Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)
Actavis Mid Atlantic LLC
Chlorhexidine Gluconate
RINSE
0.12 mg in 1 mL
ORAL
PRESCRIPTION DRUG
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 has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS. This product 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 supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in original container or in amber glass bottles. Manufactured by: Actavis MidAtlantic LLC 7205 Windsor Blvd. Baltimore, MD 21244 USA FORM NO. 0036 Rev. 10/06 VC2912
CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE ACTAVIS MID ATLANTIC LLC ---------- CHLORHEXIDINE GLUCONATE ORAL RINSE USP 0.12% FORM NO. 0036 Rev. 10/06 VC2912 RX ONLY DESCRIPTION This product 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, peppermint oil, saccharin sodium, and FD&C Blue #1. The pH may be adjusted with hydrochloric acid or sodium hydroxide. The solution is near-neutral (pH range 5–7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its molecular formula is C H Cl N •2C H O , molecular weight 897.77 and its structural formula is: CLINICAL PHARMACOLOGY Chlorhexidine gluconate provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate’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 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 0.12% chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient 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 Aqra d-dokument sħiħ