ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- chlorhexidine gluconate solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Henry Schein, Inc.

Toedieningsweg:

DENTAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

INDICATION: Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS. CONTRAINDICATION: Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. Pediatric Use: Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18. DIRECTIONS FOR USE: Swish 1 tablespoon (15ml) in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed. NOTE: To minimize medicinal taste, do not rinse with water immediately after us

Product samenvatting:

HOW SUPPLIED: Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. 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] .

Autorisatie-status:

Abbreviated New Drug Application

Productkenmerken

ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- CHLORHEXIDINE
GLUCONATE SOLUTION
HENRY SCHEIN, INC.
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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 ingested a 300-mg dose of the
drug. Detectable levels of chlorhexidine gluconate were not