Drug ID: 1d00000099
Drug Name: Amphotericin B
Generic Names: Phoricin | Amfocan | Fungitericin | Amfotex | Amphotret | Fungizone Intravenous | Ampholip | Mycol | Fungizone I. V. | Ampholip 10 | Fungsome (50 mg) | Fungisome Gel | Clamox 1.2 gm | Fungisome | Fungisome (25 mg) | Amfocare | Amphocil (100 mg) | Ampholip 20 | Talsutin Vaginal | Amphocil | Amphotec | Amphocil | Fungilin | Abelcet | AmBisome | Fungisome
Legal Status: Non Opioid Prescription only drug
Indication for Mother: Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.
Recommended Dose: Following a test dose, treatment is started with an IV dose of 0.3 mg/kg/day injected slowly. Usual dose 0.7 mg/kg. Dose in fungal meningeal infections - 0.5 mg twice weekly administered intrathecally. Since the lipid amphotericin B formulation have lower side effects, they may be administered in higher doses.
Recommended In: This medication is an antibiotic, prescribed for life-threatening fungal infections. It is also effective in treating leishmaniasis. Newer preparations of this medication with lipid are now available which show lesser side effects than the older preparations.
Directions For Use: It comes as a fluid for IV injection, administered by infusion into the vein by a health care professional once a day. It may be administered orally for fungal infection of the intestines or as eardrops for fungal infection of the ears.
Storage: Intrathecal: Store at 2-8°C. Protect from light and do not freeze it. IV: Store it in refrigerator and protect from light and do not freeze it.
Dosage Forms: Intravenous injection | Intrathecal injection | Ear drops
Side Effects: Heart- Inflammation of vein, high or low blood pressure, abnormal heart rate and rhythm, chest pain, cardiac arrest, dilatation of blood vessels, bleeding, heart valve disease, heart failure, heart attack and fast breathing.
Central Nervous System- Headache, sleeplessness, anxiety, weakness, confusion, dizziness, abnormal thinking, agitation, coma, convulsions, depression, hallucinations, uneasiness, nervousness, tingling, drowsiness, tremor, increased tone of muscle, speech disorder, fainting, stroke, abnormal movements and peripheral nerve damage.
Skin- Rash, itching, sweating, hair loss, dry skin, herpes simplex, easy bruising, skin discoloration, skin ulcer, allergic reactions and flushing.
Eye and ENT- Inflammation of conjunctiva, dry eyes, bleeding in eyes, visual impairment inflammation of pharynx, visual disturbance and deafness or ringing in the ear.
Gastrointestinal - Vomiting, nausea, loss of appetite, diarrhea, constipation, anorexia, GI bleeding, dry mouth/nose, difficulty in swallowing, increased thirst, eructation, fecal incontinence, flatulence, piles, intestinal obstruction, inflammation of gums and tongue, mouth ulcer, rectal disorder, bloody diarrhea, cramping and abdomen pain.
Genitourinary- Blood in urine, kidney failure, abnormal kidney function, painful urination, urinary incontinence or retention, vaginal bleeding, albumin or glucose in urine, decreased urine, inability to concentrate urine, impotence and accumulation of acids.
Blood- Anemia, decrease in white blood cells, platelets, fluid overload, in some people increased level of white blood cells, increase in eosinophils and coagulation defects.
Liver- Increased liver enzymes, liver damage, hepatitis, jaundice and gall bladder inflammation.
Hypersensitivity- Allergic reactions and sometimes severe enough to cause death.
Local- Pain and inflammation at injection site and inflammation of vein.
Metabolic-Nutritional- Increase in blood sugar, blood volume, weight changes and electrolyte abnormalities.
Musculoskeletal- Bone, joint and muscle pain and weakness.
Respiratory- Difficulty in breathing, increased cough, nose bleed, stuffy nose, sinusitis, hiccup, lung disorder, respiratory failure, asthma, pneumonia and fluid collection in the lungs.
Miscellaneous- Flu–like symptoms, high fever, shaking chills, immunological reactions, organ damage, infections, complications due to the procedure and swelling of the face, headache, and generalized weakness.
In Case of Overdose: Amphotericin B overdoses can result in potentially fatal cardiac or cardiorespiratory arrest. If an overdose is suspected, discontinue therapy and monitor the patient's clinical status (e.g., cardiorespiratory, renal, and liver function, hematologic status, serum electrolytes) and administer supportive therapy, as required. Amphotericin B is not hemodialyzable.
Prior to reinstituting therapy, the patient's condition should be stabilized (including correction of electrolyte deficiencies, etc.).
Avoid If: Do not use this medication for less severe infections such as oral thrush (white spots in the mouth), vaginal yeast infections, throat infections (esophageal), nor for localized (not spread throughout the body) fungal infections in people with a normal white blood count.
Caution needed in patients receiving transfusions, or have ever had diabetes or kidney disease, pregnancy.
Breastfeeding is contraindicated in patients receiving treatment with liposomal Amphotericin B.
Monitor kidney and liver function changes.
Hypersensitivity, lactation, do not give to patients receiving antineoplastics (cancer drugs).
Drug Interaction: Antineoplastic agents: may enhance the potential for renal toxicity, bronchospasm and hypotension. Antineoplastic agents (e.g., nitrogen mustard, etc.) should be given concomitantly only with great caution.
Corticosteroids and Corticotropin (ACTH): may potentiate amphotericin B-induced hypokalemia which may predispose the patient to cardiac dysfunction. Avoid concomitant use unless necessary to control side effects of amphotericin B. If used concomitantly, closely monitor serum electrolytes and cardiac function.
Digitalis glycosides: amphotericin B-induced hypokalemia may potentiate digitalis toxicity. Serum potassium levels and cardiac function should be closely monitored and any deficit promptly corrected.
Flucytosine: while a synergistic relationship with amphotericin B has been reported, concomitant use may increase the toxicity of flucytosine by possibly increasing its cellular uptake and/or impairing its renal excretion.
Imidazoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.): in vitro and animal studies with the combination of amphotericin B and imidazoles suggest that imidazoles may induce fungal resistance to amphotericin B. Combination therapy should be administered with caution, especially in immunocompromised patients.
Other nephrotoxic medications: agents such as aminoglycosides, cyclosporine, and pentamidine may enhance the potential for drug-induced renal toxicity, and should be used concomitantly only with great caution. Intensive monitoring of renal function is recommended in patients requiring any combination of nephrotoxic medications.
Skeletal muscle relaxants: amphotericin B-induced hypokalemia may enhance the curariform effect of skeletal muscle relaxants (e.g., tubocurarine). Serum potassium levels should be monitored and deficiencies corrected.
Leukocyte transfusions: acute pulmonary toxicity has been reported in patients receiving intravenous amphotericin B and leukocyte transfusions.