Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)
LLC Federal Solutions
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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. CONTRAINDICATIONS Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. Pediatric Use Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.
HOW SUPPLIED Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 15 mL unit dose cups. NDC 24451-001-15. Store at 20°C to 25°C (68°F-77°F). See USP Controlled Room Temperature. Rx Only. Repackaged by: Safecor Health, LLC 317 New Boston St. Woburn, MA 01801 Distributed by: LLC Federal Solutions Miami, FL 33132 Rev 100-01 07/2013
Abbreviated New Drug Application
CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE RINSE LLC FEDERAL SOLUTIONS ---------- RX ONLY, NDC 24451-001-15 DESCRIPTION 0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (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. Chlorhexidine gluconate product 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 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 in humans 30 minutes after they ingested a 300-mg dose of the drug. Detectable levels of chlorhexidine gluconate were not pr Preberite celoten dokument