Chlorhexidine Gluconate

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Overview

What is Chlorhexidine Gluconate?

This product is an oral rinse containing 012% chlorhexidine gluconate (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 116% 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•2CHO, molecular weight 89777 and its structural formula is:

What does Chlorhexidine Gluconate look like?

What are the available doses of Chlorhexidine Gluconate?

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What should I talk to my health care provider before I take Chlorhexidine Gluconate?

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How should I use Chlorhexidine Gluconate?

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 ½ fl. oz. (marked in cup) 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 Chlorhexidine Gluconate?

This product should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

What are the warnings of Chlorhexidine Gluconate?

A Lindane Shampoo Medication Guide must be given to the patient each time Lindane Shampoo is dispensed, as required by law.

The effect of chlorhexidine gluconate 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 use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months.

Hypersensitivity and generalized allergic reactions have occurred. See .

What are the precautions of Chlorhexidine Gluconate?

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 surveillance.

Pregnancy

Pregnancy category B.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chlorhexidine gluconate is administered to a nursing woman.

In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses up to 100 mg/kg/day.

Pediatric Use

Clinical effectiveness and safety of chlorhexidine gluconate have not been established for pediatric patients under the age of 18.

Carcinogenesis, Mutagenesis, Impairment of Fertility

In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian mutagenesis studies with chlorhexidine gluconate. The highest doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.

What are the side effects of Chlorhexidine Gluconate?

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 10%.

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 Chlorhexidine Gluconate?

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 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 use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months.

Hypersensitivity and generalized allergic reactions have occurred. See .

What might happen if I take too much Chlorhexidine Gluconate?

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 Chlorhexidine Gluconate?

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP] .Chlorhexidine Gluconate Oral Rinse 012% is supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup.Store at controlled room temperature 15°-30°C (59°-86°F).Dispense in original container or in amber glass bottles.Manufactured by: Actavis MidAtlantic LLC7205 Windsor Blvd.Baltimore, MD 21244 USA FORM NO. 0036 Rev. 10/06VC2912 Chlorhexidine Gluconate Oral Rinse 012% is supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup.Store at controlled room temperature 15°-30°C (59°-86°F).Dispense in original container or in amber glass bottles.Manufactured by: Actavis MidAtlantic LLC7205 Windsor Blvd.Baltimore, MD 21244 USA FORM NO. 0036 Rev. 10/06VC2912 Chlorhexidine Gluconate Oral Rinse 012% is supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup.Store at controlled room temperature 15°-30°C (59°-86°F).Dispense in original container or in amber glass bottles.Manufactured by: Actavis MidAtlantic LLC7205 Windsor Blvd.Baltimore, MD 21244 USA FORM NO. 0036 Rev. 10/06VC2912 Chlorhexidine Gluconate Oral Rinse 012% is supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup.Store at controlled room temperature 15°-30°C (59°-86°F).Dispense in original container or in amber glass bottles.Manufactured by: Actavis MidAtlantic LLC7205 Windsor Blvd.Baltimore, MD 21244 USA FORM NO. 0036 Rev. 10/06VC2912 Chlorhexidine Gluconate Oral Rinse 012% is supplied as a blue liquid in child-resistant bottles of one pint (473 mL), individually cartoned with a dosage cup.Store at controlled room temperature 15°-30°C (59°-86°F).Dispense in original container or in amber glass bottles.Manufactured by: Actavis MidAtlantic LLC7205 Windsor Blvd.Baltimore, MD 21244 USA FORM NO. 0036 Rev. 10/06VC2912

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Clinical Information

Chemical Structure

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Clinical 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.

Pharmacokinetics:

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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 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 use results in an increase in subgingival calculus. Calculus deposits should be removed by a dental prophylaxis at intervals not greater than six months.

Hypersensitivity and generalized allergic reactions have occurred. See .

Potential Effects Of Coadministration Of Drugs Highly Bound To Plasma Proteins:

In a study comparing prothrombin time AUC (0-120 hr) following dosing with warfarin

(0.75 mg/kg) before and after 21 days of dosing with either sertraline hydrochloride

(50-200 mg/day) or placebo, there was a mean increase in prothrombin time of 8% relative to baseline for sertraline hydrochloride compared to a 1% decrease for placebo (p<0.02). The normalization of prothrombin time for the sertraline hydrochloride group was delayed compared to the placebo group. The clinical significance of this change is unknown. Accordingly, prothrombin time should be carefully monitored when sertraline hydrochloride therapy is initiated or stopped.

Cimetidine

CNS Active Drugs

(50 to 200 mg/day escalating dose) or placebo, there was a 32% decrease relative to baseline in diazepam clearance for the sertraline hydrochloride group compared to a 19% decrease relative to baseline for the placebo group (p<0.03). There was a 23% increase in T for desmethyldiazepam in the sertraline hydrochloride group compared to a 20% decrease in the placebo group (p<0.03). The clinical significance of these changes is unknown.

In a placebo-controlled trial in normal volunteers, the administration of two doses of sertraline hydrochloride did not significantly alter steady-state lithium levels or the renal clearance of lithium.

Nonetheless, at this time, it is recommended that plasma lithium levels be monitored following initiation of sertraline hydrochloride therapy with appropriate adjustments to the lithium dose.

In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (q.d.) coadministration to steady state was associated with a mean increase in pimozide AUC and C of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of sertraline hydrochloride and pimozide should be contraindicated ().

Results of a placebo-controlled trial in normal volunteers suggest that chronic administration of sertraline 200 mg/day does not produce clinically important inhibition of phenytoin metabolism. Nonetheless, at this time, it is recommended that plasma phenytoin concentrations be monitored following initiation of sertraline hydrochloride therapy with appropriate adjustments to the phenytoin dose, particularly in patients with multiple underlying medical conditions and/or those receiving multiple concomitant medications.

The effect of sertraline on valproate levels has not been evaluated in clinical trials. In the absence of such data, it is recommended that plasma valproate levels be monitored following initiation of sertraline hydrochloride therapy with appropriate adjustments to the valproate dose.

The risk of using sertraline hydrochloride in combination with other CNS active drugs has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of sertraline hydrochloride and such drugs is required.

There is limited controlled experience regarding the optimal timing of switching from other drugs effective in the treatment of major depressive disorder to sertraline hydrochloride. Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents. The duration of an appropriate washout period which should intervene before switching from one selective serotonin reuptake inhibitor (SSRI) to another has not been established.

Monoamine Oxidase Inhibitors

Drugs Metabolized By P450 2D6

Serotonergic Drugs:

Triptans:

Sumatriptan

Tricyclic Antidepressant Drugs Effective In The Treatment Of Major Depressive Disorder (TCAs):

Hypoglycemic Drugs

Atenolol

Digoxin

Microsomal Enzyme Induction:

Drugs That Interfere With Hemostasis (Non-Selective NSAIDs, Aspirin, Warfarin, etc.):

Electroconvulsive Therapy:

Alcohol:

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 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 10%.

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.

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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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