PERIDEX- chlorhexidine gluconate rinse

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Xttrium Laboratories, Inc.

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Peridex is supplied as a blue liquid in 4-ounce (118ml), 1-pint (473ml) and 64-ounce (1893ml) white or 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]. Rx only Keep out of reach of children

Autorizacija statusas:

New Drug Application

Prekės savybės

PERIDEX- CHLORHEXIDINE GLUCONATE RINSE
XTTRIUM LABORATORIES, INC.
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PERIDEX™ (CHLORHEXIDINE GLUCONATE 0.12%) ORAL RINSE
DESCRIPTION
Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse 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. Peridex
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
Peridex (Chlorhexidine Guconate 0.12%) Oral Rinse provides
antimircobial activity during
oral rinsing. The clinical significance of Peridex 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 Peridex 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 Peridex 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 Peridex 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 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 hour