Drugs Details

Drugs Info of Peridex
Drugs Details
  • Drugs Type  : FDA
  • Date : 12th Mar 2015 04:22 am
  • Brand Name : Peridex
  • Generic Name : chlorhexidine gluconate (oral rinse) (Pronunciation: klor HEX i deen)
Descriptions

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:

 

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What are the possible side effects of chlorhexidine gluconate (Peridex, Periogard)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have a serious side effect such as:

  • white patches or sores inside your mouth or on your lips;
  • mouth ulcers; or
  • swelling of your salivary glands (underneath your jaws).

Less serious side effects may include:

  • mouth irritation;
  • dry mouth;
  • unusual or unpleasant taste in your mouth; or
  • decreased taste...

Read All Potential Side Effects and See Pictures of Peridex »
This monograph has been modified to include the generic and brand name in many instances.

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 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 (32°F or 0°C)

Keep out of reach of children

Revised: January/2013. Made in USA for: 3M ESPE Dental Products St. Paul, MN 55144-1000 USA


This monograph has been modified to include the generic and brand name in many instances.

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

Interactions

No information provided.
This monograph has been modified to include the generic and brand name in many instances.

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.


This monograph has been modified to include the generic and brand name in many instances.

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.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

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 0.206μg/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.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

What to expect when using Peridex™ Chlorhexidine Gluconate 0.12% Oral Rinse

Your dentist has prescribed Peridex™ Chlorhexidine Gluconate 0.12% 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 Peridex oral rinse regularly, as directed by your dentist, in addition to daily brushing. Spit out after use. Peridex oral rinse should not be swallowed.

Peridex 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. Peridex 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.
  • Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Peridex oral rinse should not be used by persons who have a sensitivity to it or its components.
  • Peridex 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 Peridex oral rinse.
  • To avoid taste interference, rinse with Peridex oral rinse after meals. Do not rinse with water or other mouthwashes immediately after rinsing with Peridex oral rinse.

If you have any questions or comments about Peridex oral rinse, contact your dentist or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

STORE ABOVE FREEZING (32°F or 0°C)


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

No Information Available!

Consumer Overview Side Effect

No Information Available!

Consumer Overview Missed Dose

No Information Available!

Patient Detailed Side Effect

Brand Names: Peridex, Periogard

Generic Name: chlorhexidine gluconate (oral rinse) (Pronunciation: klor HEX i deen)

  • What is chlorhexidine gluconate (Peridex)?
  • What are the possible side effects of chlorhexidine gluconate (Peridex)?
  • What is the most important information I should know about chlorhexidine gluconate (Peridex)?
  • What should I discuss with my healthcare provider before using chlorhexidine gluconate (Peridex)?
  • How should I use chlorhexidine gluconate (Peridex)?
  • What happens if I miss a dose (Peridex)?
  • What happens if I overdose (Peridex)?
  • What should I avoid while taking chlorhexidine gluconate (Peridex)?
  • What other drugs will affect chlorhexidine gluconate (Peridex)?
  • Where can I get more information?

What is chlorhexidine gluconate (Peridex)?

Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.

Chlorhexidine gluconate oral rinse is used to treat gingivitis (swelling, redness, bleeding gums). Chlorhexidine gluconate is usually prescribed by a dentist.

Chlorhexidine gluconate oral rinse is not for treating all types of gingivitis. Use the medication only to treat the condition your dentist prescribed it for. Do not share this medication with another person, even if they have the same gum symptoms you have.

Chlorhexidine gluconate may also be used for purposes not listed in this medication guide.

What are the possible side effects of chlorhexidine gluconate (Peridex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor if you have a serious side effect such as:

  • white patches or sores inside your mouth or on your lips;
  • mouth ulcers; or
  • swelling of your salivary glands (underneath your jaws).

Less serious side effects may include:

  • mouth irritation;
  • dry mouth;
  • unusual or unpleasant taste in your mouth; or
  • decreased taste sensation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Peridex (chlorhexidine gluconate 0.12% oral rinse) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about chlorhexidine gluconate (Peridex)?

You should not use this medication if you are allergic to chlorhexidine gluconate.

If you have periodontal disease, you may need special treatments while you are using chlorhexidine gluconate.

Chlorhexidine gluconate oral rinse is not for treating all types of gingivitis. Use the medication only to treat the condition your dentist prescribed it for. Do not share this medication with another person, even if they have the same gum symptoms you have.

Do not give this medication to a child or teenager without a doctor's advice.

Do not add water to chlorhexidine gluconate oral rinse. Do not rinse your mouth with water or other mouthwashes right after using chlorhexidine gluconate.

Avoid eating, drinking, or brushing your teeth just after using this medication.

Do not use any other mouthwash unless your doctor has told you to.

Chlorhexidine gluconate can stain teeth, dentures, tooth restorations, your tongue, or the inside of your mouth. Talk with your dentist about ways to remove staining from these surfaces. Stains may be harder to remove from false teeth that have scratches in their surfaces.

Visit your dentist at least every 6 months for preventive tooth and gum care.

Side Effects Centers
  • Peridex

Patient Detailed How Take

What should I discuss with my healthcare provider before using chlorhexidine gluconate (Peridex)?

You should not use this medication if you are allergic to chlorhexidine gluconate.

If you have periodontal disease, you may need special treatments while you are using chlorhexidine gluconate.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether chlorhexidine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medication to a child or teenager without a doctor's advice.

How should I use chlorhexidine gluconate (Peridex)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Rinse your mouth with chlorhexidine gluconate twice daily after brushing your teeth.

Measure your dose using the cup provided with the medication. Swish the medicine in your mouth for at least 30 seconds, then spit it out. Do not swallow the mouthwash.

Do not add water to the oral rinse. Do not rinse your mouth with water or other mouthwashes right after using chlorhexidine gluconate.

Chlorhexidine gluconate may leave an unpleasant taste in your mouth. Do not rinse your mouth to remove this taste after using the medication. You may rinse the medicine away and reduce its effectiveness.

Use this medication for the full prescribed length of time. Your symptoms may improve before your gingivitis is completely cleared. Chlorhexidine gluconate will not treat a viral or fungal infection such as cold sores, canker sores, or oral thrush (yeast infection).

Visit your dentist at least every 6 months for preventive tooth and gum care.

Store chlorhexidine gluconate at room temperature away from moisture and heat.

Side Effects Centers
  • Peridex

Patient Detailed Avoid Taking

What happens if I miss a dose (Peridex)?

Use the missed dose as soon as you remember, but brush your teeth first. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose (Peridex)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if a child has swallowed 4 or more ounces of this medicine.

An overdose of chlorhexidine would occur only if the medicine were swallowed. Overdose symptoms may include nausea, stomach pain, or the appearance of being drunk.

What should I avoid while taking chlorhexidine gluconate (Peridex)?

Avoid eating, drinking, or brushing your teeth just after using this medication.

Do not use any other mouthwash unless your doctor has told you to.

Chlorhexidine gluconate can stain teeth, dentures, tooth restorations, your tongue, or the inside of your mouth. Talk with your dentist about ways to remove staining from these surfaces. Stains may be harder to remove from false teeth that have scratches in their surfaces.

What other drugs will affect chlorhexidine gluconate (Peridex)?

It is not likely that other drugs you take orally or inject will have an effect on chlorhexidine gluconate oral rinse. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your pharmacist or dentist can provide more information about chlorhexidine gluconate.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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