Medication Guide App

Paromomycin Sulfate

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

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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 Spectrum

  • 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.

Paromomycin Sulfate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

250 mg (of paromomycin)

Paromomycin Sulfate Capsules

Caraco

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions August 1, 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]

108. Zierdt CH, Swan JC. In vitro response of Blastocystis hominis to antiprotozoal drugs. J Protozool. 1983; 30:332-4. [PubMed 6631776]

110. Anon. Drugs for parasitic infections. Med Lett Drugs Ther. Aug 2004. From the Medical Letter website ().

111. Clezy K, Gold F, Blaze F et al. Paromomycin for the treatment of cryptosporidial diarrhoea in AIDS patients. AIDS. 1991; 5:1146-7. [PubMed 1930784]

112. Fichtenbaum CJ, Ritchie DJ. Use of paromomycin for treatment of cryptosporidiosis in patients with AIDS. Clin Infect Dis. 1993; 16:298-300. [IDIS 308997] [PubMed 8443313]

113. Armitage K, Flanigan T, Carey J et al. Treatment of cryptosporidiosis with paromomycin: a report of five cases. Arch Intern Med. 1992; 152:2497-9. [IDIS 306602] [PubMed 1456862]

114. Chen XM, Keithly JS, Paya CV et al. Cryptosporidiosis. N Engl J Med. 2002; 346:1723-31. [PubMed 12037153]

115. White AC, Chappell CL, Hayate CS et al. Paromomycin for cryptosporidiosis in AIDS: a prospective double-blind trial. J Infect Dis. 1994; 170:419-24. [IDIS 335902] [PubMed 8035029]

116. Ravdin JI. Amebiasis. Clin Infect Dis. 1995; 20:1453-66. [IDIS 349015] [PubMed 7548493]

117. Aucott JN. Amebiasis and “nonpathogenic” intestinal protozoa. Infect Dis Clin North Am. 1993; 7:67-85.

118. Reed SL. Amebiasis: an update. Clin Infect Dis. 1992; 14:385-93. [IDIS 292053] [PubMed 1554822]

119. Hill DR. Giardiasis: issues in diagnosis and management. Infect Dis Clin North Am. 1993; 7:503-25. [PubMed 8254157]

120. Smith NH, Cron S, Valdez LM et al. Combination drug therapy for cryptosporidiosis in AIDS. J Infect Dis. 1998; 178:900-3. [IDIS 413483] [PubMed 9728569]

121. Berman JD. Human leishmaniasis: clinical, diagnostic, and chemotherapeutic developments in the last 10 years. Clin Infect Dis. 1997; 24:684-703. [IDIS 384365] [PubMed 9145744]

122. Caraco Pharmaceutical Laboratories. Paromomycin sulfate capsules, USP prescribing information. Detroit, MI; 1997 Mar.

123. Blei AT, Cordoba J, the Practice Parameters Committee of the American College of Gastroenterology. Hepatic encephalopathy. Am J Gastroenterol. 2001; 96:1968-76. [PubMed 11467622]

124. Chung TR, Podolsky DK. Cirrhosis and its complications. In: Harrison’s principles of internal medicine. 16th ed. Kasper DL, Braunwald E, Fauci AS et al, eds. New York: McGraw-Hill; 2007.

125. Robertson J, Shilkofski N, eds. The Harriet Lane handbook: a manual for pediatric house officers. 17th ed. Philadelphia, PA: Elsevier Mosby: 2005:916-7.

126. Chen XM, Keithly JS, Paya CV et al. Cryptosporidiosis. N Engl J Med. 2002; 346:1723-31. [PubMed 12037153]

127. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-infected adults and adolescents: recommendations from CDC, the National Institutes of Health, and the HIV Medicine Association/Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-15):1-112.

128. Centers for Disease Control and Prevention. Treating opportunistic infections among HIV-exposed and infected children: recommendations from CDC, the National Institutes of Health, and the Infectious Diseases Society of America. MMWR Recomm Rep. 2004; 53(RR-14):1-92.

129. Murray HW, Berman JD, Davies CR et al. Advances in leishmaniasis. Lancet. 2005; 366:1561-77. [PubMed 16257344]

130. Sundar S, Jha TK, Thakur CP et al. Injectable paromomycin for visceral leishmaniasis in India. N Engl J Med. 2007; 356:2571-81. [PubMed 17582067]

a. AHFS drug information 2008. McEvoy GK, ed. Paromomycin. Bethesda, MD: American Society of Health-System Pharmacists; 2008:850-1.

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