CHLORHEXIDINE GLUCONATE rinse

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)

Disponibil de la:

Actavis Mid Atlantic LLC

INN (nume internaţional):

Chlorhexidine Gluconate

Forma farmaceutică:

RINSE

Compoziție:

0.12 mg in 1 mL

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS. This product should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

Rezumat produs:

Chlorhexidine Gluconate Oral Rinse 0. 12% is supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in original container or in amber glass bottles. Manufactured by: Actavis MidAtlantic LLC 7205 Windsor Blvd. Baltimore, MD 21244 USA FORM NO. 0036 Rev. 10/06 VC2912

Caracteristicilor produsului

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
ACTAVIS MID ATLANTIC LLC
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CHLORHEXIDINE GLUCONATE ORAL RINSE USP 0.12%
FORM NO. 0036
Rev. 10/06
VC2912
RX ONLY
DESCRIPTION
This product 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, peppermint oil, saccharin sodium, and FD&C
Blue #1. The pH may be adjusted
with hydrochloric acid or sodium hydroxide. The solution is
near-neutral (pH range 5–7).
Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.
Its molecular formula is
C
H Cl
N •2C H O , molecular weight 897.77 and its structural formula is:
CLINICAL PHARMACOLOGY
Chlorhexidine gluconate provides antimicrobial activity during oral
rinsing. The clinical significance
of chlorhexidine gluconate’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 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 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