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Amphotericin B

Updated on : March - 2012
Latest prescription information about Amphotericin B. Learn how to pronounce the drug’s name, its indications, dosage, how to take, when to take, when not to take, side effects, special precautions, its storage instructions and warnings if any when taken during pregnancy. Also listed are the International and Indian trade name(s) of the drug and its price list.
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Generic Name : Amphotericin B
Pronunciation : am- foe- TER- i- sin b
Therapeutic Classification : Antifungals
ICD Code : Y40.7
Trade Name(s): 
India- Ambisome Inj, Amfocan Vial, Amfotex Vial, Ampholip Inj, Amphotin Vial, Amphotin-Lip Vial, Amphotret Vial, Fungizone I.V. Vial, Mycol Vial, Phoricin Vial, Fungisome Gel.
International- Amphotec.
Why it is prescribed (Indications) : 
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.  
When it is not to be taken (Contraindications): 
Hypersensitivity, lactation, do not give to patients receiving antineoplastics (cancer drugs).

Pregnancy Category :

A B C D X
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.

Dosage & When it is to be taken : 
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.
How it should be taken : 
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.
Warnings and Precautions : 
*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.
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- These side effects occur when amphotericin is injected into the intrathecally. These include headache, sleeplessness, anxiety, weakness, confusion, dizziness, abnormal thinking, agitation, coma, convulsions, depression, hallucinations, uneasiness, nervousness, tingling, drowsiness, tremor, increased tone of muscle, speech disorder, 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, diarrhea, constipation, anorexia, GI bleeding, dry mouth/nose, difficulty in swallowing, 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 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, immunological reactions, organ damage, infections, complications due to the procedure and swelling of the face.
Other Precautions : 
* Monitor kidney and liver function changes.
Storage Conditions : 
Intrathecal: Store at 2-8°C. Protect from light and do not freeze it. IV: Store it in refrigerator, protect from light and do not freeze it.

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Reference  

  • Food and Drug Administration (FDA)
  • National Institutes of Health (NIH)
  • PubMed
  • CIMS
  • Indian Pharma Reference Guide 2012
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