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:

Safecor Health, LLC

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 0.5-ounce (15 ml) cups (NDC 48433-214-15), packaged into boxes of 40 cups per box (NDC 48433-214-40). Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. Rx Only. This package is not child resistant. For institutional use only. REV: 214-00 10-2018 Packaged by: Safecor Health, LLC 4060 Business Park Drive Columbus, OH 43204 Manufactured by: Xttrium Laboratories, Inc. 1200 E. Business Center Dr. Mount Prospect, IL 60056

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
SAFECOR HEALTH, LLC
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CHLORHEXIDINE GLUCONATE 0.12%, ORAL RINSE, USP
RX ONLY, NDC 48433-214-15, 48433-214-40
DESCRIPTION
0.12% chlorhexidine gluconate (CHG) is an oral rinse containing
(1,1'-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 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 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 mcg/g in humans 30
minutes after
they ingested a 300-mg dose of the drug.