Erythromycin Ophth Oint 1gm Sgl/use

Manufacturer PERRIGO Active Ingredient Erythromycin (Ophthalmic)(er ith roe MYE sin) Pronunciation er-ith-roe-MYE-sin
It is used to treat or prevent eye infections.
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Drug Class
Ophthalmic Anti-infective
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Pharmacologic Class
Macrolide Antibiotic
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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 ophthalmic ointment is an antibiotic medication used to treat bacterial infections of the eye, such as conjunctivitis (pink eye). It works by stopping the growth of bacteria. It is also commonly used to prevent certain eye infections in newborns.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.

Administration

This medication is for ophthalmic use only. Before and after use, wash your hands thoroughly. To avoid contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, eyelid, or surrounding skin.

To administer the medication:

1. Place the drug inside your lower eyelid.
2. Close your eye for 1 to 2 minutes.
3. Gently roll your eyeball around to help distribute the medication.

Storage and Disposal

Store the medication at room temperature, keeping it and all other medications in a secure location out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposal, consult your pharmacist. You may also have access to drug take-back programs in your area.

Missed Dose

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

  • Wash your hands thoroughly before and after applying the ointment.
  • Do not touch the tip of the ointment tube to your eye, eyelid, fingers, or any other surface to avoid contamination.
  • Do not share your eye ointment with others.
  • If you wear contact lenses, remove them before applying the ointment and wait at least 15 minutes before reinserting them, or as advised by your doctor.
  • Complete the full course of treatment as prescribed, even if your symptoms improve, to prevent the infection from returning.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 6 times daily, depending on the severity of the infection.
Dose Range: 1 - 6 mg

Condition-Specific Dosing:

Ophthalmia Neonatorum Prophylaxis: Apply a single 1/2 inch ribbon into each conjunctival sac shortly after birth.
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Pediatric Dosing

Neonatal: For prophylaxis of ophthalmia neonatorum: Apply a 1/2 inch ribbon into each conjunctival sac once, shortly after birth. For treatment of bacterial conjunctivitis: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 6 times daily.
Infant: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 6 times daily.
Child: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 6 times daily.
Adolescent: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 6 times 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 (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 binds to the 50S ribosomal subunit of susceptible bacteria, thereby inhibiting protein synthesis without affecting nucleic acid synthesis. It is primarily bacteriostatic but may be bactericidal at high concentrations or against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic
Tmax: Not applicable (local action)
FoodEffect: Not applicable (topical ophthalmic)

Distribution:

Vd: Not applicable (local action)
ProteinBinding: Not applicable (local action)
CnssPenetration: No

Elimination:

HalfLife: Not applicable (local action)
Clearance: Not applicable (local action)
ExcretionRoute: Not applicable (local action)
Unchanged: Not applicable (local action)
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Pharmacodynamics

OnsetOfAction: Rapid (local antibacterial effect)
PeakEffect: Achieved quickly in ocular tissues
DurationOfAction: Dependent on frequency of application and infection severity

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
Changes in eyesight, eye pain, or severe eye irritation

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

Eye irritation
Eye redness

Note: This list is not exhaustive, and you may experience other side effects not mentioned here. 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:

  • Increased redness, swelling, or pain in the eye
  • Increased discharge or pus from the eye
  • Severe itching or burning in the eye
  • Any signs of an allergic reaction, such as rash, hives, severe itching, swelling of the face/lips/tongue/throat, or difficulty breathing.
  • New or worsening blurred vision.
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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 avoid potential interactions between this medication and other substances.
* Any existing health problems you have, as this medication may interact with certain conditions.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change 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. When taking this drug, exercise caution when driving or performing tasks that require clear vision to ensure your safety. Do not exceed the prescribed duration of use, as this may increase the risk of a secondary infection. If you are pregnant, planning to become pregnant, or are breastfeeding, consult 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 to occur with topical ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive application.

What to Do:

If swallowed, or if severe local irritation occurs, contact a poison control center or seek medical attention. Call 1-800-222-1222.

Drug Interactions

Monitoring

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Baseline Monitoring

Signs and symptoms of ocular infection (e.g., redness, discharge, swelling, pain)

Rationale: To assess the severity and nature of the infection before treatment initiation.

Timing: Prior to first dose

Visual acuity (if relevant to condition)

Rationale: To establish baseline ocular function.

Timing: Prior to first dose

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Routine Monitoring

Resolution of infection symptoms

Frequency: Daily

Target: Improvement or complete resolution

Action Threshold: Lack of improvement or worsening symptoms after 3-4 days may indicate resistant organisms or non-bacterial cause; re-evaluate diagnosis and treatment.

Signs of local irritation or allergic reaction (e.g., itching, burning, swelling, rash)

Frequency: Daily

Target: Absence of new or worsening irritation

Action Threshold: Discontinue if severe irritation or allergic reaction occurs.

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Symptom Monitoring

  • Increased redness of the eye
  • Increased discharge from the eye
  • Increased pain or discomfort in the eye
  • Swelling around the eye
  • Itching or burning sensation in the eye
  • Blurred vision (if new or worsening)
  • Rash or hives (systemic allergic reaction)
  • Difficulty breathing or swallowing (severe allergic reaction)

Special Patient Groups

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Pregnancy

Generally considered safe for use during pregnancy due to minimal systemic absorption following topical ophthalmic administration. Classified as Pregnancy Category B.

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 safe for use during breastfeeding. Minimal systemic absorption means negligible amounts are expected to pass into breast milk, and adverse effects on the infant are unlikely.

Infant Risk: Low risk (L2)
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Pediatric Use

Widely used and considered safe and effective in pediatric patients, including neonates, for the treatment and prophylaxis of susceptible bacterial ocular infections.

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Geriatric Use

No specific dose 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

  • Erythromycin ophthalmic ointment is a common and effective first-line treatment for bacterial conjunctivitis, especially in children.
  • It is the preferred agent for prophylaxis of ophthalmia neonatorum due to its efficacy against Neisseria gonorrhoeae and Chlamydia trachomatis.
  • Patients should be advised that temporary blurred vision may occur immediately after application due to the ointment base.
  • Proper administration technique (pulling down the lower eyelid and applying a thin ribbon into the conjunctival sac) is crucial for efficacy and to prevent contamination.
  • The single-use 1gm tube helps maintain sterility and is convenient for prophylaxis or short-term treatment.
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Alternative Therapies

  • Tobramycin ophthalmic ointment/solution
  • Gentamicin ophthalmic ointment/solution
  • Ciprofloxacin ophthalmic solution
  • Ofloxacin ophthalmic solution
  • Moxifloxacin ophthalmic solution
  • Azithromycin ophthalmic solution
  • Polymyxin B/Trimethoprim ophthalmic solution
  • Bacitracin ophthalmic ointment
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Cost & Coverage

Average Cost: Generally inexpensive per 1gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.