Mydriacyl 1% Ophth Soln 15ml
It is used before an eye exam.
Drug Class
Mydriatic; Cycloplegic
Pharmacologic Class
Anticholinergic; Muscarinic Antagonist
Pregnancy Category
Category C
FDA Approved
Jun 1959
DEA Schedule
Not Controlled
Overview
What is this medicine?
Tropicamide is an eye drop used to temporarily widen your pupil (the black center of your eye) and relax the focusing muscle inside your eye. This helps eye doctors examine the back of your eye or measure your vision more accurately.
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 precisely. This medication is for ophthalmic use only. Before applying the medication, 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.
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.
Missing a Dose
If you miss a dose, contact your doctor to receive instructions on what to do next.
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 precisely. This medication is for ophthalmic use only. Before applying the medication, 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.
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.
Missing a Dose
If you miss a dose, contact your doctor to receive instructions on what to do next.
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.
- Do not wear soft contact lenses during treatment; remove them before instilling drops and wait at least 15 minutes before reinserting.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
1-2 drops of 0.5% or 1% solution in the conjunctival sac, repeated in 5 minutes if necessary.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
refraction:
1-2 drops of 0.5% or 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.
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 conjunctival sac, repeated in 5 minutes if necessary. For cycloplegia, an additional drop may be instilled after 20-30 minutes.
Adolescent:
1-2 drops of 0.5% or 1% solution in the conjunctival sac, repeated in 5 minutes if necessary. For cycloplegia, an additional drop may be instilled after 20-30 minutes.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Dialysis:
No adjustment needed (minimal systemic absorption).
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption).
Moderate:
No adjustment needed (minimal systemic absorption).
Severe:
No adjustment needed (minimal systemic absorption).
Pharmacology
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 acetylcholine receptors.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (minimal systemic absorption after topical ophthalmic administration).
Tmax:
Not available (systemic Tmax not clinically relevant for topical use).
FoodEffect:
Not applicable (topical ophthalmic).
Distribution:
Vd:
Not available (primarily localized to the eye).
ProteinBinding:
Not available.
CnssPenetration:
Limited (systemic absorption is minimal, but can cross blood-brain barrier if significant systemic exposure occurs, leading to CNS effects).
Elimination:
HalfLife:
Not well characterized systemically (duration of action in eye is 4-8 hours for mydriasis, 2-6 hours for cycloplegia).
Clearance:
Not available.
ExcretionRoute:
Not well characterized systemically; likely renal if significant systemic absorption occurs.
Unchanged:
Not available.
Pharmacodynamics
OnsetOfAction:
Mydriasis: 15-20 minutes; Cycloplegia: 20-30 minutes.
PeakEffect:
Mydriasis: 20-35 minutes; Cycloplegia: 25-45 minutes.
DurationOfAction:
Mydriasis: 4-8 hours; Cycloplegia: 2-6 hours.
Safety & Warnings
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, or 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 does not include all possible 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.
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, or 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 does not include all possible 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.
Seek Immediate Medical Attention If You Experience:
- Severe eye pain
- Sudden decrease in vision
- Seeing halos around lights
- Redness of the eye that worsens
- Rash or itching
- Difficulty breathing or swallowing
- Unusual weakness or tiredness
- Confusion or disorientation (especially in children or elderly)
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 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 current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting 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 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 current medications and health conditions. Never start, stop, or adjust the dose of any medication without first consulting your doctor.
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. Avoid these activities 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.
While using this drug, be cautious when performing tasks that require clear vision, such as driving, as your pupils may be dilated. Avoid these activities 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.
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:
Call 1-800-222-1222 (Poison Control Center) immediately. Systemic toxicity is rare with ophthalmic use but can occur, especially in children. Treatment is supportive. Physostigmine may be considered in severe cases of systemic anticholinergic toxicity.
Drug Interactions
Moderate Interactions
- Other ophthalmic anticholinergics (e.g., atropine, scopolamine, homatropine): May potentiate mydriatic and cycloplegic effects.
- Adrenergic agonists (e.g., phenylephrine ophthalmic): May potentiate mydriatic effect.
Monitoring
Baseline Monitoring
Intraocular pressure (IOP)
Rationale: To assess baseline and identify risk of angle-closure glaucoma.
Timing: Prior to administration, especially in patients with shallow anterior chamber or narrow angles.
Ophthalmic examination (visual acuity, pupillary response)
Rationale: To establish baseline visual function and pupillary status.
Timing: Prior to administration.
Routine Monitoring
Intraocular pressure (IOP)
Frequency: Post-procedure, if clinically indicated or patient is at risk.
Target: Not applicable (monitor for significant increase).
Action Threshold: Significant increase in IOP, signs of acute angle-closure glaucoma.
Resolution of mydriasis/cycloplegia
Frequency: As needed, before patient resumes activities requiring clear vision.
Target: Return to baseline pupillary size and accommodative function.
Action Threshold: Persistent blurred vision or photophobia beyond expected duration.
Symptom Monitoring
- Blurred vision
- Photophobia (light sensitivity)
- Eye irritation or discomfort
- Headache
- Dry mouth
- Flushing
- Nausea
- Dizziness
- Signs of acute angle-closure glaucoma (e.g., severe eye pain, sudden vision loss, halos around lights, red eye)
Special Patient Groups
Pregnancy
Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal reproduction studies have not been conducted. Systemic absorption is minimal, but caution is advised.
Trimester-Specific Risks:
First Trimester:
Risk unknown, minimal systemic absorption expected.
Second Trimester:
Risk unknown, minimal systemic absorption expected.
Third Trimester:
Risk unknown, minimal systemic absorption expected.
Lactation
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. Systemic absorption is minimal, so infant exposure via breast milk is expected to be low.
Infant Risk:
Low risk (L3 - Moderately safe, but some concern).
Pediatric Use
Use with caution, especially in infants and young children, due to increased susceptibility to systemic anticholinergic effects (e.g., CNS disturbances, cardiorespiratory collapse, paralytic ileus). Close monitoring is essential. Avoid prolonged use and excessive dosage. Consider lower concentrations (0.5%) for infants.
Geriatric Use
Use with caution. Elderly patients may be more susceptible to increased intraocular pressure and precipitation of acute angle-closure glaucoma, especially if they have pre-existing narrow angles. Monitor IOP. May also be more sensitive to systemic anticholinergic effects if significant absorption occurs.
Clinical Information
Clinical Pearls
- Tropicamide is preferred over atropine for routine ophthalmic examinations due to its shorter duration of action and faster recovery, minimizing patient inconvenience.
- Always check for narrow angles or a history of angle-closure glaucoma before administering tropicamide, as it can precipitate an acute attack.
- Advise patients to bring sunglasses for post-examination comfort and safety.
- Apply pressure to the nasolacrimal duct (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption, especially in children.
- The 1% solution provides more complete cycloplegia than the 0.5% solution, but the 0.5% solution may be sufficient for routine mydriasis and has a lower risk of systemic effects.
Alternative Therapies
- Cyclopentolate (longer duration of action, stronger cycloplegia)
- Atropine (longest duration, strongest cycloplegia, used therapeutically for amblyopia)
- Homatropine (intermediate duration)
- Phenylephrine (pure mydriatic, no cycloplegia, often used in combination with cycloplegics)
Cost & Coverage
Average Cost:
$15 - $40 per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (preferred generic)
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.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to ensure prompt and effective treatment.
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.
Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred, to ensure prompt and effective treatment.