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:

LLC Federal Solutions

INN (International Name):

CHLORHEXIDINE GLUCONATE

Composition:

CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATION Chlorhexidine gluconate oral rinse 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 has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS. CONTRAINDICATIONS Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. Pediatric Use Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.

Product summary:

HOW SUPPLIED Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 15 mL unit dose cups. NDC 24451-001-15. Store at 20°C to 25°C (68°F-77°F). See USP Controlled Room Temperature. Rx Only. Repackaged by: Safecor Health, LLC 317 New Boston St. Woburn, MA 01801 Distributed by: LLC Federal Solutions Miami, FL 33132 Rev 100-01 07/2013

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE RINSE
LLC FEDERAL SOLUTIONS
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RX ONLY, NDC 24451-001-15
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 µg/g
in humans 30 minutes after they ingested a 300-mg dose of the drug.
Detectable levels of chlorhexidine
gluconate were not pr