What Is Chlorhexidine Digluconate?
Chlorhexidine digluconate is a powerful anti-microbial agent. It is notable for its effectiveness for killing a wide range of bacteria, including both gram-positive and gram-negative bacteria (the two largest classes of bacteria). It is also an effective anti-fungal and anti-spore agent. Chlorhexidine digluconate is commonly used as an active ingredient in germicidal mouthwash, pet shampoo, surgical lubricants and wipes, and hand soap.
Chlorhexidine Digluconate Composition
Chlorhexidine digluconate is a non-solid, water-soluble anti-microbial agent composed of carbon, hydrogen, chlorine, nitrogen and oxygen.
In its most common commercially available form, chlorhexidine digluconate is provided as a 20 percent aqueous solution. Higher concentrations up to 50 percent are possible, although difficult to handle due to the compound's high viscosity. Lower concentrations around 0.5 percent are available for use as a hand sanitizer or contact lens solution.
Chlorhexidine digluconate Uses
Chlorhexidine digluconate is used in disinfectants (disinfection of the skin and hands), cosmetics (additive to creams, toothpaste, deodorants, and antiperspirants), and pharmaceutical products (preservative in eye drops, active substance in wound dressings and antiseptic mouthwashes).
Chlorhexidine digluconate Animal uses
Chlorhexidine digluconate is used for several veterinary purposes. As a topical disinfectant for pet and livestock wounds, it has been demonstrated to be more effective than povidone-iodine and saline. It is also an active ingredient in pet shampoos, teat dips, skin treatments, and lubricants made from animal fat.
Chlorhexidine Digluconate Antiseptic uses
Chlorhexidine digluconate is used as a non-dental antibacterial solution. It is effective against a wide range of bacteria, including both gram-positive and gram-negative bacteria (the two primary classes of bacteria). It is also effective as an anti-fungal, anti-spore and anti-viral agent.
Common non-dental uses of chlorhexidine digluconate include use as a topical antiseptic, antibacterial hand rinse and pre-surgical scrub.
Chlorhexidine digluconate is particularly effective as an oral antiseptic because it is absorbed by tooth surfaces and thus provides long-lasting protection.
In addition to its common use a mouthwash, chlorhexidine digluconate is used as an antiseptic rinse before, during and after periodontal procedures.
Chlorhexidine digluconate is an antibacterial used as an antiseptic and for other applications. It is a cationic polybiguanide (bisbiguanide). It is used primarily as its salts (e.g., the dihydrochloride, diacetate, and digluconate).
It is on the World Health Organization's List of Essential Medicines, a list of the most important medication needed in a basic health system.
Chlorhexidine Digluconate Advantages and Disadvantages
One of the primary advantages of chlorhexidine digluconate is the persistence of its anti-microbial properties. When used orally, chlorhexidine digluconate is absorbed into the teeth and thus provides extended protection against oral bacteria such as gingivitis. When used topically, it both kills bacteria and contact and has a lingering residual effect, preventing bacteria from regrowing on the application site.
Potential side effects of chlorhexidine digluconate use include staining and yellowing of teeth after prolonged oral use and the potential for skin sensitivity after topical use.
Chlorhexidine digluconate Dental use
Among the most common uses of chlorhexidine digluconate is as an oral antiseptic. Since the compound is an effective anti-microbial agent, use as a mouthwash reduces the amount of bacteria in the mouth.
Perichlor brand 0.12% Chlorhexidine digluconate gluconate solution.
Chlorhexidine digluconate is often used as an active ingredient in mouthwash designed to reduce dental plaque and oral bacteria. It has been shown to have an immediate bactericidal action and a prolonged bacteriostatic action due to adsorption onto the pellicle-coated enamel surface. If it is not deactivated, Chlorhexidine digluconate lasts longer in the mouth than other mouthwashes, which is partly why it is to be preferred over other treatments for gingivitis. To treat periodontal pockets equal or greater than 5 mm, Chlorhexidine digluconate is also available in high concentration (36%) in a gelatin chip.
There are oral pathologic conditions in which the maintenance of oral hygiene with the twice-daily use with 0.12% Chlorhexidine digluconate gluconate solution (in which a salt of Chlorhexidine digluconate and gluconic acid has been dissolved) is required for healing and regeneration of the oral tissues. These conditions included gingivitis, periodontitis, dental traumas (such as subluxation), oral cysts, and after wisdom tooth extraction. The clinical efficacy of the application of Chlorhexidine digluconate as a component of oral rinses is well documented by many clinical studies summarized by review articles.
Continued use of products containing Chlorhexidine digluconate for long periods can cause stains on teeth, tongue, and gingiva, also on silicate and resin restorations; prolonged use can also reduce bitter and salty taste sensations – this latter symptom can be reversed by ceasing use of Chlorhexidine digluconate. The brownish discoloration of teeth and tongue is due to the disintegration of bacterial membranes, leading to the denaturation of bacterial proteins. At the same time, disulfide functions are reduced to thiol functions that form dark complexes with iron(III) ions found in saliva.
Mouthwashes containing Chlorhexidine digluconate which stain teeth less than the classic solution have been developed, many of which contain chelated zinc.
According to the prescribing information, Chlorhexidine digluconate gluconate has not been proven to reduce subgingival calculus and in some studies actually increased deposits. When combined with xylitol, a synergistic effect has been observed to enhance efficacy.
Chlorhexidine digluconate's role in preventing tooth decay (dental caries) is controversial and "the clinical data are not convincing".
Chlorhexidine digluconate is neutralized by common toothpaste additives such as sodium lauryl sulfate and sodium monofluorophosphate. Although data are limited, to maximize effectiveness, it may be best to keep more than a 30-minute interval between brushing and using the mouthwash, ″cautiously close to 2 hours after brushing".
Chlorhexidine digluconate Antiseptic
At physiologic pH, Chlorhexidine digluconate salts dissociate and release the positively charged Chlorhexidine digluconate cation. The bactericidal effect is a result of the binding of this cationic molecule to negatively charged bacterial cell walls. At low concentrations of Chlorhexidine digluconate, this results in a bacteriostatic effect; at high concentrations, membrane disruption results in cell death.
Chlorhexidine digluconate is active against Gram-positive and Gram-negative organisms, facultative anaerobes, aerobes, and yeasts. It is particularly effective against Gram-positive bacteria (in concentrations ≥ 1 µg/l). Significantly higher concentrations (10 to more than 73 μg/ml) are required for Gram-negative bacteria and fungi. Chlorhexidine digluconate is ineffective against polioviruses and adenoviruses. The effectiveness against herpes viruses has not yet been established unequivocally.
Chlorhexidine digluconate, like other cation-active compounds, remains on the skin. It is frequently combined with alcohols (ethanol and isopropyl alcohol).
Chlorhexidine digluconate Topical
Nepal is the first country in the world to use Chlorhexidine digluconate to treat the umbilical cord of newborn babies, and received a USAID Pioneers Prize for reducing the neonatal death rate. Chlorhexidine digluconate is very effective for poor countries like Nepal and its use is growing in the world for treating the umbilical cord. A recent Cochrane review has yielded high-quality evidence that within the community setting, Chlorhexidine digluconate skin or cord care can reduce the incidence of omphalitis (inflammation of the umbilical cord) by 50% and also neonatal mortality by 12%. Chlorhexidine digluconate gluconate is used as a skin cleanser for surgical scrubs, a cleanser for skin wounds, for preoperative skin preparation and germicidal hand rinses. Chlorhexidine digluconate eye drops have been used as a treatment for eyes affected by Acanthamoeba keratitis.
Chlorhexidine digluconate Toxicity
Genotoxicity study in rats indicate Chlorhexidine digluconate digluconate is able to induce primary DNA damage in leukocytes, in kidney cells and in oral mucosal cells, but no chromosome breakage or loss in erythrocytes. Chlorhexidine digluconate is highly cytotoxic in vitro being able to induce apoptotic and autophagic/necrotic cell deaths, disturbance of mitochondrial function, intracellular Ca2+ increase and oxidative stress.
Chlorhexidine digluconate does not meet current European specifications for a hand disinfectant. Under the test conditions of the European Standard EN 1499, no significant difference in the efficacy was found between a 4% solution of Chlorhexidine digluconate digluconate and soap. In the U.S., between 2007 and 2009, Hunter Holmes McGuire Veterans Administration Medical Center conducted a cluster-randomized trial and concluded that daily bathing of patients in intensive care units with washcloths saturated with Chlorhexidine digluconate gluconate reduced the risk of hospital-acquired infections.
Chlorhexidine digluconate Non-human animals
For use in non-human animals, it is used as a topical disinfectant of wounds. It is also more beneficial to wound healing than using saline solutions alone.Post-surgery respiratory problems have been associated with the use of Chlorhexidine digluconate products in cats. If the product is put into the ear in the presence of a ruptured eardrum, it can also lead to deafness. It is commonly used to manage skin infections in dogs. In addition to this, it is an active ingredient in teat disinfectant products used within the dairy farming industry.
Chlorhexidine digluconate Deactivation
Chlorhexidine digluconate is deactivated by forming insoluble salts with anionic compounds, including the anionic surfactants commonly used as detergents in toothpastes and mouthwashes, anionic thickeners such as carbomer, and anionic emulsifiers such as acrylates/C10-30 alkyl acrylate crosspolymer, among many others. For this reason, Chlorhexidine digluconate mouth rinses should be used at least 30 minutes after other dental products. For best effectiveness, food, drink, smoking, and mouth rinses should be avoided for at least one hour after use. Many topical skin products, cleansers, and hand sanitizers should also be avoided to prevent deactivation when Chlorhexidine digluconate (a topical itself or the residue from a cleanser) is meant to remain on the skin.
Care Chlorhexidine Digluconate 0.2% w/v Antiseptic Mouthwash
1. Name of the medicinal product
Care Chlorhexidine Digluconate 0.2% w/v Antiseptic Mouthwash Peppermint Flavour
2. Qualitative and quantitative composition
Chlorhexidine Digluconate 0.2% w/v (equivalent to Chlorhexidine Gluconate Solution 1.0% v/v)
For excipients see 6.1
3. Pharmaceutical form
A clear, colourless liquid with an odour of menthol and peppermint.
4. Clinical particulars
4.1 Therapeutic indications
Aids prevention of dental plaque formation. Aids the treatment and prevention of gingivitis. For the maintenance of oral hygiene. Promotes gingival healing following periodontal surgery. Management of recurrent oral ulceration. For the treatment of denture stomatitis and oral thrush.
4.2 Posology and method of administration
For oromucosal use.
Adults, the elderly and children: To be used as required up to twice daily. Rinse the mouth thoroughly for about 1 minute with 10ml. The mouthwash should be expelled from the mouth after rinsing.
Prior to dental surgery: Rinse the mouth thoroughly with 10ml for 1 minute. The mouthwash should be expelled from the mouth after rinsing.
Treatment of gingivitis: A course of one month is recommended.
Treatment of denture stomatitis: Soak the denture(s) in solution for 15 minutes twice daily.
Treatment of oral ulceration and oral thrush: Treatment should be continued for 48 hours after clinical resolution.
Known hypersensitivity to the product or any of its components, especially in those with a history of possible chlorhexidine-related allergic reactions (see sections 4.4 and 4.8).
4.4 Special warnings and precautions for use
For oral use only. Keep away from the eyes and ears. If the solution comes into contact with the eyes, rinse well with water. Keep out of the reach and sight of children. Do not swallow. If symptoms persist, stop using and consult your doctor or dentist.
Chlorhexidine Mouthwash contains chlorhexidine. Chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. The prevalence of chlorhexidine hypersensitivity is not known, but available literature suggests this is likely to be very rare. Chlorhexidine Mouthwash should not be administered to anyone with a potential history of an allergic reaction to a chlorhexidine-containing compound (see sections 4.3 and 4.8).
4.5 Interaction with other medicinal products and other forms of interaction
Chlorhexidine digluconate is incompatible with anionic agents which are usually present in conventional dentrifices. These should therefore be used before the mouthwash. Rinse the mouth thoroughly with water before using the mouthwash.
4.6 Fertility, pregnancy and lactation
No harmful effects in human pregnancy or during lactation have been reported. Nevertheless like all medicines, care should be exercised and the mouthwash should only be used on the advice of a doctor or dentist.
4.7 Effects on ability to drive and use machines
No or negligible influence.
4.8 Undesirable effects
Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.
Frequency not known: Hypersensitivity including anaphylactic shock (see sections 4.3 and 4.4).
A superficial discolouration of the dorsum of the tongue may occur which disappears after discontinuation of treatment. Discolouration of the teeth and silicate or composite restorations may also occur. The discolouration is not permanent and may be prevented by brushing daily with conventional toothpaste prior to using the mouthwash and avoiding tannin-containing food and drinks. In some cases a professional prophylaxis (scaling and polishing) may be necessary to completely remove the stain.
Transient disturbances of taste and a burning sensation of the tongue may occur on initial use of the mouthwash but usually diminishes with continued use.
In cases where oral desquamation occurs it may be necessary to discontinue treatment.
Very occasionally, swelling of the parotid glands during use has been reported. If this happens stop using the product and the effect should go away.
In all cases spontaneous resolution has occurred on discontinuation of treatment.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Care Scheme at: www.mhra.gov.uk/yellowcard.
Chlorhexidine is poorly absorbed by the oral route; therefore systemic effects are unlikely even if large volumes are swallowed. However, gastric lavage followed by supportive measures may be used as appropriate.
5. Pharmacological properties
5.1 Pharmacodynamic properties
A01A B03 – Stomatological preparations, antiinfectives for local oral treatment
Chlorhexidine digluconate is a bisbiguanide antiseptic and disinfectant, which is bactericidal or bacteriostatic against a wide range of gram negative and gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. The antimicrobial activity covers most of the important species occurring in the oral microflora.
5.2 Pharmacokinetic properties
Due to its cationic nature, chlorhexidine digluconate binds strongly to skin, mucosa and other tissues and is thus very poorly absorbed. No detectable blood levels have been found following oral use.
Chlorhexidine digluconate Material Safety Data Sheet
1: Chemical Product and Company Identification
Product Name: Chlorhexidine digluconate
Catalog Code: 40300076-1
TSCA: TSCA 8(b) inventory : Chlorhexidine digluconate
CI#: Not available.
Synonym: Not available.
Chemical Name: Chlorhexidine digluconate
Chemical Formula: C22H30Cl2N10·2C6H12O7
2: Chlorhexidine digluconate Composition and Information on Ingredients
Name CAS# % by Weight
Chlorhexidine digluconate 18472-51-0 -
Toxicological Data on Ingredients:
3: Chlorhexidine digluconate Hazards Identification
Potential Acute Health Effects: Harmful by inhalation, in contact with skin and if swallowed.
Potential Chronic Health Effects:
CARCINOGENIC EFFECTS: Not available.
MUTAGENIC EFFECTS: Not available.
TERATOGENIC EFFECTS: Not available.
DEVELOPMENTAL TOXICITY: Not available.
4: Chlorhexidine digluconate First Aid Measures
Eye Contact: Flush with copious amounts of water for at least 15 minutes. If symptoms arise, seek medical advice.
Skin Contact: Remove contaminated clothing. Wash affected area with soap and water. Rinse thoroughly. If unusual
symptoms are observed, seek medical advice. Show the physician the container details.
Serious Skin Contact: Not available.
Inhalation: Remove to fresh air. Seek medical advice if symptoms persist.
Serious Inhalation: Not available.
Ingestion: Rinse out mouth and drink lots of water. In case of unusual symptoms, seek medical attention and show
physician the container details.
Serious Ingestion: Not available.
5: Chlorhexidine digluconate Fire and Explosion Data
Flammability of the Product: May be combustible at high temperature.
Auto-Ignition Temperature: Not available.
Flash Points: Not available.
Flammable Limits: Not available.
Product of Combustion: carbon monoxide, carbon dioxide, hydrogen chloride (hydrochloric acid).
Fire Hazards in Presence of Various Substances: Not available.
Explosion Hazards in Presence of Various Substances:
Fire Fighting Media and Instructions:
SMALL FIRE: Use carbon dioxide or dry powder.
LARGE FIRE: Not available.
Special Remarks on Fire Hazards: Not available.
Special Remarks on Explosion Hazards: Not available.
6: Chlorhexidine digluconate Accidental Release Measures
Small Spill: Avoid inhalation or contact of spilled material with skin or clothing. Wear protective equipment including rubber
gloves, and eye protection. Keep unprotected persons away.
Large Spill: Not available.
7: Chlorhexidine digluconate Handling and Storage
Precautions: Chemicals should be used only by those trained in handling potentially hazardous materials. Rubber gloves,
eye protection and protective clothing should be worn. Operations should be carried out in an efficient fume hood orequivalent system.
Storage: Store in tightly sealed containers in a cool place. Protect from moisture.
8: Chlorhexidine digluconate Exposure Controls/Personal Protection
Engineering Controls: Safety shower and eye bath. Mechanical exhaust required.
Personal Protection: Avoid inhalation of product. Handle in an efficient fume hood or equivalent system.
Avoid eye contact. Wear safety spectacles or goggles.
Avoid skin contact. Wear rubber gloves and protective clothing.
Personal Protection in Case of a Large Spill: Not available.
Exposure Limits: Not available.
9: Chlorhexidine digluconate Physical and Chemical Properties
Physical State and Appearance: Solid
Odor: Not available.
Taste: Not available.
Molecular Weight: 897.76 g/mole
pH(1% soln/water): Not available.
Boiling Point: Not available.
Melting Point: Not available.
Critical Temperature: Not available.
Specific Gravity: Not available.
Vapour Pressure: Not available.
Vapor Density: Not available.
Volatility: Not available.
Odor Threshold: Not available.
Water/Oil Dist. Coeff: Not available.
Ionicity (in Water): Not available.
Dispersion Properties: Not available.
Solubility: Not available.
10: Chlorhexidine digluconate Stability and Reactivity Data
Instability Temperature: Not available.
Conditions of Instability: Not available.
Incompatibility with various substances: Strong oxidising agents.
Corrosivity: Not available.
Special Remarks on Reactivity: Not available.
Special Remarks on Corrosivity: Not available.
Polymerization: Not available.
11:Chlorhexidine digluconate Toxicological Information
Routes of Entry: Skin contact. Eye contact. Ingestion. Inhalation.
Toxicity to Animals:
Chronic Effects on Humans: Not available.
Other Toxic Effects on Humans: Skin Contact: May cause skin irritation.
Skin Absorption: May be harmful if absorbed through the skin.
Eye Contact: May cause eye irritation.
Inhalation: May be harmful if inhaled. Material may be irritating to mucous membranes and upper respiratory tract.
Ingestion: May be harmful if swallowed.
Special Remarks on Toxicity to Animals: Not available.
Special Remarks on Chronic Effects on Humans: Not available.
Special Remarks on other Toxic Effects on Humans: Not available.
12: Chlorhexidine digluconate Ecological Information
Ecotoxicity: Not available.
BOD5 and COD: Not available.
Product of Biodegradation: Not available.
Toxicity of the Products of Biodegradation: Not available.
Special Remarks on the Products of Biodegradation: Not available.
13: Chlorhexidine digluconate Disposal Considerations
Waste Disposal: Waste must be disposed of in accordance with federal, state and local environmental control regulations.
14: Chlorhexidine digluconate Transport Information
DOT Classification: Class :6.1
Identification: UN Number : 2811
Packing Group :III
Special Provisions for Transport: Not available.
15: Chlorhexidine digluconate Other Regulatory Information
Federal and State Regulations: TSCA 8(b) inventory : Chlorhexidine digluconate
Other Regulations: Not available.
WHMIS(Canada): Not available.
DSCL(EEC): Not available.
Health Hazard: 2
Fire Hazard: 0
National Fire Protection Association (U.S.A):
Protective Equipment: Gloves. Lab coat. Dust respirator. Safety goggles.
16: Chlorhexidine digluconate Other Information
References: Not available.
Other Special Considerations: Not available.
Created: 18/07/2006 3:20:04 PM
Last Updated: 11/12/2008 2:59:06 PM
Chlorhexidine digluconate Disclaimer
This product is offered by bioWORLD for research, laboratory or further manufacturing use. Not for human use or consumption.
The information above is believed to be accurate and represents the best information currently available to us. However,we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes.In no event shall Bio-World.com be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect,incidental,consequential or exemplary damages, howsoever arising,
even if Bio-World.com has been advised of the possibility of such damages.