Land: Vereinigte Staaten
Sprache: Englisch
Quelle: NLM (National Library of Medicine)
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)
Precision Dose, Inc.
ORAL
PRESCRIPTION DRUG
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.
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].
Abbreviated New Drug Application
CHLORHEXIDINE GLUCONATE- CHLORHEXIDINE GLUCONATE RINSE PRECISION DOSE, INC. ---------- 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 Lesen Sie das vollständige Dokument