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Chlorhexidine Gluconate 0.12% Oral Rinse
Overview
What is Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
ACCLEAN is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorphenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:
What does Acclean Chlorhexidine Gluconate 0.12% Oral Rinse look like?
What are the available doses of Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
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What should I talk to my health care provider before I take Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
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How should I use Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
Chlorhexidine gluconate oral rinse 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. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see
Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months.
Recommended use is twice daily rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage is 15 ml (marked in cap) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.
What interacts with Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
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What are the warnings of Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
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What are the precautions of Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
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What are the side effects of Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
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What should I look out for while using Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
The effect of chlorhexidine gluconate oral rinse on periodontitis 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.
What might happen if I take too much Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of chlorhexidine gluconate oral rinse is ingested by a small child or if signs of alcohol intoxication develop.
How should I store and handle Acclean Chlorhexidine Gluconate 0.12% Oral Rinse?
Store vials in the refrigerator at 2 to 8 °C (36 °F – 46 °F). Avoid excessive or vigorous agitation. . An unused vial of ACTIMMUNE can be stored at room temperature up to 12 hours prior to use. Discard vials if not used within the 12 hour period. Do not return to the refrigerator.Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature].Rx OnlyRevised:Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea RoadMelville, NY 11747 USAMade in USAChlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature].Rx OnlyRevised:Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea RoadMelville, NY 11747 USAMade in USAChlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature].Rx OnlyRevised:Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea RoadMelville, NY 11747 USAMade in USAChlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature].Rx OnlyRevised:Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea RoadMelville, NY 11747 USAMade in USAChlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature].Rx OnlyRevised:Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea RoadMelville, NY 11747 USAMade in USAChlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature].Rx OnlyRevised:Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea RoadMelville, NY 11747 USAMade in USAChlorhexidine gluconate oral rinse is supplied as a blue liquid in 4-ounce (118 ml) and 1-pint (473 ml) amber plastic bottles with child-resistant closures. Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F-86°F) [See USP controlled Room Temperature].Rx OnlyRevised:Distributed by (in US only): HENRY SCHEIN, INC 135 Duryea RoadMelville, NY 11747 USAMade in USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
ACCLEAN chlorhexidine gluconate oral rinse provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate oral rinse’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 of 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 oral rinse 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:
.
Non-Clinical Toxicology
Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.The effect of chlorhexidine gluconate oral rinse on periodontitis 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.
Cyclobenzaprine HCl may have life-threatening interactions with MAO inhibitors. (See .) Postmarketing cases of serotonin syndrome have been reported during combined use of Cyclobenzaprine Hydrochloride and other drugs, such as SSRIs, SNRIs, TCAs, tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. If concomitant treatment with Cyclobenzaprine Hydrochloride and other serotonergic drugs is clinically warranted, careful observation is advised, particularly during treatment initiation or dose increases (see ).
Cyclobenzaprine HCl may enhance the effects of alcohol, barbiturates, and other CNS depressants.
Tricyclic antidepressants may block the antihypertensive action of guanethidine and similarly acting compounds.
Tricyclic antidepressants may enhance the seizure risk in patients taking tramadol.
† ULTRAM (tramadol hydrochloride tablets, Ortho-McNeil Pharmaceutical)
† ULTRACET (tramadol hydrochloride and acetaminophen tablets, Ortho-McNeil Pharmaceutical)
1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse should not be used as a major indicator of underlying periodontitis.
2. Chlorhexidine gluconate oral rinse can cause staining of oral surfaces, such as tooth surfaces, restorations, and the dorsum of the tongue. Not all patients will experience a visually significant increase in tooth staining. In clinical testing, 56% of chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of chlorhexidine gluconate oral rinse users developed what was judged to be heavy stain, compared to 1% of control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque.
Stain resulting from use of chlorhexidine gluconate oral rinse does not adversely affect health of the gingivae or other oral tissues. Stain can be removed from most tooth surfaces by conventional professional prophylactic techniques. Additional time may be required to complete the prophylaxis. Discretion should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse treatment if permanent discoloration is unacceptable. Stain in these areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.
3. Some patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance.
The most common side effects associated with chlorhexidine gluconate oral rinses are: 1) an increase in staining of teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception; see WARNINGS and PRECAUTIONS. Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with the use of chlorhexidine gluconate rinse.
The following oral mucosal side effects were reported during placebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1%.
Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.
Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse.
There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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