Amphocin Side Effects

Generic Name: amphotericin b

Note: This page contains information about the side effects of amphotericin b. Some of the dosage forms included on this document may not apply to the brand name Amphocin.

Not all side effects for Amphocin may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to amphotericin b: injectable, powder for solution

In addition to its needed effects, some unwanted effects may be caused by amphotericin b (the active ingredient contained in Amphocin). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking amphotericin b:

More commonWith intravenous injection
  • Fever and chills
  • headache
  • increased or decreased urination
  • irregular heartbeat
  • muscle cramps or pain
  • nausea
  • pain at the place of injection
  • unusual tiredness or weakness
  • vomiting
Less common or rareWith intravenous injection
  • Blurred or double vision
  • convulsions (seizures)
  • numbness, tingling, pain, or weakness in hands or feet
  • shortness of breath, troubled breathing, wheezing, or tightness in chest
  • skin rash or itching
  • sore throat and fever
  • unusual bleeding or bruising
With spinal injection
  • Blurred vision or any change in vision
  • difficult urination
  • numbness, tingling, pain, or weakness

Some of the side effects that can occur with amphotericin b may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More commonWith intravenous injection
  • Diarrhea
  • headache
  • indigestion
  • loss of appetite
  • nausea or vomiting
  • stomach pain
Less commonWith spinal injection
  • Back, leg, or neck pain
  • dizziness or lightheadedness
  • headache
  • nausea or vomiting

For Healthcare Professionals

Applies to amphotericin b: compounding powder, compounding powder for reconstitution, intravenous powder for injection, oral suspension

General

General side effects have included reactions during infusions. These have included fevers, chills, and rigors in 50% of patients during intravenous administration. The intensity of these acute, infusion-related side effects usually decreased over time, were probably cytokine-mediated, and have been lessened by pretreatment with corticosteroids, nonsteroidal anti-inflammatory drugs, antihistamines, and meperidine.

Hydrocortisone 25 mg intravenously, just before or during amphotericin infusions, is usually an effective countermeasure against these side effects. In some cases, premedication with diphenhydramine hydrochloride 25 mg orally or intravenously is additionally effective.

Renal

Renal side effects have included decreased renal function, azotemia, hyposthenuria, renal tubular acidosis, and nephrocalcinosis. These symptoms usually improved with interruption of therapy. However, in those patients receiving larger amounts (over 5 g) of amphotericin B or receiving other nephrotoxic agents, some permanent impairment often occurred. Hypercalciuria, nephrotoxicity, elevations in BUN, and elevations in serum creatinine have been reported. Rare cases of renal tubular necrosis have also been reported.

Renal toxicity has been a common side effect of amphotericin B therapy and may be lessened by saline hydration, and is reversible upon temporary discontinuation of therapy. A typical regimen is the administration of 500 mL of normal saline infused prior to the amphotericin B infusion, with an additional 500 mL of normal saline infused just subsequent to the completion of a dose. Although no controlled trials have compared rapid and continuous infusions of amphotericin B, data from one controlled trial (n=80) showed a noticeable reduction in nephrotoxicity in the continuous infusion group. An amphotericin infusion rate of less than 0.08 mg/kg/hour appears to be a safe threshold associated with reduced renal impairment.

The need for hemodialysis due to amphotericin B induced nephrotoxicity appears to be greater in certain patient populations such as bone marrow transplant patients and patients whose creatinine levels exceed 2.5 mg/dL.

The hypercalciuria associated with amphotericin-induced distal renal tubular acidosis has resulted in nephrocalcinosis in rare cases.

Metabolic

Although data are limited, amiloride at a dosage of 5 mg 2 times a day may be beneficial in preventing amphotericin B induced hypokalemia and hypomagnesemia.

A 21-year-old man with beta-thalassemia experienced hypoparathyroidism after using intravenous amphotericin B for C albicans infection.

Metabolic side effects have included changes in electrolytes. Hypokalemia and hypomagnesemia have often accompanied amphotericin-induced nephrotoxicity, with up to 90% of patients requiring parenteral potassium replacement. In addition, hypothermia has been reported following intravenous administration. Hypocalcemia and hyperkalemia have been reported. Amphotericin B caused hypomagnesemia, which triggered hypoparathyroidism and hypocalcemia. All three abnormalities resolved after the drug was withdrawn. At least one case of hypoparathyroidism has also been reported.

Gastrointestinal

Gastrointestinal side effects have included nausea, emesis, diarrhea, dyspepsia, cramping, epigastric pain, and anorexia. These have been commonly associated with amphotericin infusions. Hemorrhagic gastroenteritis and melena have also been reported. Intraperitoneal amphotericin has caused severe peritoneal inflammation, which resulted in persistent abdominal discomfort and peritoneal leukocytosis.

Hematologic

Hematologic side effects have included reversible normocytic normochromic anemia. Agranulocytosis, coagulation defects, thrombocytopenia (rarely), leukopenia, eosinophilia, and leukocytosis have also been reported.

A decrease in hemoglobin concentration of up to 35% has been noted in many cases. Anemia may be more likely and more severe in patients with preexisting renal dysfunction since some patients with renal failure have suppression of erythrocyte production, low erythropoietin, and low hemoglobin levels.

Nervous system

Nervous system side effects have been reported rarely. Headaches have commonly been associated with amphotericin B infusions. Convulsions, hearing loss, tinnitus, transient vertigo, peripheral neuropathy, and encephalopathy have also been reported. Seizures, paresthesias, nerve palsies, micturition difficulties, and chemical meningitis have been associated with intrathecal amphotericin therapy.

Multiple episodes of seizures immediately following intravenous infusion of amphotericin B have been reported in a 46-year-old African-American man with AIDS. On rechallenge, the seizures recurred and the drugs therapy was changed.

Hypersensitivity

A 68-year-old male with organic brain syndrome precipitated by several strokes and who had an excision of a meningeoma experienced acute generalized exanthematous pustulosis coincident with amphotericin B therapy. He had been given amphotericin B suspension three weeks previously for oral candidosis. Upon hospitalization, amphotericin B was stopped. He was treated with corticosteroids, and the skin lesions improved dramatically. After a few days of therapy, he was discharged with near complete resolution of his skin lesions.

Hypersensitivity side effects have included bronchospasm, hypotension, and urticaria. Hypersensitivity pneumonitis and hypersensitivity myocarditis have been reported. At least one case of acute generalized exanthematous pustulosis has also been reported.

Cardiovascular

Cardiovascular side effects have been reported rarely. These have included hypotension, tachypnea, cardiac arrest, shock, cardiac failure, pulmonary edema, arrhythmia, including ventricular fibrillation, dyspnea, hypertension, and transient asystole. Thrombophlebitis has occurred in many patients because of the long duration of intravenous therapy usually required.

Thrombophlebitis may be decreased by frequent intravenous site rotation and decreasing the concentration of amphotericin in the infusate.

Musculoskeletal

Musculoskeletal side effects have included myalgias and arthralgias. These side effects have been commonly associated with amphotericin infusions.

Respiratory

Respiratory side effects have been reported rarely. Rare cases of acute respiratory deterioration, including adult respiratory syndrome and bronchiolitis obliterans, have been associated with amphotericin therapy. Dyspnea and hypoxemia associated with amphotericin therapy have been reported, especially when amphotericin is given with leukocyte transfusions.

Hepatic

Hepatic side effects have been reported rarely. These have included acute liver failure, hepatitis, and jaundice. Changes in liver function test results have included elevations of AST, ALT, GGT, bilirubin, and alkaline phosphatase.

Ocular

A rare case of blindness associated with amphotericin B therapy has been reported in a woman with lupus erythematosus and cryptococcal meningitis. Because cryptococcal meningitis may cause decreased visual acuity and optic atrophy, implication of amphotericin is difficult.

Ocular side effects have rarely included visual impairment and diplopia. At least one case of blindness has also been reported.

Local

Local side effects have included pain at the injection site with or without phlebitis or thrombophlebitis.

The administration of amphotericin B on alternate days may decrease phlebitis.

Dermatologic

Dermatologic side effects have included pruritus and maculopapular rash.

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