Chlorhexidine gluconate

Chlorhexidine gluconate
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Chlorhexidine gluconate is an antibacterial cleansing agent that is FDA approved for the treatment of gingivitis, periodontitis, and skin cleansing procedure. Common adverse reactions include staining of the teeth and other oral surfaces, calculus formation, and an alteration in taste perception.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indication

• Treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing.

Dosage

• Recommended use is twice daily, oral rinsing 30 seconds, morning and evening after toothbrushing.

• Usual dosage is 15 mL of undiluted Paroex®.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorhexidine Gluconate in adult patients.

Non–Guideline-Supported Use

Indication

• Alveolitis of jaw

• Burn - Nosocomial infectious disease

• Dental procedure - Prosthetic dental implant

• Nosocomial infectious disease, Catheter-Related

• Nosocomial infectious disease; Prophylaxis - Operation on heart

• Oral infection

• Sensitive dentin

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• Effectiveness and safety have not been established in pediatric patients younger 18 years

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Chlorhexidine Gluconate in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Chlorhexidine Gluconate in pediatric patients.

Contraindications

• Paroex® should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

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.

Precautions

GENERAL

• For patients having coexisiting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with Paroex® should not be used as a major indicator of underlying periodontitis.

• Paroex® 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 oral rinse users developed what was judged to be heavy stain, compared to 1% of the control users after six months. Stain will be more pronounced in patients who have heavier accumulations of unremoved plaque. Stain resulting from use of Paroex® 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 Paroex® 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.

• Some patients may experience an alteration in taste perception while undergoing treatment with Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%). Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing surveillance.

Adverse Reactions

Clinical Trials Experience

• The most common side effects associated with chlorhexidine gluconate oral rinse are: 1) an increase in staining of the teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception.

• Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trails: 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%.

Postmarketing Experience

Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivits, 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.

Drug Interactions

There is limited information regarding Chlorhexidine gluconate Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Chlorhexidoine Gluconate in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Chlorhexidine Gluconate during labor and delivery.

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 Paroex® oral rinse is administered to nursing women.

• 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 that were over 100 times greater than that which would results from a person's ingesting 30 mL (2 doses) of chlorhexidine gluconate per day.

Pediatric Use

There is no FDA guidance on the use of Chlorhexidine Gluconate with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Chlorhexidine Gluconate with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Chlorhexidine Gluconate with respect to specific gender populations.

Race

There is no FDA guidance on the use of Chlorhexidine Gluconate with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Chlorhexidine Gluconate in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Chlorhexidine Gluconate in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Chlorhexidine Gluconate in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Chlorhexidine Gluconate in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• 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

Monitoring

There is limited information regarding Monitoring of Chlorhexidine Gluconate in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Chlorhexidine Gluconate in the drug label.

Overdosage

• Ingestion of 1 or 2 ounces of Paroex® (Chlorhexidine Gluconate Oral Rinse USP, 0.12%) by a small child (~10 kg body weight) might result in gastric distress, including nausea. Medical attention should be sought if more than 4 ounces of Paroex® is ingested by a small child.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

There is limited information regarding Chlorhexidine gluconate Mechanism of Action in the drug label.

Structure

• 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:

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Chlorhexidine Gluconate in the drug label.

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. The 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 chlorhexidine gluconate were not present in the plasma of these subjects 12 hours after the compound was administered. Excretion of chlorhexidine gluconate occurred primarily through the feces (~90%). Less than 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, and 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 in vivo mutagensis 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.

Clinical Studies

There is limited information regarding Clinical Studies of Chlorhexidine Gluconate in the drug label.

How Supplied

Paroex® is supplied as a pink liquid in the following sizes:

• 4 fl oz (118 ml) (NDC 52376-021-04) amber plastic bottles with child-resistant cap.
• 16 fl oz (473 ml) (NDC 52376-021-02) amber plastic bottles with child-resistant cap, individually shrink wrapped with a dosage cup.

Storage

STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF).

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

• 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.

Precautions with Alcohol

• Alcohol-Chlorhexidine Gluconate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

PAROEX

Look-Alike Drug Names

There is limited information regarding Chlorhexidine gluconate Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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