CHLORHEXIDINE GLUCONATE rinse

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

VistaPharm, LLC

Az alkalmazás módja:

BUCCAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% 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 USP, 0.12% should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Termék összefoglaló:

Chlorhexidine gluconate oral rinse USP, 0.12% is a blue liquid supplied as follows: NDC 66689-106-01: 15 mL unit-dose cup NDC 66689-106-50: Case contains 50 unit-dose cups of 15 mL (NDC 66689-106-01), packaged in 5 trays of 10 unit-dose cups each. NDC 66689-106-99: Case contains 100 unit-dose cups of 15 mL (NDC 66689-106-01), packaged in 10 trays of 10 unit-dose cups each. Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. DIRECTIONS FOR USE: Swish 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 use.

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
VISTAPHARM, INC.
----------
CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%
DESCRIPTION:
Chlorhexidine gluconate oral rinse USP, 0.12% is an oral rinse
containing 0.12%
chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorophenyl)
biguanide] di-D-
gluconate) in a base containing water, propylene glycol, glycerin,
sorbitol, polyoxyl 40
hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C
blue no. 1.
Chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% 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 USP, 0.12% 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 USP, 0.12% 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 a chlorhexidine gluconate oral rinse USP,
0.12% indicate
approximately 30% of the active ingredient 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