понедельник, 11 февраля 2008 г.

Periogard(chlorhexidine gluconate) liquid [colgate oral pharmaceuticals inc.]

Gluconate in a base containing water, 11.PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD 15% of the chlorhexidine gluconate users developed what was judged to be heavy stain,pared to 1% of control users after six months.Be more pronounced in patients who have heavier accumulations of unremoved plaque.Resulting from the use of PerioGard Oral Rinse does not adversely affect health of the gingivae or other oral tissues.Can be removed from most tooth surfaces by conventional professional prophylactic techniques.Time may be required toplete the prophylaxis.Should be used when prescribing to patients with anterior facial restorations with rough surfaces or margins.Natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from the PerioGard Oral Rinse treatment if permanent discoloration is unacceptable.These areas may be difficult to remove by dental prophylaxis and on rare occasions may necessitate replacement of these restorations.Some patients may experience an alteration in taste perception while undergoing treatment with a chlorhexidine gluconate oral rinse.Of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via postmarketing surveillance.MUTAGENESIS, IMPAIRMENT OF FERTILITY: In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day.Effects were not observed in two mammalian in vivo mutagensis studies with chlorhexidine gluconate.Doses of chlorhexidine used in a mouse dominant-lethal assay and a hamster cytogenetics test were 1000 mg/kg/day and 250 mg/kg/day, respectively.Evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.PREGNANCY: TERATOGENIC EFFECTS: Pregnancy Category B.Studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40mg/kg/day, respectively, and have not revealed evidence of harm to the fetus.Adequate and well-controlled studies in pregnant women have not been done.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.Many drugs are excreted in human milk, caution should be exercised when PerioGard Oral Rinse is administered to a nursing woman.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 up to 100 mg/kg/day.USE: Clinical effectiveness and safety of PerioGard Oral Rinse have not been established in children under the age of 18.REACTIONS: The mostmon 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 and.And local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse.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.Occurred at a frequency of less than 1.Among postmarketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivitis, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia.Irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinses.Been cases of parotid gland swelling and inflammation of the salivary glands (sialadentitis) reported in patients using chlorhexidine gluconate oral rinse.Ingestion of 1 or 2 ounces of PerioGard Oral Rinse by a small child (~10 kg body weight) might result in gastric distress, including nausea, or signs of alcohol intoxication.Attention should be sought if more than 4 ounces of PerioGard Oral Rinse is ingested by a small child or if signs of alcohol intoxication develop.AND ADMINISTRATION: PerioGard Oral Rinse therapy should be initiated directly following a dental prophylaxis.Using PerioGard Oral Rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months.Use is twice daily oral rinsing for 30 seconds, morning and evening after toothbrushing.Dosage is fl.("15mL" line on dosage cap) of undiluted PerioGard Oral Rinse.Be instructed not to rinse with water or other mouthwashes, brush teeth, or eat immediately after using PerioGard Oral Rinse.Oral Rinse is not intended for ingestion and should be expectorated after rinsing.HOW SUPPLIED: PerioGard Oral Rinse is supplied as a blue liquid in 16 fluid ounce amber plastic bottle with child-resistant dosage cap.Above freezing (32 F).Colgate Oral Pharmaceuticals, Inc.Subsidiary of Colgate-Palmolivepany, 300 Park Avenue, New York, NY 10022 U.Rev.PerioGard (chlorhexidine gluconate) PRODUCT INFO Product Code 0126-0271 Dosage Form LIQUID Route Of Administration ORAL DEA Schedule INGREDIENTS Name (Active Moiety) Type Strength CHLORHEXIDINE GLUCONATE (chlorhexidine) Active 1.
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