Paroex 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:

Paroex - 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.

Indications and Usage for Paroex

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

Adverse Reactions/Side Effects

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.

Paroex 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 is Paroex 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

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 [email protected]

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 [email protected]. 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