially disorientation and weakness.
  • If the patient experiences infusion-related symptoms (eg, chills, fever, hypotension, joint pain), a nonsteroidal anti-inflammatory drug, corticosteroid, or other antipyretic may be given before administering drug. Administration of heparin, rapid infusion, removal of needle after infusion, rotation of infusion sites, and administration through large central vein or distal vein may lessen incidence of thrombophlebitis.
  • If severe side effects or signs of anaphylactic reaction occur, stop infusion and notify physician.
OVERDOSAGE: SIGNS & SYMPTOMS
  Cardiorespiratory arrest

Drug Storage/Management ::

 Administration/Storage

Amphotericin B deoxycholate

  • Administer IV infusion only in acute care setting under close supervision. Test dose is usually given before administering first therapeutic dose.
  • Follow manufacturer’s instructions for reconstitution and administration. Use Sterile Water for Injection without a bacteriostatic agent. Do not reconstitute with saline. Preservatives, bacteriostatic agents, and saline may cause precipitation.
  • Use solutions prepared for IV infusion promptly after reconstitution.
  • Use aseptic technique while handling medication.
  • Wear gloves while applying topical ointments.
  • Use volumetric IV pump to regulate delivery over the recommended 6-hr period. Shorter infusion times have also been used.
  • Use IV filter (³ 1 micron) during administration.
  • Agitate hanging solution to mix every 30 to 60 min.
  • Do not mix with other IV medications.
  • Do not administer if solution is discolored or if precipitate is present.
  • Medication is stable for 24 hr at room temperature or 7 days if kept refrigerated.
  • Store in dark area. Protect from light during administration.
  • Do not exceed a total daily dose of 1.5 mg/kg.

Liposomal amphotericin B

  • Administer IV at a rate of 2.5 mg/kg/hr. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hr.
  • Follow manufacturer’s instructions for reconstitution and administration. Use 5% Dextrose Injection for reconstitution. Do not reconstitute with other drugs or electrolytes as compatibility of liposomal amphotericin B has not been established. Flush an existing IV line with 5% Dextrose Injection before infusion of liposomal amphotericin B, or use a separate infusion line.
  • Shake the vial gently until there is no yellow sediment at the bottom.
  • Do not use an in-line filter < 5 microns.
  • Do not freeze. Retain in the carton until time of use.
  • May be stored for 15 hr if refrigerated or 6 hr at room temperature.
  • Discard any unused material.

Amphotericin B cholesteryl

  • Administer diluted in 5% Dextrose for Injection by IV infusion rate of 1 mg/kg/hr.
  • Test dose is usually given before administering first therapeutic dose.
  • Follow manufacturer’s instructions for reconstitution and administration. Reconstitute by using Sterile Water for Injection. Do not reconstitute with saline or dextrose solutions or admix with saline or electrolytes.
  • Do not filter or use an in-line filter.
  • Do not mix with other IV medications.
  • Use within 24 hr after reconstitution.
  • Store unopened vials at room temperature.
  • Refrigerate after reconstitution.

Drug Notes ::

 Patient/Family Education

  • Explain need for prolonged therapy and for close monitoring during course of therapy.
  • Encourage patient to increase fluid intake to 2000 to 3000 mL/day, if allowed.
  • Inform patient to report any discomfort at injection site immediately.
  • Instruct patient to report symptoms of chills, malaise, or fever.
  • Warn patient that contact with topical preparation can cause discoloration of fabrics. However, this is easily removed by washing with soap and water or applying common stain removers.

Disclaimer ::

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