CHLORHEXIDINE GLUCONANTE rinse

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

AMD Medicom Inc.

DCI (Denominação Comum Internacional):

CHLORHEXIDINE GLUCONATE

Composição:

CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

CONTRAINDICATIONS : Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. 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.

Resumo do produto:

HOW SUPPLIED : Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures

Status de autorização:

Abbreviated New Drug Application

Características técnicas

CHLORHEXIDINE GLUCONANTE- CHLORHEXIDINE GLUCONANTE RINSE
AMD MEDICOM INC.
----------
10025-H MINT
MEDICOM DENTICARE PRO-RINSE 0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE
CLINICAL PHARMACOLOGY
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
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 a 300 mg dose of the drug. Detectable levels of
chlorhexidine gluconate
were not present in the plasma of these
subjects 12 hours after the compound was administered. Excretion of
chlorhexidine
gluconate occurred primarily through the feces (~90%). Less than 1% of
the
chlorhexidine gluconate ingested by these subjects was excreted in the
urine.
CONTRAINDICATIONS
CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be
used by
per