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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Paromomycin: Pediatric drug information

Paromomycin: Pediatric drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Paromomycin: Drug information" and "Paromomycin: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Humatin
Brand Names: Canada
  • Humatin
Therapeutic Category
  • Amebicide
Dosing: Pediatric
Cryptosporidiosis, immunocompromised or nutritionally deficient patients

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

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

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

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

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).

Dosing: Kidney Impairment: Pediatric

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.

Dosing: Liver Impairment: Pediatric

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.

Dosing: Adult

(For additional information see "Paromomycin: Drug information")

Hepatic coma

Hepatic coma: Oral: 4 g daily in divided doses (at regular intervals) for 5 to 6 days.

Intestinal amebiasis

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

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

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

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).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Adverse Reactions

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

Contraindications

Hypersensitivity to paromomycin or any component of the formulation; intestinal obstruction

Warnings/Precautions

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.

Product Availability

Topical paromomycin is not commercially available in the US; IDSA/ASTMH guidelines for diagnosis and treatment of leishmaniasis suggest collaboration with a compounding pharmacy.

Dosage Forms: US

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]

Generic Equivalent Available: US

Yes

Pricing: US

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.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Humatin: 250 mg

Extemporaneous Preparations

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).

Nyirjesy P, Sobel JD, Weitz MV, Leaman DJ, Gelone SP. Difficult-to-treat trichomoniasis: results with paromomycin cream. Clin Infect Dis. 1998;26(4):986-988. doi:10.1086/5139519564487
Administration: Pediatric

Oral: Administer with meals.

Topical: Limited data available: Apply extemporaneously prepared cream or ointment to the affected areas (Ref).

Administration: Adult

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).

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F). Protect from moisture.

Use

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.

Metabolism/Transport Effects

None known.

Drug Interactions

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

Pregnancy Considerations

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.

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Poor oral absorption

Excretion: Feces (~100% as unchanged drug)

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Humatin;
  • (AT) Austria: Humatin;
  • (CH) Switzerland: Humatin;
  • (CZ) Czech Republic: Humatin;
  • (DE) Germany: Humatin;
  • (EE) Estonia: Humatin;
  • (ES) Spain: Humatin;
  • (FR) France: Humatin;
  • (IT) Italy: Humatin | Kaman;
  • (JP) Japan: Ameparomo | Humatin;
  • (LT) Lithuania: Humatin;
  • (LV) Latvia: Humatin;
  • (MY) Malaysia: Humatin;
  • (NL) Netherlands: Humatin;
  • (NO) Norway: Humatin;
  • (NZ) New Zealand: Humatin;
  • (PH) Philippines: Humagel;
  • (PL) Poland: Humatin;
  • (PR) Puerto Rico: Humatin;
  • (PT) Portugal: Humatin;
  • (QA) Qatar: Humatin | Kaman;
  • (SE) Sweden: Humatin;
  • (SI) Slovenia: Humatin;
  • (SK) Slovakia: Humatin;
  • (TN) Tunisia: Humatin;
  • (TW) Taiwan: Ameparomo | Humatin
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  3. Bradley JS, Nelson JD, eds. Nelson's Pediatric Antimicrobial Therapy. 25th ed. American Academy of Pediatrics; 2019.
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