CHLORHEXIDINE GLUCONATE rinse

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

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

थमां उपलब्ध:

Precision Dose, Inc.

प्रशासन का मार्ग:

ORAL

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) 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. Paroex® has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS . Paroex® should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

उत्पाद समीक्षा:

Paroex® is supplied as a pink liquid in the following sizes: NDC 68094-028-62 15 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-028-61 15 mL per unit dose cup One hundred (100) cups per shipper 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].

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

उत्पाद विशेषताएं

CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE
PRECISION DOSE, INC.
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CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%
ALCOHOL FREE
RX ONLY
_PAROEX (CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%)_
DESCRIPTION
Paroex
is an oral rinse containing 0.12% chlorhexidine gluconate
(1,1'-hexamethylene
bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base
containing deionized water,
propylene glycol, glycerin, polyoxyl 40 hydrogenated castor oil, mint
flavor, potassium
acesulfame, FD&C Red #40 and D&C Red #33. Paroex
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
Paroex
provides antimicrobial activity during oral rinsing. The clinical
significance of
chlorhexidine gluconate'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 bacteria resistance, overgrowth of
potentially opportunistic
organisms or other adverse changes in the oral microbial ecosystem.
Three months
after chlorhexidine gluconate 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 studies with 0.12% chlorhexidine gluconate oral rinse
indicate
approximately 30% of the active ingredient 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 µg/g in humans 30 minutes after they ingested a 300 mg dose
of the drug.
Detectable levels of