Tropicamide 0.5% 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 and Cycloplegic
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Pharmacologic Class
Anticholinergic; Muscarinic Antagonist
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Pregnancy Category
Category C
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FDA Approved
Sep 1959
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Tropicamide eye drops are used to temporarily make your pupils larger (dilate) and relax the focusing muscle of your eye. This is usually done for eye exams to allow the doctor to see the back of your eye more clearly.
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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 guidelines.

Administration

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. Avoid putting your contact lenses back in 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 procedures.

Missed Dose

If you miss a dose, contact your doctor to receive instructions on what to do next.
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Lifestyle & Tips

  • Do not drive or operate machinery until your vision has returned to normal (typically 4-8 hours).
  • Wear sunglasses to protect your eyes from light sensitivity (photophobia) after the drops are instilled.
  • Avoid rubbing your eyes after instillation.
  • Do not wear soft contact lenses during the eye exam; remove them before instilling drops and wait at least 15 minutes before reinserting.

Dosing & Administration

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Adult Dosing

Standard Dose: 1-2 drops of 0.5% or 1% solution in the eye(s) prior to examination, repeated in 5 minutes if necessary.
Dose Range: 1 - 2 mg

Condition-Specific Dosing:

refraction: 1-2 drops of 1% solution, repeated in 5 minutes if necessary. For cycloplegia, an additional drop may be instilled after 20-30 minutes.
fundus_examination: 1-2 drops of 0.5% solution 15-20 minutes prior to examination.
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Pediatric Dosing

Neonatal: Not established (increased risk of systemic toxicity)
Infant: Use with extreme caution; 1 drop of 0.5% solution. Increased risk of systemic toxicity.
Child: 1-2 drops of 0.5% or 1% solution in the eye(s) prior to examination, repeated in 5 minutes if necessary. Use 0.5% for routine fundus examination.
Adolescent: 1-2 drops of 0.5% or 1% solution in the eye(s) prior to examination, repeated in 5 minutes if necessary.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (topical ophthalmic, minimal systemic absorption)
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (topical ophthalmic, minimal systemic absorption)
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 muscle to cholinergic stimulation, producing mydriasis (pupil dilation) and cycloplegia (paralysis of accommodation).
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for topical ophthalmic; minimal systemic absorption occurs.
Tmax: Not well-defined for systemic absorption; ocular effects onset within minutes.
FoodEffect: Not applicable (topical ophthalmic)

Distribution:

Vd: Not well-defined for topical ophthalmic.
ProteinBinding: Not well-defined for topical ophthalmic.
CnssPenetration: Limited, but systemic absorption can lead to CNS effects, especially in children and susceptible individuals.

Elimination:

HalfLife: Not precisely quantified for topical ophthalmic; ocular effects typically last 4-8 hours.
Clearance: Not well-defined for topical ophthalmic.
ExcretionRoute: Primarily local action; minimal systemic excretion via urine.
Unchanged: Not precisely quantified.
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Pharmacodynamics

OnsetOfAction: Mydriasis: 15-20 minutes; Cycloplegia: 20-45 minutes
PeakEffect: Mydriasis: 20-30 minutes; Cycloplegia: 25-50 minutes
DurationOfAction: Mydriasis: 4-8 hours; Cycloplegia: 2-6 hours (recovery may take up to 24 hours for full accommodation)

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 for advice:

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. 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 loss (could indicate acute angle-closure glaucoma)
  • Rash or severe allergic reaction (swelling of face, lips, tongue)
  • Unusual weakness or dizziness
  • Fever, especially in children
  • Confusion or hallucinations (rare, signs of systemic toxicity)
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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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate existing health problems.

To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions

Before making any changes to your medication regimen, including starting, stopping, or adjusting the dose of any drug, consult with your doctor to confirm that it is safe to do so in conjunction with this medication.
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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.

When administering this medication 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 and dryness of skin
  • Fever
  • Tachycardia
  • Urinary retention
  • Decreased gastrointestinal motility
  • Central nervous system effects (e.g., confusion, hallucinations, ataxia, seizures, coma), especially in children.

What to Do:

Contact a poison control center immediately (e.g., 1-800-222-1222) or seek emergency medical attention. Treatment is supportive; physostigmine may be considered in severe cases of systemic anticholinergic toxicity.

Drug Interactions

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Moderate Interactions

  • Other anticholinergic drugs (e.g., tricyclic antidepressants, phenothiazines, antihistamines, quinidine, disopyramide, amantadine): May potentiate systemic anticholinergic effects if significant systemic absorption occurs.

Monitoring

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Baseline Monitoring

Intraocular Pressure (IOP)

Rationale: To identify patients at risk for acute angle-closure glaucoma, especially in those with narrow anterior chamber angles.

Timing: Prior to instillation in susceptible patients.

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Routine Monitoring

Vision (near and far)

Frequency: Post-procedure

Target: Return to baseline

Action Threshold: Persistent severe blurring beyond expected duration

Photophobia

Frequency: Post-procedure

Target: Resolving

Action Threshold: Severe or prolonged photophobia

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

Frequency: During and after procedure, especially in children and elderly

Target: Absence of symptoms

Action Threshold: Presence of any systemic symptoms

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Symptom Monitoring

  • Blurred vision (especially near vision)
  • Photophobia (light sensitivity)
  • Eye irritation or stinging upon instillation
  • Headache
  • Dry mouth
  • Flushing of skin
  • Fever (especially in children)
  • Tachycardia
  • Confusion or disorientation (rare, with systemic absorption)

Special Patient Groups

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Pregnancy

Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal, but caution is advised.

Trimester-Specific Risks:

First Trimester: Limited data; theoretical risk of anticholinergic effects.
Second Trimester: Limited data; theoretical risk of anticholinergic effects.
Third Trimester: Limited data; theoretical risk of anticholinergic effects.
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Lactation

L3 (Moderately Safe). Minimal systemic absorption suggests low risk to the infant. However, caution is advised. Monitor infant for anticholinergic effects (e.g., dry mouth, constipation, irritability).

Infant Risk: Low risk of adverse effects due to minimal systemic absorption, but theoretical risk of anticholinergic effects if significant exposure occurs.
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Pediatric Use

Increased susceptibility to systemic anticholinergic effects (e.g., CNS disturbances, cardiorespiratory collapse, fever) due to higher systemic absorption and immature metabolism. Use the lowest effective concentration (0.5%) and dose. Avoid in neonates and infants unless absolutely necessary and with extreme caution.

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Geriatric Use

Increased risk of elevated intraocular pressure (IOP) and acute angle-closure glaucoma, especially in patients with pre-existing narrow angles. May also be more susceptible to systemic anticholinergic side effects (e.g., confusion, dry mouth, urinary retention). Use with caution and monitor IOP.

Clinical Information

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Clinical Pearls

  • Apply gentle pressure to the lacrimal sac for 1-2 minutes after instillation to minimize systemic absorption and potential systemic side effects.
  • Advise patients to bring sunglasses for post-exam photophobia.
  • Ensure patients understand the temporary nature of blurred vision and photophobia and the importance of not driving.
  • Always check for narrow angles before instilling mydriatics to prevent acute angle-closure glaucoma.
  • Tropicamide is preferred over atropine for routine examinations due to its shorter duration of action and faster recovery.
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Alternative Therapies

  • Cyclopentolate (stronger cycloplegic, longer duration)
  • Atropine (strongest cycloplegic, longest duration, used for therapeutic purposes)
  • Phenylephrine (pure mydriatic, no cycloplegia)
  • Homatropine (intermediate mydriatic/cycloplegic)
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Cost & Coverage

Average Cost: $15 - $40 per 15ml bottle of 0.5% solution
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 guidance. To ensure your safety and the safety of others, never share your prescription medications with anyone, and do not take medications that have been prescribed to someone else.

Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless specifically instructed to do so by your pharmacist or healthcare provider. Instead, consult with your pharmacist to determine the best method for disposal, as some communities have drug take-back programs in place.

Additionally, some medications may come with a separate patient information leaflet; be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, it is crucial 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 information about the medication taken, including the dosage and time of ingestion, to ensure prompt and effective treatment.