Cyclomydril Ophth Solution 5ml
It makes the eye pupils larger.
Drug Class
Ophthalmic Diagnostic Agent; Mydriatic; Cycloplegic
Pharmacologic Class
Anticholinergic (Cyclopentolate); Alpha-1 Adrenergic Agonist (Phenylephrine)
Pregnancy Category
Category C
FDA Approved
Jul 1959
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 of your eye. This helps them get a better view inside your eye 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 to you. 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 find out the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided to you. 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 find out the best course of action.
Lifestyle & Tips
- Do not drive or operate machinery until your vision returns to normal (usually several hours).
- Wear sunglasses when outdoors, as your eyes will be very sensitive to light (photophobia).
- Avoid rubbing your eyes.
- Wash hands thoroughly after use, especially if administering to a child.
- Do not wear contact lenses while your pupils are dilated; wait until the effects wear off.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop instilled into the conjunctival sac, repeated in 5-10 minutes if necessary.
Dose Range:
1 - 2 mg
Condition-Specific Dosing:
refraction:
1 drop, repeated in 5-10 minutes if necessary. Examination should be performed approximately 30-60 minutes after the second instillation.
fundus_examination:
1 drop, sufficient for most cases.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to increased risk of systemic toxicity).
Infant:
1 drop instilled into the conjunctival sac. Use with extreme caution due to increased risk of systemic toxicity, especially in premature infants and those with low birth weight. Monitor closely for systemic effects.
Child:
1 drop instilled into the conjunctival sac, repeated in 5-10 minutes if necessary. Monitor for systemic effects.
Adolescent:
1 drop instilled into the conjunctival sac, repeated in 5-10 minutes if necessary.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment typically needed for topical ophthalmic use due to minimal systemic absorption.
Moderate:
No adjustment typically needed for topical ophthalmic use due to minimal systemic absorption.
Severe:
No adjustment typically needed for topical ophthalmic use due to minimal systemic absorption.
Dialysis:
No specific considerations for topical ophthalmic use.
Hepatic Impairment:
Mild:
No adjustment typically needed for topical ophthalmic use due to minimal systemic absorption.
Moderate:
No adjustment typically needed for topical ophthalmic use due to minimal systemic absorption.
Severe:
No adjustment typically needed for topical ophthalmic use 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 alpha-adrenergic receptors in the dilator muscle of the iris, causing mydriasis. It also causes vasoconstriction of conjunctival blood vessels.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for ocular absorption; minimal systemic absorption occurs but can be significant in susceptible individuals (e.g., children).
Tmax:
Ocular: Mydriasis onset 15-30 min, peak 30-60 min. Cycloplegia onset 30-60 min, peak 30-60 min.
FoodEffect:
Not applicable for ophthalmic solution.
Distribution:
Vd:
Not precisely quantified for ocular use.
ProteinBinding:
Not precisely quantified for ocular use.
CnssPenetration:
Limited, but systemic absorption can lead to CNS effects, especially in children.
Elimination:
HalfLife:
Not precisely quantified for ocular use; systemic half-life of phenylephrine is 2-3 hours.
Clearance:
Not precisely quantified for ocular use.
ExcretionRoute:
Renal excretion for systemically absorbed components.
Unchanged:
Not precisely quantified for ocular use.
Pharmacodynamics
OnsetOfAction:
Mydriasis: 15-30 minutes; Cycloplegia: 30-60 minutes.
PeakEffect:
Mydriasis: 30-60 minutes; Cycloplegia: 30-60 minutes.
DurationOfAction:
Mydriasis: 6-24 hours (phenylephrine component typically 3-6 hours, cyclopentolate component up to 24 hours); Cycloplegia: 6-24 hours (can persist longer in some individuals).
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Eye irritation
Burning sensation
* Blurred vision
Reporting Side Effects
This is not an exhaustive list of 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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. However, many people do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor or seek medical help:
Eye irritation
Burning sensation
* Blurred vision
Reporting Side Effects
This is not an exhaustive list of 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 or sudden vision loss (seek immediate medical attention)
- Rash or severe allergic reaction (swelling of face, difficulty breathing)
- Unusual drowsiness, confusion, or hallucinations (especially in children)
- Rapid or irregular heartbeat, chest pain
- Severe headache
- Flushing or fever without other cause
- Difficulty urinating
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 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 medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting 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 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 medications you are currently taking
Any natural products or vitamins you are using
Existing health problems or conditions
This information will help your doctor determine whether it is safe for you to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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 affect 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 the 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.
If you are breastfeeding, consult with your doctor to discuss any potential risks to your 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 the infant 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 affect 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 the 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.
If you are breastfeeding, consult with your doctor to discuss any potential risks to your 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 the infant for 4 hours after the examination is complete.
Overdose Information
Overdose Symptoms:
- Severe systemic anticholinergic effects (e.g., severe dry mouth, blurred vision, rapid and irregular pulse, fever, abdominal distention, convulsions, hallucinations, disorientation, ataxia, coma)
- Severe systemic adrenergic effects (e.g., severe hypertension, tachycardia, headache, palpitations, anxiety, tremor, sweating)
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive. Physostigmine may be considered for severe anticholinergic toxicity. Alpha-blockers may be considered for severe phenylephrine toxicity.
Drug Interactions
Major Interactions
- Monoamine Oxidase Inhibitors (MAOIs): May potentiate the pressor effect of phenylephrine, leading to hypertensive crisis.
- Tricyclic Antidepressants (TCAs): May potentiate the pressor effect of phenylephrine.
- Beta-blockers (systemic): May increase the risk of systemic hypertension and bradycardia due to unopposed alpha-adrenergic effects of phenylephrine.
Moderate Interactions
- Other Anticholinergic Agents (systemic): Additive anticholinergic effects (e.g., dry mouth, urinary retention, CNS effects).
- Other Adrenergic Agents (systemic): Additive adrenergic effects (e.g., increased heart rate, blood pressure).
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To identify pre-existing glaucoma or ocular hypertension, as mydriatics can sometimes cause a transient increase in IOP.
Timing: Prior to instillation.
Ocular Examination
Rationale: To assess baseline ocular health and identify any contraindications.
Timing: Prior to instillation.
Routine Monitoring
Mydriasis and Cycloplegia Response
Frequency: During and after examination
Target: Adequate pupil dilation and loss of accommodation for diagnostic purposes.
Action Threshold: If inadequate, consider re-dosing or alternative agents.
Intraocular Pressure (IOP)
Frequency: Post-procedure, especially in patients at risk for angle-closure glaucoma.
Target: Within normal limits or baseline.
Action Threshold: Significant increase in IOP requires immediate ophthalmologic evaluation and management.
Systemic Side Effects (e.g., heart rate, blood pressure, CNS symptoms)
Frequency: During and after instillation, especially in pediatric and elderly patients.
Target: Within normal physiological limits.
Action Threshold: Significant changes (e.g., tachycardia, hypertension, agitation, confusion) require medical attention.
Symptom Monitoring
- Blurred vision (expected)
- Photophobia (expected)
- Stinging/burning upon instillation
- Dry mouth
- Flushing
- Headache
- Dizziness
- Nausea/vomiting
- Increased heart rate (tachycardia)
- Increased blood pressure
- Palpitations
- Unusual drowsiness or agitation (especially in children)
- Confusion or disorientation (especially in children/elderly)
- Difficulty urinating
- Severe eye pain (indicates acute angle-closure glaucoma)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption is minimal but possible.
Trimester-Specific Risks:
First Trimester:
Limited data; theoretical risk of fetal effects from systemic absorption.
Second Trimester:
Limited data; theoretical risk of fetal effects from systemic absorption.
Third Trimester:
Limited data; theoretical risk of fetal effects from systemic absorption.
Lactation
L3 (Moderate risk). Cyclopentolate and phenylephrine are excreted in breast milk in small amounts following systemic absorption. Monitor breastfed infant for signs of anticholinergic or adrenergic effects (e.g., irritability, feeding difficulties, changes in sleep patterns, dry mouth, constipation, tachycardia). Use with caution.
Infant Risk:
Low to moderate risk of systemic effects in the infant, especially with repeated or excessive use. Consider alternative agents or temporary interruption of breastfeeding if concerns arise.
Pediatric Use
Infants and young children, especially premature infants or those with low birth weight, are highly susceptible to systemic toxicity (CNS, cardiovascular, gastrointestinal) from both cyclopentolate and phenylephrine. Use the lowest effective dose and monitor closely for adverse effects. Avoid in infants with intestinal obstruction or spastic paralysis.
Geriatric Use
Use with caution in elderly patients, especially those with pre-existing cardiovascular disease, hypertension, or narrow angles, due to the risk of increased intraocular pressure and systemic cardiovascular effects. May be more susceptible to CNS side effects.
Clinical Information
Clinical Pearls
- Always check for a history of narrow-angle glaucoma before instilling mydriatic agents.
- Apply gentle pressure to the lacrimal sac for 1-2 minutes after instillation to minimize systemic absorption, especially in children.
- Inform patients that vision will be blurred and light-sensitive for several hours; advise against driving and recommend sunglasses.
- The cycloplegic effect (loss of accommodation) typically lasts longer than the mydriatic effect (pupil dilation) for cyclopentolate.
- Systemic side effects are more common in children, elderly, and those with compromised health. Monitor for signs of anticholinergic toxicity (e.g., flushing, fever, dry mouth, confusion) or adrenergic toxicity (e.g., tachycardia, hypertension).
Alternative Therapies
- Tropicamide (shorter duration mydriatic/cycloplegic)
- Atropine (longer duration mydriatic/cycloplegic, primarily for therapeutic use)
- Homatropine (intermediate duration mydriatic/cycloplegic)
- Cyclopentolate (single agent)
- Phenylephrine (single agent)
Cost & Coverage
Average Cost:
Price varies widely per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often 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 otherwise, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist. 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. When seeking help, be prepared to provide information about the medication taken, the amount, and the time it was taken.