Erygel 2% Gel 30gm

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 antibiotic, 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
Sep 1986
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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 stopping the growth of bacteria that cause acne and by reducing inflammation. Apply a thin layer to clean, dry skin twice a day.
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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

Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Wash your hands before and after applying the medication.
Gently wash and rinse the affected skin area with warm water, then pat it dry.
Apply a thin layer of the medication to the affected area and allow it to dry.

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.
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Lifestyle & Tips

  • Cleanse skin gently before application.
  • Avoid contact with eyes, nose, mouth, and other mucous membranes.
  • Do not apply to cuts, scrapes, or irritated skin.
  • Use a non-comedogenic moisturizer if skin dryness or irritation occurs.
  • Sun protection is advisable, as some acne treatments can increase sun sensitivity.
  • 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, after the skin is thoroughly washed and dried.

Condition-Specific Dosing:

acneVulgaris: Apply a thin film to affected areas twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Apply a thin film to affected areas twice daily (typically for children 12 years and older, consult physician for younger)
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 adjustment needed (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 in susceptible organisms by reversibly binding to the 50S ribosomal subunit, thereby inhibiting the translocation of peptidyl tRNA. In acne vulgaris, erythromycin inhibits the growth of Propionibacterium acnes (now Cutibacterium acnes), a bacterium implicated in the pathogenesis of acne. It also has anti-inflammatory properties.
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Pharmacokinetics

Absorption:

Bioavailability: Negligible systemic bioavailability after topical application.
Tmax: Not applicable for systemic effects due to minimal absorption.
FoodEffect: Not applicable for topical formulation.

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: Clinical improvement typically observed within 2-4 weeks, with maximal effect in 8-12 weeks.
PeakEffect: 8-12 weeks
DurationOfAction: Maintained with continued use.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

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 attention immediately:

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 attention:

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 burning, itching, or stinging that does not subside
  • Excessive redness or swelling
  • Development of severe diarrhea or abdominal cramps (extremely rare with topical use, but report any unusual systemic symptoms)
  • Signs of an allergic reaction (e.g., rash, hives, difficulty breathing, swelling of face/lips/tongue/throat)
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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. This is crucial to avoid potential interactions between this medication and other substances.
Any existing health problems, as they may affect the safety and efficacy of this medication.

To ensure your safety, always check with your doctor before:
Starting any new medication
Stopping any medication
Changing the dose of any medication

This will help prevent potential interactions and ensure that it is safe for you to take this medication with your other medications and health conditions.
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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:

  • 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 excessive application occurs, wash the area with water. If accidental ingestion occurs, seek medical attention. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Moderate Interactions

  • Other topical acne preparations (e.g., benzoyl peroxide, tretinoin, salicylic acid) - may cause cumulative irritant or drying effects.

Monitoring

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Baseline Monitoring

Skin condition (severity of acne, presence of inflammation)

Rationale: To establish baseline for treatment efficacy assessment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Clinical response of acne

Frequency: Every 4-8 weeks initially, then as needed.

Target: Reduction in lesion count (comedones, papules, pustules), decrease in inflammation.

Action Threshold: If no improvement after 8-12 weeks, consider alternative therapies or re-evaluate diagnosis.

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

Frequency: Regularly during treatment.

Target: Mild to no irritation.

Action Threshold: If severe irritation occurs, reduce frequency of application or temporarily discontinue use. Consider emollients.

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Symptom Monitoring

  • Excessive dryness
  • Peeling
  • Redness
  • Burning or stinging sensation
  • Itching
  • Allergic reactions (rare, e.g., rash, hives, swelling)

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. Consult with a healthcare provider.

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 (L2) during breastfeeding. Minimal systemic absorption means negligible amounts are expected to pass into breast milk. Avoid applying to areas where the infant may ingest it.

Infant Risk: Low risk of adverse effects to the breastfed infant.
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Pediatric Use

Safety and effectiveness in pediatric patients under 12 years of age have not been established. Use in adolescents (12 years and older) is generally similar to adults.

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Geriatric Use

No specific dosage adjustments or precautions are generally 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

  • Consistency is key: Patients should be advised to use the gel regularly as prescribed, even if immediate results are not seen.
  • Avoid overuse: Applying more frequently or in larger amounts will not speed up results and may increase irritation.
  • Combination therapy: Often used in conjunction with other topical agents (e.g., retinoids, benzoyl peroxide) or oral medications for more severe acne, but caution should be exercised regarding potential for increased irritation.
  • Antibiotic resistance: Long-term monotherapy with topical erythromycin can lead to bacterial resistance. Combination with benzoyl peroxide can help mitigate this risk.
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Alternative Therapies

  • Topical retinoids (e.g., tretinoin, adapalene, tazarotene)
  • Topical benzoyl peroxide
  • Azelaic acid
  • Oral antibiotics (e.g., doxycycline, minocycline, erythromycin)
  • Oral isotretinoin (for severe acne)
  • Hormonal therapies (e.g., oral contraceptives, spironolactone for females)
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Cost & Coverage

Average Cost: Varies widely, typically $50 - $200+ per 30gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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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.