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:

Adrian Pharmaceuticals, LLC

INN (International Name):

Chlorhexidine Gluconate

Composition:

Chlorhexidine Gluconate 2.5 mg

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 10 chips (NDC 52096-001-12) and 20 chips (NDC 52096-001-22). Each chip is individually packed in a separate compartment of an aluminum blister pack. Store at controlled room temperature 15° - 25°C (59° - 77°F) (see USP). Rx only.

Authorization status:

New Drug Application

Summary of Product characteristics

PERIOCHIP - CHLORHEXIDINE GLUCONATE INSERT, EXTENDED RELEASE
ADRIAN PHARMACEUTICALS, LLC
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PERIOCHIP, 2.5 MG (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 7.4 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, precipiates 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 the
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
22
30
2
10
6
12
7
differs from the Regulatory Specification’s Agar Release Rate Assay.
This release prof