FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
WARNINGS: The effect of Paroex® on peridontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. See CONTRAINDICATIONS.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
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:
Sources
Paroex Manufacturers
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Sunstar Americas, Inc.
Paroex | Sunstar Americas, Inc.
DOSAGE AND ADMINISTRATION: Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) therapy should be initiated directly following a dental prophylaxis. Patients using Paroex® should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily, oral rinsing 30 seconds, morning and evening after toothbrushing. Usual dosage is 15 mL of undiluted Paroex®. Patients should be instructed not to rinse with water, or other mouthwashes, brush teeth, or eat immediately after using Paroex®. Paroex® is not intended for ingestion and should be expectorated after rinsing.
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