HUMATIN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for HUMATIN (HUMATIN).
Aminoglycoside antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, causing misreading of mRNA and production of nonfunctional proteins.
| Metabolism | Minimally absorbed from the gastrointestinal tract; systemically absorbed drug undergoes minimal hepatic metabolism. |
| Excretion | Primarily unchanged in feces (~90%); small amount absorbed is excreted renally as unchanged drug (~1%) |
| Half-life | 2-3 hours (serum half-life of absorbed fraction); clinically negligible due to minimal systemic absorption |
| Protein binding | 0% (negligible binding due to high polarity and minimal absorption) |
| Volume of Distribution | 0.2 L/kg (reflects limited distribution to extracellular fluid in absorbed fraction; primarily confined to GI tract) |
| Bioavailability | Oral: ~1% (ranges 0.5-1.5% due to poor absorption from gastrointestinal tract) |
| Onset of Action | Oral: 24-48 hours for suppression of intestinal flora; not applicable for parenteral use |
| Duration of Action | Variable; continued suppression of intestinal bacteria persists during therapy; clinical effects last 3-5 days after discontinuation |
15-25 mg/kg/day orally in 4 divided doses for hepatic coma; 50 mg/kg/day orally in 4 divided doses for infectious diarrhea, max 4 g/day.
| Dosage form | CAPSULE |
| Renal impairment | Reduce dose and/or extend interval based on CrCl: CrCl 50-90 mL/min: 60-90% of dose; CrCl 10-50 mL/min: 30-60% of dose; CrCl <10 mL/min: 20-30% of dose. |
| Liver impairment | No specific Child-Pugh based adjustments; caution in severe hepatic impairment due to potential nephrotoxicity. |
| Pediatric use | For hepatic coma: 15-25 mg/kg/day orally in 4 divided doses; for infectious diarrhea: 50 mg/kg/day orally in 4 divided doses, max 4 g/day. |
| Geriatric use | Adjust based on renal function; monitor for nephrotoxicity and ototoxicity; consider lower initial doses due to age-related renal decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for HUMATIN (HUMATIN).
| Breastfeeding | It is not known whether paromomycin is excreted in human milk after oral administration. Paromomycin is minimally absorbed systemically, so exposure to breastfed infants is expected to be low. However, because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. M/P ratio: Not available. |
| Teratogenic Risk | FDA Pregnancy Category D. Humatin (paromomycin) is an aminoglycoside antibiotic. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans. However, potential benefits may warrant use in pregnant women despite potential risks. Aminoglycosides can cause fetal harm when administered to a pregnant woman, including ototoxicity and nephrotoxicity. Paromomycin is poorly absorbed after oral administration, so systemic exposure is minimal. Risk is considered low, but caution is advised. |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Hypersensitivity to paromomycin or other aminoglycosides","Intestinal obstruction","Severe ulcerative bowel lesions"]
| Precautions | ["Ototoxicity (mainly with prolonged use or renal impairment)","Nephrotoxicity","Neuromuscular blockade (use caution in patients with myasthenia gravis or receiving neuromuscular blocking agents)","Superinfection with resistant organisms","Use in renal impairment may increase risk of toxicity","Not for systemic infections (poor absorption)"] |
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| Fetal Monitoring | No specific maternal or fetal monitoring is routinely required due to poor systemic absorption. However, patients should be monitored for signs of gastrointestinal disturbances or allergic reactions. In rare cases of systemic absorption (e.g., patients with inflammatory bowel disease or renal impairment), monitor for ototoxicity, nephrotoxicity, and fetal effects. Auditory and renal function tests may be considered. |
| Fertility Effects | No studies have been conducted on fertility effects of paromomycin. Based on its mechanism (aminoglycoside) and limited systemic absorption, significant effects on fertility are unlikely. However, animal reproduction studies have not been performed with paromomycin. |