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Peridex
Overview
What is Peridex?
Peridex™ (Chlorhexidine Gluconate 0.12%) Oral Rinse is an oral rinse containing 0.12% chlorhexidine gluconate (1, 1-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 is a near-neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:
What does Peridex look like?
What are the available doses of Peridex?
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What should I talk to my health care provider before I take Peridex?
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How should I use Peridex?
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 .
Peridex therapy should be initiated directly following a dental prophylaxis. Patients using 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.
What interacts with Peridex?
Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
What are the warnings of Peridex?
Magnesium-containing antacids and doxercalciferol should not be used concomitantly in patients on chronic renal dialysis because such use may lead to the development of hypermagnesemia.
What are the precautions of Peridex?
General
- 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.
- 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 will 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 surfaces 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 discoloration is unacceptable. Stain in 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 Peridex. Rare instances of permanent taste alteration following Peridex use have been reported via post-marketing product surveillance.
Pregnancy
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, Impairment of Fertility
In a drinking water study in rats, carcinogenic effects were not observed at doses up to 38mg/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 1000mg/kg/day and 250mg/kg/day, respectively. No evidence of impaired fertility was observed in rats at doses up to 100mg/kg/day.
What are the side effects of Peridex?
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 and . 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.
What should I look out for while using Peridex?
Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.
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. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE .
What might happen if I take too much Peridex?
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.
How should I store and handle Peridex?
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAStore at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP. FOR YOUR PROTECTION:DEA Order Form Required.To request medical information or to report Suspected Adverse Reactions, contact Alvogen Customer Service at 1-866-770-3024 or FDA at 1-800-FDA-1088 or Made in USAPeridex is supplied as a blue liquid in 0.5-ounce (15ml), 4-ounce (118ml), 1-pint (473ml) and 64-ounce (1893ml) white or amber plastic bottles with child-resistant dispensing closures.
Clinical Information
Chemical Structure
No Image foundClinical 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 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.
Non-Clinical Toxicology
Peridex should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.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. Anaphylaxis, as well as serious allergic reactions, have been reported during postmarketing use with dental products containing chlorhexidine. SEE .
Drug interactions:
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 and . 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.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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