SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS- chlorhexidine gluconate kit

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Sage Products LLC

DCI (Denominação Comum Internacional):

chlorhexidine gluconate

Composição:

chlorhexidine gluconate 1.2 mg in 1 mL

Tipo de prescrição:

OTC DRUG

Indicações terapêuticas:

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. - helps reduce bacteria that can potentially cause skin infection - for preparation of skin prior to surgery

Resumo do produto:

Chlorhexidine Gluconate Oral Rinse is supplied as a blue liquid in single dose 0.5 fluid ounce (15mL) amber plastic bottles with child-resistant dispensing 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].

Status de autorização:

New Drug Application

Características técnicas

SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS- CHLORHEXIDINE
GLUCONATE
SAGE PRODUCTS LLC
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SKIN ANTISEPSIS, ORAL CLEANSING, NASAL ANTISEPSIS
CHLORHEXIDINE GLUCONTATE 0.12% ORAL RINSE
DESCRIPTION
Chlorhexidine Gluconate is an oral rinse containing 0.12%
chlorhexidine gluconate (1,11-
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:
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 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 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