Label: ME NAPHOS MB HYO 1- urinary antiseptic antispasmodic tablet

  • NDC Code(s): 58657-454-01
  • Packager: Method Pharmaceuticals
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 5, 2019

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  • Description

    Each tablet contains:


    Methenamine, USP ................................. 81.6 mg
    Monobasic Sodium Phosphate, USP ......... 40.8 mg
    Methylene Blue ....................................... 10.8 mg
    Hyoscyamine Sulfate ............................... 0.12 mg

  • Inactive Ingredients include:

    Microcrystalline
    Cellulose, Mannitol, Croscarmellose Sodium, Magnesium
    Stearate, FD&C Blue #1


    HYOSCYAMINE SULFATE is an alkaloid of belladonna.
    Exists as a white crystalline powder. Affected by light It
    is very soluble in water; freely soluble in alcohol;
    practically insoluble in ether.
    METHENAMINE exists as colorless, lustrous crystals or
    white crystalline powder. Its solutions are alkaline to
    litmus. Freely soluble in water; soluble in alcohol and in
    chloroform.


    METHYLENE BLUE exists as dark green crystals. It is
    soluble in water and in chloroform; sparingly soluble in
    alcohol.


    MONOBASIC SODIUM PHOSPHATE exists as a white
    crystalline powder. Its solutions are acidic to litmus. It is
    freely soluble in water and practically insoluble in
    alcohol.


    This product is not an Orange Book (OB) rated
    product, therefore all prescriptions using this
    product shall be pursuant to state statutes as
    applicable. There are no claims of bioequivalence
    or therapeutic equivalence.

  • CLINICAL PHARMACOLOGY

    HYOSCYAMINE is a parasympatholytic which relaxes
    smooth muscles and thus produces an antispasmodic
    effect. It is well absorbed from the gastrointestinal tract
    and is rapidly distributed throughout body tissues. Most
    is excreted in the urine within 12 hours, 13% to 50%
    being unchanged.


    Its biotransformation is hepatic. Its protein binding is
    moderate.


    METHENAMINE degrades in an acidic urine environment
    releasing formaldehyde which provides bactericidal or
    bacteriostatic action. It is well absorbed from the
    gastrointestinal tract. 70% to 90% reaches the urine
    unchanged at which point it is hydrolyzed if the urine is
    acidic. Within 24 hours it is almost completely (90%)
    excreted; of this amount at pH 5, approximately 20% is
    formaldehyde. Protein binding: some formaldehyde is
    bound to substances in the urine and surrounding
    tissues. Methenamine is freely distributed to body tissue
    and fluids but is not clinically significant as it does not
    hydrolyze at pH greater than 6.8.


    METHYLENE BLUE possesses weak antiseptic properties.
    It is well absorbed in the gastrointestinal tract and is
    rapidly reduced to leukomethylene blue which is
    stabilized in some combination form in the urine. 75%
    is excreted unchanged.


    MONOBASIC SODIUM PHOSPHATE helps to maintain an
    acid pH in the urine necessary for the degradation of
    methenamine.

  • INDICATION AND USAGE

    ME/NaPhos/MB/Hyo 1 Tablets is indicated for the
    treatment of symptoms of irritative voiding. Indicated
    for the relief of local symptoms, such as hypermotility
    which accompany lower urinary tract infections and as
    antispasmodic. Indicated for the relief of urinary tract
    symptoms caused by diagnostic procedures.

  • WARNINGS

    Do not exceed recommended dosage. If rapid pulse,
    dizziness, or blurring of vision occurs discontinue use
    immediately.

  • PRECAUTIONS

    (Pregnancy Category C)
    hyoscyamine and methenamine cross the placenta.
    Studies have not been done in animals or humans. It is
    not known whether ME/NaPhos/MB/Hyo 1
    Tablets cause fetal harm when administered to a
    pregnant woman or can affect reproduction capacity.
    ME/NaPhos/MB/Hyo 1 Tablets should be given to
    a pregnant woman only if clearly needed.

  • Breast-feeding

    problems in humans have not been documented;
    however, methenamine and traces of hyoscyamine are
    excreted in breast milk.

  • Prolonged use

    there have been no studies to establish the safety of
    prolonged use in humans. No known long-term animal
    studies have been performed to evaluate carcinogenic
    potential.

  • Pediatric

    infants and young children are especially susceptible to
    the toxic effect of the belladonna alkaloids.

  • Geriatric

    use with caution in elderly patients as they may respond
    to usual doses of hyoscyamine with excitement,
    agitation, drowsiness, or confusion.

  • Drug Interactions

    because of this product's effect on gastrointestinal

    motility and gastric emptying, it may decrease the
    absorption of other oral medications during concurrent
    use such as: urinary alkalizers; thiazide diuretics (may
    cause the urine to become alkaline reducing the
    effectiveness of methenamine by inhibiting its
    conversion to formaldehyde); antimuscarinics
    (concurrent use may intensify antimuscarinic effects of
    hyoscyamine because of secondary antimuscarinic
    activities of these medications); antacids/antidiarrheals
    (may reduce absorption of hyoscyamine, concurrent use
    with antacids may cause urine to become alkaline
    reducing effectiveness of methenamine by inhibiting its
    conversion to formaldehyde) doses of these medications
    should be spaced 1 hour apart from doses of
    hyoscyamine; antimyasthenics (concurrent use with
    hyoscyamine may further reduce intestinal motility);
    ketoconazole (patients should be advised to take this
    combination at least 2 hours after ketoconazole);
    monoamine oxidase (MAO) Inhibitors (concurrent use
    may intensify antimuscarinic side effects, opioid
    (narcotic) analgesics may result in increased risk of
    severe constipation); sulfonamides (these drugs may
    precipitate with formaldehyde in the urine, increasing
    the danger of crystalluria).
    Patients should be advised that the urine may become
    blue to blue green and the feces may be discolored as a
    result of the excretion of methylene blue.

  • ADVERSE REACTIONS

    Cardiovascular – rapid pulse, flushing


    Central Nervous System – blurred vision, dizziness


    Respiratory – shortness of breath or troubled
    breathing


    Genitourinary – difficulty micturition, acute urinary
    retention


    Gastrointestinal – dry mouth, nausea/vomiting

  • DRUG ABUSE AND DEPENDENCE

    A dependence on the use of ME/NaPhos/MB/Hyo 1
    Tablets has not been reported and due to the nature of
    its ingredients, abuse of ME/NaPhos/MB/Hyo 1
    Tablets
    is not expected.

  • OVERDOSAGE

    Emesis or gastric lavage. Slow intravenous
    administration of physostigmine in doses of 1 mg to
    4 mg (0.5 mg to 1 mg in children), repeated as needed
    in one to two hours to reverse severe antimuscarinic
    symptoms. Administration of small doses of diazepam to
    control excitement and seizures. Artificial respiration
    with oxygen if needed for respiratory depression.
    Adequate hydration. Symptomatic treatment as
    necessary.

  • DOSAGE AND ADMINISTRATION

    Adults


    One tablet orally 4 times per day followed by liberal
    fluid intake.


    Older Children


    Dosage must be individualized by physician. Not
    recommended for use in children up to 6 years of age.

  • HOW SUPPLIED

    ME/NaPhos/MB/Hyo 1 Tablets are light blue to
    blue, oval, biconvex tablets debossed with
    "M455" with scoreline on one side and plain on
    the other side. Supplied in bottles of 100 tablets
    (NDC 58657-454-01).

  • OTHER SAFETY INFORMATION

    CAUTION


    RX ONLY


    STORAGE


    Store at 25° C (77° F); excursions permitted to 15° C to
    30° C (59° F to 86° F) [See USP Controlled
    Room Temperature]. Keep container tightly closed.


    Distributed By: Method Pharmaceuticals, LLC
    Arlington, TX 76006


    Rev. Date: 01/2016

  • GENERAL PRECAUTIONS

    DIRECTIONS: 1 Tablet 4 times daily followed by liberal fluid intake, or
    as directed by a physician.


    FOR FULL PRODUCT INFORMATION SEE ATTACHED BOOKLET.
    Store at 25° C (77° F); excursions permitted to 15° C to 30° C (59° F to
    86° F) [See USP Controlled Room Temperature]. Protect from moisture or
    direct sunlight.


    NOTE: Patient should be advised that urine will be colored blue while
    taking this medication.


    PHARMACIST: Preserve and dispense in tight-light resistant container as
    defined in the USP.

    KEEP THIS AND ALL MEDICINES OUT OF THE REACH OF

    CHILDREN.

    Tamper evident by heat seal under cap. Do not use if there is
    evidence of tampering.

    To report an adverse event, please contact Method
    Pharmaceuticals, LLC at (877) 250-3427.

  • PRINCIPAL DISPLAY PANEL

    Distributed by: Method Pharmaceuticals, LLC
    Arlington, TX 76006 Rev. Date: 01/2016

    Pinciple Display Panel

    Principle Display

    Booklet

    Booklet

  • INGREDIENTS AND APPEARANCE
    ME NAPHOS MB HYO 1 
    urinary antiseptic antispasmodic tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58657-454
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV) METHENAMINE81.6 mg
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR) SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE40.8 mg
    METHYLENE BLUE ANHYDROUS (UNII: 8NAP7826UB) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH) METHYLENE BLUE CATION10.8 mg
    HYOSCYAMINE SULFATE ANHYDROUS (UNII: OB570Z127K) (HYOSCYAMINE - UNII:PX44XO846X) HYOSCYAMINE SULFATE ANHYDROUS0.12 mg
    Inactive Ingredients
    Ingredient NameStrength
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorblue (light blue to blue) Scoreno score
    ShapeOVALSize10mm
    FlavorImprint Code M455
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58657-454-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other12/01/2015
    Labeler - Method Pharmaceuticals (060216698)