ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- chlorhexidine gluconate 0.12% oral rinse liquid

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Xttrium Laboratories, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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. 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.

Produkto santrauka:

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 dispensing closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature]. Distributed by: Henry Schein Inc. 135 Duryea Road Melville, NY 11747 USA MADE IN USA by HENRY SCHEIN® Rx Only Rev: 2022/04

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- CHLORHEXIDINE
GLUCONATE 0.12% ORAL RINSE LIQUID
XTTRIUM LABORATORIES, INC.
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HENRY SCHEIN ACCLEAN 4-OZ CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE,
USP
ACCLEAN is an oral rinse containing 0.12% chlorhexidine gluconate
(1,1’-hexamethylene
bis [5-(p-chlorphenyl) 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:
ACCLEAN 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 dos