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Paromomycin Sulfate (Caraco Pharmaceutical Laboratories, Ltd.)

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CAPSULE 100 CAPSULE in 1 BOTTLE (57664-175-08) Label Information

Complete Paromomycin Sulfate Information

  • 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 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-deoxystreptamine sulfate (salt). The molecular formula is C23H45N5O14 xH2SO4, with a molecular weight of 615.64 (base). Its structural formula is:



    Paromomycinsulfate-figure


    Each capsule, for oral administration, contains paromomycin sulfate 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.


  • 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.


  • CONTRAINDICATIONS

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


  • PRECAUTIONS

    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.

    This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.


  • ADVERSE REACTIONS

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


  • DOSAGE AND ADMINISTRATION

    Intestinal amebiasis: Adults and Children: 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

    Paromomycin Sulfate Capsules, each contain paromomycin sulfate equivalent to 250 mg paromomycin. The capsule is green/yellow, imprinted "175" in black ink on the cap and body.


    NDC 57664-175-08: Bottles of 100

    Store at controlled room temperature 15° to 30°C (59° to 86°F).

    Protect from moisture.

    Caution—Federal law prohibits dispensing without prescription.

    Manufactured by:

    ALKALOIDA Chemical Company Zrt.
    4440 Tiszavasvári

    Kabay János u. 29.

    Hungary


    Distributed by:

    Sun Pharmaceutical Industries, Inc.

    Cranbury, NJ 08512


    Revised: 04/2015


  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Paromomycin Capsules, USP 250 mg
    NDC 57664-175-08
    Rx Only
    100 Tablets
    ALKALOIDA Chemical Company Zrt.

    Paromomycinsulfate-250mg


  • INGREDIENTS AND APPEARANCE
    PAROMOMYCIN SULFATE 
    paromomycin sulfate capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:57664-175
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    PAROMOMYCIN SULFATE (UNII: 845NU6GJPS) (PAROMOMYCIN - UNII:61JJC8N5ZK) PAROMOMYCIN SULFATE 250 mg
    Inactive Ingredients
    Ingredient Name Strength
    FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    GELATIN (UNII: 2G86QN327L)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color GREEN, YELLOW Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code 175
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:57664-175-08 100 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064171 06/30/1997
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    Name Address ID/FEI Business Operations
    Sun Pharmaceutical Industries, Inc. 146974886 MANUFACTURE(57664-175) , PACK(57664-175)