DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

AMPHOTERICIN B

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Less-DIR concern

Severity Score:1

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

ADVERSE REACTIONS
Post-marketing Experience
The following infrequent adverse experiences have been reported in post-marketing surveillance, in addition to those mentioned above: angioedema, erythema, urticaria, bronchospasm, cyanosis/hypoventilation, pulmonary edema, agranulocytosis, hemorrhagic cystitis, and rhabdomyolysis.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

120

42792

Other ADRs

4241

14113038

Odds Ratio = 9.332

Drug Property Information

ATC Code(s):

J02AA01 - amphotericin b

J02AA - Antibiotics
J02A - ANTIMYCOTICS FOR SYSTEMIC USE
J02 - ANTIMYCOTICS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

A01AB04 - amphotericin b

A01AB - Antiinfectives and antiseptics for local oral treatment
A01A - STOMATOLOGICAL PREPARATIONS
A01 - STOMATOLOGICAL PREPARATIONS
A - ALIMENTARY TRACT AND METABOLISM

A07AA07 - amphotericin b

A07AA - Antibiotics
A07A - INTESTINAL ANTIINFECTIVES
A07 - "ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE "
A - ALIMENTARY TRACT AND METABOLISM

G01AA03 - amphotericin b

G01AA - Antibiotics
G01A - "ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS "
G01 - GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G - GENITO URINARY SYSTEM AND SEX HORMONES

Active Ingredient:amphotericin b

Active Ingredient UNII:7XU7A7DROE

Drugbank ID:DB00681

PubChem Compound:5280965

CAS Number:1397-89-3

Dosage Form(s):injection, powder, lyophilized, for solution

Route(s) Of Administrator:intravenous

Daily Dose:

40.0 mg/day A01AB04
400.0 mg/day A07AA07
200.0 mg/day G01AA03
35.0 mg/day J02AA01

Chemical Structure:

SMILE Code:
C[C@H]1/C=C/C=C/C=C/C=C/C=C/C=C/C=C/[C@@H](C[C@H]2[C@@H]([C@H](C[C@](O2)(C[C@H](C[C@H]([C@@H](CC[C@H](C[C@H](CC(=O)O[C@H]([C@@H]([C@@H]1O)C)C)O)O)O)O)O)O)O)C(=O)O)O[C@H]3[C@H]([C@H]([C@@H]([C@H](O3)C)O)N)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Hypokalaemia-induced rhabdomyolysis after treatment of post-Kala-azar dermal Leishmaniasis (PKDL) with high-dose AmBisome in Bangladesh-a case report.

[Marking Ulrika,den Boer Margriet,Das Asish Kumar,Ahmed Elshafie Mohamed,Rollason Victoria,Ahmed Be-Nazir,Davidson Robert N,Ritmeijer Koert]
PLoS Negl Trop Dis.2014 Jun 12;8(6):e2864. doi: 10.1371/journal.pntd.0002864. eCollection 2014 Jun. PMID: 24922279

2: Nephrotoxicity as a cause of acute kidney injury in children.

[Patzer Ludwig]
Pediatr Nephrol.2008 Dec;23(12):2159-73. doi: 10.1007/s00467-007-0721-x. Epub 2008 Jan 29. PMID: 18228043

3: Absidia Corymbifera in an immune competent accident victim with multiple abdominal injuries: case report.

[Belfiori Rita,Terenzi Adelmo,Marchesini Laura,Repetto Antonella]
BMC Infect Dis.2007 May 25;7:46. PMID: 17531089

4: Hypokalemic rhabdomyolysis in a child due to amphotericin B therapy.

[Lucas da Silva Paulo Sérgio,Iglesias Simone Brasil de Oliveira,Waisberg Jaques]
Eur J Pediatr.2007 Feb;166(2):169-71. Epub 2006 Aug 12. PMID: 16906399

5: Severe rhabdomyolysis, hyperthermia and shock after amphotericin B colloidal dispersion in an allogeneic bone marrow transplant recipient.

[Rossi M R,Longoni D V,Rovelli A M,Uderzo C]
Pediatr Infect Dis J.2000 Feb;19(2):172-3. PMID: 10694013

6: Disseminated zygomycosis due to Rhizopus schipperae after heatstroke.

[Anstead G M,Sutton D A,Thompson E H,Weitzman I,Otto R A,Ahuja S K]
J Clin Microbiol.1999 Aug;37(8):2656-62. PMID: 10405417

7: The mechanism of muscle injury in the crush syndrome: ischemic versus pressure-stretch myopathy.

[Better O S,Abassi Z,Rubinstein I,Marom S,Winaver Y,Silberman M]
Miner Electrolyte Metab.1990;16(4):181-4. PMID: 2277600

8: Hypokalemic rhabdomyolysis and myoglobinuria following amphotericin B therapy.

[Drutz D J,Fan J H,Tai T Y,Cheng J T,Hsieh W C]
JAMA.1970 Feb 2;211(5):824-6. PMID: 5536569

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