(CHLORHEXIDINE GLUCONATE)
ACTIONS/CLINICAL PHARMACOLOGY:
chlorhexidine gluconate is an antiseptic/antimicrobial skin cleanser for hand scrubbing or washing by operating room personnel, for hand-washing by medical personnel, for pre-operative skin preparation, and for skin wound and general skin cleansing.
STEL-SCRUB Surgical Scrub provides rapid bactericidal action and has a persistent
antimicrobial effect against a wide range of microorganisms.
ADVANTAGES
STEL-SCRUB Surgical Scrub is uniquely kind to hands,--a feature that encourages
hospital personnel to follow correct hand-washing procedures.
STEL-SCRUB Surgical Scrub is formulated in a highly viscous base which can help
reduce waste and per- use cost during prepping and hand-washing. No unnecessary
pink tint has been added.
DOSAGE AND ADMINISTRATION:
DIRECTIONS FOR USE
SURGICAL HAND SCRUB:
Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL of
STEL-SCRUB Surgical Scrub and a wet brush, paying particular attention to the
nails, cuticles and interdigital spaces. A separate nail cleaner may be used.
Rinse thoroughly. Wash for an additional 3 minutes with 5 mL of STEL-SCRUB
Surgical Scrub and rinse under running water. Dry thoroughly.
PERSONNEL HAND WASH:
Wet hands with water. Dispense about 5 mL of STEL-SCRUB Surgical Scrub into cupped
hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
PRE-OPERATIVE SKIN PREPARATION:
Apply STEL-SCRUB Surgical Scrub liberally to surgical site and swab for at least 2
minutes. Dry with a sterile towel. Repeat procedure for an additional 2 minutes
and again dry with a sterile towel.
SKIN WOUND AND GENERAL SKIN CLEANSING:
Wounds which involve more than the superficial layers of the skin should not be
routinely treated with STEL-SCRUB Surgical Scrub. STEL-SCRUB Surgical Scrub should
not be used for repeated general skin cleansing of large body areas except in
those patients whose underlying condition makes it necessary to reduce the
bacterial population of the skin. To use, thoroughly rinse the area to be
cleansed with water. Apply the minimum amount of STEL-SCRUB Surgical Scrub
necessary to cover the skin or wound area and wash gently. Rinse again
thoroughly.
WARNINGS:
FOR EXTERNAL USE ONLY. KEEP OUT OF EYES, EARS AND MOUTH. STEL-SCRUB SURGICAL SCRUB
SHOULD NOT BE USED AS A PRE-OPERATIVE SKIN PREPARATION OF THE FACE OR HEAD.
MISUSE OF PRODUCTS CONTAINING CHLORHEXIDINE GLUCONATE HAS BEEN REPORTED TO CAUSE
SERIOUS AND PERMANENT EYE INJURY WHEN IT HAS BEEN PERMITTED TO ENTER AND REMAIN
IN THE EYE DURING SURGICAL PROCEDURES. IF STEL-SCRUB SURGICAL SCRUB SHOULD CONTACT
THESE AREAS, RINSE OUT PROMPTLY AND THOROUGHLY WITH WATER.
AVOID CONTACT WITH MENINGES. STEL-SCRUB SURGICAL SCRUB SHOULD NOT BE USED BY
PERSONS WHO HAVE SENSITIVITY TO IT OR ITS COMPONENTS. CHLORHEXIDINE GLUCONATE
HAS BEEN REPORTED TO CAUSE DEAFNESS WHEN INSTILLED IN THE MIDDLE EAR THROUGH
PERFORATED EAR DRUMS. IRRITATION, SENSITIZATION AND GENERALIZED ALLERGIC
REACTIONS HAVE BEEN REPORTED WITH CHLORHEXIDINE-CONTAINING PRODUCTS, ESPECIALLY
IN THE GENITAL AREAS. IF ADVERSE REACTIONS OCCUR, DISCONTINUE USE IMMEDIATELY
AND IF SEVERE, CONTACT A PHYSICIAN. KEEP THIS AND ALL DRUGS OUT OF THE REACH OF
CHILDREN. IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR
CONTACT A POISON CONTROL CENTER IMMEDIATELY.
Avoid excessive heat (above 104 deg F)
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PERIDEX IS AN ORAL RINSE CONTAINING 0.12% CHLORHEXIDINE GLUCONATE (1, 11-HEXAMETHYLENE BIS [5-(P-CHLOROPHENYL) BIGUANIDE] DI-D-GLUCONATE) IN A BASE CONTAINING WATER, 11.6% ALCOHOL, GLYCERIN, PEG-40 SORBITAN DIISOSTEARATE, FLAVOR, SODIUM SACCHARIN, AND FD&C BLUE NO. 1. PERIDEX ORAL RINSE IS A NEAR-NEUTRAL SOLUTION (PH RANGE 5-7). CHLORHEXIDINE GLUCONATE IS A SALT OF CHLORHEXIDINE AND GLUCONIC ACID. ITS CHEMICAL STRUCTURE IS:
INDICATIONS
PERIDEX IS INDICATED FOR USE BETWEEN DENTAL VISITS AS PART OF A PROFESSIONAL PROGRAM FOR THE TREATMENT OF GINGIVITIS AS CHARACTERIZED BY REDNESS AND SWELLING OF THE GINGIVAE, INCLUDING GINGIVAL BLEEDING UPON PROBING. PERIDEX HAS NOT BEEN TESTED AMONG PATIENTS WITH ACUTE NECROTIZING ULCERATIVE GINGIVITIS (ANUG). FOR PATIENTS HAVING COEXISTING GINGIVITIS AND PERIODONTITIS, SEE PRECAUTIONS.
DOSAGE AND ADMINISTRATION
PERIDEX THERAPY SHOULD BE INITIATED DIRECTLY FOLLOWING A DENTAL PROPHYLAXIS. PATIENTS U SING PERIDEX SHOULD BE REEVALUATED AND GIVEN A THOROUGH PROPHYLAXIS AT INTERVALS NO LONGER THAN SIX MONTHS. RECOMMENDED USE IS TWICE DAILY ORAL RINSING FOR 30 SECONDS, MORNING AND EVENING AFTER TOOTHBRUSHING. USUAL DOSAGE IS 15ML (MARKED IN CAP) OF UNDILUTED PERIDEX. PATIENTS SHOULD BE INSTRUCTED TO NOT RINSE WITH WATER OR OTHER MOUTHWASHES, BRUSH TEETH OR EAT IMMEDIATELY AFTER USING PERIDEX. PERIDEX IS NOT INTENDED FOR INGESTION AND SHOULD BE EXPECTORATED AFTER RINSING.
HOW SUPPLIED
PERIDEX IS SUPPLIED AS A BLUE LIQUID IN THE FOLLOWING SIZES:
0.5 FLUID OUNCE (15 ML) (NDC 48878-0620-4) AMBER PLASTIC BOTTLE WITH CHILD RESISTANT DISPENSING CLOSURE
4 FLUID OUNCE (118 ML) (NDC 48878-0620-3) AMBER PLASTIC BOTTLES WITH CHILD RESISTANT DISPENSING CLOSURE
16 FLUID OUNCE OR 1 PINT (473ML) (NDC 48878-0620-1) AMBER PLASTIC BOTTLES WITH CHILD-RESISTANT DISPENSING CLOSURE
64 FLUID OUNCE (1893 ML) (NDC 48878-0620-2) WHITE PLASTIC BOTTLE WITH PUMP DISPENSING CLOSURE
STORE ABOVE FREEZING (32Β°F OR 0Β°C)
KEEP OUT OF REACH OF CHILDREN
SIDE EFFECTS
THE MOST COMMON SIDE EFFECTS ASSOCIATED WITH CHLORHEXIDINE GLUCONATE ORAL RINSES ARE: 1) AN INCREASE IN STAINING OF TEETH AND OTHER ORAL SURFACES; 2) AN INCREASE IN CALCULUS FORMATION; AND 3) AN ALTERATION IN TASTE PERCEPTION, SEE WARNINGS AND PRECAUTIONS. ORAL IRRITATION AND LOCAL ALLERGY-TYPE SYMPTOMS HAVE BEEN SPONTANEOUSLY REPORTED AS SIDE EFFECTS ASSOCIATED WITH USE OF CHLORHEXIDINE GLUCONATE RINSE. THE FOLLOWING ORAL MUCOSAL SIDE EFFECTS WERE REPORTED DURING PLACEBO-CONTROLLED ADULT CLINICAL TRIALS: APHTHOUS ULCER, GROSSLY OBVIOUS GINGIVITIS, TRAUMA, ULCERATION, ERYTHEMA, DESQUAMATION, COATED TONGUE, KERATINIZATION, GEOGRAPHIC TONGUE, MUCOCELE, AND SHORT FRENUM. EACH OCCURRED AT A FREQUENCY OF LESS THAN 1.0%. AMONG POST MARKETING REPORTS, THE MOST FREQUENTLY REPORTED ORAL MUCOSAL SYMPTOMS ASSOCIATED WITH PERIDEX ARE STOMATITIS, GINGIVITIS, GLOSSITIS, ULCER, DRY MOUTH, HYPESTHESIA, GLOSSAL EDEMA, AND PARESTHESIA. MINOR IRRITATION AND SUPERFICIAL DESQUAMATION OF THE ORAL MUCOSA HAVE BEEN NOTED IN PATIENTS USING PERIDEX. THERE HAVE BEEN CASES OF PAROTID GLAND SWELLING AND INFLAMMATION OF THE SALIVARY GLANDS (SIALADENITIS) REPORTED IN PATIENTS USING PERIDEX.
READ THE PERIDEX (CHLORHEXIDINE GLUCONATE 0.12% ORAL RINSE) SIDE EFFECTS CENTER FOR A COMPLETE GUIDE TO POSSIBLE SIDE EFFECTS "
WARNINGS
THE EFFECT OF PERIDEX ON PERIODONTITIS HAS NOT BEEN DETERMINED. AN INCREASE IN SUPRAGINGIVAL CALCULUS WAS NOTED IN CLINICAL TESTING IN PERIDEX USERS COMPARED WITH CONTROL USERS. IT IS NOT KNOWN IF PERIDEX USE RESULTS IN AN INCREASE IN SUBGINGIVAL CALCULUS. CALCULUS DEPOSITS SHOULD BE REMOVED BY A DENTAL PROPHYLAXIS AT INTERVALS NOT GREATER THAN SIX MONTHS. HYPERSENSITIVITY AND GENERALIZED ALLERGIC REACTIONS HAVE OCCURRED. SEE CONTRAINDICATIONS.
PRECAUTIONS
GENERAL
1. FOR PATIENTS HAVING COEXISTING GINGIVITIS AND PERIODONTITIS, THE PRESENCE OR ABSENCE OF GINGIVAL INFLAMMATION FOLLOWING TREATMENT WITH PERIDEX SHOULD NOT BE USED AS A MAJOR INDICATOR OF UNDERLYING PERIODONTITIS.
2. PERIDEX CAN CAUSE STAINING OF ORAL SURFACES, SUCH AS TOOTH SURFACES, RESTORATIONS, AND THE DORSUM OF THE TONGUE. NOT ALL PATIENTS WILL EXPERIENCE A VISUALLY SIGNIFICANT INCREASE IN TOOTHSTAINING. IN CLINICAL TESTING, 56% OF PERIDEX USERS EXHIBITED A MEASURABLE INCREASE IN FACIAL ANTERIOR STAIN, COMPARED TO 35% OF CONTROL USERS AFTER SIX MONTHS; 15% OF PERIDEX USERS DEVELOPED WHAT WAS JUDGED TO BE HEAVY STAIN, COMPARED TO 1% OF CONTROL USERS AFTER SIX MONTHS. STAIN WIL L BE MORE PRONOUNCED IN PATIENTS WHO HAVE HEAVIER ACCUMULATIONS OF UNREMOVED PLAQUE. STAIN RESULTING FROM USE OF PERIDEX DOES NOT ADVERSELY AFFECT HEALTH OF THE GINGIVAE OR OTHER ORAL TISSUES. STAIN CAN BE REMOVED FROM MOST TOOTH SURFACE S BY CONVENTIONAL PROFESSIONAL PROPHYLACTIC TECHNIQUES. ADDITIONAL TIME MAY BE REQUIRED TO COMPLETE THE PROPHYLAXIS. DISCRETION SHOULD BE USED WHEN PRESCRIBING TO PATIENTS WITH ANTERIOR FACIAL RESTORATIONS WITH ROUGH SURFACES OR MARGINS. IF NATURAL STAIN CANNOT BE REMOVED FROM THESE SURFACES BY A DENTAL PROPHYLAXIS, PATIENTS SHOULD BE EXCLUDED FROM PERIDEX TREATMENT IF PERMANENT DISCOLO RATION IS UNACCEPTABLE. STAIN IN THESE AREAS MAY BE DIFFICULT TO REMOVE BY DENTAL PROPHYLAXIS AND ON RARE OCCASIONS MAY NECESSITATE REPLACEMENT OF THESE RESTORATIONS.
3. SOME PATIENTS MAY EXPERIENCE AN ALTERATION IN TASTE PERCEPTION WHILE UNDERGOING TREATMENT WITH PERIDEX. RARE INSTANCES OF PERMANENT TASTE ALTERATION FOLLOWING PERIDEX USE HAVE BEEN REPORTED VIA POST-MARKETING PRODUCT SURVEILLANCE.
PREGNANCY
TERATOGENIC EFFECTS - PREGNANCY CATEGORY B
REPRODUCTION STUDIES HAVE BEEN PERFORMED IN RATS AND RABBITS AT CHLORHEXIDINE GLUCONATE DOSES UP TO 300MG/KG/DAY AND 40MG/KG/DAY, RESPECTIVELY, AND HAVE NOT REVEALED EVIDENCE OF HARM TO FETUS. HOWEVER, ADEQUATE AND WELL-CONTROLLED STUDIES IN PREGNANT WOMEN HAVE NOT BEEN DONE. BECAUSE ANIMAL REPRODUCTION STUDIES ARE NOT ALWAYS PREDICTIVE OF HUMAN RESPONSE, THIS DRUG SHOULD BE USED DURING PREGNANCY ONLY IF CLEARLY NEEDED.
NURSING MOTHERS
IT IS NOT KNOWN WHETHER THIS DRUG IS EXCRETED IN HUMAN MILK . BECAUSE MANY DRUGS ARE EXCRETED IN HUMAN MILK, CAUTION SHOULD BE EXERCISED WHEN PERIDEX IS ADMINISTERED TO NURSING WOMEN. IN PARTURITION AND LACTATION STUDIES WITH RATS, NO EVIDENCE OF IMPAIRED PARTURITION OR OF TOXIC EFFECTS TO SUCKLING PUPS WAS OBSERVED WHEN CHLORHEXIDINE GLUCONATE WAS ADMINISTERED TO DAMS AT DOSES THAT WERE OVER 100 TIMES GREATER THAN THAT WHICH WOULD RESULT FROM A PERSON'S INGESTING 30ML (2 CAPFULS) OF PERIDEX PER DAY.
PEDIATRIC USE
CLINICAL EFFECTIVENESS AND SAFETY OF PERIDEX HAVE NOT BEEN ESTABLISHED IN CHILDREN UNDER THE AGE OF 18.
CARCINOGENESIS, MUTAGENESIS, AND IMPAIRMENT OF FERTILITY
IN A DRINKING WATER STUDY IN RATS, CARCINOGENIC EFFECTS WERE NOT OBSERVED AT DOSE S UP TO 38MG/KG/DAY. MUTAGENIC EFFECTS WERE NOT OBSERVED IN TWO MAMMALIAN IN VIVO MUTAGENESIS STUDIES WITH CHLORHEXIDINE GLUCONA TE. THE HIGHEST DOSES OF CHLORHEXIDINE USED IN A MOUSE DOMINANT-LETHAL ASSAY AND A HAMSTER CYTOGENETICS TEST WERE 1000MG/KG/DAY AND 250MG/KG/DAY, RESPECTIVELY. NO EVIDENCE OF IMPAIRED FERTILITY WAS OBSERVED IN RATS AT DOSES UP TO 100MG/KG/DAY.
OVERDOSE
INGESTION OF 1 OR 2 OUNCES OF PERIDEX BY A SMALL CHILD (~10 KG BODY WEIGHT) MIGHT RESULT IN GASTRIC DISTRESS, INCLUDING NAUSEA, OR SIGNS OF ALCOHOL INTOXICATION. MEDICAL ATTENTION SHOULD BE SOUGHT IF MORE THAN 4 OUNCES OF PERIDEX IS INGESTED BY A SMALL CHILD OR IF SIGNS OF ALCOHOL INTOXICATION DEVELOP.
CONTRAINDICATIONS
PERIDEX SHOULD NOT BE USED BY PERSONS WHO ARE KNOWN TO BE HYPERSENSITIVE TO CHLORHEXIDINE GLUCONATE OR OTHER FORMULA INGREDIENTS
CLINICAL PHARMACOLOGY
PERIDEX PROVIDES ANTIMICROBIAL ACTIVITY DURING ORAL RINSING. THE CLINICAL SIGNIFICANCE OF PERIDEX'S ANTIMICROBIAL ACTIVITIES IS NOT CLEAR. MICROBIOLOGICAL SAMPLING OF PLAQUE HAS SHOWN A GENERAL REDUCTION OF COUNTS OF CERTAIN ASSAYED BACTERIA, BOTH AEROBIC AND ANAEROBIC, RANGING FROM 54-97% THROUGH SIX MONTHS USE.
USE OF PERIDEX ORAL RINSE IN A SIX MONTH CLINICAL STUDY DID NOT RESULT IN ANY SIGNIFICANT CHANGES IN BACTERIA RESISTANCE, OVERGROWTH OF POTENTIALLY OPPORTUNISTIC ORGANISMS OR OTHER ADVERSE CHANGES IN THE ORAL MICROBIAL ECOSYSTEM. THREE MONTHS AFTER PERIDEX USE WAS DISCONTINUED, THE NUMBER OF BACTERIA IN PLAQUE HAD RETURNED TO BASELINE LEVELS AND RESISTANCE OF PLAQUE BACTERIA TO CHLORHEXIDINE GLUCONATE WAS EQUAL TO THAT AT BASELINE.
PHARMACOKINETICS
PHARMACOKINETIC STUDIES WITH PERIDEX INDICATE APPROXIMATELY 30% OF THE ACTIVE INGREDIENT, CHLORHEXIDINE GLUCONATE, IS RETAINED IN THE ORAL CAVITY FOLLOWING RINSING. THIS RETAINED DRUG IS SLOWLY RELEASED INTO THE ORAL FLUIDS. STUDIES CONDUCTED ON HUMAN SUBJECTS AND ANIMALS DEMONSTRATE CHLORHEXIDINE GLUCONATE IS POORLY ABSORBED FROM THE GASTROINTESTINAL TRACT. THE MEAN PLASMA LEVEL OF CHLORHEXIDINE GLUCONATE REACHED A PEAK OF 0.206?G/G IN HUMANS 30 MINUTES AFTER THEY INGESTED A 300-MG DOSE OF THE DRUG. DETECTABLE LEVELS OF CHLORHEXIDINE GLUCONATE WERE NOT PRESENT IN THE PLASMA OF THESE SUBJECTS 12 HOURS AFTER THE COMPOUND WAS ADMINISTERED. EXCRETION OF CHLORHEXIDINE GLUCONATE OCCURRED PRIMARILY THROUGH THE FECES (~90%). LESS THAN 1% OF THE CHLORHEXIDINE GLUCONATE INGESTED BY THESE SUBJECTS WAS EXCRETED IN THE URINE.