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Paromomycin

Pronunciation

(par oh moe MYE sin)

Index Terms

  • Paromomycin Sulfate

Dosage Forms

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

Capsule, Oral:

Generic: 250 mg

Pharmacologic Category

  • Amebicide

Pharmacology

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

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: Unlabeled

Treatment of cryptosporidiosis, dientamoeba fragilis

Contraindications

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

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 2015])

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 (acute and chronic): Children and Adolescents: Refer to adult dosing.

Cryptosporidiosis-associated diarrhea in HIV-infected patients (off-label use): Adolescents: Refer to adult dosing.

Dientamoeba fragilis (off-label use): Children and Adolescents: Oral: 25-35 mg/kg/day in 3 divided doses for 7 days (CDC 2012; Vandenberg 2006)

Dosing: Renal Impairment

No dosage adjustment provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment

No dosage adjustment provided in the manufacturer’s labeling (has not been studied).

Administration

Administer orally 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: Diarrhea, abdominal cramps, nausea, vomiting, heartburn

<1% (Limited to important or life-threatening): Enterocolitis (secondary), eosinophilia, ototoxicity, pruritus, rash, steatorrhea

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 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.

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