Paromomycin sulfate

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Paromomycin sulfate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Paromomycin sulfate is a Aminoglycoside that is FDA approved for the treatment of intestinal amebiasis–acute and chronic and management of hepatic coma–as adjunctive therapy.. Common adverse reactions include Nausea, abdominal cramps, and diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • Paromomycin sulfate is indicated for intestinal amebiasis–acute and chronic (NOTE-It is not effective in extraintestinal amebiasis); management of hepatic coma–as adjunctive therapy.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Paromomycin Sulfate Capsules and other antibacterial drugs, Paromomycin Sulfate Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Dosage

  • Intestinal amebiasis: Adults and Pediatric Patients: Usual dose—25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days.

Management of hepatic coma:

Adults: Usual dose—4 g daily in divided doses, given at regular intervals for five to six days.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Paromomycin sulfate in adult patients.

Non–Guideline-Supported Use

  • Cryptosporidiosis[1]
  • Giardiasis[2]

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications and Dosage

  • Intestinal amebiasis: Adults and Pediatric Patients: Usual dose—25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Paromomycin sulfate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non-Guideline-Supported Use of Paromomycin sulfate in pediatric patients.

Contraindications

  • Condition1

Warnings

  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Paromomycin sulfate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Paromomycin sulfate in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Paromomycin sulfate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Paromomycin sulfate during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Paromomycin sulfate with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Paromomycin sulfate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Paromomycin sulfate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Paromomycin sulfate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Paromomycin sulfate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Paromomycin sulfate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Paromomycin sulfate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Paromomycin sulfate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Paromomycin sulfate in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Paromomycin sulfate in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Paromomycin sulfate in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Paromomycin sulfate in the drug label.

Pharmacology

There is limited information regarding Paromomycin sulfate Pharmacology in the drug label.

Mechanism of Action

Structure

File:Paromomycin sulfate01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Paromomycin sulfate in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Paromomycin sulfate in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Paromomycin sulfate in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Paromomycin sulfate in the drug label.

How Supplied

Storage

There is limited information regarding Paromomycin sulfate Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Paromomycin sulfate in the drug label.

Precautions with Alcohol

  • Alcohol-Paromomycin sulfate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ Flanigan TP, Ramratnam B, Graeber C, Hellinger J, Smith D, Wheeler D; et al. (1996). "Prospective trial of paromomycin for cryptosporidiosis in AIDS". Am J Med. 100 (3): 370–2. doi:10.1016/S0002-9343(97)89499-5. PMID 8629685.
  2. ↑ DOBON JF, CEDRATO AE, MARTINODECOLOM N (1963). "[THE USE OF PAROMOMYCIN IN INTESTINAL AMEBIASIS AND GIARDIASIS]". Dia Med. 35: 1012. PMID 14049466.
  3. ↑ Empty citation (help)
  4. ↑ "http://www.ismp.org". External link in |title= (help)

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