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Chlorhexidine Gluconate 0.12%, Oral Rinse, USP Rx Only, NDC 48433-214-15, 48433-214-40 | Chlorhexidine gluconate [Safecor Health, LLC] | BioPortfolio

13:39 EST 27th January 2019 | BioPortfolio

Note: While we endeavour to keep our records up-to-date one should not rely on these details being accurate without first consulting a professional. Click here to read our full medical disclaimer.

0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:

Chlorhexidine gluconate oral rinse 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 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 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 chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient, chlorhexidine gluconate, 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 mcg/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.

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

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

The effect of chlorhexidine gluconate oral rinse 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 serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. See CONTRAINDICATIONS .

WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE

Your dentist has prescribed chlorhexidine gluconate oral rinse 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 regularly, as directed by your dentist, in addition to daily brushing. Spit out after use, chlorhexidine gluconate oral rinse 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. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components.

Chlorhexidine gluconate oral rinse may cause some tooth discoloration, or increase 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.

If you have any questions or comments about Chlorhexidine gluconate oral rinse, contact your dentist, pharmacist, or Safecor Health, LLC toll free at 1-800-447-1006.

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

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 the 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.

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 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 capfuls) of chlorhexidine gluconate oral rinse per day.

Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.

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.

The most common side effects associated with chlorhexidine gluconate oral rinses 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 the 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%.

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.

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, or signs of alcohol intoxication. Medical attention should be sought if more than 4 ounces of chlorhexidine gluconate oral rinse is ingested by a small child or if signs of alcohol intoxication develop.

Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse 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 tooth brushing. Usual dosage is 15 ml of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not 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.

Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 0.5-ounce (15 ml) cups (NDC 48433-214-15), packaged into boxes of 40 cups per box (NDC 48433-214-40).

Store at 20°C to 25°C (68°F-77°F), excursions permitted to 15°C to 30°C (59°F to 86°F) [See USP controlled Room Temperature].

Rx Only.This package is not child resistant. For institutional use only.

REV: 214-00 10-2018

Packaged by: Safecor Health, LLC4060 Business Park DriveColumbus, OH 43204

Manufactured by: Xttrium Laboratories, Inc.1200 E. Business Center Dr.Mount Prospect, IL 60056

———PRINCIPAL DISPLAY PANEL———

Delivers 15 mLNDC 48433-214-15 ChlorhexidineGluconateOral Rinse USP 0.12% Pkg By: Safecor Health, LLCColumbus, OH 43204Rx Only

Manufacturer

Safecor Health, LLC

Active Ingredients

Source

Drugs and Medications [114 Associated Drugs and Medications listed on BioPortfolio]

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Drug Facts

Chlorhexidine gluconate [den-mat holdings, llc]

pro-den Rx oral rinse USP 0.12% chlorhexidine gluconate

Chlorhexidine gluconate [xttrium laboratories, inc.]

pro-den Rx oral rinse USP 0.12% chlorhexidine gluconate

Chlorhexidine gluconate [atlantic biologicals corps.]

CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE

Kimvent [halyard health]

KimVent 24-Hour Oral Care Kit q4

Clinical Trials [264 Associated Clinical Trials listed on BioPortfolio]

The Use of 2% Chlorhexidine Gluconate Impregnated Cloth Bathing in Preoperative Skin Preparation

To compare the use of towels impregnated with 2% chlorhexidine gluconate in the traditional preoperative bath with 2% chlorhexidine gluconate in preventing the occurrence of surgical site ...

Different Oral Colonization of Gram-negative Bacteria in ICU Patients When Using Chlorhexidine at 0.12% Versus Chlorhexidine at 2.0%

This study will assess the utility of different chlorhexidine mouthwash concentrations on ICU patients to decolonize their oral cavities from gram-negative bacteria, since this is a non-de...

Chlorhexidine Gel Therapy for Cariogenic Oral Microflora

The goal of this clinical research study is to find out if 1% chlorhexidine gluconate gel will decrease the amount of bacteria that causes tooth decay. Whether the gel is acceptable to pat...

Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis

The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis, in a non-surgical treatment protoc...

Efficacy of 0.12% Chlorhexidine Gluconate for Peri-implant Mucositis and Gingivitis

The purpose of this study is to analyze the efficacy of 0.12% chlorhexidine gluconate as a chemical adjuvant for the treatment of peri-implant mucositis in single implants compared with ho...

PubMed Articles [90 Associated PubMed Articles listed on BioPortfolio]

Evaluation of activity and potential for development of antimicrobial resistance to a new tinted 2% chlorhexidine gluconate / 70% isopropyl alcohol film-forming sterile preoperative skin preparation.

Chlorhexidine gluconate (CHG) is routinely used for skin antisepsis before surgery. Its activity may be affected by formulation ingredients and the presence of organic matter such as blood and protein...

Daily Bathing With 4% Chlorhexidine Gluconate In Intensive Care Settings: A Randomized Controlled Trial.

to investigate whether daily bathing with a soap-like solution of 4% chlorhexidine (CHG) followed by water rinsing (CHGwr) would decrease the incidence of hospital acquired infections (HAI) in intensi...

In Vitro Antimicrobial Effect of Bioadhesive Oral Membrane with Chlorhexidine Gel.

This study aimed to evaluate in vitro the antimicrobial effect of a bioadhesive chitosan-based oral membrane with chlorhexidine for local treatment of infections in the oral tissues. Five oral membran...

Does Wound Irrigation with Clorhexidine Gluconate Reduce the Surgical Site Infection Rate in Closure of Temporary Loop Ileostomy? A Prospective Clinical Study.

The aim of this study was to investigate the effect of irrigating the surgical site with 0.05% chlorhexidine gluconate (CHG) on surgical site infection (SSI) in temporary loop ileostomy closure.

Prophylactic infusion of calcium gluconate to prevent a symptomatic fall in plasma ionized calcium during therapeutic plasma exchange: A comparison of two methods.

We compared two methods of calcium gluconate infusion to maintain plasma ionized calcium ([Ca ]) during therapeutic plasma exchange (TPE) performed using the Spectra Optia Apheresis System. Method A, ...

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