CHLORHEXIDINE GLUCONATE rinse

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Patterson Dental Supply Inc.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Product summary:

HOW SUPPLIED : 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
PATTERSON DENTAL SUPPLY INC.
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044-1576 MINT (4 OZ)
PATTERSON 0.12% CHLORHEXIDINE GLUCONATE ORAL RINSE
0.12% USP
CLINICAL PHARMACOLOGY
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 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
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 plasma of these
subjects 12 hours after the compound was administered. Excretion of
chlorhexidine gluconate occurred
primarily through the feces (~90%). Less than 1% of the chlorhexidine
gluconate ingested by these
subjects was excreted in the urine.
CONTRAINDICATIONS
CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be
u