(klor HEKS i deen GLOO koe nate)
Oral rinse: Antibacterial dental rinse for gingivitis treatment
Periodontal chip: Adjunctive therapy to reduce pocket depth in patients with periodontitis
Topical: Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients; surgical scrub and antiseptic hand rinse for healthcare personnel
Hypersensitivity to chlorhexidine or any component of the formulation
Gingivitis: Oral rinse: Swish for 30 seconds with 15 mL (one capful) of undiluted oral rinse after toothbrushing, then expectorate; repeat twice daily (morning and evening). Therapy should be initiated immediately following a dental prophylaxis. Patient should be reevaluated and given a dental prophylaxis at intervals no longer than every 6 months.
Periodontitis:Periodontal chip: One chip is inserted into a periodontal pocket with a probing pocket depth ≥5 mm. Up to 8 chips may be inserted in a single visit. Treatment is recommended every 3 months in pockets with a remaining depth ≥5 mm. If dislodgment occurs 7 days or more after placement, the subject is considered to have had the full course of treatment. If dislodgment occurs within 48 hours, a new chip should be inserted. The chip biodegrades completely and does not need to be removed. Patients should avoid dental floss at the site of periodontal chip insertion for 10 days after placement because flossing might dislodge the chip.
Insertion of periodontal chip: Pocket should be isolated and surrounding area dried prior to chip insertion. The chip should be grasped using forceps with the rounded edges away from the forceps. The chip should be inserted into the periodontal pocket to its maximum depth. It may be maneuvered into position using the tips of the forceps or a flat instrument.
Skin cleanser for preoperative skin preparation, skin wound and general skin cleanser for patients; surgical scrub and antiseptic hand rinse for healthcare personnel: Topical:
Surgical scrub: Scrub hands and forearms for 3 minutes paying close attention to nails, cuticles, and interdigital spaces, and rinse thoroughly, wash for an additional 3 minutes, rinse, and dry thoroughly.
Surgical hand antiseptic: Lotion: Dispense 1 pumpful in palm of 1 hand; dip fingertips of opposite hand into solution and work it under nails. Spread remainder evenly over hand and just above elbow, covering all surfaces. Repeat on other hand. Dispense another pumpful in each hand and reapply to each hand up to the wrist. Allow to dry before gloving.
Healthcare personnel hand antiseptic:
Liquid or solution: Wash with ~5 mL for 15 seconds; rinse thoroughly with water and dry
Lotion: Apply to clean, dry hands and nails. Dispense 1 pumpful (2 mL) into the palm of 1 hand; apply evenly to cover both hands up to the wrists; allow to dry without wiping.
Towelette: Rub 15 seconds paying close attention to nails and interdigital spaces; no watering or toweling necessary
Preoperative skin preparation:
Solution: Apply liberally to surgical site and swab for at least 2 minutes. Dry with sterile towel. Repeat procedure (swab for additional 2 minutes and dry with sterile towel).
Applicator (ChloraPrep One-Step):
Dry surgical sites (eg, abdomen, arm): Completely wet treatment area; use gentle back and forth strokes for ~30 seconds. Allow solution to air dry for ~30 seconds. If using an ignition source (eg, electrocautery), allow solution to completely dry for a minimum of 3 minutes for hairless skin and up to 1 hour in hair; do not blot or wipe away. Note: Prior to use with electrocautery procedures, consult specific product labeling to determine if the ChloraPrep product may be used near an ignition source.
Moist surgical sites (eg, inguinal area): Completely wet treatment area; use gentle back and forth strokes for ~ 2 minutes. Allow solution to air dry for ~ 1 minute. If using an ignition source (eg, electrocautery), allow solution to completely dry for a minimum of 3 minutes for hairless skin and up to 1 hour in hair; do not blot or wipe away. Note: Prior to use with electrocautery procedures, consult specific product labeling to determine if the ChloraPrep product may be used near an ignition source.
Preparation of skin prior to an injection: Swab: Apply swab to procedure site for 15 seconds; allow to air dry for 30 seconds (do not blot or wipe dry). Note: Maximum treatment area for 1 swab is ~2.5 inches x 2.5 inches.
Wound care and general skin cleansing: Rinse area with water, then apply minimum amount necessary to cover skin or wound area and wash gently. Rinse again thoroughly.
Refer to adult dosing.
There are no dosage adjustments provided in the manufacturers labeling.
There are no dosage adjustments provided in the manufacturers labeling.
Oral rinse: Swish rinse and expectorate after rinsing; do not swallow. Use in the morning and evening after brushing teeth. Following administration, do not rinse with water or other mouthwashes, brush teeth, or eat immediately.
Periodontal chip insertion: Pocket should be isolated and surrounding area dried prior to chip insertion. The chip should be grasped using forceps with the rounded edges away from the forceps. The chip should be inserted into the periodontal pocket to its maximum depth. It may be maneuvered into position using the tips of the forceps or a flat instrument. The chip biodegrades completely and does not need to be removed. Patients should avoid dental floss at the site of periodontal chip insertion for 10 days after placement because flossing might dislodge the chip.
Topical: Keep out of eyes, ears, and mouth. Do not routinely apply to wounds which involve more than superficial layers of skin. Avoid contact with meninges (ie, do not use on lumbar puncture sites). Solutions may be flammable (may contain alcohol); consult specific product labeling to determine if product may be used with electrocautery procedures; if product can be used near an ignition source (eg, cautery, laser), avoid exposure to open flame and/or ignition source until completely dry; avoid application to hairy areas which may significantly delay drying time. When using the ChloraPrep ‚ ® applicator, do not touch sponge. Hold applicator sponge down and pinch wings of applicator once to activate ampul and release antiseptic.
Oral rinse/Periodontal chip: Store at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F); excursions permitted to 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F).
Topical: Store at room temperature. Alcohol-containing topical products are flammable; keep away from flames or fire.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Liquid, External:
Betasept Surgical Scrub: 4% (118 mL, 237 mL, 473 mL, 946 mL, 3780 mL)
Hibiclens: 4% (15 mL, 118 mL, 236 mL, 473 mL, 946 mL, 3790 mL) [contains fd&c red #40, isopropyl alcohol]
Generic: 2% (118 mL); 4% (118 mL, 237 mL, 473 mL, 946 mL, 3800 mL)
Miscellaneous, External:
Hibistat: 0.5% (50 ea [DSC]) [contains isopropyl alcohol]
Tegaderm CHG Dressing: (Dressing) (1 ea)
Pad, External:
Generic: 2% (2 ea, 6 ea)
Solution, External:
ChloraPrep One Step: 2% (3 mL, 10.5 mL) [latex free]
Dyna-Hex 2: 2% (473 mL) [contains isopropyl alcohol]
Solution, Mouth/Throat:
Paroex: 0.12% (473 mL) [alcohol free; contains fd&c red #40, propylene glycol]
Peridex: 0.12% (118 mL, 473 mL) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1), saccharin sodium]
Peridex: 0.12% (1893 mL) [contains alcohol, usp, brilliant blue fcf (fd&c blue #1), saccharin sodium; mint flavor]
Periogard: 0.12% (473 mL) [mint flavor]
Generic: 0.12% (15 mL, 473 mL)
There are no known significant interactions.
If chlorhexidine is used as a disinfectant before midstream urine collection, a false-positive urine protein may result (when using dipstick method based upon a pH indicator color change).
Oral:
>10%: Gastrointestinal: Dysgeusia, increased tartar formation, mouth discoloration
1% to 10%: Gastrointestinal: Mouth irritation, tongue irritation
Topical:
Dermatologic: Allergic sensitization, erythema, hypersensitivity reaction, rough skin, xeroderma
<1% (Limited to important or life-threatening): Anaphylaxis (Health Canada May 2016), dyspnea, facial edema, nasal congestion
Concerns related to adverse effects:
- Hypersensitivity reactions: Serious allergic reactions, including anaphylaxis, have been reported.
Dosage form specific issues:
- Oral rinse: Staining of oral surfaces (teeth, tooth restorations, dorsum of tongue) may occur; patients exhibited a measurable increase of staining in the facial anterior after 6 months of therapy that is more pronounced when there is a heavy accumulation of unremoved plaque. Stain does not adversely affect health of the gingivae or other oral tissues, and most stain can be removed from most tooth surfaces by dental prophylaxis. Because removal may not be possible, patients with anterior facial restorations with rough surfaces or margins should be advised of the potential permanency of the stain. An increase in supragingival calculus has been observed with use; it is not known if the incidence of subgingival calculus is increased. Dental prophylaxis to remove calculus deposits should be performed at least every 6 months. May alter taste perception during use; has rarely been associated with permanent taste alteration.
- Periodontal chip: Infectious events (eg, abscesses, cellulitis) have been observed rarely with adjunctive chip placement post scaling and root planing; use with caution in patients with periodontal disease and concomitant diseases potentially decreasing immune status (eg, diabetes, cancer). Use in acute periodontal abscess pocket is not recommended.
- Topical: For topical use only. Keep out of eyes, ears, and the mouth; if contact occurs, rinse with cold water immediately; permanent eye injury may result if agent enters and remains in the eye. Deafness has been reported following instillation in the middle ear through perforated ear drums. Avoid applying to wounds that involve more than the superficial skin layers. Avoid repeated use as general skin cleansing of large surfaces (unless necessary for condition). Not for preoperative preparation of face or head; avoid contact with meninges (do not use on lumbar puncture sites). Avoid applying to genital areas; generalized allergic reactions, irritation, and sensitivity have been reported. Solutions may be flammable (products may contain alcohol); avoid exposure to open flame and/or ignition source (eg, electrocautery) until completely dry; avoid application to hairy areas which may significantly delay drying time. Avoid use in children <2 months of age due to potential for increased absorption, and risk of irritation or chemical burns. May cause staining of fabrics (brown stain) due to a chemical reaction between chlorhexidine gluconate bound to fabric and chlorine (if sufficient chlorine is present from certain laundry detergents used during laundering process).
Other warnings/precautions:
- Appropriate use: Oral rinse: Effect on periodontitis has not been determined; has not been tested in patients with acute necrotizing ulcerative gingivitis.
- Appropriate use: Topical: When used as a topical antiseptic, improper use may lead to product contamination. Although infrequent, product contamination has been associated with reports of localized and systemic infections. To reduce the risk of infection, ensure antiseptic products are used according to the labeled instructions; avoid diluting products after opening; and apply single-use containers only one time to one patient and discard any unused solution (FDA Drug Safety Communication, 2013).
B/C (manufacturer specific)
Adverse events have not been observed in animal reproduction studies following use of the oral rinse; use of periodontal chip has not been studied. Chlorhexidine oral rinse is poorly absorbed from the GI tract.
Chlorhexidine has activity against gram-positive and gram-negative organisms, facultative anaerobes, aerobes, and yeast; it is both bacteriostatic and bactericidal, depending on its concentration. The bactericidal effect of chlorhexidine is a result of the binding of this cationic molecule to negatively charged bacterial cell walls and extramicrobial complexes. At low concentrations, this causes an alteration of bacterial cell osmotic equilibrium and leakage of potassium and phosphorous resulting in a bacteriostatic effect. At high concentrations of chlorhexidine, the cytoplasmic contents of the bacterial cell precipitate and result in cell death.
Oral rinse: ~30% retained in the oral cavity following rinsing and slowly released into oral fluids; poorly absorbed from GI tract and is not absorbed topically through intact skin
Periodontal chip: Chlorhexidine released from chip in a biphasic manner: ~40% within initial 24 hours, then remainder released linearly over 7-10 days; no detectable urine or plasma levels measured following insertion of 4 chips under clinical conditions
Feces ( ¢ ˆ ¼90%); Urine (<1%)
Serum concentrations: Detectable levels are not present in the plasma 12 hours after administration
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience mouth irritation; bad taste; staining of mouth, teeth, or fillings; itching; or dry skin. Have patient report immediately to prescriber severe gingival pain or edema; tingling of mouth; or severe skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.