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Paromomycin

Medically reviewed by Drugs.com. Last updated on Aug 8, 2020.

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.

Off Label Uses

Cryptosporidiosis-associated diarrhea in patients with HIV

Based on the US Department of Health and Human Services (HHS) guidelines for prevention and treatment of opportunistic infections in adults and adolescents with HIV, paromomycin is effective and recommended in the management of diarrhea caused by Cryptosporidium in patients with HIV (must be used in combination with optimized antiretroviral therapy, electrolyte replacement, symptomatic treatment, and rehydration).

Dientamoeba fragilis infection

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.

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 patients with HIV (off-label use): Oral: 500 mg 4 times daily for 14 to 21 days (must be used in conjunction with optimized antiretroviral therapy, electrolyte replacement, symptomatic treatment, and rehydration) (HHS [OI adult 2020])

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

Cryptosporidiosis, immunocompromised or nutritionally deficient patients (alternative therapy): Limited data available:

Infants, Children, and Adolescents: Oral: 25 to 35 mg/kg/day in 2 to 4 divided doses for 14 days as monotherapy or in combination with azithromycin; longer durations (>14 days) may be needed in solid organ transplant patients (Bradley 2019; Hong 2007; Hussein 2013; Trad 2003). Note: Usual adult dose: 500 mg 4 times daily (HHS [adult OI 2020]).

HIV-infected: Adolescents: Oral: 500 mg 4 times daily for 14 to 21 days in combination with optimized antiretroviral therapy, symptomatic treatment, rehydration, and electrolyte replacement (HHS [adult OI 2020]). Note: Efficacy data variable; paromomycin is not recommended for infants or children with HIV based on insufficient data (HHS [pediatric OI 2019; adult OI 2020]).

Cutaneous Leishmaniasis, simple cutaneous: Limited data available (IDSA/ASTMH [Aronson 2016]):

Note: Topical preparations are not commercially available in the US; extemporaneous preparations may be available from compounding pharmacies. Formulations are not equivalent and should not be substituted for each other; efficacy is dependent upon formulation/compounding vehicle used (IDSA/ASTMH [Aronson 2016]).

Ointment, paromomycin 15% with methylbenzethonium chloride (MBCL) 12%: Children and Adolescents: Topical: Apply ointment twice daily for 10 days, rest for 10 days (do not apply), then repeat twice daily application for 10 days.

Cream, paromomycin 15% with gentamicin 0.5% : Children and Adolescents: Topical: Apply cream once daily for 20 days.

Dientamoeba fragilis infection: Limited data available: Infants, Children, and Adolescents: Oral: 25 to 35 mg/kg/day in divided doses 3 times daily for 7 days (Red Book [AAP 2018]; Vandenberg 2007).

Giardiasis (alternative therapy): Limited data available: Infants, Children, and Adolescents: Oral: 25 to 30 mg/kg/day in divided doses 3 times daily for 5 to 10 days; maximum daily dose: 1,500 mg/day (Bradley 2019; Gardner 2001).

Intestinal amebiasis (Entamoeba histolytica): Infants, Children, and Adolescents: Oral: 25 to 35 mg/kg/day in divided doses 3 times daily for 5 to 10 days; usual duration 7 days (Red Book [AAP 2018]).

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 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

What is this drug used for?

• It is used to treat a type of bowel infection.

• It is used to lower the signs of hepatic coma.

• It may be given to you for other reasons. Talk with the doctor.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nausea

• Abdominal cramps

• Diarrhea

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.

Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.