Natacyn 5% Ophth Susp 15ml
It is used to treat eye infections.
Drug Class
Antifungal
Pharmacologic Class
Polyene Antifungal
Pregnancy Category
Category C
FDA Approved
Aug 1974
DEA Schedule
Not Controlled
Overview
What is this medicine?
Natacyn is an eye drop used to treat serious eye infections caused by fungi. It works by stopping the growth of the fungus that is causing the infection.
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. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Check the solution for any signs of leakage or particles before use. If you notice any issues, do not use the medication.
4. Shake the container well before each use.
5. To avoid contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
6. Tilt your head back, and gently drop the medication into your eye.
7. After administering the medication, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Additional Precautions
- Avoid wearing contact lenses unless your doctor advises you to do so.
Storage and Disposal
- Store the medication at room temperature or in the refrigerator. Do not freeze it.
- Protect the medication from heat and light sources.
- Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use the medication as directed, even if your symptoms improve.
Administration Instructions
1. Use this medication for the eye only.
2. Wash your hands before and after use to maintain cleanliness.
3. Check the solution for any signs of leakage or particles before use. If you notice any issues, do not use the medication.
4. Shake the container well before each use.
5. To avoid contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
6. Tilt your head back, and gently drop the medication into your eye.
7. After administering the medication, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.
Additional Precautions
- Avoid wearing contact lenses unless your doctor advises you to do so.
Storage and Disposal
- Store the medication at room temperature or in the refrigerator. Do not freeze it.
- Protect the medication from heat and light sources.
- Keep all medications in a secure location, out of the reach of children and pets.
Missed Dose Instructions
If you miss a dose, use it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Do not wear contact lenses during treatment for fungal keratitis.
- Wash hands thoroughly before and after applying eye drops.
- Avoid touching the dropper tip to the eye or any other surface to prevent contamination.
- Shake the bottle well before each use.
- If using other eye drops, wait at least 5 minutes between applications.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop into the conjunctival sac every 1 to 2 hours for the first 3-4 days, then 1 drop 6 to 8 times daily for 2-3 weeks.
Condition-Specific Dosing:
fungalKeratitis:
Initially, 1 drop into the conjunctival sac every 1 to 2 hours for the first 3-4 days. After 3-4 days, the dosage can usually be reduced to 1 drop 6 to 8 times daily. Therapy should generally be continued for 2-3 weeks or until resolution of the active fungal keratitis. In many cases, treatment may be required for 4-6 weeks.
Pediatric Dosing
Neonatal:
Not established, use with caution and clinical judgment.
Infant:
Not established, use with caution and clinical judgment.
Child:
Dosing similar to adults, based on clinical judgment and severity of infection. Safety and efficacy not fully established in pediatric patients.
Adolescent:
Dosing similar to adults.
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 for ophthalmic use due to negligible 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
Mechanism of Action
Natamycin is a polyene antifungal antibiotic. It acts by binding to ergosterol, a sterol component of the fungal cell membrane, leading to increased permeability of the cell membrane. This disruption of the membrane integrity results in the leakage of intracellular components, ultimately causing fungal cell death.
Pharmacokinetics
Absorption:
Bioavailability:
Negligible systemic absorption from ophthalmic administration.
Tmax:
Not applicable for systemic effects; local concentration achieved rapidly.
FoodEffect:
Not applicable (ophthalmic).
Distribution:
Vd:
Not quantifiable systemically; primarily localized to ocular tissues.
ProteinBinding:
Not applicable systemically.
CnssPenetration:
No (minimal systemic absorption).
Elimination:
HalfLife:
Not applicable systemically.
Clearance:
Not applicable systemically.
ExcretionRoute:
Not applicable systemically.
Unchanged:
Not applicable systemically.
Pharmacodynamics
OnsetOfAction:
Clinical improvement typically seen within days, but full therapeutic effect may take weeks.
PeakEffect:
Not precisely defined; depends on fungal load and duration of therapy.
DurationOfAction:
Dependent on dosing frequency and continued therapy.
Safety & Warnings
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, or 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 have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all 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.
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, or 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 have side effects that bother you or do not go away, contact your doctor for advice.
Reporting Side Effects
This list does not include all 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.
Seek Immediate Medical Attention If You Experience:
- Increased eye pain or discomfort
- Worsening redness or swelling of the eye
- Increased blurred vision
- Pus or discharge from the eye
- Any new or worsening symptoms
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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.
Potential interactions with other medications or health conditions. This medication may interact with other prescription or over-the-counter (OTC) drugs, natural products, or vitamins, which could affect its safety and efficacy.
All medications you are currently taking, including prescription and OTC drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions and ensure safe use.
Any existing health problems, as they may impact the safety and effectiveness of this medication.
To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions.
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 while 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.
Overdose Information
Overdose Symptoms:
- Excessive ocular irritation
- Redness
- Swelling
What to Do:
Due to minimal systemic absorption, overdose is unlikely to cause systemic toxicity. In case of accidental ingestion, no specific antidote is known; supportive care is recommended. For ocular overdose, flush the eye with copious amounts of water. Call 1-800-222-1222 (Poison Control Center) for advice if needed.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination (slit lamp, visual acuity)
Rationale: To assess the extent of fungal infection and establish baseline for monitoring treatment response.
Timing: Prior to initiation of therapy.
Corneal scrapings/culture
Rationale: To confirm fungal etiology and identify specific pathogen for targeted therapy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Clinical response (reduction in inflammation, lesion size, pain)
Frequency: Daily initially, then as clinically indicated (e.g., every 2-3 days).
Target: Improvement in signs and symptoms of fungal keratitis.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for re-evaluation, culture, or alternative therapy.
Ocular irritation/adverse effects (redness, discomfort, blurred vision)
Frequency: Daily.
Target: Minimal to no irritation.
Action Threshold: Significant or persistent irritation may require dosage adjustment or discontinuation.
Symptom Monitoring
- Ocular pain
- Redness
- Blurred vision
- Discharge
- Photophobia
- Foreign body sensation
Special Patient Groups
Pregnancy
Natamycin is Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks. Systemic absorption following ophthalmic administration is negligible, minimizing fetal exposure.
Trimester-Specific Risks:
First Trimester:
Low risk due to minimal systemic absorption, but use only if clearly needed.
Second Trimester:
Low risk due to minimal systemic absorption, but use only if clearly needed.
Third Trimester:
Low risk due to minimal systemic absorption, but use only if clearly needed.
Lactation
It is not known whether natamycin is excreted in human milk. However, systemic absorption from ophthalmic administration is negligible, making infant exposure unlikely. Use with caution.
Infant Risk:
Low risk due to negligible maternal systemic absorption and thus minimal to no exposure to the infant via breast milk.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use in pediatric patients should be based on clinical judgment and the severity of the fungal infection, considering the potential benefits outweigh the risks.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. Dosage adjustments are generally not necessary.
Clinical Information
Clinical Pearls
- Natacyn is the only commercially available ophthalmic polyene antifungal in the US, making it a critical agent for fungal keratitis.
- Treatment for fungal keratitis is often prolonged (weeks to months) and requires strict adherence to the dosing regimen.
- Early diagnosis and initiation of appropriate antifungal therapy are crucial for successful outcomes in fungal keratitis.
- Patients should be advised to shake the bottle well before each use as it is a suspension.
- Regular follow-up with an ophthalmologist is essential to monitor treatment response and adjust therapy as needed.
Alternative Therapies
- Voriconazole (topical or systemic, off-label for ophthalmic use)
- Amphotericin B (topical, compounded)
- Fluconazole (topical or systemic, less effective against filamentous fungi)
- Ketoconazole (topical, compounded)
- Itraconazole (topical, compounded)
Cost & Coverage
Average Cost:
$150 - $300 per 15ml bottle
Insurance Coverage:
Tier 3 or Non-preferred Brand
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not 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.