Atropine Sulf 1% Ophth Ointment
It is used to widen the pupil before an eye exam or eye surgery.It is used to treat eye swelling.It is used to treat lazy eye (amblyopia).
Drug Class
Mydriatic, Cycloplegic
Pharmacologic Class
Anticholinergic, Muscarinic Antagonist
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Atropine ophthalmic ointment is an eye medication that works by widening your pupil (the black center of your eye) and relaxing the focusing muscle inside your eye. This is often used during eye exams to get a better view inside your eye or to treat certain eye conditions like inflammation.
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. For optimal use:
Apply the medication only to the eye.
Wash your hands thoroughly before and after use to maintain cleanliness.
Avoid touching the container tip to the eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication, potentially leading to severe eye problems or vision loss.
To administer the medication:
1. Gently pull down the lower eyelid.
2. Squeeze in the prescribed amount of medication, as directed by your doctor.
3. Release the lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store the medication at room temperature.
Protect it from heat sources.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, follow these guidelines:
Use the missed dose as soon as you remember.
If the missed dose 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 the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal use:
Apply the medication only to the eye.
Wash your hands thoroughly before and after use to maintain cleanliness.
Avoid touching the container tip to the eye, eyelid, or surrounding skin, as this can introduce bacteria into the medication, potentially leading to severe eye problems or vision loss.
To administer the medication:
1. Gently pull down the lower eyelid.
2. Squeeze in the prescribed amount of medication, as directed by your doctor.
3. Release the lower eyelid and keep your eyes closed for 1 to 2 minutes.
Storage and Disposal
To maintain the medication's effectiveness and safety:
Store the medication at room temperature.
Protect it from heat sources.
Keep the lid tightly closed when not in use.
Missed Dose Instructions
If you miss a dose, follow these guidelines:
Use the missed dose as soon as you remember.
If the missed dose 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 the missed one.
Lifestyle & Tips
- Your vision will be blurred and you will be very sensitive to light (photophobia) for several days to up to two weeks after using this medication. Do not drive or operate heavy machinery until your vision returns to normal.
- Wear sunglasses when outdoors to protect your eyes from light sensitivity.
- Avoid rubbing your eyes after application to prevent spreading the ointment.
Available Forms & Alternatives
Available Strengths:
- Atropine Sulf 1% Ophth Ointment
- Atropine Sul 0.4mg/ml Inj, 1ml
- Atropine Sulfate 1mg/ml Inj, 1ml
- Atropine Sulfate 0.1mg/ml Inj, 10ml
- Atropine Sulf 1% Oph Soln 2ml
- Atropine Sulf 1% Oph Soln 5ml
- Atropine Sulf 1% Oph Soln 15ml
- Atropine Sul 0.1mg/ml Inj, 5ml
- Atropine Sulf 1% Oph Soln 5ml
- Atropine Sulf 1% Oph Soln 2ml
- Atropine Sulf 1% Oph Soln 15ml
- Atropine Sulfate 0.1mg/ml Inj, 10ml
- Atropine Sul 0.4mg/ml Inj, 20ml
- Atropine Sulfate 0.4mg/ml Inj 1ml
- Atropine Sul 0.4mg/ml Inj, 20ml
- Atropine Sulf 1% Oph Soln 10ml
- Atropine Sul 0.05mg/1ml Inj, 5ml
Dosing & Administration
Adult Dosing
Standard Dose:
For cycloplegia/mydriasis or uveitis: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 3 times daily.
Condition-Specific Dosing:
cycloplegia_mydriasis:
Apply a 1/2 inch ribbon into the conjunctival sac 1 to 3 times daily.
uveitis_iritis:
Apply a 1/2 inch ribbon into the conjunctival sac 1 to 3 times daily.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased risk of systemic toxicity).
Infant:
Not established (use with extreme caution due to increased risk of systemic toxicity).
Child:
For cycloplegia/mydriasis or uveitis: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 3 times daily. Use lowest effective concentration and dose due to increased risk of systemic toxicity.
Adolescent:
For cycloplegia/mydriasis or uveitis: Apply a 1/2 inch ribbon into the conjunctival sac 1 to 3 times daily.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed due to minimal systemic absorption from ophthalmic use.
Moderate:
No adjustment typically needed due to minimal systemic absorption from ophthalmic use.
Severe:
No adjustment typically needed due to minimal systemic absorption from ophthalmic use.
Dialysis:
No specific considerations for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically needed due to minimal systemic absorption from ophthalmic use.
Moderate:
No adjustment typically needed due to minimal systemic absorption from ophthalmic use.
Severe:
No adjustment typically needed due to minimal systemic absorption from ophthalmic use.
Pharmacology
Mechanism of Action
Atropine is an anticholinergic agent that blocks the muscarinic actions of acetylcholine on structures in the eye. It competitively blocks muscarinic receptors (M1, M2, M3, M4, M5) in the iris sphincter muscle and ciliary body. This blockade leads to paralysis of the iris sphincter muscle (mydriasis, pupillary dilation) and paralysis of the ciliary muscle (cycloplegia, loss of accommodation).
Pharmacokinetics
Absorption:
Bioavailability:
Not available (minimal systemic absorption from ophthalmic application, but can occur).
Tmax:
Not available (for ophthalmic use, local effects are primary).
FoodEffect:
Not applicable for ophthalmic use.
Distribution:
Vd:
Not available (primarily localized to ocular tissues).
ProteinBinding:
Not available (for ophthalmic use).
CnssPenetration:
Limited (systemic absorption can lead to CNS effects, especially in children).
Elimination:
HalfLife:
Approximately 2-4 hours (for systemically absorbed atropine).
Clearance:
Not available (for ophthalmic use).
ExcretionRoute:
Renal (for systemically absorbed atropine, largely unchanged).
Unchanged:
Approximately 50% (for systemically absorbed atropine).
Pharmacodynamics
OnsetOfAction:
Mydriasis: 30-40 minutes; Cycloplegia: 1-3 hours.
PeakEffect:
Mydriasis: 30-40 minutes; Cycloplegia: 1-3 hours.
DurationOfAction:
Mydriasis: 7-14 days; Cycloplegia: 7-12 days (can be prolonged in some individuals).
Confidence:
Medium
Safety & Warnings
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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Fast or abnormal heartbeat
Flushing
Restlessness
Irritability
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 symptoms that bother you or persist, contact your doctor:
Blurred vision
Eye pain
Stinging
Eye irritation
Dry mouth, skin, or eyes
Drowsiness
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Fainting
+ Changes in eyesight
Fast or abnormal heartbeat
Flushing
Restlessness
Irritability
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 symptoms that bother you or persist, contact your doctor:
Blurred vision
Eye pain
Stinging
Eye irritation
Dry mouth, skin, or eyes
Drowsiness
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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:
- Severe eye pain or sudden vision changes (could indicate increased eye pressure)
- Rash or severe allergic reaction (swelling of face, lips, tongue, throat, difficulty breathing)
- Signs of systemic anticholinergic toxicity: severe dry mouth, flushing, fever, rapid heart rate, difficulty urinating, constipation, confusion, disorientation, hallucinations, or unusual behavior.
- If you experience any of these symptoms, seek immediate medical attention.
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 and its symptoms.
If you have been diagnosed with glaucoma.
If you have experienced a severe reaction to this medication in the past.
If you are currently taking certain medications for depression, including isocarboxazid, phenelzine, or tranylcypromine, or medications for Parkinson's disease, such as selegiline or rasagiline.
* If you are taking linezolid or methylene blue, as these medications may interact with this drug.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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 and its symptoms.
If you have been diagnosed with glaucoma.
If you have experienced a severe reaction to this medication in the past.
If you are currently taking certain medications for depression, including isocarboxazid, phenelzine, or tranylcypromine, or medications for Parkinson's disease, such as selegiline or rasagiline.
* If you are taking linezolid or methylene blue, as these medications may interact with this drug.
This list is not exhaustive, and it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to ensure it is safe for you to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
While using this drug, be cautious when performing tasks that require clear vision, such as driving, as your pupils may be dilated. Additionally, you may experience sensitivity to bright lights for a period after administration; to minimize discomfort, wear sunglasses as directed by your doctor.
In the event that this medication is ingested, it can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
While using this drug, be cautious when performing tasks that require clear vision, such as driving, as your pupils may be dilated. Additionally, you may experience sensitivity to bright lights for a period after administration; to minimize discomfort, wear sunglasses as directed by your doctor.
In the event that this medication is ingested, it can be harmful. If swallowed, immediately contact a doctor or a poison control center for assistance.
When administering this drug to children, exercise caution, as they may be at a higher risk of experiencing certain side effects.
If you are pregnant, planning to become pregnant, or are breast-feeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe dry mouth
- Flushing of the skin
- Fever
- Rapid and irregular heartbeat (tachycardia)
- Urinary retention
- Constipation
- Central nervous system effects: confusion, disorientation, hallucinations, delirium, agitation, seizures, coma.
What to Do:
If you suspect an overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is supportive and may include physostigmine as an antidote.
Drug Interactions
Monitoring
Baseline Monitoring
Ocular examination (visual acuity, pupillary response)
Rationale: To establish baseline ocular function and assess the need for treatment.
Timing: Prior to initiation of therapy.
Intraocular pressure (IOP)
Rationale: To identify patients at risk for angle-closure glaucoma.
Timing: Prior to initiation of therapy, especially in patients with narrow angles.
Routine Monitoring
Visual acuity and pupillary response
Frequency: As clinically indicated, especially during follow-up visits.
Target: Not applicable (monitoring for therapeutic effect).
Action Threshold: Lack of desired effect or excessive effect.
Intraocular pressure (IOP)
Frequency: Periodically, especially in patients predisposed to glaucoma.
Target: Individualized.
Action Threshold: Significant increase in IOP.
Signs of systemic anticholinergic toxicity
Frequency: Daily, especially in pediatric patients.
Target: Absence of symptoms.
Action Threshold: Presence of symptoms such as flushing, fever, dry mouth, tachycardia, urinary retention, CNS effects (confusion, hallucinations).
Symptom Monitoring
- Blurred vision
- Photophobia (light sensitivity)
- Dry mouth
- Difficulty urinating
- Constipation
- Rapid heartbeat (tachycardia)
- Flushing of the skin
- Fever
- Confusion
- Disorientation
- Hallucinations
- Speech disturbances
Special Patient Groups
Pregnancy
Atropine is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption from ophthalmic use is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Potential for fetal exposure, but systemic absorption from ophthalmic use is low.
Second Trimester:
Potential for fetal exposure, but systemic absorption from ophthalmic use is low.
Third Trimester:
Potential for fetal exposure, but systemic absorption from ophthalmic use is low.
Lactation
Atropine is Lactation Risk L3 (Moderately safe). Small amounts may be excreted in breast milk. Monitor the infant for signs of anticholinergic effects (e.g., dry mouth, constipation, urinary retention, drowsiness). Use with caution.
Infant Risk:
Low to moderate risk of anticholinergic effects in the infant.
Pediatric Use
Pediatric patients, especially infants and young children, are at increased risk of systemic anticholinergic toxicity (e.g., fever, flushing, tachycardia, CNS effects) due to greater systemic absorption and increased sensitivity. Use the lowest effective concentration and dose. Children with Down syndrome, spastic paralysis, or brain damage may be particularly susceptible.
Geriatric Use
Geriatric patients may be more sensitive to the systemic anticholinergic effects of atropine, including increased intraocular pressure, central nervous system effects (e.g., confusion, hallucinations), and urinary retention. Use with caution and monitor closely.
Clinical Information
Clinical Pearls
- Atropine ophthalmic ointment has a very long duration of action (up to 2 weeks for cycloplegia and mydriasis); ensure patients are fully aware of this prolonged effect on vision and light sensitivity.
- Advise patients to apply pressure to the lacrimal sac (inner corner of the eye) for 1-2 minutes after administration to minimize systemic absorption, especially in children.
- Can precipitate acute angle-closure glaucoma in patients with anatomically narrow angles; always assess angle status before use if possible.
- Systemic toxicity, though rare with ophthalmic use, is a significant concern, particularly in infants and young children. Monitor for signs like fever, flushing, dry mouth, tachycardia, and CNS changes.
- Patients should be instructed to remove contact lenses before application and wait at least 15 minutes before reinserting them.
Alternative Therapies
- For Mydriasis (pupil dilation): Phenylephrine (alpha-agonist, no cycloplegia)
- For Cycloplegia (paralysis of accommodation) and Mydriasis (shorter duration): Cyclopentolate, Tropicamide
- For Uveitis/Iritis (other anti-inflammatory agents): Topical corticosteroids, NSAIDs (depending on severity and etiology)
Cost & Coverage
Average Cost:
$20 - $50 per 3.5g tube
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.