Erythromycin 2% Topical Soln 60ml

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
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
Jan 1980
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Erythromycin topical solution 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 the information provided. 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 before and after applying the medication.
Before applying, wash and rinse the affected skin with warm water, then gently 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 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 solution.
  • Apply a thin film 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 consistently as directed, even if acne appears to improve.
  • Be patient; it may take several weeks to see significant improvement.
  • Sun protection is advisable as some acne treatments can increase sun sensitivity.

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.
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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).
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 bacteria by reversibly binding to the 50S ribosomal subunit, thereby inhibiting the translocation of peptidyl tRNA. In acne vulgaris, it reduces the population of Propionibacterium acnes (now Cutibacterium acnes) on the skin and within follicles, and may also have anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption (<1%)
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

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)
PeakEffect: Up to 12 weeks
DurationOfAction: Continuous use required for sustained effect
Confidence: Medium

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 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
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:

Dry skin
Skin irritation
Itching
Peeling
Oily skin

This is not an exhaustive list of potential 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)
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Worsening of acne or new types of 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 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 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 skin irritation (e.g., severe dryness, redness, peeling).

What to Do:

If excessive application occurs, wash the area with water. If swallowed, contact a poison control center (Call 1-800-222-1222) or seek medical attention, though systemic toxicity from accidental ingestion of a small amount is unlikely.

Drug Interactions

Monitoring

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Baseline Monitoring

Skin assessment

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

Timing: Prior to initiation of therapy

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Routine Monitoring

Efficacy (reduction in acne lesions)

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

Target: Improvement in lesion count and overall skin appearance

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

Local skin irritation (dryness, redness, peeling, itching)

Frequency: At each follow-up visit and as reported by patient

Target: Minimal to no irritation

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

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Symptom Monitoring

  • Skin dryness
  • Redness (erythema)
  • Peeling (desquamation)
  • Itching (pruritus)
  • Burning or stinging sensation
  • Folliculitis (rare)

Special Patient Groups

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Pregnancy

Erythromycin topical is generally considered safe for use during pregnancy due to minimal systemic absorption. Animal reproduction studies have not demonstrated a risk to the fetus, but there are no adequate and well-controlled studies in pregnant women. 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 compatible with breastfeeding. Systemic absorption is minimal, making infant exposure through breast milk unlikely. If applied to the chest, ensure the area is clean before nursing to prevent direct infant ingestion.

Infant Risk: Low risk
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Pediatric Use

Erythromycin topical solution is commonly used in adolescents and children (typically 12 years and older) for acne vulgaris. Safety and efficacy in younger children have not been established.

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Geriatric Use

No specific dosage adjustments are necessary for geriatric patients. The safety and efficacy profile is similar to that in younger adults.

Clinical Information

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Clinical Pearls

  • Topical erythromycin is often used in combination with other agents like 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.
  • Resistance to topical erythromycin has become common, leading to its decreased use as monotherapy for acne. Combination therapy is preferred.
  • Alcohol-based solutions can be drying; patients with sensitive or dry skin may prefer gel or ointment formulations if available.
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Alternative Therapies

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

Average Cost: $30 - $100 per 60ml solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (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.