Paromomycin Sulfate
Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.
Human Prescription Drug
NDC 23155-038Paromomycin Sulfate is a human prescription drug labeled by 'Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc.'. National Drug Code (NDC) number for Paromomycin Sulfate is 23155-038. This drug is available in dosage form of Capsule. The names of the active, medicinal ingredients in Paromomycin Sulfate drug includes Paromomycin Sulfate - 250 mg/1 . The currest status of Paromomycin Sulfate drug is Active.
Drug Information:
| Drug NDC: | 23155-038 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Paromomycin Sulfate |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Paromomycin Sulfate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Heritage Pharmaceuticals Inc. D/b/a Avet Pharmaceuticals Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Capsule |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | PAROMOMYCIN SULFATE - 250 mg/1
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | ANDA |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 22 Oct, 2009 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 31 Mar, 2024 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | ANDA065173 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 28 Dec, 2025 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 314184
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UPC: | 0323155038019
|
| UPC stands for Universal Product Code. |
| UNII: | 845NU6GJPS
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Antiprotozoal [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 23155-038-01 | 100 CAPSULE in 1 BOTTLE (23155-038-01) | 22 Oct, 2009 | 31 Mar, 2024 | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Paromomycin sulfate paromomycin sulfate paromomycin sulfate paromomycin fd&c blue no. 1 d&c red no. 28 fd&c red no. 40 gelatin titanium dioxide d&c yellow no. 10 fd&c blue no. 2 ferrosoferric oxide shellac propylene glycol white opaque dark blue opaque hp;38
Indications and Usage:
Indications and usage paromomycin sulfate is indicated for intestinal amebiasisâacute and chronic (note-it is not effective in extraintestinal amebiasis); management of hepatic comaâas 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 and Administration:
Dosage and administration intestinal amebiasis: adults and pediatric patients: usual doseâ25 to 35 mg/kg body weight daily, administered in three doses with meals, for five to ten days. management of hepatic coma: adults: usual doseâ4 g daily in divided doses, given at regular intervals for five to six days.
Contraindications:
Contraindications paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. it is also contraindicated in intestinal obstruction.
Adverse Reactions:
Adverse reactions nausea, abdominal cramps, and diarrhea have been reported inpatients on doses over 3 g daily.
Pediatric Use:
Pediatric use see dosage and administration section.
Description:
Description paromomycin sulfate is a broad spectrum antibiotic produced by streptomyces riomosus var. paromomycinus . it is a white, amorphous, stable, water-soluble product. paromomycin sulfate is designated chemically as 0 -2, 6-diamino-2, 6-dideoxy-β -l-idopyranosyl-(1â3)- 0 -β -d-ribofuranosyl-(1â5)- 0 -[2-amino-2-deoxy-α -d-glucopyranosyl-(1â4)]-2-deoxystreptamine sulfate (salt). the molecular formula is c 23 h 45 n 5 o 14 â¢xh 2 so 4 , with a molecular weight of 615.64 (base). its structural formula is: each capsule, for oral administration, contains paromomycin sulfate equivalent to 250 mg paromomycin. each capsule also contains the following inactive ingredients: fd&c blue # 1, d&c red # 28, fd&c red # 40, gelatin and titanium dioxide. the imprinting ink for the 250 mg capsule contains d&c yellow #10, fd&c blue # 1, fd&c blue # 2, fd&c red # 40, iron oxide black, pharmaceutical shellac glaze, and propylene glycol. image[5].jpg
Clinical Pharmacology:
Clinical pharmacology the in-vitro and in-vivo antibacterial action of paromomycin closely parallels that of neomycin. it is poorly absorbed after oral administration, with almost 100% of the drug recoverable in the stool.
How Supplied:
How supplied paromomycin sulfate capsules, usp each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows: ndc 23155-038-01: bottles of 100 the capsule is dark blue opaque /white opaque, imprinted with âhp 38â in black ink on the cap and on the body. storage store at 20°-25°c (68°-77°f) [see usp controlled room temperature] protect from moisture. preserve in tight containers as defined in the usp. call your doctor for medical advice about side effects. you may report side effects to fda at 1-800-fda-1088 manufactured for: heritage pharmaceuticals inc. east brunswick, nj 08816 1.866.901.drug (3784) 51u000000176us02 issued: 11/2017
Information for Patients:
Information for patients patients should be counseled that antibacterial drugs including paromomycin sulfate capsules should only be used to treat bacterial infections. they do not treat viral infections (e.g., the common cold). when paromomycin sulfate capsules is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by paromomycin sulfate capsules or other antibacterial drugs in the future.
Package Label Principal Display Panel:
Package label.principal display panel paromomycin sulfate capsules, usp, 250 mg -100 count 250 mg 100 ct 2bcc16d-9dee-4466-b099-192dfa7ee3a6