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:

Henry Schein, 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]. Rx Only Revised: December 2015 Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea Road Melville, NY 11747 USA

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ACCLEAN CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- CHLORHEXIDINE
GLUCONATE
0.12% ORAL RINSE LIQUID
HENRY SCHEIN, INC.
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HENRY SCHEIN ACCLEAN 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 dose of the drug