Chlorhexidine gluconate is a topical antimicrobial agent. It is used as an oral rinse for the treatment of gingivitis and periodontitis and topically as a surgical scrub, health-care personnel hand wash, patient preoperative skin preparation, skin wound cleanser, general skin cleanser and for the treatment of acne vulgaris. It is also available as a 2% cloth and as a swab with 3.15% chlorhexidine gluconate and 70% isopropyl alcohol; both are indicated for use as a preoperative skin preparation. Other uses of chlorhexidine include prophylaxis and treatment of mouth infections, treatment of denture stomatitis, ulcerative stomatitis, and acute necrotizing ulcerative gingivitis (ANUG). Chlorhexidine oral rinse is commonly used to prevent and treat mucositis in patients receiving chemotherapy. Chlorhexidine is also incorporated into several types of medical devices including intravenous catheters, topical antimicrobial skin dressings and implantable dental chips and surgical mesh. Chlorhexidine dental implant is indicated as an adjunct to scaling and root planing procedures in adults with periodontitis. Chlorhexidine's bacterial spectrum includes both gram-positive and gram-negative bacteria, some viruses including HIV, and fungi; but is sporicidal only at elevated temperatures. In several studies, chlorhexidine has shown a greater decrease in initial bacterial counts of hands and a greater reduction in residual bacterial flora with continued use when compared to povidone-iodine 0.75%, hexachlorophene 3% emulsion, iodophor and alcohol containing foam. Chlorhexidine is an ideal topical antiseptic due to its persistent activity on the skin with continued use, rapid and broad bactericidal activity, and minimal absorption, although severe allergic reactions have been associated with the topical antiseptics and medical devices containing chlorhexidine.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-For external use only. Keep out of eyes, ears, and mouth; if accidental exposure occurs, rinse promptly and thoroughly with water. Serious and permanent eye injury has occurred during surgery when chlorhexidine enters and remains in the eye.
-Do not heat solution.
-Apply solution in a well ventilated area to clean, completely dry, residue-free, intact skin.
-Avoid getting the solution into areas with excess hair as the solution may take longer to dry or may not dry completely. When necessary, remove hair using surgical clippers on the morning of surgery. If a wet shave is used, thoroughly remove all soap residues.
-When applying to skin folds, toes, or fingers, use a sterile-gloved hand to hold skin apart until completely dry. Otherwise, skin may adhere to itself.
-To reduce the risk of fire, wait to drape or use ignition sources (e.g., cautery, laser) until solution is completely dry (minimum of 3 minutes on hairless skin; up to 1 hour in hair).
-Tinted solution will slowly fade from skin over time. After the procedure, alcohol may be used to remove tint if desired.
Betasept:
-Surgical hand scrub:-Wet hands and forearms with warm water.
-Scrub for 3 minutes with approximately 5 mL of product and a wet sponge. Pay close attention to nails, cuticles, and interdigital spaces. A separate nail cleaner may be used.
-Rinse thoroughly.
-Wash for an additional 3 minutes with approximately 5 mL of product and rinse under running water.
-Dry thoroughly.
-Health care personnel hand wash:-Wet hands with water.
-Dispense approximately 5 mL of product into cupped hands and wash in a vigorous manner for 15 seconds.
-Rinse and dry thoroughly.
-Patient preoperative skin preparation:-Apply liberally to surgical site and swab for at least 2 minutes.
-Dry with a sterile towel.
-Repeat swabbing process for an additional 2 minutes, and dry with a sterile towel.
-Skin wound and general skin cleansing or MRSA decolonization:-Thoroughly rinse area to be cleansed with water.
-Apply the minimum amount of product necessary to cover the skin or wound area and wash gently.
-Rinse again thoroughly.
-For no-rinse solution, may add 4% chlorhexidine solution to a basin of water and dilute 1:1 to yield a 2% solution.
Bactoshield sponge:
-Wet hands and forearms with warm water.
-Clean under nails with nail pick provided. Nails should be maintained with a 1 mm free edge.
-Wet sponge and squeeze to work up lather.
-Scrub for 3 minutes. Pay close attention to nails, cuticles, and interdigital spaces. Use the brush side to clean the interdigital spaces, and the sponge side to scrub the hands and forearms.
-Rinse thoroughly with warm water.
-Scrub for an additional 3 minutes using the sponge side, then rinse hands.
-Dry thoroughly. Discard brush-sponge.
Hibiclens:
-Surgical hand scrub:-Wet hands and forearms with warm water.
-Scrub for 3 minutes with approximately 5 mL (4 pumps) of product and a brush.
-Rinse thoroughly under running water.
-Wash for an additional 3 minutes with approximately 5 mL (4 pumps) of product and rinse under running water.
-Dry thoroughly.
-Healthcare personnel hand wash:-Wet hands with water.
-Dispense approximately 5 mL (4 pumps) of product into cupped hands and wash in a vigorous manner for 15 seconds.
-Rinse and dry thoroughly.
-Patient preoperative skin preparation:-Apply liberally to surgical site and swab for at least 2 minutes.
-Dry with a sterile towel.
-Repeat swabbing process for an additional 2 minutes, and dry with a sterile towel.
-Skin wound and general skin cleansing or MRSA decolonization:-Thoroughly rinse area to be cleansed with water.
-Apply the minimum amount of product necessary to cover the skin or wound area and wash gently.
-Rinse again thoroughly.
-For no-rinse solution, may add 4% chlorhexidine solution to a basin of water and dilute 1:1 to yield a 2% solution.
Topical pad (cloth):
-Opening package/Preparation:
-Open package by holding top of package in one hand, lift on backside of package with the other hand.
-Grasp flap at top and pull down to tear flap away and expose foam.
-Hold outside of package to present foam and cloths to prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.
Or
-Using sterile scissors, cut off the end seal of the package.
-Transfer contents onto prep table, avoiding contact between cloths and outside of package to reduce risk of cloth contamination.
-Use the first cloth to prepare the skin area indicated for a moist or dry site, making certain to keep the second cloth where it will not be contaminated. Use second cloth to prepare larger areas.
-Application:
-Dry surgical sites (such as abdomen or arm):
--Use one cloth to cleanse each 161 cm area (approximately 5 x 5 inches) of skin to be prepared.
-Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.
-Allow area to air dry for one (1) minute. Do not rinse.
-Moist surgical sites (such as inguinal fold):-Use one cloth to cleanse each 65 cm area (approximately 2 x 5 inches) of skin to be prepared.
-Vigorously scrub skin back and forth for 3 minutes, completely wetting treatment area, then discard.
-Allow area to air dry for one (1) minute. Do not rinse.
-Discard each cloth after a single use after package has been opened, discard any unused cloths.
Other Administration Route(s)
Oral Rinse
-May be dispensed in the original container, which includes a measuring cup, or in an amber bottle with a device to measure 15 mL.
-Rinse mouth with 15 mL for 30 seconds after toothbrushing.
-Do not swallow or dilute.
-Expectorate after rinsing.
-Do not rinse with water or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine oral rinse.
Dental Implantation
-Assure the periodontal pocket and surrounding area are dry prior to implant insertion.
-Grasp the implant with forceps such that the rounded end points are away from the forceps.
-Insert the implant into the periodontal pocket to its maximum depth; may be maneuvered into position using the tips of the forceps or a flat instrument.
-The implants are biodegradable and do not need to be removed.
-If the implant becomes dislodged within 48 hours after insertion, place a new implant. If the implant becomes dislodged 7 or more days after insertion, no replacement is needed. If the implant becomes dislodged more than 48 hours after insertion, do not replace the implant, reevaluate at 3 months and insert a new implant if the pocket depth is not less than 5 mm.
Chlorhexidine oral rinse may cause tooth discoloration and staining of the dorsum of the tongue, dentures or other mouth appliances, and tooth restorations (fillings) with rough surfaces or margins. Staining may be seen beginning after 1 week of therapy. After 6 months of treatment with chlorhexidine oral rinse, approximately 56% of patients had a measurable increase in tooth stain with approximately 15% having heavy stains. Staining was more severe in patients with heavier areas of unremoved plaque. The stain can be removed from most tooth surfaces by conventional dental cleaning techniques. Staining to tooth restorations may be permanent and may necessitate replacement. Chewing sugar-free gum for 20 minutes after brushing and rinsing with chlorhexidine oral rinse may decrease the amount of staining without affecting chlorhexidine efficacy in gingivitis.
Patients treated with chlorhexidine oral rinse may experience taste alterations or a metallic taste. This usually decreases with time and will resolve completely once treatment with chlorhexidine is discontinued. Permanent taste alteration has not been reported.
Increased calculus (tartar) formation has been reported with the use of chlorhexidine oral rinse. It is recommended to remove calculus deposits by dental prophylaxis every 6 months, especially during treatment with chlorhexidine oral rinse. An increase in supragingival calculus was noted in chlorhexidine users. Whether chlorhexidine increases subgingival calculus is not known.
Parotitis (parotid duct obstruction) resulting in swelling of glands on the side of the face and neck and mouth irritation (superficial desquamation lesions) have been reported in patients following use of chlorhexidine oral rinse. The lesions are usually painless and transient. In addition, tongue tip irritation has been reported. Other oral mucosal adverse events reported in < 1% of patients include aphthous ulcer, grossly obvious gingivitis, trauma, oral ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Post-marketing reports include occurrences of stomatitis, gingivitis, glossitis, ulcer, xerostomia, glossal edema, mucosal hypoesthesia, and mucosal paresthesias. Minor irritation and superficial desquamation have also been reported. Gingival hyperplasia (2.3% to 3.6%) and ulcerative stomatitis (0.5% to 2.2%) were reported in patients receiving the PerioChip insert.
The rare risk of serious hypersensitivity reactions, anaphylactoid reactions, and anaphylactic shock has been reported with the use of prescription and OTC products that contain chlorhexidine gluconate, including skin antiseptic products, dental products, and medical devices such as dressing and intravenous lines. Reactions can occur within minutes of exposure. Reactions can include wheezing, dyspnea, angioedema, rash (unspecified), and hives (urticaria). Local skin irritation may also occur. Allergy was reported in 4% to 5.9%% of patients receiving the PerioChip insert.
Mild to moderate dental pain and sensitivity may occur during the first week following placement of the chlorhexidine dental implant. This usually resolves spontaneously and is less with repeated treatments. Toothache, including dental, gingival, or mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity, was reported in 41.4% to 50.7% of patients receiving the PerioChip insert. Tooth disorder, including broken, cracked, or fractured teeth, mobile teeth, and lost bridges, crowns, or fillings, was reported in 6.2% to 6.8% of patients receiving the PerioChip insert. Pain was reported in 4.9% to 5% of patients receiving the PerioChip insert.
Infections, including abscesses (5.8% to 5.9%) and cellulitis, have been reported with the adjunctive use of PerioChip after scaling and root planing. Infection has been reported after scaling and root planing alone. Other complications reported with the use of PerioChip include upper respiratory tract infection (26.1% to 28.4%), sinusitis (13.1% to 13.8%), influenza-like symptoms (7.6% to 9.5%), bronchitis (3.2% to 6.2%), pharyngitis (2.3% to 3.6%), rhinitis (2.7% to 5%), and cough (2.7% to 3.2%).
Back pain (6.7% to 11.3%), myalgia (4% to 4.1%), arthralgia (3.1% to 5.9%), dysmenorrhea (3.1% to 5.9%), arthrosis (1.8% to 2.7%), and tendinitis (0.5% to 2.2%) were all reported in patients during the use of the PerioChip insert.
Headache (27.1% to 27.5%), dyspepsia (2.7% to 3.1%), and hypertension (2.2% to 2.7%) have been reported in patients using the PerioChip dental insert.
It is not known if chlorhexidine is excreted into breast milk. However, chlorhexidine is poorly absorbed from the gastrointestinal tract even after oral use. In studies using chlorhexidine vaginally prior to delivery to prevent mother-to-child transmission of HIV, no adverse events were reported in any breast-fed infant. In a case report, a woman who was breast-feeding sprayed chlorhexidine on her breasts to prevent mastitis. Her 2-day old infant developed bradycardia following breast feeding. The bradycardia episodes resolved when the chlorhexidine was discontinued. However, in a study of 200 nursing mothers who sprayed their breasts with chlorhexidine in alcohol before and after each feeding, there were no reported side effects in any breast-fed infant. Consider the benefits of breast-feeding, the risk of potential drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding baby experiences an adverse effect related to a maternally administered drug, healthcare providers are encouraged to report the adverse effect to the FDA.
Patients with dental work such as anterior tooth restorations (front-tooth fillings) or dentures may develop excessive and permanent discoloration of these areas after using chlorhexidine oral rinse. Replacement of fillings and appliances may be needed for cosmetic reasons. If natural stain cannot be removed from these appliances, consider avoiding treatment with chlorhexidine oral rinse due to increased risk of permanent staining. Anterior tooth restorations with rough surfaces or margins are at increased risk for staining and discretion should be used in these patients.
The use of chlorhexidine in the management of patients with some types of periodontal disease should be carefully considered. For patients having coexisting gingivitis and periodontitis, the presence or absence of gingival inflammation following treatment with chlorhexidine oral rinse (e.g., Peridex) should not be used as a major indicator of underlying periodontitis; the effect of the oral rinse on periodontitis has not been determined. Chlorhexidine dental inserts (e.g., PerioChip) have not been studied in the treatment of acute abscessed periodontal pockets and are not recommended. Rarely, infections including abscesses and cellulitis, have been reported with the adjunctive use of PerioChip after scaling and root planing. Infection has been reported after scaling and root planing alone. Management of patients with periodontal disease should include consideration of potentially contributing medical disorders, such as cancer, diabetes, and immunocompromised status. Patients should notify the dentist promptly if pain, swelling, or other problems occur.
When using topical solutions containing alcohol, including chlorhexidine, prior to surgery, be aware that the solution gives off flammable vapors. Do not drape or use ignition source such as cautery or laser until solution is completely dry (minimum of 3 minutes on hairless skin). Avoid applying solution into hairy areas because the solution may take much longer to dry or may not dry completely. Do not allow the solution to pool and remove wet materials from prep area.
Following ocular exposure of chlorhexidine topical antiseptic, serious and permanent eye injury has occurred during surgery when chlorhexidine enters and remains in the eye. Ocular effects include corneal edema, severe corneal endothelium damage requiring penetrating keratoplasty, iris atrophy, anterior chamber applanation (or flattening), and increased intraocular pressure. Inadvertent ocular exposure of chlorhexidine is characterized by streak formation in the anterior chamber.
Chlorhexidine oral rise is pregnancy category B. However, adequate, well-controlled studies in pregnant women have not been done. Safety for use of topical chlorhexidine during pregnancy has not been established. Use only if clearly indicated and when the potential benefits are greater than the potential risks to the fetus.
In the presence of tympanic membrane perforation, take precautions to prevent exposure of inner ear tissues to chlorhexidine. Hearing loss and deafness may occur when chlorhexidine becomes in contact with the middle ear.
Chlorhexidine topical antiseptic should not be used in patients with skin disease or wounds involving more than the superficial layers of skin, or for repeated cleansing of large body areas except when it is necessary to reduce the bacteria population of the skin. Do not use under an occlusive dressing. Additionally, chlorhexidine should not be used to cleanse the skin prior to lumbar puncture; contact with the meninges should be avoided.
Topically administered chlorhexidine should be used with caution in premature infants, neonates and in infants less than 2 months of age because of the potential for irritation or chemical burns. The safety and efficacy of chlorhexidine oral rinse have not been established in neonates, infants, children, and adolescents.
The rare risk of serious hypersensitivity reactions or anaphylaxis has been reported with the use of prescription and OTC products that contain chlorhexidine gluconate, including skin antiseptic products, dental products, and medical devices such as dressing and intravenous lines. Reactions can occur within minutes of exposure, and may include the following symptoms: wheezing or difficulty breathing, shock, facial swelling, hives, and rash. Allergic reactions may require emergency department visits or hospitalizations and have rarely resulted in death. PerioChip, is contraindicated in patients with a known sensitivity to chlorhexidine. Consider the use of alternative products in patients in which allergy to chlorhexidine is documented or suspected.
Some chlorhexidine gluconate products are flammable. Avoid heat, flame, and tobacco smoking during and immediately following topical application.
Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Bacteroides forsythus, Campylobacter rectus, Porphyromonas gingivalis, Prevotella intermedia
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.
This drug may also have activity against the following microorganisms: Cutibacterium acnes
NOTE: Some organisms may not have been adequately studied during clinical trials; therefore, exclusion from this list does not necessarily negate the drug's activity against the organism.
For the treatment of gingivitis:
Oral Rinse dosage:
Adults: Rinse mouth with 15 mL of chlorhexidine oral rinse for 30 seconds twice daily following toothbrushing. Do not swallow or dilute. Expectorate after rinsing. Therapy with chlorhexidine oral rinse should begin immediately following dental prophylaxis. Reevaluate and continue dental prophylaxis at least every 6 months. The rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG).
For the adjuvant treatment and maintenance of adult periodontitis:
Periodontal insert dosage (PerioChip peridontal insert):
Adults: Insert 1 chlorhexidine periodontal insert (PerioChip 2.5 mg) into a periodontal pocket with a probing pocket depth of 5 mm or more. Up to 8 periodontal inserts may be inserted in a single visit. Treatment is recommended every 3 months in pockets with a depth of 5 mm or more. This treatment is in addition to scaling and root planing for the reduction of pocket depth in adult patients with periodontitis. Chlorhexidine dental implants may be used as part of a periodontal maintenance program which, would also include good oral hygiene, scaling and root planing.
For the amelioration of oral stomatitis* and mucositis* associated with cytoreductive chemotherapy in patients preparing for bone marrow transplantation:
NOTE: This drug is designated as an orphan drug for this indication by the FDA.
Oral Rinse dosage:
Adults: The usual dosage is typically used for this off-label indication. Rinse mouth with 15 mL of chlorhexidine oral rinse for 30 seconds twice daily following toothbrushing. Do not swallow or dilute. Expectorate after rinsing.
For the treatment of denture stomatitis*:
Denture Soak and Oral Rinse dosage:
Adults: A standard treatment regimen has not been established. Soaking dentures in chlorhexidine oral rinse for 30 minutes daily has been suggested. In addition, rinsing of the mouth with 15 mL twice daily for 30 seconds (then expectorating) or brushing the gums or dentures twice daily with chlorhexidine oral rinse may be needed to remove denture biofilm. Do not dilute or swallow.
For skin antisepsis, including preoperative skin preparation and wound management:
-for skin antisepsis for surgical hand scrub:
Topical dosage (solution):
Adults: Scrub forearms and hands, with particular attention to the nails, cuticles, and interdigital spaces, with about 5 mL and wet sponge for 3 minutes and rinse thoroughly, then scrub with 5 mL for an additional 3 minutes and rinse thoroughly.
Topical dosage (sponge):
Adults: Scrub forearms and hands, with particular attention to the nails, cuticles, and interdigital spaces, for 3 minutes and rinse thoroughly, then scrub for an additional 3 minutes and rinse thoroughly.
-for skin antisepsis for health care personnel handwash:
Topical dosage (solution):
Adults: Wash hands vigorously with about 5 mL for 15 seconds and rinse thoroughly.
-for skin antisepsis for patient preoperative skin preparation:
Topical dosage (solution):
Adults: Apply liberally to surgical site and swab for at least 2 minutes, then dry with sterile towel; repeat for an additional 2 minutes and dry with a sterile towel.
Infants, Children, and Adolescents: Apply liberally to surgical site and swab for at least 2 minutes, then dry with sterile towel; repeat for an additional 2 minutes and dry with a sterile towel.
Topical dosage (cloth):
Adults: Apply to surgical site and scrub for at least 3 minutes, completely wetting treatment area, then let air dry for 1 minute. Do not rinse. Discard each cloth after single use.
Infants, Children, and Adolescents: Apply to surgical site and scrub for at least 3 minutes, completely wetting treatment area, then let air dry for 1 minute. Do not rinse. Discard each cloth after single use.
-for skin antisepsis for skin wound management and general skin cleansing:
Topical dosage (solution):
Adults: Apply minimum amount necessary to cover the affected skin or wound area and wash gently, then rinse thoroughly.
Infants, Children, and Adolescents: Apply minimum amount necessary to cover the affected skin or wound area and wash gently, then rinse thoroughly.
For use as a skin cleanser in the treatment of acne vulgaris*:
Topical dosage:
Adults and Adolescents: Not commonly used; gentle skin cleansers are usually preferred. Wet face. Gently wash affected areas of the face with approximately 5 mL chlorhexidine gluconate 4% skin cleanser (Hibiclens) twice daily, in the morning and evening before going to bed. Rinse face thoroughly. Avoid the eye area. Discontinue use if skin becomes overly dry or if skin irritation occurs.
For methicillin-resistant S. aureus decolonization* to reduce the risk of infection among high-risk persons:
-for methicillin-resistant S. aureus decolonization* to reduce the risk of infection among high-risk inpatients, including during institutional outbreaks:
Topical dosage (4% topical solution):
Adults: Apply topically to the skin once daily, as part of daily bathing and rinse off. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Infants, Children, and Adolescents: Apply topically to the skin once daily, as part of daily bathing and rinse off. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Neonates: Apply topically to the skin once daily, as part of daily bathing and rinse off. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Topical dosage (2% topical solution or impregnated cloths):
Adults: Apply topically to the skin once daily, as part of daily bathing without rinsing off. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Infants, Children, and Adolescents: Apply topically to the skin once daily, as part of daily bathing without rinsing off. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Neonates: Apply topically to the skin once daily, as part of daily bathing without rinsing off. Use in combination with mupirocin or povidone-iodine nasal decolonization.
-for preoperative methicillin-resistant S. aureus decolonization* to prevent postoperative infections:
Topical dosage (4% topical solution):
Adults: Apply topically to the skin once daily, as part of daily bathing and rinse off, for up to 5 days pre-operatively. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Infants, Children, and Adolescents: Apply topically to the skin once daily, as part of daily bathing and rinse off, for up to 5 days pre-operatively. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Topical dosage (2% topical solution or impregnated cloths):
Adults: Apply topically to the skin once daily, as part of daily bathing without rinsing off, for up to 5 days pre-operatively. Use in combination with mupirocin or povidone-iodine nasal decolonization.
Infants, Children, and Adolescents: Apply topically to the skin once daily, as part of daily bathing without rinsing off, for up to 5 days pre-operatively. Use in combination with mupirocin or povidone-iodine nasal decolonization.
-for postdischarge methicillin-resistant S. aureus decolonization* to reduce postdischarge infections and readmission:
Topical dosage (4% topical solution):
Adults: Apply topically to the skin once daily, as part of daily bathing and rinse off, for 5 days twice monthly for 6 months. Use in combination with chlorhexidine mouthwash and mupirocin nasal decolonization.
Infants, Children, and Adolescents: Apply topically to the skin once daily, as part of daily bathing and rinse off, for 5 days twice monthly for 6 months. Use in combination with chlorhexidine mouthwash and mupirocin nasal decolonization.
Topical dosage (2% topical solution or impregnated cloths):
Adults: Apply topically to the skin once daily, as part of daily bathing without rinsing off, for 5 days twice monthly for 6 months. Use in combination with chlorhexidine mouthwash and mupirocin nasal decolonization.
Infants, Children, and Adolescents: Apply topically to the skin once daily, as part of daily bathing without rinsing off, for 5 days twice monthly for 6 months. Use in combination with chlorhexidine mouthwash and mupirocin nasal decolonization.
Peridontal dosage (oral rinse):
Adults: 15 mL by oral rinse twice daily for 5 days twice monthly for 6 months. Use in combination with chlorhexidine baths and mupirocin nasal decolonization.
Infants, Children, and Adolescents: 15 mL by oral rinse twice daily for 5 days twice monthly for 6 months. Use in combination with chlorhexidine baths and mupirocin nasal decolonization.
Maximum Dosage Limits:
-Adults
Maximum dosage information not available.
-Geriatric
Maximum dosage information not available.
-Adolescents
Maximum dosage information not available.
-Children
Maximum dosage information not available.
-Infants
Maximum dosage information not available.
-Neonates
Maximum dosage information not available.
Patients with Hepatic Impairment Dosing
Chlorhexidine is poorly absorbed from the GI tract following inadvertent ingestion; excretion is primarily through the feces. Therefore, no dosage adjustments are necessary.
Patients with Renal Impairment Dosing
Chlorhexidine is poorly absorbed from the GI tract following inadvertent ingestion; excretion is primarily through the feces with < 1% excreted in urine. Therefore, no dosage adjustments are necessary.
*non-FDA-approved indication
Disulfiram: (Minor) Some chlorhexidine oral rinses contain ethanol in significant percentages. Although chlorhexidine is poorly absorbed from the GI tract and the products are intended for oral topical rinse and not for systemic ingestion, there is a potential for interaction with disulfiram when such products are swallowed.
Keratinocytes; Fibroblasts; Collagen: (Major) Avoid the use of chlorhexidine gluconate solution on the wound following application of keratinocytes and dermal fibroblast collagen. Administering these drugs together may reduce wound repair and regeneration. Chlorhexidine gluconate has been shown to be toxic to keratinocytes and human dermal fibroblasts.
Chlorhexidine destabilizes and penetrates bacterial cell membranes. Chlorhexidine precipitates the cytoplasm and interferes with membrane function by inhibiting oxygen utilization leading to a decrease in cellular ATP levels and cell death. In gram-negative bacteria, chlorhexidine affects the outer membrane allowing the release of periplasmic enzymes. The inner membrane of these organisms is not ruptured but the uptake of small molecules is impaired. At low concentrations chlorhexidine exhibits a bacteriostatic effect while at high concentrations it is bactericidal. The following organisms have a high susceptibility to chlorhexidine: some staphylococci, Streptococcus mutans, Streptococcus salivarius, Candida albicans, Escherichia coli, Selenomonas, and anaerobic propinionic bacteria. Streptococcus sanguis has moderate sensitivity to chlorhexidine. Proteus strains, Pseudomonas, Klebsiella, and gram-negative cocci resembling Veillonella have a low sensitivity to chlorhexidine. Chlorhexidine dental implants have shown a reduction in the numbers of Porphyromonas (Bacteriodes) gingivalis, Prevotella (Bacteriodes) intermedia, Bacteriodes forsythus, and Campylobacter rectus (Wolinella recta) after implant placement. During 6-month use of chlorhexidine oral rinse, dental plaque samples showed a 54-97% reduction in certain aerobic and anaerobic bacteria. Clinical studies have not shown any significant changes in bacterial resistance or overgrowth of opportunistic infections during treatment with chlorhexidine oral rinse or after placement of chlorhexidine implants. Chlorhexidine 5% (Hibitane(R) Concentrate - not available in the US) has been shown to be effective against rubella-, measles-, mumps- and HIV viruses and ineffective against roto-, polio-, rhino- and adeno-viruses. In addition, chlorhexidine is effective against cytomegalovirus and influenza virus.
Chlorhexidine is applied topically to the skin or is used as an oral rinse; it should never be ingested or used in the eye. Excretion is primarily via the feces and <1% is excreted in the urine.
-Route-Specific Pharmacokinetics
Oral Route
After oral rinsing, chlorhexidine is adsorbed onto the surfaces of teeth, plaque and oral mucosa and is slowly released over a 24-hour period as the concentration of chlorhexidine decreases in the saliva. Approximately 30% of chlorhexidine gluconate remains in the oral cavity. In vitro, the dental implants release chlorhexidine from the matrix in a biphasic manner with approximately 40% released in the first 24 hours and then the remaining chlorhexidine is released linearly over the next 7-10 days. However, clinical studies show a high degree of interpatient variability in chlorhexidine release from the matrix. Chlorhexidine is poorly absorbed through the GI tract but may be absorbed following placement within a periodontal pocket. Following the placement of 4 implants, chlorhexidine plasma concentrations were at or below the limit of detection. The mean peak plasma concentration 30 minutes after inadvertent oral ingestion of chlorhexidine gluconate 300 mg was 0.206 mcg/mL.
Topical Route
After single application to intact skin, the residual concentration of chlorhexidine is higher than the MICs for most skin flora and some infectious organisms up to 24 hours after application. There is no evidence that chlorhexidine is absorbed through intact skin. For chlorhexidine topical antisepsis activity the optimal pH is 5.0-7.0, the normal pH of the skin.