Hibiclens (chlorhexidine gluconate) dose, indications, adverse effects, interactions... from PDR.net (2023)

CLASSES

Antiinfectives and Antiseptics for Local Oral Treatment
Antiseptics and Disinfectants, Excluding Hand Products

DEA CLASS

Rx, OTC

DESCRIPTION

Topical antimicrobial agent
Bacterial spectrum includes both gram-positive and gram-negative organisms, some viruses including HIV, and fungi; sporicidal only at elevated temperatures
Used as an oral rinse, topical skin cleanser, and is incorporated into several types of medical devices

COMMON BRAND NAMES

Betasept, Chlorostat, Hibiclens, Oro Clense, Peridex, Periogard, PerioRx, Perisol

HOW SUPPLIED

Betasept/Hibiclens Topical Sol: 4%
Chlorhexidine/Chlorhexidine Gluconate/Oro Clense/Peridex/Periogard/PerioRx/Perisol Oral Sol: 0.12%
Chlorhexidine/Chlorhexidine Gluconate/Oro Clense/Peridex/Periogard/PerioRx/Perisol Periodontal Sol: 0.12%
Peridex Buccal Liq: 0.12%

DOSAGE & INDICATIONS

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 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.

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 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 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.

†Indicates off-label use

MAXIMUM DOSAGE

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.

DOSING CONSIDERATIONS

Hepatic Impairment

Chlorhexidine is poorly absorbed from the GI tract following inadvertent ingestion; excretion is primarily through the feces. Therefore, no dosage adjustments are necessary.

Renal Impairment

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.

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:
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.

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 of product and a brush.
Rinse thoroughly under running water.
Wash for an additional 3 minutes with approximately 5 mL of product and rinse under running water.
Dry thoroughly.
Healthcare 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:
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.

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.

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 <= 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 > 48 hours after insertion, do not replace the implant, reevaluate the patient at 3 months and insert a new implant if the pocket depth is not < 5 mm.

STORAGE

Betasept:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 77 degrees F
Chlorostat:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 77 degrees F
Hibiclens:
- Avoid excessive heat (above 104 degrees F)
- Store between 68 to 77 degrees F
Oro Clense :
- Avoid extreme temperatures
- Do not freeze
- Do not refrigerate
- Protect from heat
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
- Store in a cool, well ventilated, dry place
Peridex:
- Avoid extreme temperatures
- Do not freeze
- Do not refrigerate
- Protect from heat
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
- Store in a cool, well ventilated, dry place
Periogard:
- Avoid extreme temperatures
- Do not freeze
- Do not refrigerate
- Protect from heat
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
- Store in a cool, well ventilated, dry place
PerioRx :
- Avoid extreme temperatures
- Do not freeze
- Do not refrigerate
- Protect from heat
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
- Store in a cool, well ventilated, dry place
Perisol:
- Avoid extreme temperatures
- Do not freeze
- Do not refrigerate
- Protect from heat
- Protect from light
- Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
- Store in a cool, well ventilated, dry place

CONTRAINDICATIONS / PRECAUTIONS

Breast-feeding

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.

Dental work

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.

Infection, periodontal disease

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.

Surgery

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.

Ocular exposure

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.

Pregnancy

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.

Tympanic membrane perforation

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.

Lumbar puncture, occlusive dressing, skin disease

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.

Children, infants, neonates

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.

Risk of serious hypersensitivity reactions or anaphylaxis

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.

Tobacco smoking

Some chlorhexidine gluconate products are flammable. Avoid heat, flame, and tobacco smoking during and immediately following topical application.

ADVERSE REACTIONS

Severe

angioedema / Rapid / Incidence not known
anaphylactic shock / Rapid / Incidence not known
anaphylactoid reactions / Rapid / Incidence not known

Moderate

gingival hyperplasia / Delayed / 2.3-3.6
hypertension / Early / 2.2-2.7
stomatitis / Delayed / 0-2.2
oral ulceration / Delayed / 0-1.0
erythema / Early / 0-1.0
edema / Delayed / 0-1.0
glossitis / Early / 0-1.0
parotitis / Delayed / Incidence not known
dyspnea / Early / Incidence not known
wheezing / Rapid / Incidence not known

Mild

tooth discoloration / Delayed / 0-56.0
dental pain / Delayed / 0-50.7
infection / Delayed / 0-28.4
headache / Early / 27.1-27.5
sinusitis / Delayed / 13.1-13.8
back pain / Delayed / 6.7-11.3
influenza / Delayed / 7.6-9.5
arthralgia / Delayed / 3.1-5.9
myalgia / Early / 4.0-4.1
pharyngitis / Delayed / 2.3-3.6
rhinitis / Early / 2.7-3.2
cough / Delayed / 2.7-3.2
dyspepsia / Early / 2.7-3.1
paresthesias / Delayed / 0-1.0
hypoesthesia / Delayed / 0-1.0
xerostomia / Early / 0-1.0
gingivitis / Delayed / 0-1.0
metallic taste / Early / Incidence not known
calculus (tartar) formation / Delayed / Incidence not known
skin irritation / Early / Incidence not known
rash / Early / Incidence not known
urticaria / Rapid / Incidence not known

DRUG INTERACTIONS

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.

PREGNANCY AND LACTATION

Pregnancy

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.

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.

MECHANISM OF ACTION

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.

PHARMACOKINETICS

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.

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.

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