Chlorhexidine Gluc 4% Topical Soln

Manufacturer RISING PHARMACEUTICALS Active Ingredient Chlorhexidine Gluconate (Topical)(klor HEKS i deen GLOO koe nate) Pronunciation klor HEKS i deen GLOO koe nate
It is used to clean the skin to prevent infection.
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Drug Class
Antiseptic
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Pharmacologic Class
Biguanide 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 gluconate 4% topical solution is an antiseptic skin cleanser used to kill germs on the skin. It's commonly used before surgery, for handwashing in healthcare settings, and for general skin cleansing to prevent infections.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. For all uses of this medication:

Apply this medication only to your skin. Do not take it by mouth.
Avoid getting this medication in your mouth, nose, ears, or eyes, as it may cause burning. If you accidentally get it in these areas, rinse well with water.
Be aware that this medication can cause severe and long-lasting eye problems if it comes into contact with your eyes. If you have a perforated eardrum and this medication gets in your ear, it could lead to hearing loss.

Application Instructions

For use as a hand sanitizer: Apply the medication under your fingertips, then spread it over your hands and up to just above your elbows. Add another pumpful to both hands and spread it over your hands and up to your wrists. Rub the medication into your hands until they are dry.
For use as a hand wash: Wet your hands and forearms, then apply 1 teaspoon (5 mL) of the medication. Wash your hands for 1 minute, then rinse the affected area with water and dry well.
For use before surgery or other procedures: Your doctor may provide personalized instructions on how to apply the medication.

Storage and Disposal

Store this medication at room temperature, away from heat or open flames.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in local drug take-back programs.

Missed Dose

If you use this medication on a regular basis and miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not apply two doses at the same time or use extra doses.
If you use this medication as needed, do not apply it more frequently than directed by your doctor.
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Lifestyle & Tips

  • For external use only. Do not swallow.
  • Avoid contact with eyes, ears, mouth, and other mucous membranes. If contact occurs, rinse thoroughly with water.
  • Do not use on open wounds, broken skin, or deep cuts unless directed by a healthcare professional.
  • Do not use if you are allergic to chlorhexidine or any other ingredients.
  • Allow the solution to dry completely on the skin before applying dressings or drapes, especially with alcohol-containing formulations, to prevent chemical burns.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: For skin cleansing: Apply to the skin, lather, and rinse thoroughly. For surgical scrub: Wet hands and forearms, apply 5 mL, scrub for 3 minutes, rinse, then apply another 5 mL and scrub for 3 minutes, rinse. For patient preoperative skin preparation: Apply to the surgical site, allow to dry.

Condition-Specific Dosing:

skin_cleansing: Apply as needed.
surgical_scrub: Use 5 mL for each scrub phase.
preoperative_skin_prep: Apply to surgical site and allow to dry completely.
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Pediatric Dosing

Neonatal: Not recommended for routine use in premature infants or infants less than 2 months of age due to risk of chemical burns. If used, apply sparingly and rinse thoroughly.
Infant: Use with caution; apply sparingly and rinse thoroughly. Avoid prolonged contact with skin.
Child: Apply as directed by a healthcare professional, similar to adult dosing but with caution to avoid prolonged skin contact.
Adolescent: Apply as directed by a healthcare professional, similar to adult dosing.
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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).
Confidence: High

Pharmacology

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Mechanism of Action

Chlorhexidine gluconate is a cationic biguanide that exhibits broad-spectrum antimicrobial activity. It acts by binding to the negatively charged bacterial cell wall, disrupting the cell membrane, increasing its permeability, and causing leakage of intracellular components (e.g., potassium, phosphorus, ATP). At higher concentrations, it causes coagulation of cytoplasmic proteins, leading to bacterial cell death. It is effective against a wide range of Gram-positive and Gram-negative bacteria, some fungi, and viruses.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal (<1%)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical)

Distribution:

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

Elimination:

HalfLife: Not applicable (minimal systemic absorption)
Clearance: Not applicable (minimal systemic absorption)
ExcretionRoute: Not applicable (minimal systemic absorption)
Unchanged: Not applicable (minimal systemic absorption)
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Pharmacodynamics

OnsetOfAction: Rapid (within seconds to minutes)
PeakEffect: Within minutes of application
DurationOfAction: Persistent antimicrobial activity for several hours (up to 6 hours or more) due to binding to the stratum corneum.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when 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
Skin irritation

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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 advice:

Dryness
Itching

Reporting Side Effects

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. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe skin irritation, redness, or rash that worsens or does not go away.
  • Swelling, blistering, or chemical burns on the skin.
  • Signs of a severe allergic reaction: difficulty breathing, wheezing, swelling of the face/lips/tongue/throat, severe rash, dizziness.
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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, any of 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.

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 your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

To avoid staining, take precautions to protect your clothing and fabrics when using this product. Note that some formulations are intended for wound cleaning, while others should not be applied to open skin wounds. Ensure you understand the correct usage of this medication to avoid any complications.

Certain products in this category are flammable, so it is crucial to exercise caution and avoid using them near open flames or while smoking, as this can pose a significant fire hazard.

If this medication is ingested, it can cause harm. In the event of accidental ingestion, immediately contact a doctor or a poison control center for assistance.

When using this medication in children under 2 months old, extra caution is necessary. It is recommended that you consult with your doctor to discuss the potential risks and benefits.

If you are pregnant, planning to become pregnant, or are breastfeeding, inform your doctor. It is essential to have a discussion with your doctor about the potential benefits and risks of using this medication to ensure the best outcome for both you and your baby.
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Overdose Information

Overdose Symptoms:

  • If ingested: Nausea, vomiting, abdominal pain, irritation of the gastrointestinal tract. Large ingestions may lead to systemic effects, though rare.
  • Excessive topical use: Severe skin irritation, chemical burns.

What to Do:

If ingested, call a Poison Control Center immediately (1-800-222-1222 in the US) or seek emergency medical attention. For severe topical reactions, wash off thoroughly with water and seek medical advice.

Drug Interactions

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Moderate Interactions

  • Soaps (anionic agents)
  • Other topical antiseptics (e.g., povidone-iodine, hydrogen peroxide)

Monitoring

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Routine Monitoring

Skin integrity and signs of irritation/allergic reaction

Frequency: Visually inspect during and after application

Target: No redness, swelling, itching, or rash

Action Threshold: Discontinue use if irritation or allergic reaction occurs; seek medical attention if severe.

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Symptom Monitoring

  • Skin irritation (redness, itching, rash)
  • Swelling
  • Blistering
  • Chemical burns (especially in infants)
  • Difficulty breathing (rare, severe allergic reaction)
  • Wheezing (rare, severe allergic reaction)
  • Facial swelling (rare, severe allergic reaction)

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy due to minimal systemic absorption. Consult with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Low risk for topical use.
Second Trimester: Low risk for topical use.
Third Trimester: Low risk for topical use.
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Lactation

Considered safe for topical use during lactation. Minimal systemic absorption means negligible transfer into breast milk. Avoid applying to the breast area if breastfeeding.

Infant Risk: Low risk.
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Pediatric Use

Use with caution, especially in premature infants and infants under 2 months of age, due to increased risk of chemical burns. Avoid prolonged contact with skin. Rinse thoroughly after use.

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Geriatric Use

No specific dose adjustments or precautions are generally needed for geriatric patients, as systemic absorption is minimal. Use as directed for adults.

Clinical Information

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Clinical Pearls

  • Chlorhexidine gluconate is inactivated by soaps and other anionic agents; ensure skin is free of soap residue before application.
  • Avoid contact with the brain, meninges, and middle ear, as it can cause neurotoxicity.
  • Do not use for lumbar puncture or in contact with neural tissue.
  • Ensure the solution dries completely on the skin before applying occlusive dressings or drapes, especially with alcohol-containing formulations, to prevent skin irritation or chemical burns.
  • Rare but serious allergic reactions (anaphylaxis) have been reported; be aware of symptoms and have emergency protocols in place.
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Alternative Therapies

  • Povidone-iodine (Betadine)
  • Alcohol-based hand rubs (e.g., ethanol, isopropanol)
  • Triclosan (less common now due to resistance concerns)
  • Quaternary ammonium compounds (e.g., benzalkonium chloride)
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Cost & Coverage

Average Cost: Varies widely per bottle (e.g., 16 oz, 32 oz)
Generic Available: Yes
Insurance Coverage: Often covered by insurance for medical necessity; over-the-counter versions may not be covered.
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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 emergency 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.