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Chlorhexidine Gluconate 0.12% Oral Rinse
Overview
What is DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
This product is an oral rinse containing 0.12% chlorhexidine gluconate (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-0-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, peppermint oil, saccharin sodium, and FD&C Blue #1. The pH may be adjusted with hydrochloric acid or sodium hydroxide. The solution is near-neutral (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its molecular formula is CHClN •2CH0, molecular weight 897.77 and its structural formula is:
What does DASH Chlorhexidine Gluconate 0.12% Oral Rinse look like?
What are the available doses of DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
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What should I talk to my health care provider before I take DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
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How should I use DASH 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 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 should be reevaluated and given a thorough prophylaxis at intervals no longer than six months.
Recommended use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing. Usual dosage is 15ml (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 DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
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What are the warnings of DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
As with levodopa, treatment with carbidopa and levodopa extended-release tablets may increase the possibility of upper gastrointestinal hemorrhage in patients with a history of peptic ulcer.
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.
See .
What are the precautions of DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
General:
1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate 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 toothstaining. 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 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 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 use of chlorhexidine gluconate oral rinse have been reported via postmarketing product surveillance.
What are the side effects of DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
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 and . 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 1.0%.
Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate 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.
What should I look out for while using DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
This product 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.
See .
What might happen if I take too much DASH 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 DASH Chlorhexidine Gluconate 0.12% Oral Rinse?
Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes:1/2 fluid ounce (15 ml) (NDC 69339-138-15) amber plastic unit-dose cups.1/2 fluid ounce (15 ml) (NDC 69339-138-17) amber plastic unit-dose cups in 40 pack.1/2 fluid ounce (15 ml) (NDC 69339-138-19) amber plastic unit-dose cups in 100 pack.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Dispense in original container or in amber glass bottles.Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes:1/2 fluid ounce (15 ml) (NDC 69339-138-15) amber plastic unit-dose cups.1/2 fluid ounce (15 ml) (NDC 69339-138-17) amber plastic unit-dose cups in 40 pack.1/2 fluid ounce (15 ml) (NDC 69339-138-19) amber plastic unit-dose cups in 100 pack.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Dispense in original container or in amber glass bottles.Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes:1/2 fluid ounce (15 ml) (NDC 69339-138-15) amber plastic unit-dose cups.1/2 fluid ounce (15 ml) (NDC 69339-138-17) amber plastic unit-dose cups in 40 pack.1/2 fluid ounce (15 ml) (NDC 69339-138-19) amber plastic unit-dose cups in 100 pack.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Dispense in original container or in amber glass bottles.Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes:1/2 fluid ounce (15 ml) (NDC 69339-138-15) amber plastic unit-dose cups.1/2 fluid ounce (15 ml) (NDC 69339-138-17) amber plastic unit-dose cups in 40 pack.1/2 fluid ounce (15 ml) (NDC 69339-138-19) amber plastic unit-dose cups in 100 pack.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Dispense in original container or in amber glass bottles.Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes:1/2 fluid ounce (15 ml) (NDC 69339-138-15) amber plastic unit-dose cups.1/2 fluid ounce (15 ml) (NDC 69339-138-17) amber plastic unit-dose cups in 40 pack.1/2 fluid ounce (15 ml) (NDC 69339-138-19) amber plastic unit-dose cups in 100 pack.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Dispense in original container or in amber glass bottles.Chlorhexidine Gluconate Oral Rinse USP 0.12% is supplied as a blue liquid in the following sizes:1/2 fluid ounce (15 ml) (NDC 69339-138-15) amber plastic unit-dose cups.1/2 fluid ounce (15 ml) (NDC 69339-138-17) amber plastic unit-dose cups in 40 pack.1/2 fluid ounce (15 ml) (NDC 69339-138-19) amber plastic unit-dose cups in 100 pack.Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].Dispense in original container or in amber glass bottles.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Chlorhexidine gluconate 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.
Non-Clinical Toxicology
This product 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.
See .
Caution should be exercised when the following drugs are administered concomitantly with carbidopa and levodopa extended-release tablets.
Symptomatic postural hypotension has occurred when carbidopa and levodopa preparations were added to the treatment of patients receiving some antihypertensive drugs. Therefore, when therapy with carbidopa and levodopa extended-release tablets is started, dosage adjustment of the antihypertensive drug may be required.
For patients receiving MAO inhibitors (Type A or B), see . Concomitant therapy with selegiline and carbidopa and levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa and levodopa alone (see ).
There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa and levodopa preparations.
Dopamine D receptor antagonists (e.g., phenothiazines, butyrophenones, risperidone) and isoniazid may reduce the therapeutic effects of levodopa. In addition, the beneficial effects of levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with carbidopa and levodopa extended-release tablets should be carefully observed for loss of therapeutic response.
Use of carbidopa and levodopa extended-release tablets with dopamine-depleting agents (e.g., reserpine and tetrabenazine) or other drugs known to deplete monoamine stores is not recommended.
Carbidopa and levodopa extended-release tablets iron salts or multivitamins containing iron salts should be coadministered with caution. Iron salts can form chelates with levodopa and carbidopa and consequently reduce the bioavailability of carbidopa and levodopa.
Although metoclopramide may increase the bioavailability of levodopa by increasing gastric emptying, metoclopramide may also adversely affect disease control by its dopamine receptor antagonistic properties.
General:
1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate 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 toothstaining. 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 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 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 use of chlorhexidine gluconate oral rinse have been reported via postmarketing 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 and . 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 1.0%.
Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate 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/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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