UROGESIC BLUE- methenamine, sodium phosphate, monobasic, methylene blue, and hyoscyamine sulfate tablet, coated

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV), SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW) (SODIUM CATION - UNII:LYR4M0NH37), METHYLENE BLUE (UNII: T42P99266K) (METHYLENE BLUE CATION - UNII:ZMZ79891ZH), HYOSCYAMINE SULFATE (UNII: F2R8V82B84) (HYOSCYAMINE - UNII:PX44XO846X)

Commercializzato da:

EDWARDS PHARMACEUTICALS, INC.

INN (Nome Internazionale):

METHENAMINE

Composizione:

METHENAMINE 81.6 mg

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

UROGESIC-BLUE™ 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. UROGESIC-BLUE™ is contraindicated in patients with a hypersensitivity to any of the ingredients. Risk-benefit should be considered when the following medical problems exist: Cardiac disease (especially cardiac arrythmias, 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). A dependence on the use of UROGESIC-BLUE™ has not been reported and due to the nature of its ingredients, abuse of UROGESIC-BLUE™ is not expected.

Dettagli prodotto:

UROGESIC-BLUE™ are light blue to blue, oval, biconvex tablets debossed with "ED UB" with scoreline on one side and plain on the other side. Supplied in bottles of 100 tablets (NDC 0485-0151-01). RX ONLY 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.

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

UROGESIC BLUE- METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE
BLUE, AND HYOSCYAMINE SULFATE TABLET, COATED
EDWARDS PHARMACEUTICALS, INC.
_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._
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UROGESIC-BLUE™
RX ONLY
DESCRIPTION
Each tablet contains:
Methenamine, USP
81.6 mg
Monobasic Sodium
Phosphate, USP
40.8 mg
Methylene Blue, USP
10.8 mg
Hyoscyamine Sulfate, USP
0.12 mg
INACTIVE INGREDIENTS INCLUDE: microcrystalline cellulose, NF,
mannitol, USP,
croscarmellose sodium, NF, magnesium stearate, NF and lake blend blue.
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.
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 t