CHLORHEXIDINE GLUCONATE liquid

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Xttrium Laboratories, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Chlorhexidine gluconate oal 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 oral rinse have not been established in children under the age of 18.

Produkt oppsummering:

Chlorhexidine gluconate oral rinse is suppplied as a blue liquid in 4-ounce (118 mL) and 1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures. NDC 0116-0101-04 / 0116-0101-01 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] Rx Only Manufactured for: Patterson Dental Supply, Inc. 1031 Mendota Heights Road Saint Paul, MN 55120

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE LIQUID
XTTRIUM LABORATORIES, INC.
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CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE PATTERSON
0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1
-hexamethylene bis [5 - (p-
chlorophenyl) biguanide] di-D-gluconate) in a base containing wate,
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:
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 of 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 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 prese