CHLORHEXIDINE GLUCONATE rinse

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)

Disponible depuis:

Carilion Materials Management

DCI (Dénomination commune internationale):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL

Mode d'administration:

ORAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Descriptif du produit:

Product: 68151-5230 NDC: 68151-5230-1 15 mL in a CUP, UNIT-DOSE

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
CARILION MATERIALS MANAGEMENT
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CHLORHEXIDINE GLUCONATE 0.12%, ORAL RINSE, USP
RX ONLY, NDC 0116-2001-16, 0116-2001-04, 0116-2001-15
CLINICAL PHARMACOLOGY
Chlorhexidine gluconate oral rinse provides antimicrobial activity
during oral rinsing. The clinical
significance of chlorhexidine gluconate oral rinse’s antimicrobial
activities is not clear.
Microbiological sampling of plaque has shown a general reduction of
counts of certain assayed
bacteria, both aerobic and anaerobic, ranging from 54–97% through
six-months use.
Use of chlorhexidine gluconate oral rinse in a six-month clinical
study did not result in any significant
changes in bacterial resistance, overgrowth of potentially
opportunistic organisms or other adverse
changes in the oral microbial ecosystem. Three months after
chlorhexidine gluconate oral rinse use
was discontinued, the number of bacteria in plaque had returned to
baseline levels and resistance of
plaque bacteria to chlorhexidine gluconate was equal to that at
baseline.
PHARMACOKINETICS: Pharmacokinetic studies with chlorhexidine gluconate
oral rinse indicate
approximately 30% of the active ingredient, chlorhexidine gluconate,
is retained in the oral cavity
following rinsing. This retained drug is slowly released into the oral
fluids. Studies conducted on
human subjects and animals demonstrate chlorhexidine gluconate is
poorly absorbed from the
gastrointestinal tract. The mean plasma level of chlorhexidine
gluconate reached a peak of 0 .206 mcg/g
in humans 30 minutes after they ingested a 300-mg dose of the drug.
Detectable levels of chlorhexidine
gluconate were not present in the plasma of these subjects 12 hours
after the compound was
administered. Excretion of chlorhexidine gluconate occurred primarily
through the feces (~90%). Less
than 1% of the chlorhexidine gluconate ingested by these subjects was
excreted in the urine.
INDICATION
Chlorhexidine gluconate oral rinse is indicated for use between dental
visits as part of a