Tropicamide 1% Ophth Soln 3ml

Manufacturer SANDOZ Active Ingredient Tropicamide(troe PIK a mide) Pronunciation troe PIK a mide
It is used before an eye exam.
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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
Aug 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tropicamide is an eye drop used to temporarily widen your pupils (the black center of your eye) and relax the focusing muscle inside your eye. This helps your eye doctor examine the back of your eye more easily.
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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. Use this medication only as directed and follow all instructions carefully.

Administration

This medication is for eye use only. Before applying, remove your contact lenses and consult with your doctor to determine when it is safe to put them back in after using the medication. Do not reinsert your contact lenses if your eyes are irritated or infected.

Storage and Disposal

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Do not drive or operate machinery until your vision returns to normal (typically 4-8 hours).
  • Wear sunglasses to protect your eyes from bright light, as your pupils will be dilated and sensitive to light.
  • Avoid rubbing your eyes after instillation.
  • Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
  • Wash hands thoroughly before and after use.

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 drops of 0.5% or 1% solution in the eye(s) as needed for examination.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

Refraction: 1-2 drops of 1% solution, repeated in 5 minutes if necessary. Examination should be performed within 20-30 minutes after instillation.
Fundus Examination: 1-2 drops of 0.5% solution 15-20 minutes prior to examination. A 1% solution may be used if greater mydriasis is desired.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to potential for systemic absorption and toxicity)
Infant: Not established (use with extreme caution due to potential for systemic absorption and toxicity)
Child: 1-2 drops of 0.5% or 1% solution in the eye(s) as needed for examination. Use lowest effective concentration and number of drops.
Adolescent: 1-2 drops of 0.5% or 1% solution in the eye(s) as needed for examination.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Tropicamide is an anticholinergic agent that blocks the responses of the sphincter muscle of the iris and the ciliary body muscle to cholinergic stimulation, producing mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation). It acts by competitively blocking muscarinic receptors (M1, M2, M3, M4, M5) in the eye.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (minimal systemic absorption after ophthalmic administration)
Tmax: Not applicable (local action)
FoodEffect: Not applicable

Distribution:

Vd: Not available (primarily local action)
ProteinBinding: Not available
CnssPenetration: Limited (systemic absorption is minimal, but can cross blood-brain barrier if significant systemic levels occur, especially in infants)

Elimination:

HalfLife: Not precisely determined for ophthalmic use (effects typically last 4-8 hours)
Clearance: Not available
ExcretionRoute: Primarily local action; any systemically absorbed drug is likely excreted renally.
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Mydriasis: 15-20 minutes; Cycloplegia: 20-30 minutes
PeakEffect: Mydriasis: 20-30 minutes; Cycloplegia: 25-40 minutes
DurationOfAction: Mydriasis: 4-8 hours; Cycloplegia: 2-6 hours
Confidence: Medium

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help 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 attention 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
Eye pain
Fast heartbeat
Mood changes
Changes in behavior
Pale skin
Muscle stiffness

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 or seek medical help:

Stinging
Eye irritation
Blurred vision
Dry mouth
Headache
* Upset stomach or vomiting

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor for medical advice. 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 discomfort
  • Sudden vision changes (other than expected blurring)
  • Redness or swelling around the eye that worsens
  • Rash or itching
  • Difficulty urinating
  • Unusual drowsiness or confusion (especially in children)
  • Rapid heartbeat
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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 symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that it is safe to take this medication with all your current medications and health conditions. Do not initiate, discontinue, or modify 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, as your pupils may be dilated. Avoid driving and other activities that demand sharp eyesight until your vision returns to normal.

You may experience sensitivity to bright lights for a period after using this medication. To minimize discomfort, wear sunglasses as directed by your doctor.

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 breastfeeding, consult your doctor to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Flushing and dryness of skin (a rash may be present in children)
  • Blurred vision
  • Rapid and irregular pulse
  • Fever
  • Abdominal distention in infants
  • Convulsions
  • Hallucinations
  • Loss of neuromuscular coordination

What to Do:

Discontinue use. Systemic toxicity is rare but can occur, especially in children. If severe systemic symptoms occur, supportive measures should be instituted. In infants and young children, a cool environment may be necessary to reduce fever. Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention.

Drug Interactions

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Moderate Interactions

  • Other ophthalmic anticholinergics (e.g., atropine, scopolamine): May lead to additive systemic anticholinergic effects.
  • Oral anticholinergics (e.g., tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide): May increase risk of systemic anticholinergic side effects if significant systemic absorption occurs.

Monitoring

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Baseline Monitoring

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

Rationale: To establish baseline ocular health and identify contraindications (e.g., narrow angle glaucoma).

Timing: Prior to first administration

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Routine Monitoring

Pupillary response and accommodation

Frequency: During and after examination

Target: Desired mydriasis and cycloplegia

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

Intraocular pressure (IOP)

Frequency: Post-dilation, especially in patients at risk for angle-closure glaucoma

Target: Normal range (typically <21 mmHg)

Action Threshold: Significant increase in IOP requires immediate ophthalmologic evaluation.

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

Frequency: During and after administration, especially in pediatric patients

Target: Absence of symptoms

Action Threshold: Presence of symptoms requires monitoring and supportive care.

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Symptom Monitoring

  • Blurred vision (expected)
  • Photophobia (expected)
  • Eye irritation/stinging (common)
  • Dry mouth
  • Flushing of skin
  • Fever
  • Tachycardia
  • Urinary retention
  • Confusion or disorientation (rare, especially in children)
  • Severe eye pain (seek immediate medical attention)

Special Patient Groups

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Pregnancy

Use with caution during pregnancy. While systemic absorption is minimal, animal reproduction studies have not been conducted. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Risk unknown, but generally considered low due to minimal systemic absorption.
Second Trimester: Risk unknown, but generally considered low due to minimal systemic absorption.
Third Trimester: Risk unknown, but generally considered low due to minimal systemic absorption.
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Lactation

Use with caution. It is not known whether tropicamide is excreted in human milk. Due to minimal systemic absorption, risk to the infant is likely low. Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for tropicamide and any potential adverse effects on the breastfed infant from tropicamide or from the underlying maternal condition.

Infant Risk: Low risk (L3) due to minimal systemic absorption. Monitor infant for signs of anticholinergic effects (e.g., dry mouth, constipation, irritability).
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Pediatric Use

Use with extreme caution, especially in infants and young children, due to increased susceptibility to systemic anticholinergic toxicity (e.g., CNS disturbances, cardiorespiratory collapse, fever, abdominal distention). Use the lowest effective concentration and number of drops. Apply pressure to the lacrimal sac for 2-3 minutes after instillation to minimize systemic absorption.

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Geriatric Use

Use with caution in elderly patients, especially those with a predisposition to angle-closure glaucoma, as mydriatics can precipitate an acute attack. Monitor intraocular pressure. May be more sensitive to systemic anticholinergic effects, though rare with ophthalmic use.

Clinical Information

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Clinical Pearls

  • Always check for a history of narrow-angle glaucoma or shallow anterior chamber before administering tropicamide, as it can precipitate an acute angle-closure attack.
  • Educate patients about expected blurred vision and photophobia, and advise them not to drive or operate machinery until vision returns to normal.
  • Provide disposable sunglasses to patients after dilation.
  • In pediatric patients, apply nasolacrimal occlusion (gentle pressure on the inner corner of the eye for 2-3 minutes) after instillation to minimize systemic absorption and reduce the risk of adverse effects.
  • Tropicamide has a faster onset and shorter duration of action compared to atropine, making it preferred for routine ophthalmic examinations.
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Alternative Therapies

  • Cyclopentolate (stronger cycloplegic, longer duration)
  • Atropine (strongest cycloplegic, longest duration, used therapeutically)
  • Phenylephrine (pure mydriatic, no cycloplegic effect)
  • Homatropine (intermediate mydriatic/cycloplegic)
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Cost & Coverage

Average Cost: $15 - $40 per 15ml bottle of 1% solution
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective use of your medication, never share your prescription with others, and do not take medication prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed otherwise by a healthcare professional or pharmacist, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist, who can provide guidance on safe disposal practices and inform you about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. 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 contact your local poison control center or seek emergency medical attention. Be prepared to provide critical information, including the name of the medication, the amount taken, and the time it was taken, to ensure prompt and effective treatment.