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Paromomycin Drug Information Provided by Lexi-Comp

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Pronunciation

(par oh moe MYE sin)

Generic Available (U.S.)

Yes

Index Terms

  • Paromomycin Sulfate

Brand Names: Canada

  • Humatin®

Pharmacologic Category

  • Amebicide

Use: Labeled Indications

Treatment of acute and chronic intestinal amebiasis; hepatic coma

Use: Unlabeled/Investigational

Treatment of cryptosporidiosis

Pregnancy Considerations

Paromomycin is poorly absorbed when given orally. Because it does not reach the maternal serum, it would not be expected to adversely affect the fetus. No adverse effects were observed in two infants whose mothers took paromomycin during pregnancy.

Breast-Feeding Considerations

Paromomycin is poorly absorbed when given orally. Because it does not reach the maternal serum, it would not be expected to distribute into human milk.

Contraindications

Hypersensitivity to paromomycin or any component of the formulation; intestinal obstruction

Warnings/Precautions

Concerns related to adverse effects:

• Superinfection: Prolonged use may result in fungal or bacterial superinfection, including C. difficile-associated diarrhea (CDAD) and pseudomembranous colitis; CDAD has been observed >2 months postantibiotic treatment.

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment.

• Ulcerative bowel lesions: Use with caution in patients with possible or proven ulcerative bowel lesions.

Adverse Reactions

1% to 10%: Gastrointestinal: Diarrhea, abdominal cramps, nausea, vomiting, heartburn

<1%: Headache, vertigo, exanthema, rash, pruritus, steatorrhea, secondary enterocolitis, eosinophilia, ototoxicity

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Ethanol/Nutrition/Herb Interactions

Food: Paromomycin may cause malabsorption of xylose, sucrose, and fats.

Mechanism of Action

Acts directly on ameba; has antibacterial activity against normal and pathogenic organisms in the GI tract; interferes with bacterial protein synthesis by binding to 30S ribosomal subunits

Pharmacodynamics/Kinetics

Absorption: Poor oral absorption

Excretion: Feces (100% as unchanged drug)

Dosage

Oral:

Intestinal amebiasis: Children and Adults: 25-35 mg/kg/day in 3 divided doses for 5-10 days

Dientamoeba fragilis: Children and Adults: 25-30 mg/kg/day in 3 divided doses for 7 days

Cryptosporidium (unlabeled use): Adults with AIDS: 1.5-2.25 g/day in 3-6 divided doses for 10-14 days (occasionally courses of up to 4-8 weeks may be needed)

Tapeworm (fish, dog, bovine, porcine):

Children: 11 mg/kg every 15 minutes for 4 doses

Adults: 1 g every 15 minutes for 4 doses

Hepatic coma: Adults: 4 g/day in 2-4 divided doses for 5-6 days

Dwarf tapeworm: Children and Adults: 45 mg/kg/dose every day for 5-7 days

Dental Health: Effects on Dental Treatment

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions

No information available to require special precautions

Mental Health: Effects on Mental Status

May cause dizziness

Mental Health: Effects on Psychiatric Treatment

None reported

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, oral: 250 mg

References

Danziger LH, Kanyok TP, and Novak RM, “Treatment of Cryptosporidial Diarrhea in an AIDS Patient With Paromomycin,” Ann Pharmacother, 1993, 27(12):1460-2.

“Drugs for Parasitic Infections,” Med Lett Drugs Ther, 1998, 40(1017):1-12.

Liu LX and Weller PF, “Antiparasitic Drugs,” N Engl J Med, 1996, 334(18):1178-84.

International Brand Names

  • Aminosidine (JP)
  • Gabbroral (BE, IT, LU)
  • Gabbryl (ID)
  • Gabrosidina (DO, GT, HN, NI, SV)
  • Humagel (FR)
  • Humatin (AT, CH, DE, ES, IT)

Lexi-Comp.com

Last full review/revision October 2011

Content last modified October 2011

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