Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)
NuCare Pharmaceuticals,Inc.
ORAL
PRESCRIPTION DRUG
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.
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.
Abbreviated New Drug Application
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 Preberite celoten dokument