URELLE- hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate tablet

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X), METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV), METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH), PHENYL SALICYLATE (UNII: 28A37T47QO) (PHENYL SALICYLATE - UNII:28A37T47QO), SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR)

Disponible depuis:

Meda Pharmaceuticals

DCI (Dénomination commune internationale):

HYOSCYAMINE SULFATE

Composition:

HYOSCYAMINE SULFATE 0.12 mg

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Urelle® is indicated for the treatment of symptoms of irritative voiding. Indicated for the relief of local symptoms, such as inflammation, hypermotility, and pain, which accompany lower urinary tract infections. Indicated for the relief of urinary tract symptoms caused by diagnostic procedures. Hypersensitivity to any of the ingredients is possible. Risk - benefit should be carefully considered when the following medical problems exist: cardiac disease (especially cardiac arrhythmias, congestive heart failure, coronary heart disease, mitral stenosis); gastrointestinal tract obstructive disease; glaucoma; myasthenia gravis; acute urinary retention may be precipitated in obstructive uropathy (such as bladder neck obstruction due to prostatic hypertrophy).

Descriptif du produit:

Urelle® tablets for oral administration are supplied in child resistant bottles of 90 tablets (NDC 0037-6321-90). Store at controlled room temperature 20°-25°C (68°-77°F). Dispense in a tight, light resistant container as defined in the USP. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Statut de autorisation:

unapproved drug other

Résumé des caractéristiques du produit

URELLE- HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL
SALICYLATE, AND SODIUM
PHOSPHATE, MONOBASIC, MONOHYDRATE TABLET
MEDA PHARMACEUTICALS
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
URELLE
URINARY ANTISEPTIC
DESCRIPTION:
Urelle
tablets for oral administration are supplied as navy blue round
tablets with “A-002” debossed
on one side.
Each Tablet Contains:
Hyoscyamine Sulfate 0.12 mg
Methenamine 81.0 mg
Methylene Blue 10.8 mg
Phenyl Salicylate 32.4 mg
Sodium Phosphate Monobasic 40.8 mg
INACTIVE INGREDIENTS:
Corn Starch, Dicalcium Phosphate, FD&C Blue #2/Indigo Carmine Aluminum
Lake, Magnesium
Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polyvinyl
Alcohol, Talc, Titanium Dioxide.
INDICATIONS AND USAGE:
Urelle
is indicated for the treatment of symptoms of irritative voiding.
Indicated for the relief of local
symptoms, such as inflammation, hypermotility, and pain, which
accompany lower urinary tract
infections. Indicated for the relief of urinary tract symptoms caused
by diagnostic procedures.
CONTRAINDICATIONS:
Hypersensitivity to any of the ingredients is possible. Risk - benefit
should be carefully considered
when the following medical problems exist: cardiac disease (especially
cardiac arrhythmias,
congestive heart failure, coronary heart disease, mitral stenosis);
gastrointestinal tract obstructive
disease; glaucoma; myasthenia gravis; acute urinary retention may be
precipitated in obstructive
uropathy (such as bladder neck obstruction due to prostatic
hypertrophy).
WARNINGS:
IF RAPID PULSE, DIZZINESS, OR BLURRING OF VISION OCCURS, DISCONTINUE
USE IMMEDIATELY.
Patients should be advised that urine will be colored blue when taking
this medication. Do not exceed
recommended dosage.
PRECAUTIONS:
Cross sensitivity and/or related problems - patients intolerant of
belladonna alkaloids or salicylates may
®
®
®
be intolerant of this medi