Erythromycin Ophth Oint 3.5gm

Manufacturer BAUSCH HEALTH 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
Jun 1953
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Erythromycin ophthalmic ointment is an antibiotic medicine used to treat bacterial eye infections, such as pink eye (conjunctivitis), or to prevent eye infections in newborns.
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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. Continue using the medication as directed, even if your symptoms improve. This medication is for eye use only.

Administration Instructions

1. Wash your hands before and after using the medication to maintain cleanliness.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
3. To administer the medication, place it inside your lower eyelid.
4. Close your eye for 1 to 2 minutes and gently roll your eyeball around to help distribute the medication.

Storage and Disposal

Store the medication at room temperature, keeping it in a safe location that is out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the proper disposal method, which may include participating in a local drug take-back program.

Missed Dose Instructions

If you miss a dose, use 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 use two doses at the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash hands thoroughly before and after applying the ointment.
  • Do not touch the tip of the ointment tube to the eye or any other surface to avoid contamination.
  • Remove contact lenses before applying the ointment and wait at least 15 minutes after application before reinserting them, or as advised by your doctor.
  • Do not share eye medications with others.
  • Complete the full course of treatment, even if symptoms improve, to prevent recurrence and antibiotic resistance.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a 1 cm 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:

bacterial_conjunctivitis: Apply 1 cm ribbon 2-6 times daily.
neonatal_ophthalmia_prophylaxis: Apply a 1 cm ribbon into each conjunctival sac once, immediately after birth.
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Pediatric Dosing

Neonatal: Apply a 1 cm ribbon into each conjunctival sac once, immediately after birth, for prophylaxis of ophthalmia neonatorum (e.g., due to N. gonorrhoeae or C. trachomatis). For active infection, 1 cm ribbon 2-6 times daily.
Infant: Apply a 1 cm ribbon into the conjunctival sac 2-6 times daily.
Child: Apply a 1 cm ribbon into the conjunctival sac 2-6 times daily.
Adolescent: Apply a 1 cm ribbon into the conjunctival sac 2-6 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 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).
Confidence: High

Pharmacology

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Mechanism of Action

Erythromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding reversibly to the 50S ribosomal subunit of susceptible microorganisms. This binding inhibits the translocation of peptidyl tRNA, thereby preventing the elongation of the polypeptide chain.
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Pharmacokinetics

Absorption:

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

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: Rapid local antibacterial effect
PeakEffect: Not precisely quantified for ophthalmic use, local concentration achieved quickly.
DurationOfAction: Several hours, requiring multiple daily applications.
Confidence: High

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
Changes in eyesight, eye pain, or severe eye irritation

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although 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 persist, contact your doctor for guidance:

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:

  • Worsening eye redness, pain, or discharge
  • Severe burning, stinging, or itching after application
  • Swelling of the eyelids or around the eye
  • Vision changes
  • Signs of an allergic reaction (e.g., rash, hives, difficulty breathing - seek immediate medical attention)
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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 identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken 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. 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 with ophthalmic use due to minimal systemic absorption. Local irritation may occur with excessive application.

What to Do:

If excessive local irritation occurs, discontinue use and rinse eye with lukewarm water. If ingested, call a poison control center (1-800-222-1222) or seek medical attention, though systemic toxicity from ophthalmic ingestion is unlikely.

Drug Interactions

Monitoring

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Baseline Monitoring

Visual acuity

Rationale: To establish baseline and monitor for changes due to infection or treatment.

Timing: Prior to initiation of therapy.

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

Rationale: To confirm diagnosis and assess severity.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Resolution of ocular signs and symptoms

Frequency: Daily

Target: Improvement or complete resolution

Action Threshold: Lack of improvement or worsening symptoms after 3-5 days; consider re-evaluation and alternative therapy.

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

Frequency: Daily

Target: Absence of irritation

Action Threshold: Presence of significant irritation; discontinue use and consult physician.

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Symptom Monitoring

  • Ocular redness
  • Ocular discharge (purulent, watery)
  • Eye pain or discomfort
  • Swelling of eyelids or conjunctiva
  • Itching or burning sensation in the eye
  • Blurred vision (if related to infection)

Special Patient Groups

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Pregnancy

Erythromycin ophthalmic ointment 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, minimal systemic absorption.
Second Trimester: Low risk, minimal systemic absorption.
Third Trimester: Low risk, minimal systemic absorption.
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Lactation

Erythromycin ophthalmic ointment is considered compatible with breastfeeding (Lactation Risk L1). Minimal systemic absorption means negligible amounts are transferred into breast milk.

Infant Risk: Low risk to breastfed infant.
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Pediatric Use

Commonly used and well-tolerated in pediatric patients, including neonates for prophylaxis of ophthalmia neonatorum. Dosing is similar to adults.

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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

  • Erythromycin ophthalmic ointment is a common first-line treatment for bacterial conjunctivitis, especially in children, due to its broad spectrum of activity against common ocular pathogens and good safety profile.
  • It is the preferred agent for prophylaxis of ophthalmia neonatorum in newborns, particularly against Neisseria gonorrhoeae and Chlamydia trachomatis.
  • Advise patients that vision may be temporarily blurred after application due to the ointment base.
  • Instruct patients on proper administration technique to ensure efficacy and prevent contamination.
  • If symptoms do not improve within 3-5 days, or worsen, re-evaluate the diagnosis and consider bacterial culture and sensitivity testing.
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Alternative Therapies

  • Tobramycin ophthalmic ointment/solution
  • Gentamicin ophthalmic ointment/solution
  • Polymyxin B/Trimethoprim ophthalmic solution
  • Azithromycin ophthalmic solution
  • Fluoroquinolone ophthalmic solutions (e.g., Moxifloxacin, Gatifloxacin)
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Cost & Coverage

Average Cost: $10 - $30 per 3.5gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 (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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.