Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Generic: 250 mg
Pharmacology
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
Pharmacokinetics/Pharmacodynamics
Absorption
Poor oral absorption
Excretion
Feces (~100% as unchanged drug)
Use: Labeled Indications
Intestinal amebiasis: Treatment of acute and chronic intestinal amebiasis (not effective for extraintestinal amebiasis).
Hepatic coma: Management (adjunctive) of hepatic coma.
Use: Off Label
Cryptosporidiosis-associated diarrhea in HIV-infected patientsyes
Based on the US Department of Health and Human Services (HHS) guidelines for prevention and treatment of opportunistic infections in HIV-infected adults and adolescents, paromomycin may be considered as an alternative agent in the management of diarrhea caused by Cryptosporidium in HIV-infected patients (must be used in combination with optimized ART, electrolyte replacement, and symptomatic treatment and rehydration).
Dientamoeba fragilis infectioncyes
Based on the Centers for Disease Control and Prevention: Parasites – Dientamoeba fragilis (resources for health professionals) guidelines, paromomycin given for the treatment of dientamoeba fragilis is effective and recommended for the management of this condition.
Contraindications
Hypersensitivity to paromomycin or any component of the formulation; intestinal obstruction
Documentation of allergenic cross-reactivity for aminoglycosides is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity cannot be ruled out with certainty.
Dosage and Administration
Dosing: Adult
Hepatic coma: Oral: 4 g daily in divided doses (at regular intervals) for 5 to 6 days
Intestinal amebiasis: Oral: 25 to 35 mg/kg/day in 3 divided doses for 5 to 10 days
Cryptosporidiosis-associated diarrhea in HIV-infected patients (off-label use): Oral: 500 mg 4 times daily for 14 to 21 days (must be used in conjunction with optimized ART, electrolyte replacement, and symptomatic treatment and rehydration) (HHS [OI adult 2019])
Dientamoeba fragilis (off-label use): Oral: 25 to 35 mg/kg/day in 3 divided doses for 7 days (CDC 2012)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Intestinal amebiasis (Entamoeba histolytica): Infants, Children, and Adolescents: Oral: 25 to 35 mg/kg/day divided every 8 hours for 5 to 10 days; usual duration 7 days (Red Book [AAP 2015])
Cryptosporidial diarrhea: Limited data available: Adolescents with HIV: Oral: 500 mg 4 times daily for 14 to 21 days in combination with optimized ART (DHHS [adult] 2015)
Dientamoeba fragilis infection: Limited data available: Infants, Children, and Adolescents: Oral: 25 to 35 mg/kg/day divided every 8 hours for 7 days (Red Book [AAP 2015]; Vandenberg 2007)
Administration
Oral: Administer with meals.
Storage
Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%: Gastrointestinal: Abdominal cramps, diarrhea, heartburn, nausea, vomiting
<1%, postmarketing, and/or case reports: Enterocolitis (secondary), eosinophilia, headache, ototoxicity, pruritus, steatorrhea, vertigo
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 ulcerative bowel lesions; may lead to renal toxicity due to inadvertent absorption.
Other warnings/precautions:
- Appropriate use: Use in the absence of proven (or strongly suspected) susceptible infection is unlikely to provide benefit and may increase the risk for drug-resistance.
Pregnancy
Pregnancy Considerations
Paromomycin is poorly absorbed when given orally. Information related to the use of paromomycin in pregnancy is limited (Kreutner 1981). Use may be considered for the treatment of giardiasis throughout pregnancy (Gardner 2001) or cryptosporidiosis after the first trimester (DHHS 2013) in pregnant women.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience nausea, abdominal cramps, or diarrhea (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
