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| Product NDC Code | 66467-2560 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Chlorhexidine gluconate |
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| Type | Generic | ||||||
| Pharm Class | Decreased Cell Wall Integrity [PE] | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | RINSE | ||||||
| RxCUI drug identifier | 834127 | ||||||
| Application Number | ANDA077789 | ||||||
| Labeler Name | Darby Dental Supply, LLC | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Overdosage of Chlorhexidine Gluconate
Information about signs, symptoms, and laboratory findings of acute ovedosage and the general principles of overdose treatment.Overdosage OVERDOSAGE: Ingestion of 1 or 2 ounces of chlorhexidine gluconate oral rinse 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 chlorhexidine gluconate oral rinse is ingested by a small child or if signs of alcohol intoxication develop.
Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.Adverse Reactions ADVERSE REACTIONS: 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%. Among post marketing reports, the most frequent reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse 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 chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.Clinical Pharmacology CLINICAL PHARMACOLOGY: Chlorhexidine gluconate oral rinse provides antimicrobial activity during oral rinsing. The clinical significance of chlorhexidine gluconate oral rinse'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 chlorhexidine gluconate oral rinse in a six month clinical study did not result in any significant changes in bacterial resistance, overgrowth of potentially opportunistic organisms or other adverse changes in the oral microbial ecosystem. Three months after chlorhexidine gluconate oral rinse 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
Information about the clinically significant pharmacokinetics of a drug or active metabolites, for instance pertinent absorption, distribution, metabolism, and excretion parameters.Pharmaccokinetics Pharmacokinetics : Pharmacokinetic studies with chlorhexidine gluconate oral rinse indicate approximately 30% of the active ingredient, chlorhexidine gluconate, is retained in the oral cavity following rinsing. This retained drug is slowly released in 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 mcg/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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.Contrainidcations CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Dosage & Administration DOSAGE AND ADMINISTRATION : Chlorhexidine gluconate oral rinse therapy should be initiated directly following a dental prophylaxis. Patients using chlorhexidine gluconate oral rinse should be reevaluated and given a thorough prophylaxis at intervals no longer than six months. Recommended use is twice daily rinsing for 30 seconds, morning and evening after tooth brushing. Usual dosage is 15 mL (marked in cap) of undiluted chlorhexidine gluconate oral rinse. Patients should be instructed to not rinse with water, or other mouthwashes, brush teeth, or eat immediately after using chlorhexidine gluconate oral rinse. Chlorhexidine gluconate oral rinse is not intended for ingestion and should be expectorated after rinsing.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Ingredients : 11.6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD&C Blue No. 1
Spl product data elements
Usually a list of ingredients in a drug product.Chlorhexidine Gluconate Chlorhexidine Gluconate GLYCERIN SACCHARIN SODIUM CHLORHEXIDINE GLUCONATE CHLORHEXIDINE FD&C BLUE NO. 1 WATER ALCOHOL PEG-40 SORBITAN DIISOSTEARATE
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.Carcinogenesis & Mutagenesis & Impairment of Fertility Carcinogenesis, Mutagenesis, and Impairment of Fertility : In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38 mg/kg/day. Mutagenic effects were not observed in two mammalian in vivo mutagenesis studies with chlorhexidine gluconate. The highest 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. No evidence of impaired fertility was observed in rats at doses up to 100 mg/kg/day.
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Panel NDC 66467-2560-4 6020499 Main Panel
Main Panel NDC 66467-2560-1 6020500 Main Panel
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Full Label NDC 66467-2560-1 6020500 Panel 1a 6020500 Panel 2 6020500 Panel 3 6020500 Panel 4 6020500 Panel 5
Full Label NDC 66467-2560-4 6020499 Panel 3 6020499 Panel 4 6020499 Panel 5 6020499 Panel 6 6020499 Panel 7 6020499 Panel 8 6020499 Panel 9
Chlorhexidine Gluconate: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.What to Expect when using Chlorhexidine Gluconate WHAT TO EXPECT WHEN USING CHLORHEXIDINE GLUCONATE ORAL RINSE Your dentist has prescribed chlorhexidine gluconate oral rinse to treat your gingivitis, to help reduce the redness and swelling of your gums, and also to help you control any gum bleeding. Use chlorhexidine gluconate oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use; chlorhexidine gluconate oral rinse should not be swallowed. If you develop allergic symptoms such as skin rash, itch, generalized swelling, breathing difficulties, light headedness, rapid heart rate, upset stomach or diarrhea, seek medical attention immediately. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or to its components. Chlorhexidine gluconate oral rinse may cause some tooth discoloration, or increase in tartar (calculus) formation, particularly in areas where stain and tartar usually form. It is important to see your dentist for removal of any stain or tartar at least every six months or more frequently if your dentist advises. • Both stain and tartar can be removed by your dentist or hygienist. Chlorhexidine gluconate oral rinse may cause permanent discoloration of some front-tooth fillings. • To minimize discoloration, you should brush and floss daily, emphasizing areas which begin to discolor. • Chlorhexidine gluconate oral rinse may taste bitter to some patients and can affect how foods and beverages taste. This will become less noticeable in most cases with continued use of chlorhexidine gluconate oral rinse. • To avoid taste interference, rinse with chlorhexidine gluconate oral rinse after meals. Do not rinse with water or other mouthwashes immediately after rinsing with chlorhexidine gluconate oral rinse. If you have any questions or comments about chlorhexidine gluconate oral rinse, contact your dentist, pharmacist or call toll free at 1-800-361-2862. Call your health care provider for medical advice about side effects. You may report side effects to FDA at 1-800-332-1088.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.Nursing Mothers 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 chlorhexidine gluconate oral rinse 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 30 mL (2 capfuls) of chlorhexidine gluconate oral rinse per day.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Pediatric Use : Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under the age of 18.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy Pregnancy : Teratogenic Effects Pregnancy Category B. Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.How Supplied HOW SUPPLIED: Chlorhexidine gluconate oral rinse is supplied as a blue liquid in 1-pint (473 mL) amber plastic bottles with child-resistant dispensing closures, NDC 66467-2560-1.
Storage and handling
Information about safe storage and handling of the drug product.Storage and Handling Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted to 15ºC to 30ºC (59ºF to 86ºF) [See USP controlled Room Temperature]. Rx Only Keep out of reach of children. To open : Squeeze smooth areas near bottom of cap and turn. To close : Turn cap until it locks.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API