CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- chlorhexidine gluconate liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Xttrium Laboratories, Inc.

Administration route:

BUCCAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. 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 safety of Chlorhexidine Gluconate Oral Rinse have not been established in children under the age of 18.

Product summary:

Chlorhexidine Gluconate Oral Rinse is supplied as a blue liquid in single dose 0.5 fluid ounce (15mL) amber plastic bottles with child-resistant dispencing closures. 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]. Rx Only KEEP OUT OF REACH OF CHILDREN.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE- CHLORHEXIDINE GLUCONATE
LIQUID
XTTRIUM LABORATORIES, INC.
----------
CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE SAGE
DESCRIPTION
Chlorhexidine Gluconate is an oral rinse containing 0.12%
chlorhexidine gluconate (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 is a near-neutral solution (pH range 5-7).
Chlorhexidine Gluconate is a salt of
chlorhexidine and gluconic acid. Its chemical structure is:
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 Glucoante Oral Rinse 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.
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