Chlorhexidine 0.12% Oral Rins 473ml

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, Oral
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Pharmacologic Class
Bisbiguanide 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 is an antiseptic mouthwash used to treat gingivitis, a common gum disease that causes redness, swelling, and bleeding of the gums. It works by killing the bacteria in your mouth that cause gingivitis.
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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 any potential impact on the taste of 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 it 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 use extra doses to make up 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 for at least 30 minutes (preferably several hours) after using chlorhexidine to allow it to work effectively.
  • Use after brushing your teeth, but rinse your mouth thoroughly with water after brushing and before using chlorhexidine, especially if your toothpaste contains sodium lauryl sulfate (SLS).
  • Brush and floss regularly as directed by your dentist.
  • Be aware that chlorhexidine may cause temporary staining of teeth, tongue, and dental restorations. This staining is usually reversible with professional dental cleaning.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mL (one capful) undiluted, rinsed for 30 seconds, twice daily, morning and evening after toothbrushing.
Dose Range: 15 - 15 mg

Condition-Specific Dosing:

gingivitis: 15 mL twice daily for 30 seconds
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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)
Adolescent: Not established (safety and efficacy not established for children under 18 years of age)
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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 bisbiguanide with broad-spectrum antimicrobial activity. It binds to the negatively charged bacterial cell wall, disrupting its integrity and increasing its permeability, leading to leakage of intracellular components and cell death. It also binds to the pellicle and tooth surface, slowly releasing over time, providing sustained antimicrobial action.
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Pharmacokinetics

Absorption:

Bioavailability: <0.0002% (systemic absorption from oral rinse)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Food/drink can reduce efficacy if consumed immediately after rinsing; advise waiting several hours.

Distribution:

Vd: Not applicable (minimal systemic absorption)
ProteinBinding: Not applicable (minimal systemic absorption)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Primarily expectorated; swallowed portion is largely unabsorbed and excreted in feces.
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Rapid (antimicrobial effect upon contact)
PeakEffect: Not applicable (local action)
DurationOfAction: Prolonged (due to binding to oral tissues, up to 12 hours)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

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. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor for guidance:

Mouth irritation
Staining of the mouth, teeth, or fillings
Tartar buildup on teeth
* Change in taste (in rare cases, this may be permanent)

Remember: This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, don't hesitate to reach out to your doctor for medical advice.
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Seek Immediate Medical Attention If You Experience:

  • Severe allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
  • Swelling of the face, lips, tongue, or throat.
  • Oral irritation, redness, or swelling that worsens.
  • Persistent or severe taste changes or loss of taste.
  • Increased tooth or tongue staining that is bothersome.
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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 you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that it is safe to take this medication in conjunction with all your other 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, large amounts may cause stomach upset, nausea, or vomiting. Systemic toxicity is rare due to poor absorption.

What to Do:

If a large amount is accidentally swallowed, contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is generally supportive.

Drug Interactions

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Moderate Interactions

  • Anionic agents (e.g., sodium lauryl sulfate found in many toothpastes)

Monitoring

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Baseline Monitoring

Oral cavity examination

Rationale: Assess baseline gingival inflammation and overall oral health.

Timing: Prior to initiation of therapy

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Routine Monitoring

Gingival index/inflammation

Frequency: Periodically, as determined by dental professional

Target: Reduction in inflammation

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

Tooth and tongue staining

Frequency: Regularly (patient self-monitoring)

Target: Minimal to no staining

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

Taste alteration

Frequency: Regularly (patient self-monitoring)

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
  • Swelling of salivary glands
  • Desquamation (peeling) of oral mucosa
  • Dry mouth
  • Unusual taste or loss of taste
  • Tooth or tongue staining

Special Patient Groups

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Pregnancy

Chlorhexidine gluconate is Pregnancy Category B. Studies in animals have not shown harm to the fetus, and due to minimal systemic absorption, risk to the human fetus is considered low. Use only if clearly needed.

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 L2 (Safer) for breastfeeding. Due to minimal systemic absorption, it is unlikely to be excreted in breast milk in clinically significant amounts. No adverse effects on breastfed infants have been reported.

Infant Risk: Low risk
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Pediatric Use

Safety and efficacy have not been established for children under 18 years of age. Use in pediatric patients should only be under the direct supervision and recommendation of a dental professional or physician.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. However, due to minimal systemic absorption, age-related pharmacokinetic differences are not expected to be clinically significant.

Clinical Information

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Clinical Pearls

  • Chlorhexidine is a prescription-only oral rinse for gingivitis, not a cosmetic mouthwash.
  • Advise patients to use it after brushing and flossing, but to rinse their mouth thoroughly with water before using chlorhexidine, especially if their toothpaste contains sodium lauryl sulfate (SLS), to prevent inactivation.
  • Warn patients about potential tooth and tongue staining, which is usually reversible with professional dental cleaning.
  • Emphasize that the rinse should be spit out and not swallowed.
  • Patients should avoid eating or drinking for at least 30 minutes (preferably longer) after rinsing to maximize efficacy.
  • Taste alteration is a common side effect; reassure patients it is usually temporary.
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Alternative Therapies

  • Improved oral hygiene (brushing, flossing)
  • Professional dental cleanings (scaling and root planing)
  • Other antimicrobial mouthwashes (e.g., essential oil-based rinses, cetylpyridinium chloride, povidone-iodine - generally less effective for established gingivitis than chlorhexidine)
  • Systemic antibiotics (for severe or refractory periodontitis, not routine gingivitis)
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Cost & Coverage

Average Cost: $15 - $40 per 473ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (often covered by dental plans or some medical plans if prescribed)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them 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 medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.