CHLORHEXIDINE GLUCONATE rinse

Chlorhexidine Gluconate by

Drug Labeling and Warnings

Chlorhexidine Gluconate by is a Prescription medication manufactured, distributed, or labeled by VistaPharm, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION:

Chlorhexidine gluconate oral rinse USP, 0.12% is an oral rinse containing 0.12% chlorhexidine gluconate (1,1’-hexamethylene bis [5-(p-chlorophenyl) biguanide] di-D-gluconate) in a base containing water, propylene glycol, glycerin, sorbitol, polyoxyl 40 hydrogenated castor oil, flavor, cetylpyridinium chloride, and FD&C blue no. 1. Chlorhexidine gluconate oral rinse USP, 0.12% product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

CLINICAL PHARMACOLOGY:

Chlorhexidine gluconate oral rinse USP, 0.12% 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’ use.

Use of chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% 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:

Pharmacokinetic studies with a chlorhexidine gluconate oral rinse USP, 0.12% indicate approximately 30% of the active ingredient is retained in the oral cavity following rinsing. This 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.

INDICATIONS AND USAGE:

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. Chlorhexidine gluconate oral rinse USP, 0.12% has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.

CONTRAINDICATIONS:

Chlorhexidine gluconate oral rinse USP, 0.12% should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

WARNINGS:

The effect of chlorhexidine gluconate oral rinse USP, 0.12% on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing with users of chlorhexidine gluconate oral rinse USP, 0.12% compared with control users. It is not known if chlorhexidine gluconate use results in an increase of 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.

PRECAUTIONS:

General:

1. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse USP, 0.12% should not be used as a major indicator of underlying periodontitis.

2. Chlorhexidine gluconate oral rinse USP, 0.12% 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 the chlorhexidine gluconate oral rinse USP, 0.12% users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of the chlorhexidine gluconate oral rinse USP, 0.12% 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 the use of chlorhexidine gluconate oral rinse USP, 0.12% 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 USP, 0.12% 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 a chlorhexidine gluconate oral rinse USP, 0.12%. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse USP, 0.12% use have been reported via postmarketing product surveillance.

Pregnancy: 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.

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 oral rinse USP, 0.12% 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 result from a person’s ingesting 30 mL (2 doses) of chlorhexidine gluconate oral rinse USP, 0.12% per day.

Pediatric Use:

Clinical effectiveness and safety of chlorhexidine gluconate oral rinse USP, 0.12% have not been established in children 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 in vivo 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.

ADVERSE REACTIONS:

The most common side effects associated with chlorhexidine gluconate oral rinse USP, 0.12% 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 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 oral rinse USP, 0.12% 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.

OVERDOSAGE:

Ingestion of 1 or 2 ounces of 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 chlorhexidine gluconate oral rinse USP, 0.12% is ingested by a small child.

DOSAGE AND ADMINISTRATION:

Chlorhexidine gluconate oral rinse USP, 0.12% therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse USP, 0.12% 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 1/2 fl. oz. (one 15 mL unit-dose cup) of undiluted chlorhexidine gluconate oral Rinse USP, 0.12%. Patients should be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse USP, 0.12%. Chlorhexidine gluconate oral rinse USP, 0.12% is not intended for ingestion and should be expectorated after rinsing.

HOW SUPPLIED:

Chlorhexidine gluconate oral rinse USP, 0.12% is a blue liquid supplied as follows:

NDC: 66689-106-01: 15 mL unit-dose cup

NDC: 66689-106-50: Case contains 50 unit-dose cups of 15 mL (NDC: 66689-106-01), packaged in 5 trays of 10 unit-dose cups each.

NDC: 66689-106-99: Case contains 100 unit-dose cups of 15 mL (NDC: 66689-106-01), packaged in 10 trays of 10 unit-dose cups each.

Store at 20° to 25°C (68° to 77°F) excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

DIRECTIONS FOR USE:Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed.

NOTE: To minimize medicinal taste, do not rinse with water immediately after use.

WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE USP, 0.12%

Your dentist has prescribed chlorhexidine gluconate oral rinse USP, 0.12% to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use chlorhexidine gluconate oral rinse USP, 0.12% regularly, as directed by your dentist, in addition to daily brushing. Spit out after use. Chlorhexidine gluconate oral rinse USP, 0.12% should not be swallowed.

If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, lightheadedness, rapid heart rate, upset stomach or diarrhea, seek medical
attention immediately. Chlorhexidine gluconate oral rinse USP, 0.12% should not be used by persons who have a sensitivity to it or its components.

Chlorhexidine gluconate oral rinse USP, 0.12% may cause some tooth discoloration, or increases in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every six months, or more frequently if your dentist advises.

Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse USP, 0.12% may cause permanent discoloration of some front tooth fillings.

• To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor.
• Chlorhexidine gluconate oral rinse USP, 0.12% may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of chlorhexidine gluconate oral rinse USP, 0.12%.
• To avoid taste interference, rinse with chlorhexidine gluconate oral rinse USP, 0.12% after meals. Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse USP, 0.12%.

If you have any questions or comments about chlorhexidine gluconate oral rinse USP, 0.12%, contact your dentist, pharmacist or call VistaPharm, Inc. at 1-888-655-1505.

Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Rx Only. Keep out of reach of children.

Distributed by:
VistaPharm, Inc.
Largo, FL, USA

VP2536
06/2021

PRINCIPAL DISPLAY PANEL

Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Alcohol-Free

Delivers 15 mL

Store at 20°-25°C [68°-77°F]; [see USP CRT conditions].

Distributed by:

VistaPharm

Largo, FL 33771, USA

XactDose

Rx Only

VP2535

06/21

NDC: 66689-106-01

INGREDIENTS AND APPEARANCE

CHLORHEXIDINE GLUCONATE 
chlorhexidine gluconate rinse

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 66689-106(NDC:0126-0282)
Route of Administration	BUCCAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	1.2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	blue (Clear, light blue fluid)	Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66689-106-50	50 in 1 CASE	01/24/2022
1	NDC: 66689-106-01	15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
2	NDC: 66689-106-99	100 in 1 CASE	01/24/2022
2	NDC: 66689-106-01	15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA203212	01/24/2022

Labeler - VistaPharm, LLC (116743084)