Abelcet

Name: Abelcet

Uses For Abelcet

Amphotericin B lipid complex is an antifungal medicine. It is used to help the body overcome serious infections caused by fungus.

This medicine is available only with your doctor's prescription.

Proper Use of Abelcet

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For injection dosage form:
    • For treatment of serious infection caused by fungus:
      • Adults and children—5 milligrams per kilogram (2.27 mg per pound) of body weight per day, injected slowly into a vein.

What do I need to tell my doctor BEFORE I take Abelcet?

  • If you have an allergy to amphotericin or any other part of Abelcet (amphotericin B (lipid complex)).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are receiving a transfusion of a certain kind of white blood cell (leukocyte).
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Abelcet with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Abelcet Dosage and Administration

The recommended daily dosage for adults and children is 5 mg/kg given as a single infusion. Abelcet® should be administered by intravenous infusion at a rate of 2.5 mg/kg/h. If the infusion time exceeds 2 hours, mix the contents by shaking the infusion bag every 2 hours.

Renal toxicity of Abelcet®, as measured by serum creatinine levels, has been shown to be dose dependent. Decisions about dose adjustments should be made only after taking into account the overall clinical condition of the patient.

Preparation of Admixture for Infusion: Shake the vial gently until there is no evidence of any yellow sediment at the bottom. Withdraw the appropriate dose of Abelcet® from the required number of vials into one or more sterile syringes using an 18-gauge needle. Remove the needle from each syringe filled with Abelcet® and replace with the 5-micron filter needle supplied with each vial. Each filter needle may be used to filter the contents of up to four 100 mg vials. Insert the filter needle of the syringe into an IV bag containing 5% Dextrose Injection USP, and empty the contents of the syringe into the bag. The final infusion concentration should be 1 mg/mL. For pediatric patients and patients with cardiovascular disease the drug may be diluted with 5% Dextrose Injection to a final infusion concentration of 2 mg/mL. Before infusion, shake the bag until the contents are thoroughly mixed. Do not use the admixture after dilution with 5% Dextrose Injection if there is any evidence of foreign matter. Vials are for single use. Unused material should be discarded. Aseptic technique must be strictly observed throughout handling of Abelcet®, since no bacteriostatic agent or preservative is present.

DO NOT DILUTE WITH SALINE SOLUTIONS OR MIX WITH OTHER DRUGS OR ELECTROLYTES as the compatibility of Abelcet® with these materials has not been established. An existing intravenous line should be flushed with 5% Dextrose Injection before infusion of Abelcet®, or a separate infusion line should be used. DO NOT USE AN IN-LINE FILTER.

The diluted ready-for-use admixture is stable for up to 48 hours at 2° to 8°C (36° to 46°F) and an additional 6 hours at room temperature.

For Healthcare Professionals

Applies to amphotericin b lipid complex: intravenous suspension

General

General side effects during infusions have included fever (15%), chills (15%), and shivering. These symptoms usually begin 1 to 2 hours after the beginning of an amphotericin B lipid complex infusion, and are more common with the first few doses administered.

Severe infusion-related side effects have been associated with conventional amphotericin B administration, and may be lessened by treatment with corticosteroids, acetaminophen, antihistamines, and meperidine.[Ref]

Renal

Renal side effects have been reported less frequently with amphotericin B lipid complex than with conventional amphotericin B, and often included increased serum creatinine and BUN. Renal failure occurred in about 5% of treated patients. Decreased renal function, including oliguria, anuria, and renal tubular acidosis have also been reported.[Ref]

Metabolic

Metabolic side effects have occurred less frequently with amphotericin B lipid complex than with conventional amphotericin B. Hypokalemia and hypomagnesemia often accompany amphotericin-induced nephrotoxicity. Hypocalcemia has also been reported in treated patients.[Ref]

Gastrointestinal

Gastrointestinal (GI) side effects, including nausea, vomiting, or diarrhea in 5% to 8% of patients, have been associated with amphotericin B lipid complex infusions. GI hemorrhage, abdominal pain, anorexia, dyspepsia, epigastric pain, cramping, malaise, and weight loss have occurred less frequently.[Ref]

Hematologic

Hematologic side effects have included thrombocytopenia, leukopenia, anemia, and less frequently, coagulation defects, blood dyscrasias, and leukocytosis.[Ref]

Nervous system

Nervous system side effects have been reported rarely, except for headache, which occurred in about 4% of treated patients. Less frequently, convulsions, peripheral neuropathy visual impairment, including diplopia, hearing loss, tinnitus, and transient vertigo have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects have been reported. These may present as bronchospasm, wheezing, or anaphylactoid reactions. Erythema multiforme has also been reported.[Ref]

Cardiovascular

Cardiovascular side effects including cardiac arrest and hypotension have been reported in 6% to 8% of treated patients. Hypertension, cardiac failure, cardiomyopathy, arrhythmias, and ventricular fibrillation have been uncommonly reported.[Ref]

Respiratory

Respiratory side effects including respiratory failure, dyspnea, pneumonia, or other respiratory disorders have been reported in treated patients.[Ref]

Dermatologic

Dermatologic side effects have included maculopapular rash, pruritus, and exfoliative dermatitis. Exanthema has been reported in a patient who was treated concomitantly with amphotericin B lipid complex and imipenem-cilastatin. The exact cause is unknown.[Ref]

Local

Local side effects including thrombophlebitis and inflammation at the injection site have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including generalized bone, joint, or muscle pain have been reported.[Ref]

Hepatic

Hepatic side effects have been uncommonly reported. These have included liver failure, jaundice, hepatitis, and increased AST, ALT, and alkaline phosphatase levels.[Ref]

Genitourinary

Genitourinary side effects have rarely included impotence.[Ref]

Some side effects of Abelcet may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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