Chlorhexidine 0.12% Oralrinse U/d

Manufacturer DASH PHARMACEUTICALS 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
Anti-infective, Oral; Antiseptic, Oral
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Pharmacologic Class
Bisbiguanide Antiseptic
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Pregnancy Category
Category B
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Chlorhexidine 0.12% oral rinse is an antiseptic mouthwash used to treat gum disease (gingivitis) by killing bacteria in your mouth. It helps reduce gum inflammation, redness, and bleeding.
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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 daily, 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 once or use extra doses to compensate for a missed dose.
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Lifestyle & Tips

  • Do not swallow the rinse; spit it out after use.
  • Rinse your mouth thoroughly with water after brushing your teeth and before using chlorhexidine rinse. This prevents toothpaste ingredients from inactivating the chlorhexidine.
  • Do not eat or drink for at least 30 minutes (preferably longer, e.g., 2-3 hours) after using the rinse to allow it to work effectively.
  • Avoid foods and drinks that can cause staining (e.g., coffee, tea, red wine) during treatment, as chlorhexidine can temporarily stain teeth, tongue, and dental restorations.
  • Maintain good oral hygiene practices (brushing, flossing) in addition to using the rinse.

Dosing & Administration

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Adult Dosing

Standard Dose: 15 mL (1/2 fl oz) twice daily, after breakfast and before bedtime, for 30 seconds. Do not swallow.
Dose Range: 15 - 15 mg

Condition-Specific Dosing:

gingivitis: Rinse for 30 seconds, then expectorate.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for routine use; use only under dental/medical supervision for specific indications (e.g., severe gingivitis, post-surgical) due to risk of swallowing.
Adolescent: Generally same as adult dose if able to rinse and expectorate reliably.
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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 is a cationic bisbiguanide with broad-spectrum antimicrobial activity. It binds to the negatively charged bacterial cell wall, disrupting its integrity and increasing permeability, leading to leakage of intracellular components and eventual cell lysis. It also adsorbs to the pellicle-coated tooth surface, releasing slowly over time, providing sustained antibacterial action.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (<1%) from oral rinse
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Food/drink immediately after rinsing can reduce efficacy; advise waiting at least 30 minutes.

Distribution:

Vd: Not applicable (primarily local action)
ProteinBinding: Binds to oral tissues (mucosa, pellicle, teeth)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (minimal systemic absorption); local retention in oral cavity for several hours
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Primarily by expectoration; small amounts swallowed are excreted via feces.
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Rapid antibacterial effect upon contact
PeakEffect: Sustained antibacterial activity due to binding to oral tissues
DurationOfAction: Up to 8-12 hours due to substantivity (slow release from binding sites)
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some individuals may experience severe and potentially life-threatening side effects while taking this medication. If you exhibit any of the following symptoms, contact your doctor or seek medical help right away:

Signs of an allergic reaction, including:
+ 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
As with all medications, side effects can occur. 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 if they persist or bother you, contact your doctor or seek medical help:

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

Important Note
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 (rare): Hives, rash, swelling of face/lips/tongue/throat, difficulty breathing. Seek immediate medical attention.
  • Significant or persistent brownish staining of teeth, tongue, or dental restorations.
  • Persistent changes in taste perception or loss of taste.
  • Oral irritation, burning, or soreness that does not resolve.
  • Swelling of the salivary glands (parotid glands) under the ears (rare).
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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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is vital 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 of 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. Your doctor will discuss the potential benefits and risks of this medication with you, considering both your health and the health of your baby.
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Overdose Information

Overdose Symptoms:

  • If accidentally swallowed in large amounts: Stomach upset, nausea, vomiting, diarrhea. Systemic toxicity is unlikely due to poor absorption.

What to Do:

Contact a poison control center (1-800-222-1222) or seek medical attention if a large amount is swallowed, especially by a child. Treatment is generally supportive.

Drug Interactions

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Moderate Interactions

  • Anionic agents (e.g., sodium lauryl sulfate found in many toothpastes): Can inactivate chlorhexidine. Advise patients to rinse thoroughly with water after brushing and before using chlorhexidine oral rinse.

Monitoring

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Baseline Monitoring

Oral cavity assessment

Rationale: To establish baseline gingival health, presence of inflammation, bleeding, and any pre-existing staining or oral lesions.

Timing: Before initiating therapy

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Routine Monitoring

Gingival index/bleeding on probing

Frequency: As per dental professional's recommendation (e.g., at follow-up visits)

Target: Reduction in inflammation and bleeding

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

Oral mucosa and tooth examination

Frequency: At follow-up visits, or if patient reports adverse effects

Target: Absence of significant staining, irritation, or other adverse reactions

Action Threshold: Significant staining, persistent taste alteration, oral irritation, or parotid gland swelling may necessitate discontinuation or adjustment.

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Symptom Monitoring

  • Tooth and tongue staining (brownish discoloration)
  • Taste alteration (dysgeusia), including temporary loss of taste
  • Oral irritation (burning sensation, dryness)
  • Increased calculus formation
  • Swelling of the parotid glands (rare)
  • Allergic reactions (rash, itching, swelling, severe dizziness, trouble breathing - rare but serious)

Special Patient Groups

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Pregnancy

Category B. Studies in animals have not shown harm to the fetus, and human data suggest minimal systemic absorption. 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

L3 (Moderately safe). Minimal systemic absorption means very little, if any, chlorhexidine is excreted into breast milk. Unlikely to cause adverse effects in a breastfed infant.

Infant Risk: Low risk
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Pediatric Use

Not routinely recommended for children under 18 years of age unless specifically directed by a dentist or physician, due to the risk of accidental swallowing. If used, ensure the child can reliably rinse and expectorate. Dosage may need adjustment based on age/weight for specific indications.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. Use with caution in patients with pre-existing oral sensitivities or dry mouth, as it may exacerbate symptoms.

Clinical Information

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Clinical Pearls

  • Chlorhexidine is highly substantive, meaning it binds to oral tissues and is slowly released, providing prolonged antimicrobial activity.
  • Advise patients to rinse thoroughly with water after brushing and before using chlorhexidine to prevent inactivation by anionic surfactants (e.g., sodium lauryl sulfate) commonly found in toothpastes.
  • Temporary staining of teeth, tongue, and restorations (especially composite or glass ionomer) is a common side effect. This can often be reduced by good oral hygiene and professional cleaning.
  • Taste alteration is also common and usually reversible upon discontinuation.
  • Chlorhexidine oral rinse is indicated for the treatment of gingivitis, not periodontitis alone. It is an adjunct to mechanical debridement (scaling and root planing).
  • Not intended for long-term continuous use without professional guidance.
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Alternative Therapies

  • Improved mechanical oral hygiene (proper brushing and flossing)
  • Professional dental cleaning (scaling and root planing)
  • Systemic antibiotics (for severe or refractory periodontal disease, in conjunction with mechanical therapy)
  • Local drug delivery systems (e.g., chlorhexidine chips, doxycycline hyclate gel)
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Cost & Coverage

Average Cost: $10 - $30 per 480 mL bottle
Generic Available: Yes
Insurance Coverage: Often covered by dental or medical insurance plans, especially for specific indications.
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General Drug Facts

If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to 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 details about the medication taken, the amount, and the time it happened.