CHLORHEXIDINE- chlorhexidine gluconate solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

NuCare Pharmaceuticals,Inc.

Droga podania:

ORAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

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.

Podsumowanie produktu:

Chlorhexidine Gluconate Oral Rinse, 0.12% is a blue, peppermint flavored liquid and is supplied as: NDC 0121-0893-04: 4 fl oz (118 mL) NDC 68071-2377-6: 16 fl oz (473 mL) Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Rx only Keep out of reach of children Dispense in bottle as provided or in an amber plastic bottle with a child-resistant closure.

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

CHLORHEXIDINE- CHLORHEXIDINE GLUCONATE SOLUTION
NUCARE PHARMACEUTICALS,INC.
----------
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% alcohol, FD&C Blue No. 1,
glycerin, peppermint
flavor, polysorbate 80, purified water, and saccharin sodium.
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 chemical structure is:
C
H
CI
N
∙2C
H
O M.W. 897.72
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
antimicrobial activities is not clear. Microbiological sampling of
plaque has shown a
general reduction of counts of certain assayed bacteria, both aerobic
and anaerobic,
1
22
30
2
10
6
12
7
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 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
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 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