CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

American Health Packaging

Verabreichungsweg:

DENTAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in: 15 ml unit dose cups: 40 cups (4 x 10) NDC 60687‐714‐64 15 ml unit dose cups: 100 cups (10 x 10) NDC 60687‐714‐16 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]. DO NOT USE IF SEAL IS BROKEN.

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE- CHLORHEXIDINE GLUCONATE,
0.12% ORAL RINSE SOLUTION
AMERICAN HEALTH PACKAGING
----------
CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP
RX ONLY
8471464/0922F
DESCRIPTION
0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,
1'-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 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 ingeste