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chlorhexidine gluconate

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Overview

What is PAROEX?

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:



What does PAROEX look like?



What are the available doses of PAROEX?

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

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How should I use 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, .

Chlorhexidine Gluconate Oral Rinse therapy should be initiated directly following a dental prophylaxis. Patients using Chlorhexidine Oral Rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily, oral rinsing 30 seconds, morning and evening after toothbrushing. Usual dosage is 15 mL (1/2 FL OZ marked in cup) of undiluted Chlorhexidine Gluconate Oral Rinse. Patients should be instructed not to 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 PAROEX?

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What are the warnings of PAROEX?

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What are the precautions of PAROEX?

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What are the side effects of PAROEX?

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What should I look out for while using PAROEX?

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

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. .


What might happen if I take too much PAROEX?

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. Medical attention should be sought if more than 4 ounces of Chlorhexidine Gluconate Oral Rinse is ingested by a small child.


How should I store and handle PAROEX?

Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.Store VPRIV at 2 °C to 8°C (36°F to 46°F). Do not use VPRIV after the expiration date on the vial. Do not freeze.Protect vial from light.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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015Paroex® 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 shirnk wrapped with a dosage cup.STORE at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF)[See USP controlled room temperature].Rx OnlyKeep Out Of Reach Of ChildrenManufactured for:Revised: September 2015


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Clinical Information

Chemical Structure

No Image found
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 bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine oral rinse 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.

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

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. .

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). Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance.

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; and .

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%. 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.

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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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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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