Atropine Sulf 1% Oph Soln 2ml

Manufacturer AMNEAL PHARMACEUTICALS Active Ingredient Atropine Eye Drops(A troe peen) Pronunciation A-troe-peen Sul-fate
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).
đŸˇī¸
Drug Class
Mydriatic; Cycloplegic
đŸ§Ŧ
Pharmacologic Class
Anticholinergic; Muscarinic Antagonist
🤰
Pregnancy Category
Category C
✅
FDA Approved
Jan 1970
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Atropine eye drops are used to temporarily make your pupil larger (dilate) and to relax the focusing muscle inside your eye. This is often done for eye exams or to treat certain eye conditions like lazy eye (amblyopia) or 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 results, use this medication as directed.

Administration

This medication is for eye use only.
Before and after use, wash your hands thoroughly to prevent contamination.
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.
To administer the medication, tilt your head back and gently drop the medication into your eye.
After use, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes. This helps retain the medication in your eye.

Special Precautions

Remove contact lenses before using this medication. Consult your doctor to determine when it is safe to reinsert your lenses after using the medication. Do not reinsert your lenses if your eyes are irritated or infected.

Storage and Disposal

Store this medication at room temperature, protected from heat.
Keep the lid tightly closed to maintain the medication's potency.

Missed Dose

If you miss a dose, use it as soon as you remember.
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 once or take extra doses to make up for a missed dose.
💡

Lifestyle & Tips

  • Wear sunglasses outdoors, as your eyes will be very sensitive to light (photophobia) due to pupil dilation.
  • Avoid driving or operating machinery until your vision returns to normal, as your vision will be blurred and focusing will be difficult.
  • Wash hands thoroughly after administering the drops to prevent accidental systemic absorption, especially in children.
  • Apply pressure to the tear duct (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: For cycloplegic refraction: 1 drop of 1% solution 1 hour before refraction. For uveitis/inflammation: 1 drop of 1% solution 1-2 times daily.

Condition-Specific Dosing:

cycloplegic_refraction: 1 drop of 1% solution 1 hour before refraction
uveitis_inflammation: 1 drop of 1% solution 1-2 times daily
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established (use with extreme caution due to systemic toxicity risk)
Infant: For cycloplegic refraction: 1 drop of 0.5% solution twice daily for 1-3 days prior to refraction. For amblyopia (penalization): 1 drop of 1% solution daily in the sound eye (or 0.5% for younger children).
Child: For cycloplegic refraction: 1 drop of 0.5% or 1% solution twice daily for 1-3 days prior to refraction. For amblyopia (penalization): 1 drop of 1% solution daily in the sound eye.
Adolescent: For cycloplegic refraction: 1 drop of 1% solution 1 hour before refraction. For uveitis/inflammation: 1 drop of 1% solution 1-2 times daily.
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: Not typically required for ophthalmic use due to minimal systemic absorption.
Moderate: Not typically required for ophthalmic use due to minimal systemic absorption.
Severe: Not typically required for ophthalmic use due to minimal systemic absorption.
Dialysis: Not typically required for ophthalmic use due to minimal systemic absorption.

Hepatic Impairment:

Mild: Not typically required for ophthalmic use due to minimal systemic absorption.
Moderate: Not typically required for ophthalmic use due to minimal systemic absorption.
Severe: Not typically required for ophthalmic use due to minimal systemic absorption.

Pharmacology

đŸ”Ŧ

Mechanism of Action

Atropine is a muscarinic acetylcholine receptor antagonist. In the eye, it blocks the action of acetylcholine on the muscarinic receptors of the ciliary body and the iris sphincter muscle. This leads to paralysis of accommodation (cycloplegia) and pupillary dilation (mydriasis).
📊

Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from ophthalmic administration, but can be significant in children or with excessive use.
Tmax: Ocular effects: Mydriasis onset 30-40 minutes, peak 1 hour. Cycloplegia onset 1 hour, peak 1-3 hours.
FoodEffect: Not applicable for ophthalmic administration.

Distribution:

Vd: Not available (primarily localized ocularly)
ProteinBinding: Not available (primarily localized ocularly)
CnssPenetration: Limited (can occur with systemic absorption, especially in children, leading to CNS effects)

Elimination:

HalfLife: Systemic: Approximately 2-4 hours (for systemically absorbed drug). Ocular effects: Mydriasis up to 7-10 days, cycloplegia up to 1-2 weeks.
Clearance: Not available (primarily localized ocularly)
ExcretionRoute: Renal (for systemically absorbed drug)
Unchanged: Not available
âąī¸

Pharmacodynamics

OnsetOfAction: Mydriasis: 30-40 minutes; Cycloplegia: 1 hour
PeakEffect: Mydriasis: 1 hour; Cycloplegia: 1-3 hours
DurationOfAction: Mydriasis: 7-10 days; Cycloplegia: 1-2 weeks
Confidence: Medium

Safety & Warnings

âš ī¸

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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Fast or abnormal heartbeat
Flushing
Restlessness
Irritability

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 symptoms that bother you or do not go away, 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, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice about side effects.
🚨

Seek Immediate Medical Attention If You Experience:

  • Severe eye pain or sudden vision changes (could indicate angle-closure glaucoma, though rare with proper screening).
  • Signs of systemic toxicity: unusual flushing or redness of the face, fever, rapid heartbeat, dry mouth, difficulty urinating, confusion, or unusual behavior (especially in children). Seek immediate medical attention if these occur.
📋

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 conditions and situations to ensure safe treatment:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction and its symptoms.
A diagnosis of glaucoma.
A history of severe reactions to this medication in the past.
Current or recent use of certain medications, including:
+ Antidepressants like isocarboxazid, phenelzine, or tranylcypromine.
+ Medications for Parkinson's disease, such as selegiline or rasagiline.
+ Specific drugs like linezolid or methylene blue.
* All your current medications, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is not an exhaustive list, and you should discuss all your medications and health conditions with your doctor.

To ensure your safety, it is crucial to verify that this medication can be taken with all your existing medications and health conditions. Never start, stop, or adjust the dose of any medication without consulting your doctor.
âš ī¸

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, avoid operating a vehicle or performing any activities that require clear vision until your pupils return to normal. You may experience sensitivity to bright lights for a period after administration, so wear sunglasses as directed by your doctor to minimize discomfort.

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 for 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 to both you and your baby.

This medication is not recommended for children under 3 months of age. Do not administer it to infants in this age group.
🆘

Overdose Information

Overdose Symptoms:

  • Severe dry mouth and throat
  • Flushing and dry skin
  • Fever
  • Rapid and weak pulse
  • Dilated pupils (already expected, but extreme)
  • Blurred vision
  • Difficulty urinating
  • Abdominal distension
  • Restlessness, confusion, hallucinations, delirium
  • Ataxia (loss of coordination)
  • Convulsions
  • Coma

What to Do:

If systemic overdose is suspected, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and may include physostigmine for severe anticholinergic toxicity.

Drug Interactions

🟡

Moderate Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide): May lead to additive systemic anticholinergic effects if significant systemic absorption occurs.

Monitoring

đŸ”Ŧ

Baseline Monitoring

Ocular examination (including slit lamp and fundoscopy)

Rationale: To assess baseline ocular health and identify any contraindications (e.g., narrow angles).

Timing: Prior to initiation of therapy.

Intraocular Pressure (IOP)

Rationale: To establish baseline and monitor for potential increase, especially in patients predisposed to angle-closure glaucoma.

Timing: Prior to initiation of therapy.

📊

Routine Monitoring

Visual acuity and refractive error

Frequency: As clinically indicated, especially after cycloplegic refraction.

Target: Not applicable (monitoring for effect)

Action Threshold: Significant changes or lack of desired effect.

Intraocular Pressure (IOP)

Frequency: Periodically, especially in patients at risk for glaucoma.

Target: Typically <21 mmHg, but depends on individual baseline and glaucoma status.

Action Threshold: Sustained elevation above baseline or target range.

Signs of systemic anticholinergic toxicity

Frequency: Daily, especially in children or with prolonged use.

Target: Absence of symptoms

Action Threshold: Presence of fever, flushing, tachycardia, dry mouth, urinary retention, CNS effects (e.g., ataxia, hallucinations).

đŸ‘ī¸

Symptom Monitoring

  • Blurred vision (expected effect)
  • Photophobia (expected effect)
  • Dry mouth
  • Flushing of skin
  • Fever (especially in children)
  • Tachycardia
  • Urinary retention
  • Constipation
  • Confusion, disorientation, hallucinations (rare, especially in children with systemic toxicity)

Special Patient Groups

🤰

Pregnancy

Atropine is Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with ophthalmic use, but caution is advised.

Trimester-Specific Risks:

First Trimester: Risk not well-established, but generally considered low due to minimal systemic absorption.
Second Trimester: Risk not well-established, but generally considered low due to minimal systemic absorption.
Third Trimester: Risk not well-established, but generally considered low due to minimal systemic absorption.
🤱

Lactation

Atropine is rated L3 (Moderately Safe) for lactation. While systemic absorption from ophthalmic use is minimal, there is a theoretical risk of anticholinergic effects in the infant or reduction in milk supply. Monitor the infant for signs of anticholinergic effects (e.g., dry mouth, constipation, drowsiness).

Infant Risk: Low to moderate risk of anticholinergic effects in the infant; potential for decreased milk supply.
đŸ‘ļ

Pediatric Use

Children, especially infants and young children, are more susceptible to the systemic toxic effects of atropine due to higher systemic absorption and lower body weight. Use the lowest effective concentration (e.g., 0.5% or 0.01%) and dose. Monitor closely for signs of systemic toxicity (fever, flushing, tachycardia, CNS effects).

👴

Geriatric Use

Caution should be exercised in elderly patients, particularly those with narrow anterior chamber angles, as atropine can precipitate acute angle-closure glaucoma. May also exacerbate existing urinary retention or constipation.

Clinical Information

💎

Clinical Pearls

  • Atropine ophthalmic has a very long duration of action; inform patients that blurred vision and light sensitivity can last for up to 1-2 weeks.
  • Always check for narrow angles before administering atropine to prevent acute angle-closure glaucoma.
  • For amblyopia penalization, ensure parents understand the importance of consistent daily dosing and monitoring for systemic side effects.
  • Advise patients to apply nasolacrimal occlusion (pressing on the inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption, especially in children.
  • Lower concentrations (e.g., 0.01%) are increasingly used for myopia control, which is a different indication than cycloplegia/mydriasis or amblyopia penalization.
🔄

Alternative Therapies

  • Cyclopentolate (shorter duration, faster onset for cycloplegia/mydriasis)
  • Tropicamide (shortest duration, primarily for mydriasis)
  • Homatropine (intermediate duration for cycloplegia/mydriasis)
  • Phenylephrine (mydriatic only, no cycloplegic effect)
💰

Cost & Coverage

Average Cost: Varies widely per 2ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with additional patient information leaflets, so it is a good idea to consult with your pharmacist for more details. 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 information about the medication taken, the amount, and the time it was taken, as this will aid in your treatment.