Atropine Sulf 1% Oph Soln 5ml

Manufacturer AMNEAL PHARMACEUTICALS Active Ingredient Atropine Eye Drops(A troe peen) Pronunciation AT-roe-peen
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).
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Drug Class
Mydriatic; Cycloplegic
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Pharmacologic Class
Anticholinergic; Muscarinic Antagonist
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Pregnancy Category
Category C
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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?

Atropine eye drops are used to temporarily widen your pupil (the black center of your eye) and relax the focusing muscle inside your eye. This is helpful for eye exams, to treat certain eye conditions like inflammation, or to help improve vision in children with a 'lazy eye' (amblyopia).
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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.

Administration Instructions

Use this medication only in the eye.
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.
Tilt your head back, and gently drop the medication into your eye.
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.

Special Precautions

Remove contact lenses before using this medication. Consult your doctor to determine when it is safe to replace your lenses after using the medication. Avoid putting your lenses back in if your eyes are irritated or infected.

Storage and Disposal

Store the medication at room temperature, away from heat sources.
Keep the container lid tightly closed when not in use.

Missed Dose Instructions

If you miss a dose, use it 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 extra doses or take two doses at the same time.
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Lifestyle & Tips

  • Do not drive or operate machinery while your pupils are dilated and vision is blurred.
  • Wear sunglasses outdoors to protect your eyes from light sensitivity (photophobia).
  • Wash hands thoroughly before and after use.
  • Do not touch the dropper tip to any surface to prevent contamination.
  • Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
  • Apply pressure to the tear duct (inner corner of the eye) for 1-2 minutes after instilling drops to minimize systemic absorption, especially in children.

Dosing & Administration

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Adult Dosing

Standard Dose: For cycloplegia/mydriasis: Instill 1 drop of 1% solution 1 hour before refraction. For uveitis: Instill 1 drop of 1% solution up to 4 times daily.

Condition-Specific Dosing:

cycloplegia_mydriasis: 1 drop of 1% solution 1 hour before refraction
uveitis: 1 drop of 1% solution up to 4 times daily
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to risk of systemic toxicity)
Infant: For cycloplegia/mydriasis: Instill 1 drop of 0.5% solution (or 1% diluted) 1 hour before refraction. For amblyopia (penalization): 1 drop of 1% solution once daily or 2-3 times per week in the sound eye.
Child: For cycloplegia/mydriasis: Instill 1 drop of 0.5% or 1% solution 1 hour before refraction. For amblyopia (penalization): 1 drop of 1% solution once daily or 2-3 times per week in the sound eye.
Adolescent: For cycloplegia/mydriasis: Instill 1 drop of 1% solution 1 hour before refraction. For uveitis: Instill 1 drop of 1% solution up to 4 times daily.
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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

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Mechanism of Action

Atropine is a muscarinic acetylcholine receptor antagonist. In the eye, it blocks the action of acetylcholine at the muscarinic receptors of the ciliary body and iris sphincter muscle. This blockade leads to paralysis of accommodation (cycloplegia) and dilation of the pupil (mydriasis). It also reduces ocular pain and prevents synechia formation in inflammatory conditions.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from ophthalmic administration, but can be significant in infants and young children.
Tmax: Not precisely quantified for ophthalmic systemic absorption; ocular effects peak within 30-40 minutes for mydriasis and 1-3 hours for cycloplegia.
FoodEffect: Not applicable for ophthalmic administration.

Distribution:

Vd: Not precisely quantified for ophthalmic systemic absorption.
ProteinBinding: Not precisely quantified for ophthalmic systemic absorption.
CnssPenetration: Limited from ophthalmic administration, but systemic absorption can lead to CNS effects, especially in children.

Elimination:

HalfLife: Systemic half-life is approximately 2-4 hours, but ocular effects can last much longer.
Clearance: Renal excretion of unchanged drug and metabolites.
ExcretionRoute: Renal
Unchanged: Approximately 50% of systemically absorbed atropine is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Mydriasis: 15-30 minutes; Cycloplegia: 30-60 minutes.
PeakEffect: Mydriasis: 30-40 minutes; Cycloplegia: 1-3 hours.
DurationOfAction: Mydriasis: 7-14 days; Cycloplegia: 7-14 days (can be longer in some individuals).
Confidence: High

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
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. 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:

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 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:

  • Severe eye pain or worsening redness
  • Vision changes not related to expected blurring/dilation
  • Signs of systemic toxicity: fever, flushing, dry mouth, rapid heartbeat, difficulty urinating, constipation, confusion, unusual excitement or drowsiness, rash.
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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 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 dosage 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.

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 cause harm. 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.
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Overdose Information

Overdose Symptoms:

  • Severe dry mouth and throat
  • Flushing and dry skin
  • Fever
  • Rapid and irregular heartbeat (tachycardia)
  • Dilated pupils (already expected, but extreme)
  • Blurred vision (already expected, but extreme)
  • Urinary retention
  • Constipation
  • Confusion, disorientation, hallucinations
  • Ataxia (loss of coordination)
  • Seizures
  • Coma

What to Do:

Immediately seek emergency medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and may include physostigmine for severe anticholinergic toxicity.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, phenothiazines, antihistamines, quinidine, disopyramide): May potentiate systemic anticholinergic effects if significant systemic absorption occurs.
  • Monoamine Oxidase Inhibitors (MAOIs): Theoretical potentiation of anticholinergic effects.

Monitoring

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Baseline Monitoring

Ocular examination (visual acuity, pupillary response, intraocular pressure)

Rationale: To establish baseline ocular status and assess suitability for treatment.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Visual acuity

Frequency: As clinically indicated, especially during amblyopia treatment.

Target: Improvement or maintenance of vision in the treated eye.

Action Threshold: Significant decrease in vision or lack of expected improvement.

Intraocular pressure (IOP)

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

Target: Normal range (e.g., 10-21 mmHg).

Action Threshold: Significant increase in IOP.

Signs of systemic anticholinergic toxicity

Frequency: During initial treatment, especially in pediatric patients.

Target: Absence of symptoms.

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

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Symptom Monitoring

  • Blurred vision (expected effect)
  • Photophobia (expected effect)
  • Ocular irritation or redness
  • Systemic anticholinergic effects: dry mouth, dry skin, flushing, fever, rapid pulse, urinary retention, constipation, confusion, hallucinations, ataxia (especially in children).

Special Patient Groups

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Pregnancy

Atropine is Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption from ophthalmic use is generally low, but caution is advised.

Trimester-Specific Risks:

First Trimester: Limited data, theoretical risk of fetal effects if significant systemic absorption occurs.
Second Trimester: Limited data, theoretical risk of fetal effects if significant systemic absorption occurs.
Third Trimester: Limited data, theoretical risk of fetal effects if significant systemic absorption occurs.
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Lactation

Atropine is excreted in breast milk. While systemic absorption from ophthalmic use is minimal, caution is advised. Monitor the infant for signs of anticholinergic effects (e.g., dry mouth, constipation, irritability). The risk to the infant is generally considered low with ophthalmic use.

Infant Risk: Low risk (L3) due to minimal systemic absorption, but monitor for anticholinergic effects.
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Pediatric Use

Infants and young children are highly susceptible to the systemic toxic effects of atropine due to higher systemic absorption and increased sensitivity. Use the lowest effective concentration (e.g., 0.5%) and dose. Apply nasolacrimal occlusion (pressure on the inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption. Monitor closely for signs of systemic toxicity (fever, flushing, tachycardia, CNS effects).

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Geriatric Use

Geriatric patients may be more susceptible to systemic anticholinergic effects (e.g., confusion, urinary retention, constipation) if significant systemic absorption occurs. Use with caution in patients with prostatic hypertrophy or narrow-angle glaucoma. Monitor intraocular pressure.

Clinical Information

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Clinical Pearls

  • Atropine ophthalmic has a very long duration of action (up to 2 weeks for cycloplegia/mydriasis), which can be inconvenient for patients.
  • It is the most potent cycloplegic agent and is often used for cycloplegic refraction in children or for therapeutic purposes in uveitis/amblyopia.
  • Always warn patients about prolonged blurred vision and photophobia.
  • Systemic toxicity, though rare with ophthalmic use, is a significant concern, especially in infants and young children. Educate parents on signs of toxicity.
  • Nasolacrimal occlusion is crucial, especially in pediatric patients, to reduce systemic absorption.
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Alternative Therapies

  • Other cycloplegics/mydriatics: Cyclopentolate (shorter duration, less potent cycloplegia), Tropicamide (shortest duration, primarily mydriatic), Homatropine (intermediate duration).
  • For amblyopia: Patching therapy.
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Cost & Coverage

Average Cost: Varies widely, typically $20-$100+ per 5ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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.