Erygel 2% Gel 60gm

Manufacturer MYLAN 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
Topical anti-acne agent
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Pharmacologic Class
Macrolide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Jun 1992
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Erygel is a topical antibiotic gel used to treat acne. It works by reducing the bacteria on your skin that can cause acne and by helping to reduce 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 to ensure safe and effective treatment.

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

  • Cleanse skin gently before application.
  • Apply a thin layer to all affected areas, not just individual pimples.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Wash hands thoroughly after application.
  • Use sunscreen and protective clothing as skin may become more sensitive to sun.
  • Be patient; it may take several weeks to see improvement.
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Available Forms & Alternatives

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.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Safety and efficacy established for children 12 years and older.
Adolescent: Apply a thin film to affected areas twice daily.
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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 due to 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 protein synthesis by reversibly binding to the 50S ribosomal subunit of susceptible microorganisms. In the treatment of acne vulgaris, erythromycin reduces the population of *Cutibacterium acnes* (formerly *Propionibacterium acnes*) on the skin and within follicles, and also exerts anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (<1%)
Tmax: Not clinically relevant for topical use
FoodEffect: Not applicable for topical use

Distribution:

Vd: Not clinically relevant for topical use
ProteinBinding: Not clinically relevant for topical use
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Not clinically relevant for topical use
Clearance: Not clinically relevant for topical use
ExcretionRoute: Not clinically relevant for topical use
Unchanged: Not clinically relevant for topical use
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Pharmacodynamics

OnsetOfAction: Several weeks (typically 4-6 weeks for noticeable improvement)
PeakEffect: Up to 12 weeks
DurationOfAction: Maintained with continued use
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
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 first consulting your doctor.

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 symptoms that bother you or do not go away, contact your doctor:

Dry skin
Skin irritation
Itching
Peeling
Oily skin

This is not an exhaustive list of possible side effects. If you have questions or concerns, contact 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 burning, itching, or stinging that does not subside
  • Excessive redness, dryness, or peeling
  • Signs of allergic reaction (e.g., rash, hives, swelling, difficulty breathing)
  • Severe diarrhea (rare, but possible with systemic absorption)
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 breastfeeding, 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:

  • Unlikely with topical application due to minimal systemic absorption. Ingestion of large quantities may lead to gastrointestinal upset (nausea, vomiting, diarrhea).

What to Do:

For accidental ingestion, seek medical attention. For severe local irritation, discontinue use and consult a healthcare provider. Call 1-800-222-1222 for poison control.

Drug Interactions

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Minor Interactions

  • Other topical acne preparations (e.g., benzoyl peroxide, retinoids): May increase skin irritation, dryness, or peeling if used concurrently. Use with caution or at different times of day.

Monitoring

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Baseline Monitoring

Skin assessment

Rationale: To establish baseline severity of acne and identify any pre-existing skin conditions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in acne lesions)

Frequency: Monthly or as clinically indicated

Target: Progressive improvement

Action Threshold: Lack of improvement after 8-12 weeks may warrant re-evaluation of treatment plan.

Local skin irritation (dryness, peeling, erythema, burning)

Frequency: At each follow-up visit

Target: Mild to none

Action Threshold: Severe or persistent irritation may require reduction in frequency of application or temporary discontinuation.

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Symptom Monitoring

  • Skin dryness
  • Peeling
  • Redness (erythema)
  • Burning sensation
  • Itching
  • Stinging
  • Oily skin

Special Patient Groups

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Pregnancy

Erythromycin topical is generally considered safe for use during pregnancy (Category B) due to minimal systemic absorption. 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

Erythromycin topical is considered low risk during breastfeeding (L2) due to minimal systemic absorption. It is unlikely to cause adverse effects in a breastfed infant. Avoid applying to areas where the infant may ingest the medication.

Infant Risk: Low risk
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Pediatric Use

Safety and efficacy have been established for children 12 years of age and older. Use in younger children is not well-established.

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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 or topical retinoids, to enhance efficacy and reduce the development of antibiotic resistance.
  • Patients should be advised that improvement may not be seen for several weeks, and consistent application is key.
  • Resistance to topical erythromycin has become more common, leading to decreased efficacy over time. This is why combination therapy is often preferred.
  • The gel formulation may be preferred for patients with oily skin, while solutions or lotions might be better for drier skin types.
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Alternative Therapies

  • Topical Clindamycin (e.g., Cleocin T)
  • Topical Retinoids (e.g., Tretinoin, Adapalene, Tazarotene)
  • Benzoyl Peroxide (various formulations)
  • Azelaic Acid
  • Oral Antibiotics (e.g., Doxycycline, Minocycline, Erythromycin - for more severe acne)
  • Oral Isotretinoin (for severe, recalcitrant acne)
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Cost & Coverage

Average Cost: Varies widely, typically $50-$200 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic formulations)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. It's also important to note that some medications may have additional patient information leaflets, 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 for guidance. 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 name of the medication taken, the amount, and the time it occurred.