Betasept

Generic Name: chlorhexidine (Topical application route)

klor-HEX-i-deen

Commonly used brand name(s)

In the U.S.

• Betasept


• Biopatch w/Chlorhexidine Gluconate


• Chlorostat


• Dyna-Hex


• Dyna-Hex2


• Hibiclens


• Hibistat


• Operand Chg Surgical Scrub Brush


• Operand Chlorhexidine Gluconate


• Operand Closed Loop Chg Scrub

In Canada

• Stanhexidine Solution


• Stanley Chlorhexidine Tinted


• Stanley Chlorhexidine Untinted

Available Dosage Forms:

• Dressing


• Gel/Jelly


• Lotion


• Solution


• Liquid


• Pad


• Sponge


• Cream

Therapeutic Class: Antibacterial Cleansing Agent

Uses For Betasept

Chlorhexidine belongs to a group of medicines called antiseptic antibacterial agents. It is used to clean the skin after an injury, before surgery, or before an injection. Chlorhexidine is also used to clean the hands before a procedure. It works by killing or preventing the growth of bacteria on the skin.

Before Using Betasept

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Because of chlorhexidine's potential for causing excessive skin irritation and the risk of increased absorption through the skin, use in children less than 2 months of age is not recommended.

Geriatric

No information is available on the relationship of age to the effects of chlorhexidine in geriatric patients.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Deep or open skin wounds—Some products should not be used for this condition. Use the medicine only as directed by your doctor.

Proper Use of chlorhexidine

This section provides information on the proper use of a number of products that contain chlorhexidine. It may not be specific to Betasept. Please read with care.

Some of the chlorhexidine products will be used in a hospital or clinic setting. The medicine will be applied by a nurse or other trained health professional.

You may be instructed to use this medicine at home. It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause irritation of the skin.

Different forms of the medicine are used in different ways. Be sure you understand the directions for the product you are given before you use it. Ask your doctor or pharmacist if you have any questions.

Follow your doctor's instructions about how to clean and care for your skin before and after you use this medicine. Make sure you understand all of the directions, and ask questions if you find something is not clear.

Chlorhexidine should only be used on the skin. Do not swallow it or get it in the eyes, ears, mouth, or nose. Do not use it on the genital area (sex organs) or anal area. If it does get on these areas, rinse it off right away.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For topical dosage form (hand rinse or wipe, solution, or swabstick applicator):
  
  • To clean the hands (eg, Hibistat®):
    
    • The Hibistat® product contains large amounts of alcohol (70%) and is flammable. Apply the medicine in a well-ventilated place and do not use it while you are smoking.
    
    
    • Adults, teenagers, and children 2 months of age and older:
      
      • Wash your hands with soap and water. Dry your hands with a towel.
      
      
      • Rub the hands with the hand wipe for 15 seconds. Make sure to use the wipe under the fingernails and between the fingers. The medicine will dry quickly so you should not use a towel for drying. Do not wet your hands a second time.
      
      
      • Pour 1 teaspoonful (5 milliliters) of the hand rinse in your cupped hand. Rub the hands together for 15 seconds. Make sure to apply the rinse under the fingernails and between the fingers. The medicine will dry quickly so you should not use a towel for drying. Do not wet your hands a second time.
      
      
    
    
    • Children younger than 2 months of age—Use is not recommended.
    
    
  
  
  • To clean the skin or a wound (eg, Betasept®, Hibiclens®):
    
    • Adults, teenagers, and children 2 months of age and older—Rinse the area to be cleaned with water. Apply the smallest amount of liquid needed to cover the skin or wound area and wash gently. Thoroughly rinse the area again with water.
    
    
    • Children younger than 2 months of age—Use is not recommended.
    
    
  
  
  • To use before surgery or an injection (eg, Chloraprep®):
    
    • The Chloraprep® product contains large amounts of alcohol (70%) and is flammable. Do not use it on skin areas that have cuts or scrapes. Apply the medicine in a well-ventilated place and do not use it while you are smoking.
    
    
    • Adults, teenagers, and children 2 months of age and older:
      
      • Open the pouch and use the handle to remove the swabstick applicator. Do not touch the applicator tip. Rub the applicator on the skin with the flat side against the skin. Use a back and forth motion for 30 seconds.
      
      
      • Make sure the skin is completely wet. Let the skin air dry for one minute. Do not use a towel for drying.
      
      
      • Do not cover the treated area until the skin is completely dry. This is usually one minute or longer for hairless skin. If you must apply the medicine to a hairy area of the body, wipe the area with a towel to remove extra medicine.
      
      
    
    
    • Children younger than 2 months of age—Use is not recommended.
    
    
  
  

Storage

Ask your healthcare professional how you should dispose of any medicine you do not use.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

The Chloraprep® and Hibistat® products contain large amounts of alcohol (70%) and are flammable. Do not store them near a flame, heater, or electrical device.

Precautions While Using Betasept

Check with your doctor if your skin problem becomes worse. Call your doctor if you have skin irritation that does not go away, such as redness, itching, or burning in the area where you used this medicine.

This medicine should not be used for an extended period of time on large areas of the body. Follow your doctor's instructions about how long to use this medicine.

This medicine may cause serious and permanent injury when placed in the eyes, ears, or mouth. Carefully follow all instructions before using this medicine to prevent serious side effects.

This medicine may cause a brown stain on clothing when chlorine is also present. These stains may not be removed by regular washing. Use only non-chlorine products to wash or bleach fabrics exposed to this medicine. If the medicine has directions on the package about washing fabrics, follow them carefully.

The Chloraprep® and Hibistat® products contain large amounts of alcohol (70%) and are flammable. Do not use them or store them near a flame, heater, or electrical device. Do not use the medicine while you are smoking. Apply the medicine in a well-ventilated place.

Betasept Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blistering, burning, itching, peeling, skin rash, redness, swelling, or other signs of irritation on the skin


• swelling of the face, hands, or feet


• trouble breathing

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Betasept side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More Betasept resources

• Betasept Side Effects (in more detail)
• Betasept Use in Pregnancy & Breastfeeding
• Betasept Support Group
• 0 Reviews for Betasept - Add your own review/rating

• Betasept Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Betasept Concise Consumer Information (Cerner Multum)


• Hibistat Concise Consumer Information (Cerner Multum)


• Peridex Solution MedFacts Consumer Leaflet (Wolters Kluwer)


• Peridex Prescribing Information (FDA)


• Peridex oral rinse Concise Consumer Information (Cerner Multum)


• PerioGard Prescribing Information (FDA)


• Periochip Prescribing Information (FDA)

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Denti-Care Denti-Rinse Chlorhexidine Oral Rinse

Generic Name: chlorhexidine gluconante

Dosage Form: liquid
Denti-Care Denti-Rinse 0.12 % Chlorhexidine Gluconate Oral Rinse Mint DENTI-CARE

MEDICOM

DENTI-RINSE

 

0.12 % CHLORHEXIDINE GLUCONATE ORAL RINSE


MINT


Item 10025-H




Ingredients: 0.12 % chlorhexidine gluconate in a base containing water, 11.6 % alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin and FD and C Blue No.1.


Rx Only


KEEP OUT OF REACH OF CHILDREN

1 Pint (473 ml)

NDC 64778-0244-1



M0701707V.2

DIRECTIONS FOR USE: Fill cap to the “fill line” (15 mL). Swish in mouth undiluted for 30 seconds, then spit out. Use after breakfast and before bedtime. Or, use as prescribed. NOTE: To minimize medicinal taste, do not rinse with water immediately after use.

To open: Squeeze smooth areas near bottom of cap and turn.

To close: Turn Cap until it locks.

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. 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. • Local hypersensitivity and sometimes generalized allergic reactions have also been reported. Chlorhexidine gluconate oral rinse should not be used by persons who have a sensitivity to it or its components. • 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 or pharmacist.

Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)).

Manufactured for and distributed by: A.R. Medicom Inc. Montreal, Canada H8T 3J8

DESCRIPTION: Chlorhexidine gluconate 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 and C Blue No.1. Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid.

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: 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 μg/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 that 1% of the chlorhexidine gluconate ingested by these subjects was excreted in the urine.

INDICATION: Chlorhexidine gluconate oral rinse 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. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis; see PRECAUTIONS.

CONTRAINDICATIONS: Chlorhexidine gluconate oral rinse should not be used by persons who are known to be hypersensitive to chlorhexidine gluconate or other formula ingredients.

WARNINGS: The effect of chlorhexidine gluconate oral rinse on periodontitis has not been determined. An increase in supragingival calculus was noted in clinical testing in chlorhexidine gluconate oral rinse users compared with control users. It is not known if chlorhexidine gluconate oral rinse 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 of absence of gingival inflammation following treatment with chlorhexidine gluconate oral rinse should not be used as a major indicator of underlying periodontitis. 2. Chlorhexidine gluconate oral rinse 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 tooth staining. In clinical testing, 56% of chlorhexidine gluconate oral rinse users exhibited a measurable increase in facial anterior stain, compared to 35% of control users after six months; 15% of chlorhexidine gluconate oral rinse 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 chlorhexidine gluconate oral rinse 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 of margins. If natural stain cannot be removed from these surfaces by a dental prophylaxis, patients should be excluded from chlorhexidine gluconate oral rinse 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. 3. Some patients may experience an alteration in taste perception while undergoing treatment with chlorhexidine gluconate oral rinse. Rare instances of permanent taste alteration following chlorhexidine gluconate oral rinse use have been reported via post-marketing product surveillance.

Pregnancy: Teratogenic EffectsPregnancy 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.

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: Clinical effectiveness and safety of chlorhexidine gluconate oral rinse have not been established in children under age of 18.

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.

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 symptomshave been spontaneously reported as side effects associated with use of chlorhexidinegluconate rinse. The following oral mucosal side effects were reported duringplacebo-controlled adult clinical trials: aphthous ulcer, grossly obvious gingivitis,trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographictongue, 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 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.

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.

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 of 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. 

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 64778-0244-1.

Store at USP Controlled Room Temperature (20°C - 25°C (68°F - 77°F)).

Rx Only. Keep out of reach of children. Revised: December 2009 Manufactured for and distributed by: A.R. Medicom Inc. Montreal, Canada H8T 3J8

DENTI-CARE DENTI-RINSE  CHLORHEXIDINE GLUCONATE ORAL RINSE chlorhexidine gluconante  liquid

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64778-0244 Route of Administration DENTAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength chlorhexidine gluconate (chlorhexidine) chlorhexidine 0.12 g  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color blue Score      Shape Size Flavor MINT Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 64778-0244-1 473 mL In 1 BOTTLE, PLASTIC None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/02/2006

Labeler - AR Medicom Inc. (247876295)

Revised: 04/2010AR Medicom Inc.

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• Denti-Care Denti-Rinse Chlorhexidine Oral Rinse Side Effects (in more detail)
• Denti-Care Denti-Rinse Chlorhexidine Oral Rinse Use in Pregnancy & Breastfeeding
• Denti-Care Denti-Rinse Chlorhexidine Oral Rinse Support Group
• 1 Review for Denti-Care Denti-Rinse Chlorhexidine Oral - Add your own review/rating

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