Label: HUMATIN- paromomycin sulfate capsule

  • NDC Code(s): 69784-510-01
  • Packager: Woodward Pharma Services LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 19, 2021

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    To reduce the development of drug-resistant bacteria and maintain the effectiveness of HUMATIN™ Capsules, and other antibacterial drugs, HUMATIN™ Capsules should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

  • 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-(1→3)-0-β -D-ribofuranosyl-(1→5)-0-[2-amino-2-deoxy-α -D-glucopyranosyl-(1→4)]-2-deoxystreptamine sulfate (salt). The molecular formula is C23H45N5O14•xH2SO4, with a molecular weight of 615.64 (base).

    Its structural formula is:

    Image

    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.

  • 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.

  • INDICATIONS AND USAGE

    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 HUMATIN™ Capsules and other antibacterial drugs, HUMATIN™ 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.

  • CONTRAINDICATIONS

    Paromomycin sulfate is contraindicated in individuals with a history of previous hypersensitivity reactions to it. It is also contraindicated in intestinal obstruction.

  • PRECAUTIONS

    Prescribing HUMATIN™ Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

    The use of this antibiotic, as with other antibiotics, may result in an overgrowth of nonsusceptible organisms, including fungi. Constant observation of the patient is essential. If new infections caused by nonsusceptible organisms appear during therapy, appropriate measures should be taken. The drug should be used with caution in individuals with ulcerative lesions of the bowel to avoid renal toxicity through inadvertent absorption.

    Information for Patients

    Patients should be counseled that antibacterial drugs including HUMATIN™ Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When HUMATIN™ 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 HUMATIN™ Capsules or other antibacterial drugs in the future.

    PEDIATRIC USE

    See DOSAGE AND ADMINISTRATION section.

  • ADVERSE REACTIONS

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

    To report SUSPECTED ADVERSE REACTIONS, contact Woodward Pharma Services LLC at 844-200-7910 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • DOSAGE AND ADMINISTRATION

    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.

  • HOW SUPPLIED

    HUMATIN™ Capsules each contain paromomycin sulfate equivalent to 250 mg paromomycin, are supplied as follows:

    NDC 69784-510-01: Bottles of 100

    The capsule is Dark Blue Opaque /White Opaque, imprinted with "HP 38" 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:

    Woodward Pharma Services LLC

    Wixom, MI 48393

    logo

    51UWW0000002US01

    Revised: 11/2020

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 69784-510-01

    Humatin™

    Paromomycin Sulfate Capsules, USP

    250 mg

    100 Capsules

    Rx only

    250 mg 100 ct
  • INGREDIENTS AND APPEARANCE
    HUMATIN 
    paromomycin sulfate capsule
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:69784-510
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PAROMOMYCIN SULFATE (UNII: 845NU6GJPS) (PAROMOMYCIN - UNII:61JJC8N5ZK) PAROMOMYCIN SULFATE250 mg
    Inactive Ingredients
    Ingredient NameStrength
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    SHELLAC (UNII: 46N107B71O)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    Product Characteristics
    ColorWHITE (White opaque) , BLUE (Dark blue opaque) Scoreno score
    ShapeCAPSULESize19mm
    FlavorImprint Code HP;38
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69784-510-01100 in 1 BOTTLE; Type 0: Not a Combination Product02/19/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06517302/19/2021
    Labeler - Woodward Pharma Services LLC (026749066)
    Registrant - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.189630168ANALYSIS(69784-510) , LABEL(69784-510) , MANUFACTURE(69784-510) , PACK(69784-510)