SKY ORAL RINSE- chlorhexidine gluconate rinse

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

McKesson

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.

Produkt oppsummering:

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in: NDC 63739-052-74 0.5-ounce (15 mL) white plastic unit dose cup NDC63739-052-57 0.5-ounce (15 mL) white plastic unit dose cups (40 pack) NDC 63739-052-69 0.5-ounce (15 mL) white plastic unit dose cups (100 pack) 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].

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

SKY ORAL RINSE- CHLORHEXIDINE GLUCONATE RINSE
MCKESSON
----------
0.12% SKY UNIT DOSE CUP
DESCRIPTION
0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,
11-hexamethylene
bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base
containing water, 11.6%
alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium
saccharin, and FD&C
Blue No. 1. Chlorhexidine gluconate product is a near neutral solution
(pH range 5-7).
Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.
Its chemical
structure is:
CLINICAL PHARMACOLOGY
Chlorhexidine golconate 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
clorhexidine 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. Thisi 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 s