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
Introduction
Antibacterial and antiprotozoal; aminoglycoside antibiotic obtained from cultures of Streptomyces rimosus var. paromomycinus.122 a
Uses for Paromomycin Sulfate
Amebiasis
Treatment of acute and chronic intestinal amebiasis caused by Entamoeba histolytica.100 110 116 117 118 122
Treatment of asymptomatic cyst passers (intraluminal infections), especially in children and pregnant women.100 110 116 117 118
Not effective for and should not be used alone for treatment of extraintestinal amebiasis (including amebic liver abscess) caused by E. histolytica.117 122 Used to eradicate encysted E. histolytica in the intestinal lumen as follow-up after treatment with a tissue amebicide (metronidazole or tinidazole).100 110
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.100 110 116 117 118
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).100 110 116 117 118
Some strains of Entamoeba are nonpathogenic (e.g., E. dispar, E. hartmanni) and asymptomatic intraluminal infections with these organisms generally do not require treatment.100 116 117 118
Balantidiasis
Has been used for treatment of balantidiasis† caused by Balantidium coli.a
Not a drug of choice.100 110 Tetracycline is the drug of choice and metronidazole and iodoquinol are alternatives for treatment of balantidiasis.100 110
Cestode (Tapeworm) Infections
Has been used for treatment of cestodiasis (tapeworm infection) caused by certain cestodes 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).a
Not a drug of choice.110 Praziquantel, niclosamide (not commercially available in the US), and nitazoxanide usually recommended for treatment of these tapeworm infections.110
Cryptosporidiosis
Treatment of cryptosporidiosis† caused by Cryptosporidium parvum in patients with HIV infection; used alone or in conjunction with azithromycin.100 111 115 120 126 127 128
No anti-infective has been found to reliably eradicate Cryptosporidium, although several drugs (e.g., paromomycin, azithromycin, nitazoxanide) appear to suppress the infection.114 126 127 128
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.126 127 128
Dientamoeba fragilis Infections
Treatment of infections caused by Dientamoeba fragilis†.110
Iodoquinol, paromomycin, tetracycline, or metronidazole are drugs of choice for treatment of D. fragilis infections.110
Giardiasis
Treatment of giardiasis† caused by Giardia duodenalis (also known as G. lamblia or G. intestinalis).100 110 119
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).100 110
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.100 110 119
Hepatic Encephalopathy
Has been used in the management of hepatic coma as an adjunct122 to protein restriction and supportive therapy to inhibit nitrogen-forming bacteria in the GI tract.a
Not a preferred or alternative treatment; nonabsorbable disaccharides (lactulose) or certain other anti-infectives (neomycin or metronidazole) usually recommended.123 124 a
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.103 104 105 106 110 121 129
Has been used IM† for treatment of visceral leishmaniasis (kala azar) caused by L. donovani.121 129 130
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;110 121 129 topical† paromomycin or IM or IV pentamidine are alternatives.110 121
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;110 121 129 130 IM or IV pentamidine or IM† paromomycin are alternatives.110
Topical† paromomycin should be used only in geographic regions where cutaneous Leishmania species have low potential for mucosal spread.110 Topical treatment cannot cure lymph node infection or protect against mucosal disease if metastasis has already started.121
Paromomycin Sulfate Dosage and Administration
Administration
Oral Administration
Administer orally with a meal.122
Topical Administration
Has been administered topically† for treatment of cutaneous leishmaniasis† as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum.103 104 105 106 110 A topical preparation is not commercially available in the US.
IM Administration
Has been administered IM† for treatment of visceral leishmaniasis (kala azar)†.129 130 A parenteral preparation is not commercially available in the US.
Dosage
Available as paromomycin sulfate; dosage expressed in terms of paromomycin.122
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).110 122
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).110 122 Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).100 110
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.125 a
Hymenolepis nana† (Dwarf Tapeworm) Infections.
Oral
45 mg/kg daily, given as a single daily dose, for 5–7 days.125 a
Cryptosporidiosis†
Oral
25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected children or adolescents.127 128 Maximum dosage is 500 mg 4 times daily in children.128
Dientamoeba fragilis Infections†
Oral
25–35 mg/kg daily, in 3 divided doses, given for 7 days.110
Giardiasis†
Oral
25–35 mg/kg daily, in 3 divided doses, given for 7 days.110
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.103 104 105 106 110 121
If effective, clinical healing of lesions usually is complete within several weeks to a month after topical† paromomycin treatment is completed.103 104 105
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.103
Visceral Leishmaniasis (Kala Azar)†
IM†
11–20 mg/kg daily for 10–21 days.121 129 130
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).110 122
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).110 122 Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).100 110
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.a
Hymenolepis nana† (Dwarf Tapeworm) Infections.
Oral
45 mg/kg daily, given as a single daily dose, for 5–7 days.a
Cryptosporidiosis†
Oral
25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected adults.127
1.5–2.25 g daily, in 3–6 divided doses, given for 10–14 days has been used.111 112 113 Occasionally, more prolonged therapy (e.g., 4–8 weeks) may be necessary.111
Dientamoeba fragilis Infections†
Oral
25–35 mg/kg daily, in 3 divided doses, given for 7 days.110
Giardiasis†
Oral
25–35 mg/kg daily, in 3 divided doses, given for 7 days.110
Hepatic Encephalopathy
Adjunct in the Management of Hepatic Coma
Oral
4 g daily in divided doses given for 5–6 days.122
Leishmaniasis†
Cutaneous Leishmaniasis†
Topical†
Apply topically† (as a preparation containing paromomycin 15% and methylbenzethonium chloride12% in white petrolatum) twice daily for 10–20 days.103 104 105 106 110 121
If effective, clinical healing of lesions usually is complete within several weeks to a month after topical† paromomycin treatment is completed.103 104 105
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.103
Visceral Leishmaniasis (Kala Azar)†
IM†
11–20 mg/kg daily for 10–21 days.121 129 130
Special Populations
No special population dosage recommendations at this time.
Cautions for Paromomycin Sulfate
Contraindications
Known hypersensitivity to the drug.122
Intestinal obstruction.122
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.a 130
Avoid high dosage or prolonged therapy.a
Use oral paromomycin with caution in patients with ulcerative intestinal lesions since inadvertent GI absorption of the drug may result in renal toxicity.122
Sensitivity Reactions
Tartrazine Sensitivity
Capsules may contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.122 Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.122
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.122 Secondary Staphylococcus enterocolitis may occur.a
Appropriate therapy should be instituted if superinfection occurs.122
Specific Populations
Pregnancy
Category C.125
Because oral paromomycin is minimally absorbed from the GI tract, it may be a drug of choice for treatment of amebiasis100 110 116 117 118 or giardiasis† in pregnant women.100 110
Lactation
No specific precautions in breast-feeding women.125
Common Adverse Effects
Oral: GI effects including anorexia,a nausea,122 vomiting,a epigastric burning and pain,a increased GI motility,a abdominal cramps,122 diarrhea,122 pruritus ani.a
Topical† (combined with topical methylbenzethonium chloride): Local reactions including burning,104 105 121 pruritus,121 erythema,129 pain,129 edema,129 blisters.121 129
IM†: Injection site pain, fever, elevated liver enzymes, reversible ototoxicity.130
Interactions for Paromomycin Sulfate
No formal drug interaction studies to date.a
Paromomycin Sulfate Pharmacokinetics
Absorption
Bioavailability
Poorly absorbed from the GI tract.122
Impaired GI motility or intestinal lesions or ulcerations may facilitate GI absorption.122 a
Rapidly absorbed following IM† injection (parenteral preparation not commercially available in the US); peak plasma concentrations attained within 1 hour.130
Elimination
Elimination Route
Almost 100% of an oral dose is eliminated unchanged in feces;122 a any absorbed drug is slowly excreted in urine.a
Special Populations
Impaired renal function: Accumulation can occur.a
Stability
Storage
Oral
Capsules
15–30°C; protect from moisture.122
Actions and SpectrumActions
Broad spectrum of activity;122 a active against bacteria, protozoa, and cestodes.a
Like other aminoglycosides, paromomycin is bactericidal and appears to inhibit protein synthesis in susceptible bacteria at the 30S segment of the ribosome.a
Has an antibacterial spectrum similar to that of neomycin.122 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.a Has some activity against Mycobacterium tuberculosis.a
A luminal or contact amebicide; acts principally in the intestinal lumen.a A direct-acting amebicide effective either in the presence or absence of bacteria.a
Active against Entamoeba histolytica;a believed to act against both the trophozoite and encysted forms of Entamoeba.a Limited in vitro studies indicate some activity against Acanthamoeba.101
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).a
Advice to Patients
Importance of taking with a meal.122
Importance of completing full course of treatment, even if feeling better after a few days.122
Importance of notifying clinician of persistent or worsening symptoms of infection.122
Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness.122
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.122
Importance of informing patients of other important precautionary information.122
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
---|---|---|---|---|
Oral | Capsules | 250 mg (of paromomycin) | Paromomycin Sulfate Capsules | Caraco |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
References
100. American Academy of Pediatrics. 2006 Red Book: Report of the Committee on Infectious Diseases. 27th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2006.
101. Samples JR, Binder PS, Luibel FJ et al. Acanthamoeba keratitis possibly acquired from a hot tub. Arch Ophthalmol. 1984; 102:707-10. [PubMed 6372764]
102. Caccio S, Pinter E, Fantini R et al. Human infection with Cryptosporidium felis: case report and literature review. Emerg Infect Dis. 2002; 8:85-6. [PubMed 11749756]
103. El-On J, Weinrauch L, Livshin R et al. Topical treatment of recurrent cutaneous leishmaniasis with ointment containing paromomycin and methylbenzethonium chloride. BMJ. 1985; 291:704-5. [IDIS 205687] [PubMed 3929905]
104. El-On J, Livshin R, Even Paz Z et al. Topical treatment of cutaneous leishmaniasis. BMJ. 1985; 291:1280-1.
105. El-On J, Livshin R, Even-Paz Z et al. Topical treatment of cutaneous leishmaniasis. J Invest Dermatol. 1986; 87:284-8. [IDIS 219637] [PubMed 3734476]
106. Weinrauch L, Katz M. Leishmania aethiopica: topical treatment with paromomycin and methylbenzethonium chloride ointment. J Am Acad Dermatol. 1987; 16:1268-70. [PubMed 3597872]
107. Hewitt RG, Yiannoutsos CT, Higgs ES et al. Paromomycin: no more effective than placebo for treatment of cryptosporidiosis in patients with advanced human immunodeficiency virus infection. Clin Infect Dis. 2000; 31:1084-92. [IDIS 456006] [PubMed 11049793]
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110. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter website ().
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a. AHFS drug information 2008. McEvoy GK, ed. Paromomycin. Bethesda, MD: American Society of Health-System Pharmacists; 2008:850-1.
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Compare Paromomycin Sulfate with other medications
- Amebiasis
- Cryptosporidiosis
- Dientamoeba fragilis
- Dog Tapeworm
- Fish Tapeworm Infection
- Giardiasis
- Hepatic Coma
- Hymenolepis nana, Dwarf Tapeworm
- Taenia saginata, beef tapeworm
- Taenia solium, pork tapeworm