PAROEX- chlorhexidine gluconate rinse

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

ATLANTIC BIOLOGICALS CORP.

INN (Διεθνής Όνομα):

Chlorhexidine Gluconate

Σύνθεση:

Chlorhexidine Gluconate 1.2 mg in 1 mL

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

INDICATIONS AND USAGE: 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. CONTRAINDICATIONS: Paroex® should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients. Pediatric Use: Clinical effectiveness and safety of Paroex® have not been established in children under the age of 18.

Περίληψη προϊόντος:

HOW SUPPLIED: Paroex® is supplied as a pink liquid in the following sizes: 4 fl oz (118 ml) (NDC 52376-021-04) amber plastic bottles with child-resistant cap. 16 fl oz (473 ml) (NDC 52376-021-02) amber plastic bottles with child-resistant cap, individually shrink wrapped with a dosage cup. STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP controlled room temperature]. Rx Only Keep Out of Reach of Children. Manufactured for: Sunstar Americas, Inc., Chicago, IL 60630 Revised: July 2014

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

PAROEX- CHLORHEXIDINE GLUCONATE RINSE
ATLANTIC BIOLOGICALS CORP.
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_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 bacterial 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. The
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 chlorhexidine
gluconate were not present in
the plasma of these subj