UROGESIC BLUE methenamine sodium phosphate monobasic methylene and hyoscyamine sulfate tablet

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

METHENAMINE (UNII: J50OIX95QV) (METHENAMINE - UNII:J50OIX95QV)

Commercializzato da:

EDWARDS PHARMACEUTICAL, INC.

INN (Nome Internazionale):

METHENAMINE

Composizione:

METHENAMINE 81.6 mg

Tipo di ricetta:

PRESCRIPTION DRUG

Stato dell'autorizzazione:

unapproved drug other

Scheda tecnica

UROGESIC BLUE- METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE
BLUE, AND
HYOSCYAMINE SULFATE TABLET
EDWARDS PHARMACEUTICAL, 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
DES CRIPTION
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 this amoun