Version May 2024
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).
Refer to adult dosing.
(For additional information see "Paromomycin: Pediatric drug information")
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.
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): $128.90
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
Humatin is only available through a specialty pharmacy. For ordering and enrollment information refer to https://humatintotalcare.com/ or call (844) 486-2846.
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).
Oral: Administer with meals.
Topical: Limited data available: Apply extemporaneously prepared cream or ointment to the affected areas (Ref).
Intestinal amebiasis: Treatment of acute and chronic intestinal amebiasis (not effective for extraintestinal amebiasis).
Hepatic coma: Management (adjunctive) of hepatic coma.
Cryptosporidiosis-associated diarrhea in patients with HIV; Dientamoeba fragilis infection; Trichomoniasis, refractory or resistant infection
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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Aminoglycosides: May enhance the nephrotoxic effect of other Aminoglycosides. Aminoglycosides may enhance the neurotoxic effect of other Aminoglycosides. Risk X: Avoid combination
Amphotericin B: May enhance the nephrotoxic effect of Aminoglycosides. Amphotericin B may enhance the neurotoxic effect of Aminoglycosides. Risk C: Monitor therapy
Ataluren: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, an increased risk of nephrotoxicity may occur with the concomitant use of ataluren and aminoglycosides. Risk X: Avoid combination
Bacillus clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification
Bacitracin (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Bacitracin (Systemic) may enhance the neurotoxic effect of Aminoglycosides. Risk X: Avoid combination
Bisphosphonate Derivatives: Aminoglycosides may enhance the hypocalcemic effect of Bisphosphonate Derivatives. Aminoglycosides may enhance the nephrotoxic effect of Bisphosphonate Derivatives. Risk C: Monitor therapy
Botulinum Toxin-Containing Products: Aminoglycosides may enhance the neuromuscular-blocking effect of Botulinum Toxin-Containing Products. Risk C: Monitor therapy
Capreomycin: May enhance the neuromuscular-blocking effect of Aminoglycosides. Risk C: Monitor therapy
CARBOplatin: May enhance the nephrotoxic effect of Aminoglycosides. Aminoglycosides may enhance the ototoxic effect of CARBOplatin. Especially with higher doses of carboplatin. Risk C: Monitor therapy
Cardiac Glycosides: Aminoglycosides may decrease the serum concentration of Cardiac Glycosides. This effect has only been demonstrated with oral aminoglycoside administration. Risk C: Monitor therapy
Cephalosporins: May enhance the nephrotoxic effect of Aminoglycosides. Cephalosporins may decrease the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Cholera Vaccine: Antibiotics may diminish the therapeutic effect 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 combination
CISplatin: May enhance the nephrotoxic effect of Aminoglycosides. CISplatin may enhance the neurotoxic effect of Aminoglycosides. Risk X: Avoid combination
Colistimethate: Aminoglycosides may enhance the nephrotoxic effect of Colistimethate. Aminoglycosides may enhance the neuromuscular-blocking effect 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 enhance the ototoxic effect of Aminoglycosides. Risk C: Monitor therapy
CycloSPORINE (Systemic): Aminoglycosides may enhance the nephrotoxic effect of CycloSPORINE (Systemic). Risk C: Monitor therapy
Distigmine: Aminoglycosides may diminish the therapeutic effect of Distigmine. Risk C: Monitor therapy
Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination
Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination
Foscarnet: May enhance the nephrotoxic effect of Aminoglycosides. Risk X: Avoid combination
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy
Loop Diuretics: May enhance the adverse/toxic effect of Aminoglycosides. Specifically, nephrotoxicity and ototoxicity. Risk C: Monitor therapy
Mannitol (Systemic): May enhance the nephrotoxic effect of Aminoglycosides. Risk X: Avoid combination
Mecamylamine: Aminoglycosides may enhance the neuromuscular-blocking effect of Mecamylamine. Risk X: Avoid combination
Methoxyflurane: Aminoglycosides may enhance the nephrotoxic effect of Methoxyflurane. Risk X: Avoid combination
Netilmicin (Ophthalmic): Aminoglycosides may enhance the nephrotoxic effect of Netilmicin (Ophthalmic). Risk X: Avoid combination
Neuromuscular-Blocking Agents: Aminoglycosides may enhance the therapeutic effect of Neuromuscular-Blocking Agents. Risk C: Monitor therapy
Nonsteroidal Anti-Inflammatory Agents: May decrease the excretion of Aminoglycosides. Data only in premature infants. Risk C: Monitor therapy
Oxatomide: May enhance the ototoxic effect of Aminoglycosides. Risk C: Monitor therapy
Penicillins: May decrease the serum concentration of Aminoglycosides. Primarily associated with extended spectrum penicillins, and patients with renal dysfunction. Risk C: Monitor therapy
Polymyxin B: May enhance the nephrotoxic effect of Aminoglycosides. Polymyxin B may enhance the neurotoxic effect of Aminoglycosides. Risk X: Avoid combination
Sodium Picosulfate: Antibiotics may diminish the therapeutic effect 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 enhance the nephrotoxic effect of Tacrolimus (Systemic). Risk C: Monitor therapy
Tenofovir Products: Aminoglycosides may increase the serum concentration of Tenofovir Products. Tenofovir Products may increase the serum concentration of Aminoglycosides. Risk C: Monitor therapy
Typhoid Vaccine: Antibiotics may diminish the therapeutic effect 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 enhance the nephrotoxic effect of Aminoglycosides. Vancomycin may enhance the neurotoxic effect 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.
Paromomycin is poorly absorbed when given orally. Available information suggests that paromomycin may be used in nursing women when renal function is normal in both the mother and infant (Davidson 2009).
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)
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