Paromomycin Sulfate

Name: Paromomycin Sulfate

Description

Paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) is a broad spectrum antibiotic produced by Streptomyces riomosus var. paromomycinus. It is a white, amorphous, stable, water-soluble product. Paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) is designated chemically as O-2,6-Diamino-2,6-dideoxy-β-L-idopyranosyl-(1→3)-O-β-D-ribofuranosyl-(1→5)-O-[2-amino-2-deoxy-α-D-glucopyranosyl-(1→4)]-2-deoxystrepta-mine sulfate (salt). The molecular formula is C23H45N5O14 • xH2SO4, with a molecular weight of 615.64 (base). Its structural formula is:

Each capsule, for oral administration, contains paromomycin sulfate (paromomycin sulfate (paromomycin sulfate capsules) capsules) equivalent to 250 mg paromomycin. Each capsule also contains the following inactive ingredients: FD&C Green #3; FD&C Yellow #5 (tartrazine); gelatin, NF; and titanium dioxide, USP.

Patient information

No information provided. Please refer to the PRECAUTIONS section.

What should i discuss with my healthcare provider before taking paromomycin (paromycin)?

Before taking paromomycin, tell your doctor if you have

  • stomach or intestinal problems such as stomach ulcer, inflammatory bowel disease, or intestinal blockage (obstruction);
  • kidney disease; or
  • liver disease.

You may not be able to take paromomycin, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Do not take paromomycin without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Do not take paromomycin without first talking to your doctor if you are breast-feeding a baby.

Side effects

Nausea, abdominal cramps, and diarrhea have been reported in patients on doses over 3 g daily.

Read the entire FDA prescribing information for Paromomycin Sulfate (Paromomycin Sulfate Capsules)

Read More »

Paromomycin Sulfate Dosage and Administration

Administration

Oral Administration

Administer orally with a meal.122

Topical Administration

Has been administered topically† for treatment of cutaneous leishmaniasis† as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum.103 104 105 106 110 A topical preparation is not commercially available in the US.

IM Administration

Has been administered IM† for treatment of visceral leishmaniasis (kala azar)†.129 130 A parenteral preparation is not commercially available in the US.

Dosage

Available as paromomycin sulfate; dosage expressed in terms of paromomycin.122

Pediatric Patients

Amebiasis Caused by Entamoeba histolytica Asymptomatic Cyst Passers (Intraluminal Infections) Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122

Symptomatic Intestinal Amebiasis or Extraintestinal Disease (Including Amebic Liver Abscess) Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122 Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).100 110

Cestode (Tapeworm) Infections† Diphyllobothrium latum† (Fish Tapeworm), Dipylidium caninum† (Dog and Cat Tapeworm), Taenia saginata† (Beef Tapeworm), or T. solium† (Pork Tapeworm) Infections Oral

11 mg/kg every 15 minutes for 4 doses.125 a

Hymenolepis nana† (Dwarf Tapeworm) Infections. Oral

45 mg/kg daily, given as a single daily dose, for 5–7 days.125 a

Cryptosporidiosis† Oral

25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected children or adolescents.127 128 Maximum dosage is 500 mg 4 times daily in children.128

Dientamoeba fragilis Infections† Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110

Giardiasis† Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110

Leishmaniasis† Cutaneous Leishmaniasis† Topical†

Apply topically† (as a preparation containing paromomycin 15% and methylbenzethonium chloride 12% in white petrolatum) twice daily for 10–20 days.103 104 105 106 110 121

If effective, clinical healing of lesions usually is complete within several weeks to a month after topical† paromomycin treatment is completed.103 104 105

In patients with recurrent disease (leishmaniasis recidivans), more prolonged topical treatment (e.g., twice daily for about 3 months) may eliminate the protozoa from cutaneous lesions.103

Visceral Leishmaniasis (Kala Azar)† IM†

11–20 mg/kg daily for 10–21 days.121 129 130

Adults

Amebiasis Caused by Entamoeba histolytica Asymptomatic Cyst Passers (Intraluminal Infections) Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122

Symptomatic Intestinal Amebiasis or Extraintestinal Disease (Including Amebic Liver Abscess) Oral

25–35 mg/kg daily, in 3 divided doses, given for 5–10 days (usually 7 days).110 122 Used as follow-up after initial treatment with a tissue amebicide (oral metronidazole or oral tinidazole).100 110

Cestode (Tapeworm) Infections† Diphyllobothrium latum† (Fish Tapeworm), Dipylidium caninum† (Dog and Cat Tapeworm), Taenia saginata† (Beef Tapeworm), or T. solium† (Pork Tapeworm) Infections Oral

11 mg/kg given every 15 minutes for 4 doses.a

Hymenolepis nana† (Dwarf Tapeworm) Infections. Oral

45 mg/kg daily, given as a single daily dose, for 5–7 days.a

Cryptosporidiosis† Oral

25–35 mg/kg daily in 2–4 divided doses recommended by CDC, NIH, and IDSA for HIV-infected adults.127

1.5–2.25 g daily, in 3–6 divided doses, given for 10–14 days has been used.111 112 113 Occasionally, more prolonged therapy (e.g., 4–8 weeks) may be necessary.111

Dientamoeba fragilis Infections† Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110

Giardiasis† Oral

25–35 mg/kg daily, in 3 divided doses, given for 7 days.110

Hepatic Encephalopathy Adjunct in the Management of Hepatic Coma Oral

4 g daily in divided doses given for 5–6 days.122

Leishmaniasis† Cutaneous Leishmaniasis† Topical†

Apply topically† (as a preparation containing paromomycin 15% and methylbenzethonium chloride12% in white petrolatum) twice daily for 10–20 days.103 104 105 106 110 121

If effective, clinical healing of lesions usually is complete within several weeks to a month after topical† paromomycin treatment is completed.103 104 105

In patients with recurrent disease (leishmaniasis recidivans), more prolonged topical† treatment (e.g., twice daily for about 3 months) may eliminate the protozoa from cutaneous lesions.103

Visceral Leishmaniasis (Kala Azar)† IM†

11–20 mg/kg daily for 10–21 days.121 129 130

Special Populations

No special population dosage recommendations at this time.

Cautions for Paromomycin Sulfate

Contraindications

  • Known hypersensitivity to the drug.122

  • Intestinal obstruction.122

Warnings/Precautions

Warnings

Nephrotoxicity, Ototoxicity, Neuromuscular Blockade

Like other aminoglycosides, paromomycin has the potential to cause nephrotoxic, ototoxic, and probably neuromuscular blocking effects if absorbed systemically.a 130

Avoid high dosage or prolonged therapy.a

Use oral paromomycin with caution in patients with ulcerative intestinal lesions since inadvertent GI absorption of the drug may result in renal toxicity.122

Sensitivity Reactions

Tartrazine Sensitivity

Capsules may contain tartrazine (FD&C yellow No. 5), which may cause allergic reactions including bronchial asthma in susceptible individuals.122 Incidence of tartrazine sensitivity is low, but it frequently occurs in patients who are sensitive to aspirin.122

General Precautions

Superinfection

As with other anti-infectives, use of paromomycin may result in overgrowth of nonsusceptible organisms, including fungi, and patients should be carefully monitored for development of new infections caused by nonsusceptible organisms.122 Secondary Staphylococcus enterocolitis may occur.a

Appropriate therapy should be instituted if superinfection occurs.122

Specific Populations

Pregnancy

Category C.125

Because oral paromomycin is minimally absorbed from the GI tract, it may be a drug of choice for treatment of amebiasis100 110 116 117 118 or giardiasis† in pregnant women.100 110

Lactation

No specific precautions in breast-feeding women.125

Common Adverse Effects

Oral: GI effects including anorexia,a nausea,122 vomiting,a epigastric burning and pain,a increased GI motility,a abdominal cramps,122 diarrhea,122 pruritus ani.a

Topical† (combined with topical methylbenzethonium chloride): Local reactions including burning,104 105 121 pruritus,121 erythema,129 pain,129 edema,129 blisters.121 129

IM†: Injection site pain, fever, elevated liver enzymes, reversible ototoxicity.130

Paromomycin Sulfate Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the GI tract.122

Impaired GI motility or intestinal lesions or ulcerations may facilitate GI absorption.122 a

Rapidly absorbed following IM† injection (parenteral preparation not commercially available in the US); peak plasma concentrations attained within 1 hour.130

Elimination

Elimination Route

Almost 100% of an oral dose is eliminated unchanged in feces;122 a any absorbed drug is slowly excreted in urine.a

Special Populations

Impaired renal function: Accumulation can occur.a

Advice to Patients

  • Importance of taking with a meal.122

  • Importance of completing full course of treatment, even if feeling better after a few days.122

  • Importance of notifying clinician of persistent or worsening symptoms of infection.122

  • Advise patients that skipping doses or not completing the full course of therapy may decrease effectiveness.122

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.122

  • Importance of informing patients of other important precautionary information.122

(web3)