Atropine Sulf 1% Oph Soln 15ml

Manufacturer AMNEAL 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
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 make your pupils 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 inflammation or '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. For optimal results, use this medication as directed.

Administration Instructions

This medication is for eye use only.
Before and after use, wash your hands thoroughly to prevent contamination.
To avoid introducing bacteria into the medication, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to severe eye problems or vision loss.
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 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 you can safely reinsert your lenses after using this medication. If your eyes are irritated or infected, do not put your contact lenses back in.

Storage and Disposal

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

Missed Dose Instructions

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 the same time or take extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Do not drive or operate machinery until your vision has returned to normal, as your vision will be blurred and you will be sensitive to light.
  • Wear sunglasses outdoors to protect your eyes from light sensitivity (photophobia).
  • Avoid rubbing your eyes after administration to prevent systemic absorption.
  • Wash hands thoroughly after use.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

cycloplegic_refraction: 1 drop of 1% solution 1 hour prior to examination.
uveitis_iritis: 1 drop of 1% solution 1-2 times daily, or 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 cycloplegic refraction (6 months to 6 years): 1 drop of 0.5% solution twice daily for 1-3 days prior to examination. For amblyopia (penalization): 1 drop of 1% solution once daily in the sound eye.
Child: For cycloplegic refraction (over 6 years): 1 drop of 1% solution 1 hour prior to examination. For amblyopia (penalization): 1 drop of 1% solution once daily in the sound eye.
Adolescent: Same as adult dosing for cycloplegic refraction or uveitis/iritis.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed for ophthalmic use.
Moderate: No adjustment needed for ophthalmic use.
Severe: No adjustment needed for ophthalmic use.
Dialysis: No specific considerations for ophthalmic use, as systemic absorption is minimal.

Hepatic Impairment:

Mild: No adjustment needed for ophthalmic use.
Moderate: No adjustment needed for ophthalmic use.
Severe: No adjustment needed for ophthalmic use.

Pharmacology

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Mechanism of Action

Atropine is an anticholinergic agent that blocks the responses of the sphincter muscle of the iris and the ciliary muscle to cholinergic stimulation, thereby producing mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation). It acts by competitively blocking muscarinic acetylcholine receptors.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for ophthalmic, but systemic absorption can occur, especially in children.
Tmax: Ocular effects: Mydriasis peaks in 30-40 minutes, cycloplegia peaks in 1-3 hours.
FoodEffect: Not applicable for ophthalmic administration.

Distribution:

Vd: Not well-quantified for ophthalmic use; widely distributed after systemic absorption.
ProteinBinding: Approximately 50% (systemic).
CnssPenetration: Yes (after systemic absorption, can cross blood-brain barrier).

Elimination:

HalfLife: Approximately 2-4 hours (systemic). Ocular effects persist much longer.
Clearance: Not precisely quantified for ophthalmic use.
ExcretionRoute: Renal (primarily unchanged drug and metabolites).
Unchanged: Approximately 30-50% (systemic).
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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, especially children).

Safety & Warnings

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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
+ 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 unusual symptoms that bother you or persist, contact your doctor for advice:

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 sudden vision changes (could indicate angle-closure glaucoma)
  • Rash or severe itching around the eyes
  • Signs of systemic toxicity: unusual dryness of mouth, flushing, fever, rapid heartbeat, difficulty urinating, confusion, or unusual excitement (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 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, avoid operating a vehicle or performing any activities that require clear vision until your pupils return to normal, as your eyesight may be affected. Additionally, you may experience sensitivity to bright lights for a period after administration; wear sunglasses as directed by your doctor to minimize discomfort.

In case of accidental ingestion, this medication 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 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 dryness of skin
  • Fever
  • Rapid and irregular pulse
  • Dilated pupils (even more than intended)
  • Blurred vision
  • Difficulty swallowing
  • Restlessness, confusion, hallucinations, delirium
  • Urinary retention
  • Convulsions (severe cases)
  • Coma (severe cases)

What to Do:

Immediately seek emergency medical attention. Call 911 or your local poison control center (e.g., 1-800-222-1222 in the US). Treatment is supportive and may involve physostigmine in severe cases.

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): May potentiate systemic anticholinergic effects.

Monitoring

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Baseline Monitoring

Intraocular pressure (IOP)

Rationale: To rule out narrow-angle glaucoma or predisposition, as mydriatics can precipitate acute angle-closure glaucoma.

Timing: Prior to administration.

Ocular examination (visual acuity, pupillary response, fundus exam)

Rationale: To establish baseline ocular status and assess the need for cycloplegia/mydriasis.

Timing: Prior to administration.

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Routine Monitoring

Pupillary response and accommodation

Frequency: As needed to assess therapeutic effect.

Target: Desired mydriasis and cycloplegia.

Action Threshold: If inadequate effect, consider re-dosing or alternative agent; if excessive, monitor for systemic effects.

Signs of systemic anticholinergic toxicity (e.g., flushing, fever, dry mouth, tachycardia, urinary retention, CNS effects)

Frequency: During and after treatment, especially in children.

Target: Absence of symptoms.

Action Threshold: If symptoms appear, discontinue use and provide supportive care.

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Symptom Monitoring

  • Blurred vision (prolonged)
  • Photophobia
  • Dry mouth
  • Flushing of skin
  • Fever
  • Tachycardia
  • Urinary retention
  • Constipation
  • Confusion or disorientation (especially in children and elderly)
  • Hallucinations (rare, especially in children)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. Atropine is classified as Pregnancy Category C. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, but data are limited for ophthalmic use.
Second Trimester: Potential for fetal harm, but data are limited for ophthalmic use.
Third Trimester: Potential for fetal harm, but data are limited for ophthalmic use.
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Lactation

Use with caution during breastfeeding. Atropine is excreted in breast milk. While systemic absorption from ophthalmic drops is generally low, infants are more susceptible to anticholinergic effects. Monitor the infant for signs of anticholinergic effects (e.g., dry mouth, constipation, urinary retention, irritability). Consider using the lowest effective dose and applying nasolacrimal occlusion to minimize systemic absorption.

Infant Risk: L3 - Moderate risk. Potential for anticholinergic effects in the infant.
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Pediatric Use

Children, especially infants and young children, are more susceptible to the systemic toxic effects of atropine due to higher systemic absorption and increased sensitivity. Use the lowest effective concentration and dose. Apply nasolacrimal occlusion (pressing on the tear duct) for several minutes after instillation to minimize systemic absorption. Monitor closely for signs of systemic toxicity (e.g., flushing, fever, tachycardia, CNS effects).

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Geriatric Use

Elderly patients may be more susceptible to the systemic anticholinergic effects of atropine, including confusion, hallucinations, and increased intraocular pressure. Use with caution and monitor for adverse effects. Consider lower concentrations or less frequent dosing if appropriate.

Clinical Information

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Clinical Pearls

  • Atropine ophthalmic solution has a very long duration of action (up to 2 weeks), which can significantly impair vision for an extended period. Patients should be fully informed of this.
  • Always apply nasolacrimal occlusion (gentle pressure on the inner corner of the eye for 1-2 minutes) after instilling drops, especially in children, to minimize systemic absorption and potential side effects.
  • Atropine is a potent cycloplegic and mydriatic. It is often used for cycloplegic refraction in children to accurately measure refractive error by paralyzing accommodation.
  • Contraindicated in patients with narrow anterior chamber angles or angle-closure glaucoma due to the risk of precipitating an acute attack.
  • Patients should be advised to wear sunglasses outdoors due to prolonged photophobia.
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Alternative Therapies

  • Cyclopentolate (Cyclogyl): Shorter duration of action (24-48 hours), commonly used for routine cycloplegic refraction.
  • Tropicamide (Mydriacyl): Shortest duration of action (4-6 hours), primarily for mydriasis for fundus examination.
  • Homatropine: Intermediate duration of action (1-3 days), used for cycloplegia and uveitis.
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Cost & Coverage

Average Cost: Varies, typically $20-$50 per 15ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 for more information. 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 details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.