CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Chartwell RX, LLC

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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.

Resumen del producto:

Chlorhexidine Gluconate 0.12% Oral Rinse, USP is supplied as a light blue color clear solution in 4-ounce (120 ml) [NDC 62135-649-41] and 16 ounce (473ml) [62135-649-47] child-resistant bottles. 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]. Dispense in original container or in amber glass bottles. Rx only Keep out of reach of children. Manufactured for: Chartwell RX, LLC. Congers, NY 10920 L71503 Revised: 07/2023

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- CHLORHEXIDINE GLUCONATE
0.12% ORAL RINSE SOLUTION
CHARTWELL RX, LLC
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CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE, USP
DESCRIPTION:
Chlorhexidine Gluconate 0.12% Oral Rinse, USP is an oral rinse
containing 0.12%
chlorhexidine gluconate (1, 11-hexamethylene bis [5-(p-chlorophenyl)
biguanide] di-D-
gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40
sorbitan
diisostearate, peppermint flavor, sodium saccharin, and FD&C Blue No.
1. Chlorhexidine
gluconate oral solution is a near-neutral solution (pH range 5-7).
Chlorhexidine gluconate
is a salt of chlorhexidine and gluconic acid. Its molecular formula is
C
H
C
N
·2C
H
O
, the molecular weight is 897 and 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 bacteria 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 le