NUPRO CHLORHEXIDINE GLUCONATE- 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:

Dentsply LLC. Professional Division Trading as "DENTSPLY Professional"

INN (International Name):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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:

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures. NDC 65222-800-16. 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].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NUPRO CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
DENTSPLY LLC. PROFESSIONAL DIVISION TRADING AS "DENTSPLY PROFESSIONAL"
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NUPRO CHLORHEXIDINE GLUCONATE – CHLORHEXIDINE GLUCONATE RINSE
DENTSPLY PROFESSIONAL
CHLORHEXIDINE GLUCONATE 0.12%, ORAL RINSE, USP
RX ONLY, NDC 65222-800-16
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
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.
INDI