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Drug overview for HUMATIN (paromomycin sulfate):
Generic name: paromomycin sulfate (PAIR-oh-mow-MY-sin)
Drug class: Amebicides, Systemic
Therapeutic class: Anti-Infective Agents
Paromomycin sulfate is an aminoglycoside antibiotic with antibacterial and antiprotozoal activity.
No enhanced Uses information available for this drug.
Generic name: paromomycin sulfate (PAIR-oh-mow-MY-sin)
Drug class: Amebicides, Systemic
Therapeutic class: Anti-Infective Agents
Paromomycin sulfate is an aminoglycoside antibiotic with antibacterial and antiprotozoal activity.
No enhanced Uses information available for this drug.
DRUG IMAGES
HUMATIN 250 MG CAPSULE
The following indications for HUMATIN (paromomycin sulfate) have been approved by the FDA:
Indications:
Acute intestinal amebiasis
Chronic intestinal amebiasis
Hepatic coma
Professional Synonyms:
Acute amebic dysentery
Indications:
Acute intestinal amebiasis
Chronic intestinal amebiasis
Hepatic coma
Professional Synonyms:
Acute amebic dysentery
The following dosing information is available for HUMATIN (paromomycin sulfate):
Dosage of paromomycin sulfate is expressed in terms of paromomycin.
Paromomycin sulfate is administered orally with a meal. Paromomycin sulfate has been administered topically+ for the treatment of cutaneous leishmaniasis+ as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum. Topical preparations of the drug are not commercially available in the US.
Paromomycin sulfate has been administered IM+ for the treatment of visceral leishmaniasis (kala azar)+. Parenteral preparations of the drug are not commercially available in the US. Store paromomycin sulfate capsules in a tight container at 20-25degreesC; protect capsules from moisture.
Paromomycin sulfate has been administered IM+ for the treatment of visceral leishmaniasis (kala azar)+. Parenteral preparations of the drug are not commercially available in the US. Store paromomycin sulfate capsules in a tight container at 20-25degreesC; protect capsules from moisture.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| HUMATIN 250 MG CAPSULE | Maintenance | Adults take 1 capsule (250 mg) by oral route 3 times per day |
No generic dosing information available.
The following drug interaction information is available for HUMATIN (paromomycin sulfate):
There are 0 contraindications.
There are 1 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Misc Antibiotics/Neuromuscular Blocking Agents SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Aminoglycosides, bacitracin, clindamycin, lincomycin, and polymyxins may enhance the pharmacologic effects of neuromuscular blocking agents. CLINICAL EFFECTS: May see an increase in the pharmacologic effects of neuromuscular blocking agents, including prolonged respiratory depression and apnea. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: If it is necessary to administer these drugs concurrently, do so with extreme caution. Monitor neuromuscular function and adjust the dose of the neuromuscular blocking agent accordingly. DISCUSSION: Concomitant administration of aminoglycosides, bacitracin, clindamycin, lincomycin, and polymixins with neuromuscular blocking agents has been shown to produce synergism of the effects on skeletal muscles. Concurrent administration of these drugs has been associated with prolonged respiratory depression, respiratory paralysis, and fatal apnea. The interaction usually occurs when the antibiotic is given prior to or concurrently with the neuromuscular blocking drug, but it may also occur when given after administration. Any antibiotic dosage or route of administration may produce respiratory depression. |
ANECTINE, ATRACURIUM BESYLATE, BOTOX, BOTOX COSMETIC, CISATRACURIUM BESYLATE, DAXXIFY, DYSPORT, JEUVEAU, LETYBO, MYOBLOC, QUELICIN, ROCURONIUM BROMIDE, SUCCINYLCHOLINE CHLORIDE, SUCCINYLCHOLINE CHLORIDE-NACL, VECURONIUM BROMIDE, VECURONIUM BROMIDE-WATER, XEOMIN |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Digoxin, Oral/Aminoglycosides, Oral SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Aminoglycosides appears to inhibit gastrointestinal absorption of digoxin but the precise mechanism is unknown. CLINICAL EFFECTS: Therapeutic effects of digoxin may be decreased. However, in a minority of patients (10%) gut flora inactivates digoxin. In these patients, due to an aminoglycoside-induced reduction in GI bacteria, serum digoxin concentrations may be increased. Symptoms of digoxin toxicity can include anorexia, nausea, vomiting, headache, fatigue, malaise, drowsiness, generalized muscle weakness, disorientation, hallucinations, visual disturbances, and arrhythmias. PREDISPOSING FACTORS: None Determined. PATIENT MANAGEMENT: If both drugs are administered, monitor serum digoxin levels when initiating, discontinuing or changing the dose of the aminoglycoside. Measure serum digoxin concentrations before initiating gentamicin. Reduce digoxin concentrations by decreasing dose by approximately 30-50% or by modifying the dosing frequency and continue monitoring. (3) DISCUSSION: Separating the administration times of digoxin and the aminoglycoside is not likely to prevent this interaction. Digoxin levels were found to be decreased when neomycin was taken 3 or 6 hours before digoxin. Additionally, serum digoxin concentrations may increase when the aminoglycoside is stopped. Concomitant administration of gentamicin and digoxin caused an increase in digoxin serum concentration of 129-212%. (3) |
DIGOXIN, DIGOXIN MICRONIZED, LANOXIN |
The following contraindication information is available for HUMATIN (paromomycin sulfate):
Drug contraindication overview.
*Known hypersensitivity to the drug. *Intestinal obstruction.
*Known hypersensitivity to the drug. *Intestinal obstruction.
There are 2 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Gastrointestinal obstruction |
| Mt-RNr1 increased risk of aminoglycoside-induced hearing loss |
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disorder of the vestibulocochlear nerve |
| Gastrointestinal ulcer |
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Kidney disease with reduction in glomerular filtration rate (GFr) |
The following adverse reaction information is available for HUMATIN (paromomycin sulfate):
Adverse reaction overview.
Adverse effects reported following oral administration of paromomycin at doses >3 g daily include nausea, abdominal cramps, and diarrhea. Adverse effects following topical+ administration of paromomycin (combined with topical methylbenzethonium chloride) include local reactions such as burning, pruritus, erythema, pain, edema, and blisters. Adverse effects following IM+ administration of paromomycin include injection site pain, fever, elevated liver enzymes, and reversible ototoxicity.
Adverse effects reported following oral administration of paromomycin at doses >3 g daily include nausea, abdominal cramps, and diarrhea. Adverse effects following topical+ administration of paromomycin (combined with topical methylbenzethonium chloride) include local reactions such as burning, pruritus, erythema, pain, edema, and blisters. Adverse effects following IM+ administration of paromomycin include injection site pain, fever, elevated liver enzymes, and reversible ototoxicity.
There are 0 severe adverse reactions.
There are 3 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Abdominal pain with cramps Diarrhea Nausea |
| Rare/Very Rare |
|---|
| None. |
The following precautions are available for HUMATIN (paromomycin sulfate):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Because oral paromomycin is minimally absorbed from the GI tract, it may be a drug of choice for treatment of amebiasis or giardiasis+ in pregnant women.
No specific precautions are recommended for use of paromomycin in breast-feeding women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for HUMATIN (paromomycin sulfate):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for HUMATIN (paromomycin sulfate)'s list of indications:
| Acute intestinal amebiasis | |
| A06.0 | Acute amebic dysentery |
| A06.2 | Amebic nondysenteric colitis |
| Chronic intestinal amebiasis | |
| A06.1 | Chronic intestinal amebiasis |
| Hepatic coma | |
| B15.0 | Hepatitis A with hepatic coma |
| B16.0 | Acute hepatitis B with delta-agent with hepatic coma |
| B16.2 | Acute hepatitis B without delta-agent with hepatic coma |
| B17.11 | Acute hepatitis C with hepatic coma |
| B19.0 | Unspecified viral hepatitis with hepatic coma |
| B19.11 | Unspecified viral hepatitis B with hepatic coma |
| B19.21 | Unspecified viral hepatitis C with hepatic coma |
| K70.41 | Alcoholic hepatic failure with coma |
| K71.11 | Toxic liver disease with hepatic necrosis, with coma |
| K72.01 | Acute and subacute hepatic failure with coma |
| K72.11 | Chronic hepatic failure with coma |
| K72.91 | Hepatic failure, unspecified with coma |
| K76.82 | Hepatic encephalopathy |
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