Erythromycin 2% Gel 60gm

Manufacturer PERRIGO Active Ingredient Erythromycin (Topical)(er ith roe MYE sin) Pronunciation er ith roe MYE sin
It is used to treat pimples (acne).
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Drug Class
Anti-acne agent
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Pharmacologic Class
Macrolide antibiotic (topical)
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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?

Erythromycin gel is an antibiotic medicine applied to the skin to treat acne. It works by stopping the growth of bacteria that cause acne and by reducing inflammation.
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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 accompanying information carefully. It is essential to use this medication as directed.

Application Instructions

Apply this medication only to your skin, as directed by your doctor. Do not take it by mouth.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands thoroughly before and after applying the medication.
Before applying, wash and rinse the affected skin area with warm water, then gently pat it dry.
Apply a thin layer of the medication to the affected area and allow it to dry completely.

Important Safety Precautions

This medication is flammable, so do not use it near an open flame or while smoking.

Storage and Disposal

Store the medication in its original container at room temperature, keeping the lid tightly closed.
Protect the medication from heat and open flames.

Missed Dose Instructions

If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next scheduled dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash affected areas gently before applying the gel.
  • Apply a thin layer of gel to the entire affected area, not just individual pimples.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Do not use on broken or irritated skin.
  • Use a non-comedogenic (non-pore clogging) moisturizer if skin dryness occurs.
  • Be patient; it may take several weeks to see improvement.
  • Continue using as directed by your doctor, even if acne improves, to prevent recurrence and antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to affected areas twice daily, morning and evening.

Condition-Specific Dosing:

acne_vulgaris: Apply a thin film to affected areas twice daily, morning and evening, after washing the skin.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for children under 12 years; consult physician.
Adolescent: Apply a thin film to affected areas twice daily, morning and evening, after washing the skin (typically for ages 12 and older).
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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

Erythromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. In acne, it reduces the population of *Cutibacterium acnes* (formerly *Propionibacterium acnes*) on the skin, which contributes to inflammation and lesion formation. It also has anti-inflammatory properties.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible (minimal systemic absorption)
Tmax: Not applicable (minimal systemic absorption)
FoodEffect: Not applicable (topical administration)

Distribution:

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

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: Several weeks (typically 4-8 weeks for noticeable improvement in acne)
PeakEffect: Up to 12 weeks
DurationOfAction: Maintained with continued use

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
Eye irritation
Diarrhea, bloody diarrhea, or a bowel problem (colitis), which can be severe and potentially life-threatening. If you experience:
+ Stomach pain or cramps
+ Severe or watery diarrhea
+ Bloody diarrhea
do not attempt to treat diarrhea without consulting your doctor first.

Other Possible Side Effects

Like all medications, this drug can cause side effects, although many people may not experience any or may only have mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:

Dry skin
Skin irritation
Itching
Peeling
Oily skin

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult 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 (excessive redness, burning, itching, peeling)
  • Swelling of the face, lips, or tongue (signs of allergic reaction)
  • Difficulty breathing
  • Worsening of acne or new types of skin lesions
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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 ensure safe use and avoid potential interactions.
* Any existing health problems, as this medication may interact with other medical conditions or drugs.

To guarantee your safety, do not start, stop, or change the dosage of any medication without first consulting your doctor. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions. Your doctor and pharmacist will work together to ensure that all your medications, including this one, are safe and appropriate for you to take.
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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. Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use. When using other acne treatments, exercise caution as they may increase the risk of skin irritation. If you are pregnant, planning to become pregnant, or are breast-feeding, notify your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Topical overdose is unlikely to cause systemic toxicity due to minimal absorption. Excessive application may lead to increased local irritation (redness, dryness, peeling).

What to Do:

If swallowed, seek medical attention. For excessive topical application, wash off with water. For severe local irritation, discontinue use and consult a healthcare provider. Call 1-800-222-1222 (Poison Control) for advice if needed.

Drug Interactions

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Moderate Interactions

  • Other topical acne preparations (e.g., benzoyl peroxide, retinoids, abrasive cleansers) - may cause excessive dryness, irritation, or peeling.

Monitoring

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Routine Monitoring

Skin irritation (redness, dryness, peeling, itching)

Frequency: Daily, during initial treatment and as needed

Target: Minimal to no irritation

Action Threshold: If severe irritation occurs, reduce frequency or discontinue use and consult physician.

Acne lesion count/severity

Frequency: Monthly or as assessed by physician

Target: Reduction in inflammatory and non-inflammatory lesions

Action Threshold: If no improvement after 8-12 weeks, re-evaluate treatment.

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Symptom Monitoring

  • Skin dryness
  • Redness
  • Peeling
  • Itching
  • Burning sensation
  • Stinging
  • Folliculitis
  • Urticaria

Special Patient Groups

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Pregnancy

Generally considered safe for topical use during pregnancy (Category B). Systemic absorption is minimal.

Trimester-Specific Risks:

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

Considered low risk (L2) for use during breastfeeding. Minimal systemic absorption by the mother means negligible amounts are expected to pass into breast milk or be absorbed by the infant.

Infant Risk: Low risk of adverse effects in breastfed infants.
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Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established. Used commonly in adolescents (12 years and older) for acne.

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Geriatric Use

No specific dosage adjustments or precautions are necessary for geriatric patients. Systemic absorption is minimal, so age-related changes in renal or hepatic function are not expected to significantly impact safety or efficacy.

Clinical Information

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Clinical Pearls

  • Topical erythromycin is often used in combination with other acne treatments, such as benzoyl peroxide, to enhance efficacy and reduce the development of antibiotic resistance.
  • Patients should be advised that improvement in acne may not be seen for several weeks (typically 6-8 weeks) and consistent application is crucial.
  • To minimize the risk of bacterial resistance, topical erythromycin should ideally be used for limited durations or in combination with a non-antibiotic agent (e.g., benzoyl peroxide).
  • Avoid applying the gel to areas with cuts, abrasions, or sunburn, as this may increase irritation.
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Alternative Therapies

  • Topical clindamycin (e.g., Clindamycin 1% Gel)
  • Topical retinoids (e.g., Tretinoin, Adapalene, Tazarotene)
  • Benzoyl peroxide (topical)
  • Azelaic acid (topical)
  • Oral antibiotics (e.g., doxycycline, minocycline - for more severe acne)
  • Oral isotretinoin (for severe, recalcitrant acne)
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Cost & Coverage

Average Cost: $50 - $150 per 60gm tube (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 occurred.