国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)
Dexcel Pharma Technologies Ltd.
Chlorhexidine Gluconate
Chlorhexidine Gluconate 2.5 mg
PERIODONTAL
PRESCRIPTION DRUG
PerioChip is indicated as an adjunct to scaling and root planing procedures for reduction of pocket depth in patients with adult periodontitis. PerioChip may be used as a part of a periodontal maintenance program, which includes good oral hygiene and scaling and root planing. PerioChip should not be used in any patient who has a known sensitivity to chlorhexidine.
PerioChip (chlorhexidine gluconate) 2.5 mg is supplied as a small, orange-brown, rectangular chip (rounded at one end), in cartons of 20 chips (NDC 64239-101-20) . Each chip is individually packed in a separate compartment of an aluminum blister pack. Store at 20° - 25°C with excursions permitted to 15° - 30° C (59° - 86°F). Rx only.
New Drug Application
PERIOCHIP- CHLORHEXIDINE GLUCONATE INSERT, EXTENDED RELEASE DEXCEL PHARMA TECHNOLOGIES LTD. ---------- PERIOCHIP 2.5MG (CHLORHEXIDINE GLUCONATE) DESCRIPTION PerioChip® (chlorhexidine gluconate) is a small, orange-brown, rectangular chip (rounded at one end) for insertion into periodontal pockets. Each PerioChip weighs approximately 6.9 mg and contains 2.5 mg of chlorhexidine gluconate in a biodegradable matrix of hydrolyzed gelatin (cross-linked with glutaraldehyde). PerioChip also contains glycerin and purified water. Chlorhexidine gluconate is an antimicrobial agent. Chemically, it is designated as 1,1'- hexamethylenebis [5-(_p_-chlorophenyl)biguanide] di-D-gluconate, and its molecular formula is C H Cl N .2C H O . The molecular weight is 897.8. The structural formula of chlorhexidine gluconate is: CLINICAL PHARMACOLOGY MICROBIOLOGY Chlorhexidine gluconate is active against a broad spectrum of microbes. The chlorhexidine molecule, due to its positive charge, reacts with the microbial cell surface, destroys the integrity of the cell membrane, penetrates into the cell, precipitates the cytoplasm, and the cell dies. Studies with PerioChip showed reductions in the numbers of the putative periodontopathic organisms _Porphyromonas (Bacteroides) gingivalis,_ _Prevotella (Bacteroides) intermedia, Bacteroides forsythus,_ and _Campylobacter rectus_ _(Wolinella recta)_ after placement of the chip. No overgrowth of opportunistic organisms or other adverse changes in the oral microbial ecosystem were noted. The relationship of the microbial findings to clinical outcome has not been established. PHARMACOKINETICS PerioChip releases chlorhexidine _in vitro_ in a biphasic manner, initially releasing approximately 40% of the chlorhexidine within the first 24 hours and then releasing the remaining chlorhexidine in an almost linear fashion for 7-10 days. This enzymatic release rate assay is an experimental collagenase assay that differs from the Regulatory Specification's Agar Release Rate Assay. This release profile may be expla 阅读完整的文件