Atropine Sulf 1% Oph Soln 10ml

Manufacturer BAUSCH & LOMB AMERICAS Active Ingredient Atropine Eye Drops(A troe peen) Pronunciation A-troe-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
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 often done for eye exams or to treat certain eye conditions like inflammation or lazy eye.
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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 accompanying information carefully. This medication is for eye use only.

Administration Instructions

1. Wash your hands before and after using the medication to prevent contamination.
2. Avoid touching the container tip to your eye, eyelid, or surrounding skin, as this can introduce bacteria and potentially cause severe eye problems or vision loss.
3. Tilt your head back and gently drop the medication into your eye.
4. After administration, 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 administration. Do not reinsert lenses if your eyes are irritated or infected.

Storage and Disposal

Store this medication at room temperature, protected from heat, and keep the lid tightly closed.

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 once or take extra doses.
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Lifestyle & Tips

  • Vision will be blurred and sensitive to light for several days to a week or more. Wear sunglasses outdoors.
  • Do not drive or operate machinery until vision returns to normal.
  • Avoid rubbing eyes after administration to prevent systemic absorption.
  • Apply pressure to the tear duct (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption.

Dosing & Administration

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Adult Dosing

Standard Dose: For cycloplegia/mydriasis: 1 drop of 1% solution 1 hour before refraction. For uveitis/iritis: 1 drop of 1% solution 1-2 times daily.

Condition-Specific Dosing:

cycloplegia_mydriasis: 1 drop of 1% solution 1 hour prior to refraction.
uveitis_iritis: 1 drop of 1% solution 1-2 times daily as directed by physician.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to increased risk of systemic toxicity).
Infant: For cycloplegia/mydriasis: 1 drop of 0.5% solution (or 1% diluted) in each eye twice daily for 1-3 days prior to examination. Use with extreme caution due to increased risk of systemic toxicity.
Child: For cycloplegia/mydriasis: 1 drop of 0.5% or 1% solution in each eye twice daily for 1-3 days prior to examination. For amblyopia (penalization): 1 drop of 1% solution in the sound eye once daily or 2-3 times per week.
Adolescent: Same as adult dosing for cycloplegia/mydriasis.
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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 an anticholinergic (antimuscarinic) agent. When applied topically to the eye, it blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, producing mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation). This action results from competitive antagonism of acetylcholine at muscarinic receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Minimal systemic absorption from ophthalmic administration.
Tmax: Not well-defined for ophthalmic systemic absorption; ocular effects typically peak within 30-40 minutes for mydriasis and 1-3 hours for cycloplegia.
FoodEffect: Not applicable for ophthalmic administration.

Distribution:

Vd: Not well-defined for ophthalmic systemic absorption; primarily localized in ocular tissues.
ProteinBinding: Not well-defined for ophthalmic systemic absorption.
CnssPenetration: Limited systemic penetration from ophthalmic use, but can occur, especially in children, leading to CNS effects.

Elimination:

HalfLife: Systemic half-life is approximately 2-4 hours, but ocular effects can last for days.
Clearance: Renal excretion if systemically absorbed.
ExcretionRoute: Renal (primarily unchanged drug) if systemically absorbed.
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: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

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 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 or 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. 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 do not go away, contact your doctor or seek medical help:

Blurred vision
Eye pain
Stinging
Eye irritation
Dry mouth, skin, or eyes
Feeling sleepy

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe eye pain or sudden vision changes (could indicate angle-closure glaucoma).
  • Signs of systemic toxicity: severe dry mouth, fever, rapid heartbeat, flushing of skin, difficulty urinating, confusion, unusual excitement or restlessness (especially in children).
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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 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.

While using this drug, avoid operating a vehicle or performing any tasks that require clear vision, as your pupils may be dilated. Additionally, you may experience discomfort from bright lights for a period after administration; therefore, wear sunglasses as directed by your doctor to minimize this effect.

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 breastfeeding, 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:

  • Exaggerated systemic anticholinergic effects: severe dry mouth, thirst, difficulty swallowing, hot and dry skin, fever, flushing, tachycardia, palpitations, hypertension, urinary urgency/retention, constipation, abdominal distention, nausea, vomiting, headache, dizziness, restlessness, irritability, confusion, disorientation, hallucinations, delirium, ataxia, seizures, coma, respiratory depression.

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, especially in children or with excessive use.

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline ocular status and rule out contraindications (e.g., narrow-angle glaucoma).

Timing: Prior to initiation of therapy.

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Routine Monitoring

Intraocular pressure (IOP)

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

Target: Normal range (typically 10-21 mmHg)

Action Threshold: Significant increase in IOP; discontinue use and seek ophthalmologic evaluation.

Visual acuity and pupillary response

Frequency: As clinically indicated, to assess therapeutic effect and recovery.

Target: Desired mydriasis/cycloplegia, eventual return to baseline.

Action Threshold: Lack of desired effect or prolonged effects beyond expected duration.

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Symptom Monitoring

  • Photophobia (light sensitivity)
  • Blurred vision (especially near vision)
  • Eye irritation or redness
  • Signs of systemic anticholinergic toxicity (especially in children): dry mouth, flushing, fever, tachycardia, urinary retention, constipation, confusion, hallucinations, ataxia.

Special Patient Groups

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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: Limited data, theoretical risk of fetal effects.
Second Trimester: Limited data.
Third Trimester: Limited data.
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Lactation

L3 (Moderately Safe). Atropine is excreted in breast milk. While systemic absorption from ophthalmic use is minimal, caution is advised, especially with prolonged use or in premature/neonatal infants. Monitor infant for signs of anticholinergic effects (e.g., dry mouth, constipation, decreased feeding).

Infant Risk: Low risk with proper administration (punctal occlusion) and short-term use. Higher risk with prolonged use or in sensitive infants.
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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 punctal occlusion after instillation. Monitor closely for signs of systemic toxicity (fever, flushing, tachycardia, CNS effects). Not recommended for routine use in infants under 3 months.

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Geriatric Use

Increased risk of precipitating acute angle-closure glaucoma due to pupillary dilation. Use with caution in patients with narrow anterior chamber angles. May be more susceptible to systemic anticholinergic side effects (e.g., confusion, urinary retention, constipation).

Clinical Information

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Clinical Pearls

  • Atropine ophthalmic solution causes prolonged mydriasis and cycloplegia, lasting up to 2 weeks. Patients must be warned about blurred vision and photophobia.
  • Always check for a history of narrow-angle glaucoma or shallow anterior chamber before administering atropine to prevent acute angle-closure glaucoma.
  • In pediatric patients, especially infants, systemic absorption can lead to significant anticholinergic toxicity (e.g., fever, flushing, tachycardia, CNS effects). Use the lowest effective concentration and apply punctal occlusion.
  • Atropine 1% is commonly used for penalization therapy in amblyopia (lazy eye) by blurring vision in the stronger eye.
  • Patients should be advised to wear sunglasses and avoid driving or activities requiring clear vision until the effects wear off.
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Alternative Therapies

  • Other cycloplegics/mydriatics: Cyclopentolate (shorter duration, faster onset), Tropicamide (shortest duration, fastest onset), Homatropine (intermediate duration).
  • For amblyopia: Eye patching.
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Cost & Coverage

Average Cost: Varies widely by pharmacy and insurance plan per 10ml 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 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's a good idea 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 occurred.