Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)
Bajaj Medical, LLC
DENTAL
PRESCRIPTION DRUG
Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 ml) amber plastic bottle with child-resistant dispensing closure and 1-pint (473 ml) amber plastic bottle with child-resistant closure, 4-ounce (118 ml) amber plastic bottle with child-resistant closure, 64-ounce (1893 ml) white plastic bottle with foam-lined closure and 15 ml unit-dose cup. STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature]. Rx Only. Revised: November 2021 Manufactured by: Bajaj Medical 415 W Pershing Rd. Chicago, IL 60609 USA
Abbreviated New Drug Application
CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION- CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION SOLUTION BAJAJ MEDICAL, LLC ---------- CHLORHEXIDINE GLUCONATE, 0.12% ORAL RINSE SOLUTION BAJAJ MEDICAL, LLC 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 mcg/g in humans 30 minutes after Citiți documentul complet