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 recipients (Ref). Note: Usual adult dose: 500 mg 4 times daily (Ref).
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 (Ref). Note: Efficacy data variable; paromomycin is not recommended for infants or children with HIV based on insufficient data (Ref).
Cutaneous Leishmaniasis, simple cutaneous: Limited data available (Ref):
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 (Ref).
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 (Ref).
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 (Ref).
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 (Ref).
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, dosage adjustment is likely unnecessary due to low systemic absorption.
There are no dosage adjustments provided in the manufacturer's labeling (has not been studied); however, dosage adjustment is likely unnecessary due to low systemic absorption.
(For additional information see "Paromomycin: Drug information")
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) (Ref).
Dientamoeba fragilis (off-label use): Oral: 25 to 35 mg/kg/day in 3 divided doses for 7 days (Ref).
Trichomoniasis, refractory or resistant infection (off-label use):
Note: For patients with infection refractory to multiple prior regimens (Ref).
Intravaginal: 4 g (equivalent to 250 mg paromomycin) of an extemporaneously compounded 6.25% cream once daily at bedtime in combination with oral tinidazole for 14 days (Ref).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
1% to 10%: Gastrointestinal: Abdominal cramps, diarrhea, heartburn, nausea, vomiting
<1%, postmarketing, and/or case reports: Enterocolitis (secondary), eosinophilia, headache, ototoxicity, pruritus, steatorrhea, vertigo
Hypersensitivity to paromomycin or any component of the formulation; intestinal obstruction
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.
Topical paromomycin is not commercially available in the US; IDSA/ASTMH guidelines for diagnosis and treatment of leishmaniasis suggest collaboration with a compounding pharmacy.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral:
Humatin: 250 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]
Generic: 250 mg [DSC]
Yes
Capsules (Humatin Oral)
250 mg (per each): $145.87
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Humatin: 250 mg
6.25% intravaginal cream:
A 6.25% cream may be made with fourteen 250 mg capsules; open into a mortar and reduce to fine powder. Levigate powder with a hydrophilic cream base to form a smooth paste; add additional hydrophilic cream base for a total weight of 56 g. Blend until smooth; each dose is 250 mg per 4 g intravaginal applicator (Nyirjesy 1998).
Oral: Administer with meals.
Topical: Limited data available: Apply extemporaneously prepared cream or ointment to the affected areas (Ref).
Oral: Administer with meals.
Intravaginal (off-label route): Administer intravaginal cream at bedtime, using an appropriately sized intravaginal applicator to deliver the correct dose (Ref). Do not use tampons, douches, spermicides, or other vaginal products or have vaginal intercourse during treatment (Ref).
Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.
Treatment of acute and chronic intestinal amebiasis due to susceptible Entamoeba histolytica (FDA approved in pediatric patients [age not specified] and adults); adjunctive management of hepatic coma (FDA approved in adults); has also been used for the treatment of cryptosporidiosis, giardiasis, Dientamoeba fragilis infection, and topically for cutaneous leishmaniasis.
Note: Paromomycin is not effective in the treatment of extraintestinal amebiasis.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program
Aminoglycosides: May increase nephrotoxic effects of Aminoglycosides. Aminoglycosides may increase neurotoxic effects of Aminoglycosides. Risk X: Avoid
Amphotericin B: May increase nephrotoxic effects of Aminoglycosides. Amphotericin B may increase neurotoxic effects of Aminoglycosides. Risk C: Monitor
Ataluren: May increase adverse/toxic effects of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Risk X: Avoid
Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification
Bacitracin (Systemic): May increase nephrotoxic effects of Aminoglycosides. Bacitracin (Systemic) may increase neurotoxic effects of Aminoglycosides. Risk X: Avoid
Bisphosphonate Derivatives: Aminoglycosides may increase hypocalcemic effects of Bisphosphonate Derivatives. Aminoglycosides may increase nephrotoxic effects of Bisphosphonate Derivatives. Risk C: Monitor
Botulinum Toxin-Containing Products: Aminoglycosides may increase neuromuscular-blocking effects of Botulinum Toxin-Containing Products. Risk C: Monitor
Capreomycin: May increase neuromuscular-blocking effects of Aminoglycosides. Risk C: Monitor
CARBOplatin: Aminoglycosides may increase ototoxic effects of CARBOplatin. Especially with higher doses of carboplatin. CARBOplatin may increase nephrotoxic effects of Aminoglycosides. Risk C: Monitor
Cardiac Glycosides: Aminoglycosides may decrease serum concentration of Cardiac Glycosides. This effect has only been demonstrated with oral aminoglycoside administration. Risk C: Monitor
Cephalosporins: May increase nephrotoxic effects of Aminoglycosides. Cephalosporins may decrease serum concentration of Aminoglycosides. Risk C: Monitor
Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid
CISplatin: May increase nephrotoxic effects of Aminoglycosides. CISplatin may increase neurotoxic effects of Aminoglycosides. Risk X: Avoid
Colistimethate: Aminoglycosides may increase nephrotoxic effects of Colistimethate. Aminoglycosides may increase neuromuscular-blocking effects of Colistimethate. Management: Avoid coadministration of colistimethate and aminoglycosides whenever possible due to the risk of nephrotoxicity and neuromuscular blockade. If coadministration cannot be avoided, monitor renal and neuromuscular function. Risk D: Consider Therapy Modification
Cyclizine: May increase ototoxic effects of Aminoglycosides. Risk C: Monitor
CycloSPORINE (Systemic): Aminoglycosides may increase nephrotoxic effects of CycloSPORINE (Systemic). Risk C: Monitor
Distigmine: Aminoglycosides may decrease therapeutic effects of Distigmine. Risk C: Monitor
Fecal Microbiota (Live) (Oral): May decrease therapeutic effects of Antibiotics. Risk X: Avoid
Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid
Foscarnet: May increase nephrotoxic effects of Aminoglycosides. Management: Avoid concomitant use of foscarnet and aminoglycoside antibiotics, unless the expected benefits of combined treatment outweigh the risks. If combined, monitor renal function closely. Risk D: Consider Therapy Modification
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Loop Diuretics: May increase adverse/toxic effects of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Risk C: Monitor
Mannitol (Systemic): May increase nephrotoxic effects of Aminoglycosides. Risk X: Avoid
Mecamylamine: Aminoglycosides may increase neuromuscular-blocking effects of Mecamylamine. Risk X: Avoid
Methoxyflurane: Aminoglycosides may increase nephrotoxic effects of Methoxyflurane. Risk X: Avoid
Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor
Netilmicin (Ophthalmic): Aminoglycosides may increase nephrotoxic effects of Netilmicin (Ophthalmic). Risk X: Avoid
Neuromuscular-Blocking Agents: Aminoglycosides may increase therapeutic effects of Neuromuscular-Blocking Agents. Risk C: Monitor
Nonsteroidal Anti-Inflammatory Agents: May decrease excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor
Oxatomide: May increase ototoxic effects of Aminoglycosides. Risk C: Monitor
Penicillins: May decrease serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Risk C: Monitor
Polymyxin B: May increase nephrotoxic effects of Aminoglycosides. Polymyxin B may increase neurotoxic effects of Aminoglycosides. Risk X: Avoid
Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification
Tacrolimus (Systemic): Aminoglycosides may increase nephrotoxic effects of Tacrolimus (Systemic). Risk C: Monitor
Tenofovir Products: Aminoglycosides may increase serum concentration of Tenofovir Products. Tenofovir Products may increase serum concentration of Aminoglycosides. Risk C: Monitor
Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification
Vancomycin: May increase nephrotoxic effects of Aminoglycosides. Vancomycin may increase neurotoxic effects of Aminoglycosides. Management: Consider avoiding coadministration of aminoglycosides and vancomycin unless clinically indicated. If coadministered, monitor closely for signs of nephrotoxicity and neurotoxicity. Risk D: Consider Therapy Modification
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 (Gardner 2001; Vivancos 2018) or cryptosporidiosis after the first trimester (HHS [OI 2019]) in pregnant women.
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)