MAJOR ORAL RINSE- 0.12% chlorhexidine gluconate rinse

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Major Pharmaceuticals

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 safey of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.

Produktbesonderheiten:

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 0.5-ounce (15 ml) (NDC 0904-7035-88) white plastic unit dose cups, 0.5-ounce (15 ml) (NDC 0904-7035-87) white plastic unit dose cups (40 pack) and 0.5-ounce (15 ml) (NDC 0904-7035-80) white plastic unit dose cups (100 pack). Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MAJOR ORAL RINSE- 0.12% CHLORHEXIDINE GLUCONATE RINSE
MAJOR PHARMACEUTICALS
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0.12% MAJOR UNIT DOSE CUPS
DESCRIPTION
0.12% chlorhexidine gluconate (CHG) is an oral rinse
containing (1, 11-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 becteria, 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 was equal to that as 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 in 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 present
in the plas