Paromomycin (Monograph)

Drug class: Amebicides
VA class: AP900
Chemical name: O-2,6-Diamino-2,6-dideoxy-β-L-idopyranosyl-(1-3)-O-β-D-ribofuranosyl(1-5)-O-[2-amino-2-deoxy-α-D-glucopyranosyl-(1-4)]-2-deoxystreptamine sulfate (salt)
Molecular formula: C₂₃H₄₅N₅O₁₄• xH₂SO₄
CAS number: 1263-89-4

Medically reviewed by Drugs.com on Jul 24, 2023. Written by ASHP.

Introduction

Antibacterial and antiprotozoal; aminoglycoside antibiotic obtained from cultures of Streptomyces rimosus var. paromomycinus.

Uses for Paromomycin

Amebiasis

Treatment of acute and chronic intestinal amebiasis caused by Entamoeba histolytica.

Treatment of asymptomatic cyst passers (intraluminal infections), especially in children and pregnant women.

Not effective for and should not be used alone for treatment of extraintestinal amebiasis (including amebic liver abscess) caused by E. histolytica. Used to eradicate encysted E. histolytica in the intestinal lumen as follow-up after treatment with a tissue amebicide (metronidazole or tinidazole).

Treatment of mild to moderate or severe symptomatic intestinal amebiasis or extraintestinal disease (including amebic liver abscess) involves the use of both a tissue and a luminal amebicide to ensure eradication of tissue-invading trophozoites as well as cysts in the intestinal lumen.

Regimen of choice for symptomatic intestinal amebiasis or extraintestinal disease (including liver abscess) is a nitroimidazole derivative (oral metronidazole or oral tinidazole) followed by a luminal amebicide (oral iodoquinol or oral paromomycin).

Some strains of Entamoeba are nonpathogenic (e.g., E. dispar, E. hartmanni) and asymptomatic intraluminal infections with these organisms generally do not require treatment.

Balantidiasis

Has been used for treatment of balantidiasis^{† [off-label]} caused by Balantidium coli.

Not a drug of choice. Tetracycline is the drug of choice and metronidazole and iodoquinol are alternatives for treatment of balantidiasis.

Cestode (Tapeworm) Infections

Has been used for treatment of cestodiasis (tapeworm infection) caused by certain cestodes pathogenic to humans including Diphyllobothrium latum^{† [off-label]} (fish tapeworm), Dipylidium caninum^{† [off-label]} (dog and cat tapeworm), Hymenolepis nana^{† [off-label]} (dwarf tapeworm), Taenia saginata^{† [off-label]} (beef tapeworm), and T. solium^† (pork tapeworm).

Not a drug of choice. Praziquantel, niclosamide (not commercially available in the US), and nitazoxanide usually recommended for treatment of these tapeworm infections.

Cryptosporidiosis

Treatment of cryptosporidiosis^† caused by Cryptosporidium parvum in patients with HIV infection; used alone or in conjunction with azithromycin.

No anti-infective has been found to reliably eradicate Cryptosporidium, although several drugs (e.g., paromomycin, azithromycin, nitazoxanide) appear to suppress the infection.

CDC, NIH, IDSA, and others state that the most appropriate treatment for cryptosporidiosis in HIV-infected individuals is the use of potent antiretroviral agents (to restore immune function) and symptomatic treatment of diarrhea.

Dientamoeba fragilis Infections

Treatment of infections caused by Dientamoeba fragilis^†.

Iodoquinol, paromomycin, tetracycline, or metronidazole are drugs of choice for treatment of D. fragilis infections.

Giardiasis

Treatment of giardiasis^† caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis).

Drugs of choice are metronidazole, tinidazole, or nitazoxanide; alternatives are paromomycin (especially in pregnant women), furazolidone (not commercially available in the US), or quinacrine (not commercially available in the US).

Although paromomycin may be less effective than the other agents, it is poorly absorbed from the GI tract and may be useful for treatment of giardiasis in pregnant women.

Hepatic Encephalopathy

Has been used in the management of hepatic coma as an adjunct to protein restriction and supportive therapy to inhibit nitrogen-forming bacteria in the GI tract.

Not a preferred or alternative treatment; nonabsorbable disaccharides (lactulose) or certain other anti-infectives (neomycin or metronidazole) usually recommended.

Leishmaniasis

Has been used topically^† (in conjunction with topical methylbenzethonium chloride) for treatment of cutaneous leishmaniasis^†, including infections caused by Leishmania major, L. braziliensis, and L. mexicana.

Has been used IM^† for treatment of visceral leishmaniasis (kala azar) caused by L. donovani.

For treatment of cutaneous leishmaniasis, pentavalent antimony compounds (IM or IV sodium stibogluconate or meglumine antimonate [drugs not commercially available in the US]) are drugs of choice; topical^† paromomycin or IM or IV pentamidine are alternatives.

For treatment of visceral leishmaniasis, pentavalent antimony compounds (e.g., IM or IV sodium stibogluconate or meglumine antimonate [drugs not commercially available in the US]) or IV amphotericin B (conventional or liposomal) are drugs of choice; IM or IV pentamidine or IM^† paromomycin are alternatives.

Topical^† paromomycin should be used only in geographic regions where cutaneous Leishmania species have low potential for mucosal spread. Topical treatment cannot cure lymph node infection or protect against mucosal disease if metastasis has already started.

Paromomycin Dosage and Administration

Administration

Oral Administration

Administer orally with a meal.

Topical Administration

Has been administered topically^† for treatment of cutaneous leishmaniasis^† as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum. A topical preparation is not commercially available in the US.

IM Administration

Has been administered IM^† for treatment of visceral leishmaniasis (kala azar)^†. A parenteral preparation is not commercially available in the US.

Dosage

Available as paromomycin sulfate; dosage expressed in terms of paromomycin.

Pediatric Patients

Amebiasis Caused by Entamoeba histolytica

Asymptomatic Cyst Passers (Intraluminal Infections)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).

Symptomatic Intestinal Amebiasis or Extraintestinal Disease (Including Amebic Liver Abscess)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days). Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).

Cestode (Tapeworm) Infections†

Diphyllobothrium latum† (Fish Tapeworm), Dipylidium caninum† (Dog and Cat Tapeworm), Taenia saginata† (Beef Tapeworm), or T. solium† (Pork Tapeworm) Infections

Oral

11 mg/kg every 15 minutes for 4 doses.

Hymenolepis nana† (Dwarf Tapeworm) Infections.

Oral

45 mg/kg daily, given as a single daily dose, for 5–7 days.

Cryptosporidiosis†

Oral

25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected children or adolescents. Maximum dosage is 500 mg 4 times daily in children.

Dientamoeba fragilis Infections†

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.

Giardiasis†

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.

Leishmaniasis†

Cutaneous Leishmaniasis†

Topical^†

Apply topically^† (as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum) twice daily for 10–20 days.

If effective, clinical healing of lesions usually is complete within several weeks to a month after topical^† paromomycin treatment is completed.

In patients with recurrent disease (leishmaniasis recidivans), more prolonged topical treatment (e.g., twice daily for about 3 months) may eliminate the protozoa from cutaneous lesions.

Visceral Leishmaniasis (Kala Azar)†

IM^†

11–20 mg/kg daily for 10–21 days.

Adults

Amebiasis Caused by Entamoeba histolytica

Asymptomatic Cyst Passers (Intraluminal Infections)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).

Symptomatic Intestinal Amebiasis or Extraintestinal Disease (Including Amebic Liver Abscess)

Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days). Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).

Cestode (Tapeworm) Infections†

Diphyllobothrium latum† (Fish Tapeworm), Dipylidium caninum† (Dog and Cat Tapeworm), Taenia saginata† (Beef Tapeworm), or T. solium† (Pork Tapeworm) Infections

Oral

11 mg/kg given every 15 minutes for 4 doses.

Hymenolepis nana† (Dwarf Tapeworm) Infections.

Oral

45 mg/kg daily, given as a single daily dose, for 5–7 days.

Cryptosporidiosis†

Oral

25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected adults.

1.5–2.25 g daily, in 3–6 divided doses, given for 10–14 days has been used. Occasionally, more prolonged therapy (e.g., 4–8 weeks) may be necessary.

Dientamoeba fragilis Infections†

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.

Giardiasis†

Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.

Hepatic Encephalopathy

Adjunct in the Management of Hepatic Coma

Oral

4 g daily in divided doses given for 5–6 days.

Leishmaniasis†

Cutaneous Leishmaniasis†

Topical^†

Apply topically^† (as a preparation containing paromomycin 15% and methylbenzethonium chloride12% in white petrolatum) twice daily for 10–20 days.

If effective, clinical healing of lesions usually is complete within several weeks to a month after topical^† paromomycin treatment is completed.

In patients with recurrent disease (leishmaniasis recidivans), more prolonged topical^† treatment (e.g., twice daily for about 3 months) may eliminate the protozoa from cutaneous lesions.

Visceral Leishmaniasis (Kala Azar)†

IM^†

11–20 mg/kg daily for 10–21 days.

Special Populations

No special population dosage recommendations at this time.

Cautions for Paromomycin

Contraindications

• Known hypersensitivity to the drug.

• Intestinal obstruction.

Warnings/Precautions

Warnings

Nephrotoxicity, Ototoxicity, Neuromuscular Blockade

Like other aminoglycosides, paromomycin has the potential to cause nephrotoxic, ototoxic, and probably neuromuscular blocking effects if absorbed systemically.

Avoid high dosage or prolonged therapy.

Use oral paromomycin with caution in patients with ulcerative intestinal lesions since inadvertent GI absorption of the drug may result in renal toxicity.

Sensitivity Reactions

Tartrazine Sensitivity

Capsules may contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals. Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.

General Precautions

Superinfection

As with other anti-infectives, use of paromomycin may result in overgrowth of nonsusceptible organisms, including fungi, and patients should be carefully monitored for development of new infections caused by nonsusceptible organisms. Secondary Staphylococcus enterocolitis may occur.

Appropriate therapy should be instituted if superinfection occurs.

Specific Populations

Pregnancy

Category C.

Because oral paromomycin is minimally absorbed from the GI tract, it may be a drug of choice for treatment of amebiasis or giardiasis^† in pregnant women.

Lactation

No specific precautions in breast-feeding women.

Common Adverse Effects

Oral: GI effects including anorexia, nausea, vomiting, epigastric burning and pain, increased GI motility, abdominal cramps, diarrhea, pruritus ani.

Topical^† (combined with topical methylbenzethonium chloride): Local reactions including burning, pruritus, erythema, pain, edema, blisters.

IM^†: Injection site pain, fever, elevated liver enzymes, reversible ototoxicity.

Drug Interactions

No formal drug interaction studies to date.

Paromomycin Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the GI tract.

Impaired GI motility or intestinal lesions or ulcerations may facilitate GI absorption.

Rapidly absorbed following IM^† injection (parenteral preparation not commercially available in the US); peak plasma concentrations attained within 1 hour.

Elimination

Elimination Route

Almost 100% of an oral dose is eliminated unchanged in feces; any absorbed drug is slowly excreted in urine.

Special Populations

Impaired renal function: Accumulation can occur.

Stability

Storage

Oral

Capsules

15–30°C; protect from moisture.

Actions and Spectrum

• Broad spectrum of activity; active against bacteria, protozoa, and cestodes.

• Like other aminoglycosides, paromomycin is bactericidal and appears to inhibit protein synthesis in susceptible bacteria at the 30S segment of the ribosome.

• Has an antibacterial spectrum similar to that of neomycin. Active against some gram-positive bacteria (e.g., some strains of Staphylococcus) and many gram-negative aerobic bacteria, but generally inactive against Pseudomonas aeruginosa and anaerobic bacteria. Has some activity against Mycobacterium tuberculosis.

• A luminal or contact amebicide; acts principally in the intestinal lumen. A direct-acting amebicide effective either in the presence or absence of bacteria.

• Active against Entamoeba histolytica; believed to act against both the trophozoite and encysted forms of Entamoeba. Limited in vitro studies indicate some activity against Acanthamoeba.

• Active against certain cestodes (tapeworms) pathogenic to humans including Diphyllobothrium latum (fish tapeworm), Dipylidium caninum (dog and cat tapeworm), Hymenolepis nana (dwarf tapeworm), Taenia saginata (beef tapeworm), and T. solium (pork tapeworm).

Advice to Patients

• Importance of taking with a meal.

• Importance of completing full course of treatment, even if feeling better after a few days.

• Importance of notifying clinician of persistent or worsening symptoms of infection.

• Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of informing patients of other important precautionary information.

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

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