PAROEX CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate rinse

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L)
Available from:
Precision Dose, Inc.
Administration route:
ORAL
Prescription type:
PRESCRIPTION DRUG
Therapeutic indications:
Paroex® (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. Paroex® has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS . Paroex® should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
Product summary:
Paroex® is supplied as a pink liquid in the following sizes: NDC 68094-028-62 15 mL per unit dose cup Thirty (30) cups per shipper NDC 68094-028-61 15 mL per unit dose cup One hundred (100) cups per shipper STORE at 20 °C to 25 °C (68 °F to 77 °F), excursions permitted to 15 °C to 30 °C (59 °F to 86 °F) [See USP controlled room temperature].
Authorization status:
Abbreviated New Drug Application
Authorization number:
68094-028-59, 68094-028-61, 68094-028-62

PAROEX CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate rinse

Precision Dose, Inc.

----------

Chlorhexidine Gluconate Oral Rinse USP, 0.12%

Alcohol Free

Rx Only

Paroex (Chlorhexidine Gluconate Oral Rinse USP, 0.12%)

DESCRIPTION

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:

CLINICAL PHARMACOLOGY

Paroex

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 bacteria 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

Pharmacokinetics studies with 0.12% chlorhexidine gluconate oral rinse 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

Paroex

(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. Paroex

has not been tested among

®

patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis

and periodontitis, see PRECAUTIONS.

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 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 CONTRAINDICATIONS.

PRECAUTIONS

General

1. For patients having coexisting 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.

2. 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 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.

3. 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

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 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 result from a person's ingesting 30 mL (2 doses) of

chlorhexidine gluconate per day.

Pediatric Use

Clinical effectiveness and safety of Paroex

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 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 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.

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.

DOSAGE AND ADMINISTRATION

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. Recommended use is twice daily, oral rinsing for 30

seconds, morning and evening after toothbrushing. Usual dosage is 15 mL (½ FL OZ) of undiluted

Paroex

. 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.

HOW SUPPLIED

Paroex

is supplied as a pink liquid in the following sizes:

NDC 68094-028-62

15 mL per unit dose cup

Thirty (30) cups per shipper

NDC 68094-028-61

15 mL per unit dose cup

One hundred (100) cups per shipper

STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)

[See USP controlled room temperature].

Rx Only

Keep Out Of Reach Of Children

Manufactured for:

Sunstar Americas, Inc.

Schaumburg, IL 60195

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com

Directions for Use: (15 mL). Swish in your mouth undiluted for 30 seconds, then spit out. Use after

breakfast and before bedtime. Or, use as prescribed by your dentist.

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

Rx Only

Keep Out Of Reach Of Children

Ingredients: 0.12% chlorhexidine 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.

WHAT TO EXPECT WHEN USING Paroex (Chlorhexidine Gluconate Oral Rinse USP, 0.12%):

Your dentist has prescribed Paroex

to treat your gingivitis - to help reduce the redness and swelling

of your gums, and also to help you control any gum bleeding.

Use Paroex

regularly, as directed by your dentist, in addition to daily brushing and flossing.

Spit out after use. Paroex

should not be swallowed.

If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties,

light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately.

Paroex

should not be used by persons who have a sensitivity to it or its components.

Paroex

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

may cause permanent discoloration of some front-tooth fillings.

To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to

discolor.

Paroex

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 Paroex

®

To avoid taste interference, rinse with Paroex

after meals. Do not rinse with water or other

mouthwashes immediately after rinsing with Paroex

If you have any questions or comments about Paroex

, contact your dentist, pharmacist or Precision

Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com. Call your health care provider

for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

STORE at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30°C (59°F to 86°F)

[See USP controlled room temperature].

Manufactured for:

Sunstar Americas, Inc.

Schaumburg, IL 60195

Packaged by:

Precision Dose, Inc.

South Beloit, IL 61080

LI1246 Rev. 04/19

PRINCIPAL DISPLAY PANEL - 15 mL Cup Label

NDC 68094-028-59

PrecisionDose™

G·U·M Paroex

CHLORHEXIDINE GLUCONATE

ORAL RINSE USP, 0.12%

Delivers 15 mL

Alcohol Free

Rx Only

STORE at 20° to 25°C (68° to 77°F)

Pkg. By: Precision Dose, Inc.

S. Beloit, IL 61080

1245 R0

PAROEX CHLORHEXIDINE GLUCONATE

chlorhexidine gluconate rinse

Product Information

Product T ype

HUMAN PRESCRIPTION DRUG

Ite m Code (Source )

NDC:6 8 0 9 4-0 28 (NDC:52376 -0 21)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Chlo rhexidine Gluco na te (UNII: MOR8 4MUD8 E) (Chlo rhexidine - UNII:R4KO0 DY52L)

Chlo rhexidine Gluco nate

1.2 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

WATER (UNII: 0 59 QF0 KO0 R)

Pro pylene g lyco l (UNII: 6 DC9 Q16 7V3)

Glycerin (UNII: PDC6 A3C0 OX)

Po lyo xyl 4 0 hydro g ena ted ca sto r o il (UNII: 7YC6 8 6 GQ8 F)

ACESULFAME PO TASSIUM (UNII: 23OV73Q5G9 )

Precision Dose, Inc.

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

Product Characteristics

Color

PINK

S core

S hap e

S iz e

Flavor

MINT

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 8 0 9 4-0 28 -

3 in 1 CASE

0 8 /23/20 19

1

10 in 1 TRAY

1

NDC:6 8 0 9 4-0 28 -

15 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

2

NDC:6 8 0 9 4-0 28 -

10 in 1 CASE

0 8 /23/20 19

2

10 in 1 TRAY

2

NDC:6 8 0 9 4-0 28 -

15 mL in 1 CUP, UNIT-DOSE; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

ANDA

ANDA0 76 434

0 8 /23/20 19

Labeler -

Precision Dose, Inc. (035886746)

Revised: 8/2019

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