PERIOCHIP- chlorhexidine gluconate insert, extended release

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)

Available from:

Dexcel Pharma Technologies Ltd.

INN (International Name):

Chlorhexidine Gluconate

Composition:

Chlorhexidine Gluconate 2.5 mg

Administration route:

PERIODONTAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

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.

Authorization status:

New Drug Application

Summary of Product characteristics

PERIOCHIP- CHLORHEXIDINE GLUCONATE INSERT, EXTENDED RELEASE
DEXCEL PHARMA TECHNOLOGIES LTD.
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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