Oro (Chlorhexidine / Gluconate)

ORO-CLENSE

Germiphene

Chlorhexidine Gluconate

Antigingivitis Oral Rinse

Action And Clinical Pharmacology: Chlorhexidine provides antimicrobial activity during oral rinsing which is maintained between rinsings. Microbiologic sampling of plaque has shown a general reduction of both aerobic and anaerobic bacterial counts through 6 months’ clinical use. Rinsing with chlorhexidine inhibits the build up and maturation of plaque by reducing certain microbes regarded as gingival pathogens, thereby reducing gingivitis. Chlorhexidine provides antimicrobial activity during rinsing and for several hours thereafter. No significant changes in bacterial sensitivity, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial flora were observed following the use of chlorhexidine for 6 months. Three months after discontinued use, the number of bacteria in plaque had returned to pretreatment levels and sensitivity of plaque bacteria to chlorhexidine remained unchanged.

Pharmacokinetics: Studies conducted with human subjects and animals demonstrate that any ingested chlorhexidine is poorly absorbed in the gastrointestinal tract. Excretion of chlorhexidine occurred primarily through the feces (approximately 90%). Less than 1% of the chlorhexidine ingested by these subjects was excreted in the urine.

Indications And Clinical Uses: For use as part of a professional program for the treatment of moderate to severe gingivitis, and for management of associated gingival bleeding and inflammation according to the recommended dosage and frequency under supervision of a dentist. For patients having coexisting gingivitis and periodontitis, see Precautions.

Contra-Indications: Should not be used by persons who are known to be hypersensitive to chlorhexidine, chlorhexidine compounds or other ingredients.

Manufacturers’ Warnings In Clinical States: Pregnancy: Reproduction and fertility studies with chlorhexidine have been conducted. No evidence of impaired fertility was observed in male and female rats at doses up to 100 mg/kg/day. No evidence of harm to the fetus was observed in rats and rabbits at doses up to 300 mg/kg/day and 40 mg/kg/day, respectively. These doses are approximately 100, 300, and 40 times that which would result from a person ingesting 30 mL of 0.12% chlorhexidine/day. Reproduction and fertility studies with chlorhexidine in pregnant women have not been conducted, so the benefits of using chlorhexidine should be weighed against possible risk to the fetus.

Lactation: It is not known whether chlorhexidine is excreted in human milk. In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine was administered at doses over 100 times greater than ingesting the recommended daily dose for rinsing. As many drugs are excreted in human milk, caution should be exercised and the benefits of use weighed against possible risk to the infant being nursed.

Children: Clinical effectiveness and safety of chlorhexidine have not been determined in children. The benefits of its use should be weighed against the possible risks.

Precautions: Chlorhexidine can cause staining of tooth surfaces, restorations, and the dorsum of the tongue in some patients especially with prolonged use and in patients who have heavier accumulations of plaque. Staining does not affect the health of oral tissues and can be removed from most tooth surfaces by professional dental prophylaxis. Discretion should be used in prescribing chlorhexidine for patients who have exposed root surfaces or anterior facial restorations with rough surfaces or margins, as stains on this area may be difficult to remove and may require restoration replacement in rare instances. If natural stains cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from treatment if the risk of permanent discoloration is unacceptable.

Use of chlorhexidine may cause an alteration in taste perception in some patients.

For patients having coexisting gingivitis and periodontitis, the absence of gingival inflammation following treatment with chlorhexidine may not be indicative of the absence of underlying periodontitis. Appropriate treatment of periodontitis is therefore indicated.

For maximum effectiveness the patients should avoid rinsing their mouths, eating or drinking for about 30 minutes after using chlorhexidine.

Adverse Reactions: Common side effects occurring from the use of chlorhexidine are staining of teeth and other oral surfaces, a slight and temporary alteration in taste perception, and an increase in supra gingival calculus formation (see Precautions). Epithelial irritation and superficial desquamation of the oral mucosa have been noted in studies of children using chlorhexidine which were reversible upon discontinuation. Parotitis and inflammation of the salivary glands have been reported in some patients using chlorhexidine.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Ingestion of 30 to 60 mL of chlorhexidine by a small child may result in gastric distress, including nausea, and/or signs of alcohol intoxication. Medical attention should be sought if more than 100 mL is ingested or if signs of alcohol intoxication develop.

Dosage And Administration: Use of chlorhexidine should begin immediately following professional dental prophylaxis. Patients should be re-examined at intervals of not more than 6 months and given a thorough prophylaxis. Patient referral for periodontal consultation should be done as necessary.

Rinse with 15 mL of solution for 30 seconds, then expectorate. Use twice daily, after breakfast and before bedtime, or as prescribed. Chlorhexidine is not intended for ingestion and should be expectorated after rinsing.

Do not swallow.

Note: Wait 30 minutes after brushing with conventional toothpastes before using chlorhexidine. Do not rinse the mouth, eat or drink for 30 minutes after using chlorhexidine.

The suggested initial therapy is 3 months, at which time patients should be recalled for evaluation. At the time of the recall visit, the dental professional should: evaluate progress, remove any stain, and reinforce proper home care techniques; discontinue use of chlorhexidine if gingival inflammation and bleeding is controlled and recall the patient in 3 months to assess gingival health; continue use of chlorhexidine for an additional 3 months if gingival inflammation and bleeding persist and schedule a 3-month recall for evaluation; evaluate for evidence of epithelial irritation, desquamation and parotitis.

SuppliedSupplied: Each mL of a near neutral (pH range: 5 to 7), green-colored, spearmint-flavored liquid contains: chlorhexidine gluconate 0.12%. Nonmedicinal ingredients: ethanol, FD&C Blue #1, FD&C Yellow #5, flavor, glycerin, methylparaben, polysorbate 60, propylparaben, purified water, sodium cyclamate and sorbitol. White containers of 227 mL, 480 mL and 4 L. Store between 15 and 25°C.

ORO-CLENSE Germiphene Chlorhexidine Gluconate Antigingivitis Oral Rinse

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