Cyclomydril Ophth Solution 2ml
It makes the eye pupils larger.
Drug Class
Mydriatic and Cycloplegic Agent
Pharmacologic Class
Anticholinergic (Cyclopentolate) & Alpha-1 Adrenergic Agonist (Phenylephrine)
Pregnancy Category
Category C
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Cyclomydril is an eye drop used by eye doctors to make your pupils (the black center of your eye) larger and to temporarily relax the focusing muscle inside your eye. This helps the doctor get a better view of the back of your eye during an examination and accurately check your vision.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is for eye use only and will be administered by your doctor.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. It is essential to follow the instructions carefully. This medication is for eye use only and will be administered by your doctor.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage method.
Missing a Dose
If you miss a dose, contact your doctor to receive guidance on what to do next.
Lifestyle & Tips
- Your vision will be blurry and you will be sensitive to light for several hours after using these drops. Do not drive or operate machinery until your vision returns to normal.
- Wear sunglasses to protect your eyes from bright light after the examination.
- Do not rub your eyes after the drops are instilled.
- Inform your doctor about all medications you are taking, especially if you have glaucoma or heart conditions.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
Instill 1 drop into the conjunctival sac, repeat in 5-10 minutes if needed.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
routine_examination:
1 drop, may repeat once in 5-10 minutes if necessary for adequate dilation/cycloplegia.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased risk of systemic toxicity)
Infant:
Instill 1 drop into the conjunctival sac, repeat in 5-10 minutes if needed. Use lower concentrations (e.g., 0.5% cyclopentolate, 2.5% phenylephrine) if available, or single drop of Cyclomydril. Monitor closely for systemic effects.
Child:
Instill 1 drop into the conjunctival sac, repeat in 5-10 minutes if needed. Monitor closely for systemic effects.
Adolescent:
Instill 1 drop into the conjunctival sac, repeat in 5-10 minutes if needed.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Dialysis:
No specific considerations; minimal systemic absorption.
Hepatic Impairment:
Mild:
No adjustment typically required due to minimal systemic absorption.
Moderate:
No adjustment typically required due to minimal systemic absorption.
Severe:
No adjustment typically required due to minimal systemic absorption.
Pharmacology
Mechanism of Action
Cyclopentolate 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). Phenylephrine is an alpha-1 adrenergic agonist that stimulates the dilator muscle of the iris, causing mydriasis.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for ophthalmic use; minimal systemic absorption occurs.
Tmax:
Not precisely quantified for systemic absorption; ocular peak effects vary.
FoodEffect:
Not applicable for ophthalmic solution.
Distribution:
Vd:
Not precisely quantified; primarily localized to ocular tissues.
ProteinBinding:
Not precisely quantified for ophthalmic use.
CnssPenetration:
Limited, but can occur, especially in pediatric patients, leading to CNS effects.
Elimination:
HalfLife:
Not precisely quantified for ophthalmic use; systemic half-life of cyclopentolate is approximately 1.5-2 hours, phenylephrine is 2-3 hours.
Clearance:
Not precisely quantified for ophthalmic use.
ExcretionRoute:
Renal (if systemically absorbed).
Unchanged:
Not precisely quantified.
Pharmacodynamics
OnsetOfAction:
Mydriasis: 15-30 minutes (Phenylephrine), 25-75 minutes (Cyclopentolate). Cycloplegia: 25-75 minutes (Cyclopentolate).
PeakEffect:
Mydriasis: 30-90 minutes. Cycloplegia: 30-60 minutes.
DurationOfAction:
Mydriasis: 3-6 hours (Phenylephrine), 24 hours (Cyclopentolate). Cycloplegia: 6-24 hours (Cyclopentolate).
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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
Changes in eyesight, eye pain, or severe eye irritation
Rapid heartbeat
Fever
Severe headache
Flushing
Difficulty urinating
Confusion
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance
Trouble walking
Slurred speech
Restlessness
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 symptoms that bother you or do not go away, contact your doctor:
Eye irritation
Burning sensation
* Blurred vision
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 help 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
Changes in eyesight, eye pain, or severe eye irritation
Rapid heartbeat
Fever
Severe headache
Flushing
Difficulty urinating
Confusion
Hallucinations (seeing or hearing things that are not there)
Seizures
Changes in balance
Trouble walking
Slurred speech
Restlessness
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 symptoms that bother you or do not go away, contact your doctor:
Eye irritation
Burning sensation
* Blurred vision
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 or sudden vision loss after the drops are given (could indicate angle-closure glaucoma).
- Rash, itching, or swelling (signs of allergic reaction).
- Severe headache, dizziness, or fainting.
- Fast or irregular heartbeat.
- Unusual behavior, confusion, or hallucinations (especially in children).
- Fever or flushing (especially in children).
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:
If you have a known allergy to cyclopentolate, phenylephrine, or any other component of this medication. Be sure to discuss the specifics of your allergy, including any symptoms you have experienced.
If you have been diagnosed with narrow-angle glaucoma.
Any other allergies you may have, including those to foods, substances, or other medications.
Additionally, to ensure your safety, it is crucial to 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
Your complete medical history, including any health problems you are experiencing
This information will help your doctor determine whether it is safe for you to take this medication, and if so, whether any special precautions or monitoring are necessary. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
It is essential to inform your doctor about the following:
If you have a known allergy to cyclopentolate, phenylephrine, or any other component of this medication. Be sure to discuss the specifics of your allergy, including any symptoms you have experienced.
If you have been diagnosed with narrow-angle glaucoma.
Any other allergies you may have, including those to foods, substances, or other medications.
Additionally, to ensure your safety, it is crucial to 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
Your complete medical history, including any health problems you are experiencing
This information will help your doctor determine whether it is safe for you to take this medication, and if so, whether any special precautions or monitoring are necessary. Do not start, stop, or change the dose of any medication without first consulting your doctor to confirm that it is safe to do so.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Precautions and Safety Measures
Avoid driving and performing tasks that require clear vision while your pupils are dilated, as this may impair your ability to see clearly.
You may be sensitive to bright lights, so wearing sunglasses can help minimize discomfort.
When using this medication in children, it is crucial to exercise caution, as they may be more prone to side effects. Consult with your doctor to discuss potential risks and benefits.
If you are pregnant or planning to become pregnant, inform your doctor to weigh the benefits and risks of using this medication during pregnancy.
Breastfeeding mothers should also consult their doctor to discuss any potential risks to their baby.
Special Considerations for Infants
Closely monitor infants for at least 30 minutes after administering this medication.
* If this medication is used on an infant, do not feed them for 4 hours after the examination is complete.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.
Precautions and Safety Measures
Avoid driving and performing tasks that require clear vision while your pupils are dilated, as this may impair your ability to see clearly.
You may be sensitive to bright lights, so wearing sunglasses can help minimize discomfort.
When using this medication in children, it is crucial to exercise caution, as they may be more prone to side effects. Consult with your doctor to discuss potential risks and benefits.
If you are pregnant or planning to become pregnant, inform your doctor to weigh the benefits and risks of using this medication during pregnancy.
Breastfeeding mothers should also consult their doctor to discuss any potential risks to their baby.
Special Considerations for Infants
Closely monitor infants for at least 30 minutes after administering this medication.
* If this medication is used on an infant, do not feed them for 4 hours after the examination is complete.
Overdose Information
Overdose Symptoms:
- Severe dry mouth and skin
- Flushing
- Fever
- Tachycardia
- Hypertension
- Urinary retention
- Abdominal distention
- Convulsions
- Hallucinations
- Ataxia
- Disorientation
- Speech disturbances
- Coma
What to Do:
Call 1-800-222-1222 (Poison Control). Seek immediate medical attention. Treatment is supportive; physostigmine may be used for severe anticholinergic toxicity, and alpha-blockers for severe hypertensive effects from phenylephrine.
Drug Interactions
Major Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (e.g., phenelzine, tranylcypromine): Risk of hypertensive crisis with phenylephrine.
- Tricyclic Antidepressants (TCAs) (e.g., amitriptyline, imipramine): Potentiation of phenylephrine's pressor effects.
- Anticholinergic agents (systemic or ophthalmic) (e.g., atropine, scopolamine): Additive anticholinergic effects, increased risk of systemic toxicity.
Moderate Interactions
- Antihypertensive agents (e.g., beta-blockers, ACE inhibitors): Phenylephrine may reduce the hypotensive effect.
- Cardiac glycosides (e.g., digoxin): Increased risk of arrhythmias with phenylephrine.
- Halogenated anesthetics (e.g., halothane): Increased risk of arrhythmias with phenylephrine.
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To identify patients at risk for angle-closure glaucoma, especially in older adults or those with narrow angles.
Timing: Prior to instillation.
Ocular Examination (anterior chamber depth)
Rationale: To assess risk of angle-closure glaucoma.
Timing: Prior to instillation.
Routine Monitoring
Pupillary response and cycloplegia
Frequency: As needed during examination
Target: Adequate dilation and paralysis of accommodation for diagnostic purposes.
Action Threshold: If inadequate, consider repeat dose or alternative agent.
Intraocular Pressure (IOP)
Frequency: Post-dilation, if clinically indicated or patient is at risk.
Target: Within normal limits or patient's baseline.
Action Threshold: Significant increase in IOP may indicate angle-closure glaucoma; requires immediate intervention.
Symptom Monitoring
- Blurred vision
- Photophobia
- Eye irritation or discomfort
- Headache
- Dizziness
- Nausea/vomiting
- Dry mouth
- Flushing
- Tachycardia
- Palpitations
- Hypertension
- Unusual behavior or confusion (especially in children)
- Fever (especially in children)
Special Patient Groups
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:
Potential risk cannot be ruled out; use only if clearly needed.
Second Trimester:
Potential risk cannot be ruled out; use only if clearly needed.
Third Trimester:
Potential risk cannot be ruled out; use only if clearly needed.
Lactation
L3 (Moderate risk). Cyclopentolate and phenylephrine are excreted in breast milk in small amounts. Use with caution. Monitor infant for signs of anticholinergic effects (e.g., dry mouth, constipation, irritability) or adrenergic effects (e.g., irritability, poor feeding). Consider delaying breastfeeding for a few hours after administration.
Infant Risk:
Low to moderate risk of adverse effects due to minimal systemic absorption and low excretion into milk. Premature or ill infants may be more susceptible.
Pediatric Use
Increased susceptibility to systemic toxicity (CNS, cardiovascular, respiratory, gastrointestinal) from both cyclopentolate and phenylephrine, especially in premature infants, low birth weight infants, infants with Down syndrome, spastic paralysis, or brain damage. Use the lowest effective concentration and number of drops. Monitor closely for systemic adverse effects.
Geriatric Use
Increased risk of precipitating angle-closure glaucoma due to pupillary dilation. Careful assessment of anterior chamber depth is crucial before administration. May also be more sensitive to systemic effects.
Clinical Information
Clinical Pearls
- Always check intraocular pressure and anterior chamber depth before administering mydriatic/cycloplegic agents to prevent angle-closure glaucoma.
- Warn patients, especially children and their parents, about the prolonged blurry vision and light sensitivity.
- Advise patients to wear sunglasses after the examination.
- Systemic absorption, though minimal, can lead to significant adverse effects, particularly in vulnerable populations (infants, elderly, those with underlying cardiac or CNS conditions).
- The combination provides both rapid mydriasis (phenylephrine) and sustained cycloplegia/mydriasis (cyclopentolate), making it effective for comprehensive eye exams.
Alternative Therapies
- Tropicamide (for rapid mydriasis/cycloplegia)
- Cyclopentolate (single agent)
- Phenylephrine (single agent)
- Atropine (for prolonged cycloplegia, e.g., amblyopia treatment)
- Homatropine
Cost & Coverage
Average Cost:
Varies, typically $20-$50 per 2ml bottle
Generic Available:
Yes
Insurance Coverage:
Usually covered by most insurance plans for diagnostic use.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. 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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. 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 contact 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 occurred.