NUPRO CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate rinse

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Xttrium Laboratories, Inc.

Via di somministrazione:

ORAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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

Dettagli prodotto:

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures. NDC 65222-800-16. Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature].

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

NUPRO CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
XTTRIUM LABORATORIES, INC.
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NUPRO DENTSPLY CHLORHEXIDINE GLUCONATE 0.12%, USP
CHLORHEXIDINE GLUCONATE 0.12%, ORAL RINSE, USP
RX ONLY, NDC 65222-800-16
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 in 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
vis