Chlorhexidine 0.12% Oral Rinse

Manufacturer XTTRIUM Active Ingredient Chlorhexidine Gluconate (Oral)(klor HEKS i deen GLOO koe nate) Pronunciation klor HEKS i deen GLOO koe nate
It is used to treat or prevent gingivitis.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiseptic, Antiplaque Agent
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Pharmacologic Class
Biguanide Antiseptic
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Pregnancy Category
Category B
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FDA Approved
Sep 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Chlorhexidine oral rinse is a germ-killing mouthwash used to treat gum disease (gingivitis). It helps reduce redness, swelling, and bleeding of the gums by killing bacteria in your mouth.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Before rinsing, brush and floss your teeth thoroughly. Then, rinse with 1 tablespoon (15 mL) of the medication for 30 seconds. It is essential not to swallow the medication; instead, spit it out. Repeat this process twice a day, once in the morning and once in the evening. To minimize potential taste disturbances with food, use the medication after meals. After using the medication, avoid eating, brushing your teeth, or rinsing with water or other mouthwashes for a while.

Storing and Disposing of Your Medication

Store the medication at room temperature, protected from heat sources. Keep all medications in a secure location, out of the reach of children and pets, to ensure safety.

Managing Missed Doses

If you miss a dose, take it as soon as you remember. However, if the missed dose is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to compensate for the missed one.
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Lifestyle & Tips

  • Do not swallow the rinse; spit it out after use.
  • Do not rinse with water, eat, or drink immediately after using chlorhexidine rinse (wait at least 30 minutes, preferably longer, to maximize effectiveness).
  • Brush your teeth before using chlorhexidine rinse. If your toothpaste contains sodium lauryl sulfate (SLS), rinse your mouth thoroughly with water after brushing and before using chlorhexidine, or wait at least 30 minutes between brushing and rinsing.
  • Regular dental check-ups and professional cleanings are still essential while using this rinse.

Dosing & Administration

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Adult Dosing

Standard Dose: Rinse with 15 mL of undiluted oral rinse for 30 seconds, twice daily, morning and evening, after toothbrushing.
Dose Range: 15 - 15 mg

Condition-Specific Dosing:

gingivitis: Rinse with 15 mL for 30 seconds, twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established (safety and efficacy not established for children under 18 years of age). Use with caution in children due to risk of swallowing.
Adolescent: Not established (safety and efficacy not established for children under 18 years of age). If used, adult dosing may be considered with caution and supervision.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption).
Moderate: No adjustment needed (minimal systemic absorption).
Severe: No adjustment needed (minimal systemic absorption).
Dialysis: No specific considerations (minimal systemic absorption).

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption).
Moderate: No adjustment needed (minimal systemic absorption).
Severe: No adjustment needed (minimal systemic absorption).

Pharmacology

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Mechanism of Action

Chlorhexidine gluconate is a cationic biguanide with broad-spectrum antimicrobial activity. It binds to the negatively charged bacterial cell wall, disrupting the cell membrane and precipitating cytoplasmic contents, leading to bacterial cell death. It also adsorbs to the pellicle-coated tooth surface, releasing slowly over time, providing sustained antimicrobial activity.
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Pharmacokinetics

Absorption:

Bioavailability: <1% (systemic from oral rinse)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Food and drink should be avoided for several hours after use to maximize efficacy.

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Primarily via saliva/swallowing, then feces (unabsorbed portion)
Unchanged: >90% (unabsorbed portion)
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Pharmacodynamics

OnsetOfAction: Rapid local antimicrobial effect within minutes of contact.
PeakEffect: Local concentration peaks during and immediately after rinsing.
DurationOfAction: Sustained antimicrobial activity for several hours due to binding to oral tissues and slow release.
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as:
- Rash
- Hives
- Itching
- Red, swollen, blistered, or peeling skin (with or without fever)
- Wheezing
- Tightness in the chest or throat
- Trouble breathing, swallowing, or talking
- Unusual hoarseness
- Swelling of the mouth, face, lips, tongue, or throat
- Severe gum pain or swelling
- Numbness or tingling in the mouth

Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you and do not go away:
- Mouth irritation
- Staining of the mouth, teeth, or fillings
- Tartar buildup on teeth
- Change in taste (in rare cases, this may be permanent)

Additional Information
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor for medical advice.
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Seek Immediate Medical Attention If You Experience:

  • Severe allergic reaction (hives, rash, swelling of face/lips/tongue/throat, difficulty breathing, dizziness) - seek immediate medical attention.
  • Persistent or worsening oral irritation, burning, or pain.
  • Swelling of salivary glands.
  • Significant or widespread peeling of oral tissues.
  • Severe or persistent taste changes.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. To maintain good oral health, practice proper dental care and schedule regular dental check-ups. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor promptly. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • If swallowed, symptoms may include stomach upset, nausea, or vomiting. Systemic toxicity is unlikely due to poor absorption.
  • Large ingestions may rarely cause liver enzyme elevations.

What to Do:

If a large amount is accidentally swallowed, contact a poison control center or emergency room immediately. Call 1-800-222-1222.

Drug Interactions

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Minor Interactions

  • Anionic agents (e.g., sodium lauryl sulfate in toothpastes): May inactivate chlorhexidine. Advise patients to rinse thoroughly with water after brushing and before using chlorhexidine rinse, or to wait at least 30 minutes between brushing and rinsing.

Monitoring

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Baseline Monitoring

Oral cavity examination

Rationale: To assess baseline gingival health and identify any pre-existing conditions or contraindications.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Gingival health assessment

Frequency: Periodically, as determined by dental professional (e.g., every 3-6 months).

Target: Reduction in gingival inflammation and bleeding.

Action Threshold: Lack of improvement or worsening of gingivitis may require re-evaluation of treatment plan.

Tooth and restoration staining

Frequency: Periodically, as determined by dental professional.

Target: Minimal to no staining.

Action Threshold: Significant staining may require professional cleaning or discontinuation if unacceptable.

Taste alteration

Frequency: Patient self-report.

Target: Acceptable taste perception.

Action Threshold: Persistent or severe taste alteration may lead to non-compliance or require discontinuation.

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Symptom Monitoring

  • Oral irritation or burning
  • Swelling of salivary glands
  • Desquamation (peeling) of oral mucosa
  • Taste disturbances (dysgeusia)
  • Tooth or tongue staining
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing)

Special Patient Groups

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Pregnancy

Chlorhexidine gluconate is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and systemic absorption in humans from oral rinse is minimal. Generally considered safe for use during pregnancy when indicated.

Trimester-Specific Risks:

First Trimester: Low risk due to minimal systemic absorption.
Second Trimester: Low risk due to minimal systemic absorption.
Third Trimester: Low risk due to minimal systemic absorption.
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Lactation

Chlorhexidine gluconate is considered L3 (moderately safe) or L4 (possibly hazardous) by different sources, but due to minimal systemic absorption from oral rinse, it is generally considered compatible with breastfeeding. It is unlikely to be excreted in breast milk in clinically significant amounts.

Infant Risk: Low risk to infant due to minimal maternal systemic absorption.
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Pediatric Use

Safety and efficacy have not been established for children under 18 years of age. Use with caution in children due to the risk of accidental swallowing, which could lead to stomach upset. Not recommended for routine use in children unless specifically advised by a dental professional.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. The minimal systemic absorption makes age-related changes in renal or hepatic function largely irrelevant. Use with caution if patients have difficulty with rinsing and spitting.

Clinical Information

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Clinical Pearls

  • Chlorhexidine rinse is an adjunct to, not a substitute for, good oral hygiene practices (brushing and flossing).
  • Advise patients about potential side effects, especially temporary tooth/tongue staining and altered taste perception, which are common.
  • Staining is usually extrinsic and can be removed by professional dental cleaning.
  • Instruct patients to spit out the rinse completely and not to swallow it.
  • Emphasize the importance of avoiding food, drink, and other mouth rinses for at least 30 minutes after use to allow chlorhexidine to bind to oral tissues.
  • For patients with significant gingivitis, a professional dental cleaning (scaling and root planing) is often recommended prior to or in conjunction with chlorhexidine rinse therapy.
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Alternative Therapies

  • Essential oil mouthrinses (e.g., Listerine)
  • Cetylpyridinium chloride (CPC) mouthrinses (e.g., Crest Pro-Health)
  • Povidone-iodine oral rinses (less common for daily use)
  • Mechanical plaque control (brushing, flossing, interdental cleaners)
  • Professional dental cleanings (scaling and root planing)
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Cost & Coverage

Average Cost: $10 - $30 per 480 mL bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered by dental plans or medical plans for specific indications)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist. If you have any questions or concerns about this medication, consult with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the substance taken, the amount, and the time it occurred.