Hibiclens

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

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 (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:
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.

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.

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

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

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

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

Rx, OTC

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

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).

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.

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.

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.

Wash hands vigorously with about 5 mL for 15 seconds and rinse thoroughly.

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.

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.

Apply minimum amount necessary to cover the affected skin or wound area and wash gently, then rinse thoroughly.

Apply minimum amount necessary to cover the affected skin or wound area and wash gently, then rinse thoroughly.

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.

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.

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

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

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.

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.

Betasept/Chlorhexidine/Chlorhexidine Gluconate/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%

Maximum dosage information not available.

Maximum dosage information not available.

Maximum dosage information not available.

Maximum dosage information not available.

Maximum dosage information not available.

Maximum dosage information not available.

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.

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.

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.

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.