Erythromycin 2% Gel 30gm

Manufacturer PADAGIS /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
Topical anti-acne agent, Antibiotic
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Pharmacologic Class
Macrolide antibiotic
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Pregnancy Category
Category B
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FDA Approved
Aug 1986
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Erythromycin 2% Gel is a topical antibiotic medication used to treat acne. It works by stopping the growth of bacteria that contribute to 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 the information provided. It is essential to use this medication as directed.

Application Instructions

Apply this medication only to your skin. Do not take it by mouth.
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 avoid using 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 dose, skip the missed dose and resume your regular schedule.
* Do not apply two doses at the same time or use extra doses.
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Lifestyle & Tips

  • Cleanse skin gently before applying the gel.
  • 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 some acne treatments can increase sun sensitivity.
  • Be patient; it may take several weeks to see noticeable improvement.
  • Do not use more often than prescribed, as this will not speed up results and may increase side effects.

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 not established for children under 12 years of age. For children 12 years and older, apply a thin film to affected areas twice daily.
Adolescent: Apply a thin film to affected areas twice daily, morning and evening.
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Dose Adjustments

Renal Impairment:

Mild: Not applicable due to minimal systemic absorption.
Moderate: Not applicable due to minimal systemic absorption.
Severe: Not applicable due to minimal systemic absorption.
Dialysis: Not applicable due to minimal systemic absorption.

Hepatic Impairment:

Mild: Not applicable due to minimal systemic absorption.
Moderate: Not applicable due to minimal systemic absorption.
Severe: Not applicable due to 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 Propionibacterium acnes (now Cutibacterium acnes) on the skin and within follicles, and may also exert anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (less than 0.5%)
Tmax: Not applicable for systemic effect due to minimal absorption
FoodEffect: Not applicable

Distribution:

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

Elimination:

HalfLife: Not applicable for systemic effect
Clearance: Not applicable for systemic effect
ExcretionRoute: Not applicable for systemic effect
Unchanged: Not applicable for systemic effect
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Pharmacodynamics

OnsetOfAction: Clinical improvement typically observed within 4-6 weeks
PeakEffect: Optimal results usually seen after 6-8 weeks of continuous use
DurationOfAction: Maintained with continued twice-daily application

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
Severe gastrointestinal symptoms, including:
+ Stomach pain or cramps
+ Severe or watery diarrhea
+ Bloody diarrhea
+ Colitis (a bowel problem that can be life-threatening if left untreated)

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 persist, 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 skin irritation (e.g., extreme redness, burning, itching, peeling)
  • Swelling of the face, lips, or tongue (signs of allergic reaction)
  • Difficulty breathing
  • Persistent or worsening acne after several weeks of use
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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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Never start, stop, or adjust the dose 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. 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 (e.g., severe dryness, redness, peeling).

What to Do:

If excessive application occurs, wash the area with mild soap and water. If irritation is severe or persists, discontinue use and consult a healthcare professional. In case of accidental ingestion, contact a poison control center (e.g., 1-800-222-1222) or seek medical attention immediately, though systemic effects from ingestion of a small amount are unlikely.

Drug Interactions

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Minor Interactions

  • Topical peeling agents (e.g., salicylic acid, benzoyl peroxide, resorcinol, sulfur, tretinoin): May increase skin irritation, dryness, or peeling if used concurrently. Use with caution and monitor for excessive irritation.

Monitoring

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Baseline Monitoring

Skin assessment (severity of acne, presence of lesions)

Rationale: To establish baseline for treatment efficacy and identify any pre-existing skin conditions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Skin irritation (redness, dryness, peeling, burning, itching)

Frequency: Regularly during treatment, especially during the first few weeks

Target: Minimal to mild irritation

Action Threshold: Moderate to severe irritation; consider reducing frequency or temporarily discontinuing use.

Acne lesion count and overall improvement

Frequency: Every 4-8 weeks

Target: Reduction in inflammatory and non-inflammatory lesions

Action Threshold: No improvement after 8-12 weeks; consider alternative or adjunctive therapy.

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Symptom Monitoring

  • Excessive dryness
  • Peeling
  • Redness (erythema)
  • Burning sensation
  • Itching
  • Stinging
  • Oily skin (paradoxical effect)
  • Folliculitis

Special Patient Groups

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Pregnancy

Erythromycin topical gel is generally considered safe for use during pregnancy (Pregnancy Category B). Systemic absorption is minimal, limiting fetal exposure.

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

Considered compatible with breastfeeding (Lactation Risk L2). Minimal systemic absorption means negligible amounts are expected to be transferred into breast milk. Apply to areas where infant contact is unlikely.

Infant Risk: Low risk to the infant.
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Pediatric Use

Safety and efficacy have not been established in children under 12 years of age. For adolescents 12 years and older, dosing is similar to adults. Use with caution in younger children, and only if prescribed by a healthcare professional.

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Geriatric Use

No specific dose 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

  • 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 is gradual and consistent use is key. Discontinuation too early may lead to recurrence of acne.
  • Warn patients about potential dryness, peeling, or redness, especially during the initial weeks of treatment. Advise using a non-comedogenic moisturizer if needed.
  • Resistance to topical erythromycin can develop over time, which is why it's often combined with benzoyl peroxide or used for a limited duration.
  • Avoid using abrasive soaps, cleansers, or other topical products that may cause excessive drying or irritation while on erythromycin gel.
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Alternative Therapies

  • Benzoyl peroxide (topical)
  • Azelaic acid (topical)
  • Oral antibiotics (e.g., doxycycline, minocycline, oral erythromycin - for more severe acne)
  • Oral retinoids (e.g., isotretinoin - for severe, recalcitrant acne)
  • Hormonal therapies (for female patients)
  • Light and laser therapies
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Cost & Coverage

Average Cost: Varies, typically $30-$100+ per 30gm tube
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.