Tropicamide 1% Ophth Soln 15ml

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
Jan 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tropicamide is an eye drop that makes your pupil (the black center of your eye) larger and temporarily blurs your near vision. This helps your eye doctor examine the back of your eye.
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How to Use This Medicine

Taking Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the instructions closely. This medication is for ocular use only. Before applying, remove your contact lenses and consult with your doctor to determine when it is safe to reinsert them after administration. Do not put your contact lenses back in if your eyes are irritated or infected.

Storing and Disposing of Your Medication

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

What to Do If You Miss a Dose

If you miss a dose, contact your doctor to receive instructions on how to proceed.
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Lifestyle & Tips

  • Do not drive or operate machinery until your vision returns to normal (usually within 6 hours).
  • Wear sunglasses to protect your eyes from bright light, as your pupils will be dilated and sensitive to light.
  • Do not rub your eyes.
  • Avoid getting the solution in your mouth or on your skin.

Dosing & Administration

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Adult Dosing

Standard Dose: For refraction: 1-2 drops of 0.5% or 1% solution, repeated in 5 minutes. Additional drop may be given in 20-30 minutes if needed. For examination of fundus: 1-2 drops of 0.5% solution 15-20 minutes prior to examination.
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Pediatric Dosing

Neonatal: Not recommended for routine use due to increased risk of systemic toxicity. Use with extreme caution if necessary.
Infant: Not recommended for routine use due to increased risk of systemic toxicity. Use with extreme caution if necessary.
Child: Similar to adult dosing, but caution with 1% solution in very young children due to increased risk of systemic effects.
Adolescent: Similar to adult dosing.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.
Dialysis: No specific considerations due to minimal systemic absorption.

Hepatic Impairment:

Mild: No adjustment needed due to minimal systemic absorption.
Moderate: No adjustment needed due to minimal systemic absorption.
Severe: No adjustment needed due to minimal systemic absorption.

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 muscle to cholinergic stimulation, producing mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation).
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Pharmacokinetics

Absorption:

Bioavailability: Not quantifiable for ophthalmic use
Tmax: Mydriasis: 20-30 minutes; Cycloplegia: 20-45 minutes
FoodEffect: Not applicable

Distribution:

Vd: Not quantifiable for ophthalmic use
ProteinBinding: Not extensively studied
CnssPenetration: Limited (can occur with systemic absorption, especially in children)

Elimination:

HalfLife: Not well-defined for ophthalmic use
Clearance: Not well-defined for ophthalmic use
ExcretionRoute: Not well-defined for ophthalmic use
Unchanged: Not well-defined for ophthalmic use
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Pharmacodynamics

OnsetOfAction: Mydriasis: 15-20 minutes; Cycloplegia: 20-30 minutes
PeakEffect: Mydriasis: 20-30 minutes; Cycloplegia: 20-45 minutes
DurationOfAction: Mydriasis: 6 hours; Cycloplegia: 2-6 hours

Safety & Warnings

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Side Effects

Serious 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 immediately or seek emergency 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
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:

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. 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.
  • Rash, itching, or swelling (especially of the face, tongue, or throat).
  • Difficulty breathing.
  • Unusual weakness or tiredness.
  • Fever, flushing, dry mouth, rapid heartbeat, confusion, or difficulty urinating (especially in children, as these can be signs of systemic absorption).
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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 you experienced, including any symptoms that occurred.
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 identify potential interactions between this medication and other substances you are taking.
* 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 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, be cautious when performing tasks that require clear vision, such as driving, as your pupils may be dilated. Until the effects of the dilation wear off, it is recommended to avoid activities that demand sharp eyesight.

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

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:

  • Severe dry mouth
  • Flushing
  • Hyperpyrexia (high fever)
  • Tachycardia (rapid heartbeat)
  • Urinary retention
  • Abdominal distension
  • Convulsions
  • Hallucinations
  • Delirium
  • Coma

What to Do:

Contact a poison control center (1-800-222-1222) or seek emergency medical attention. Treatment is supportive and symptomatic. Physostigmine may be considered in severe cases.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic drugs (systemic): May potentiate systemic anticholinergic effects if significant absorption occurs (rare).
  • Sympathomimetics (e.g., phenylephrine ophthalmic): Additive mydriatic effect.

Monitoring

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Baseline Monitoring

Visual acuity

Rationale: To establish baseline ocular health.

Timing: Prior to administration

Intraocular pressure (IOP)

Rationale: To identify contraindications (e.g., narrow-angle glaucoma).

Timing: Prior to administration

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Routine Monitoring

Pupil size and accommodation

Frequency: During and after examination

Target: Desired mydriasis/cycloplegia

Action Threshold: Inadequate dilation/cycloplegia may require additional drops; excessive systemic effects require monitoring.

Intraocular pressure (IOP)

Frequency: Post-procedure, especially in patients at risk for angle closure.

Target: Normal range

Action Threshold: Significant increase in IOP.

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Symptom Monitoring

  • Blurred vision
  • Photophobia
  • Eye irritation
  • Eye pain
  • Signs of systemic anticholinergic toxicity (e.g., dry mouth, flushing, tachycardia, confusion, fever, abdominal distension, urinary retention - rare but more likely in children).

Special Patient Groups

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Pregnancy

Use with caution; benefits should outweigh potential risks. Minimal systemic absorption is expected.

Trimester-Specific Risks:

First Trimester: Not well-established for ophthalmic use. Systemic anticholinergics are generally avoided unless necessary.
Second Trimester: Not well-established for ophthalmic use. Systemic anticholinergics are generally avoided unless necessary.
Third Trimester: Not well-established for ophthalmic use. Systemic anticholinergics are generally avoided unless necessary.
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Lactation

Use with caution. Minimal systemic absorption is expected, so infant exposure via breast milk is likely low.

Infant Risk: Low risk, but monitor infant for 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 effects, hyperpyrexia, flushing, abdominal distension, paralytic ileus). Close monitoring is essential.

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Geriatric Use

Use with caution. Elderly patients may be more susceptible to increased intraocular pressure (risk of angle-closure glaucoma) and potential systemic anticholinergic effects, especially if pre-existing conditions or other medications are present.

Clinical Information

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Clinical Pearls

  • Tropicamide provides rapid onset and relatively short duration of action, making it ideal for routine ophthalmic examinations.
  • It is a weaker cycloplegic than atropine or cyclopentolate, which can be an advantage when less profound cycloplegia is desired.
  • Always check for narrow-angle glaucoma risk before administration.
  • Advise patients about temporary blurred vision and photophobia, and the importance of wearing sunglasses and avoiding driving.
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Alternative Therapies

  • Phenylephrine (mydriatic)
  • Cyclopentolate (cycloplegic, mydriatic)
  • Atropine (cycloplegic, mydriatic)
  • Homatropine (cycloplegic, mydriatic)
  • Scopolamine (cycloplegic, mydriatic)
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Cost & Coverage

Average Cost: Typically inexpensive per 15ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2
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General Drug Facts

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly: do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best disposal method, consult with your pharmacist, who can also inform you about potential drug take-back programs in your area. Additionally, some medications may have a separate patient information leaflet; check with your pharmacist for more information. If you have any questions or concerns about your medication, 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. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.