Страна: Соединенные Штаты
Язык: английский
Источник: NLM (National Library of Medicine)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)
AMD Medicom Inc.
CHLORHEXIDINE GLUCONATE
CHLORHEXIDINE GLUCONATE 1.2 mg in 1 mL
ORAL
PRESCRIPTION DRUG
CONTRAINDICATIONS : Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. 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.
HOW SUPPLIED : Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures
Abbreviated New Drug Application
CHLORHEXIDINE GLUCONANTE- CHLORHEXIDINE GLUCONANTE RINSE AMD MEDICOM INC. ---------- 10025-H MINT MEDICOM DENTICARE PRO-RINSE 0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE CLINICAL PHARMACOLOGY 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 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 in 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 hours after the compound was administered. Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine. CONTRAINDICATIONS CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be used by per Прочитать полный документ