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:

Proficient Rx LP

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, 0.12% 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, 0.12% 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, 0.12% 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, 0.12% is a blue, peppermint flavored liquid in: A 16 fl oz (473 mL) amber plastic bottle with a child-resistant closure and dosage cup for consumer use, and in 15 mL unit dose cups. It should be dispensed in original container or in amber glass. Store above freezing 0°C (32°F)    Rx only Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701 Rev. 720:05 7/10 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
PROFICIENT RX LP
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CHLORHEXIDINE GLUCONATE ORAL RINSE, 0.12%
DESCRIPTION
Chlorhexidine Gluconate Oral Rinse, 0.12% is an oral rinse containing
0.12% chlorhexidine gluconate
(1, 1'-hexamethylene bis[5-(p-chlorophenyl) biguanide] di-D-gluconate)
in a base containing 11.6% v/v
alcohol, FD&C Blue No. 1, glycerin, PEG-40 sorbitan diisostearate,
peppermint flavor, sodium
saccharin, and purified water. Chlorhexidine Gluconate Oral Rinse,
0.12% is a near-neutral solution
(pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and
gluconic acid. Its structural
formula is: C
H Cl
N •2C H O MW = 897.8
CLINICAL PHARMACOLOGY
Chlorhexidine Gluconate Oral Rinse, 0.12% provides antimicrobial
activity during oral rinsing. The
clinical significance of 0.12% chlorhexidine gluconate oral rinse's
anti-microbial 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 bacteria resistance, overgrowth of potentially
opportunistic organisms or other adverse
changes in the oral microbial ecosystem. Three months after
chlorhexidine gluconate 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 0.12% 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