Brimonid/timol 0.2/0.5% Op Sol 15ml
It is used to treat glaucoma.It is used to lower high eye pressure.
Drug Class
Antiglaucoma agents
Pharmacologic Class
Alpha-2 adrenergic agonist (Brimonidine) & Beta-adrenergic blocker (Timolol)
Pregnancy Category
Category C
FDA Approved
Apr 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
This eye drop contains two medicines, brimonidine and timolol, that work together to lower the pressure inside your eye. This helps to prevent damage to your optic nerve and preserve your vision, especially if you have glaucoma or ocular hypertension.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication as directed.
Administration
Apply this medication to the eye only.
Remove contact lenses before using this medication and wait 15 minutes after application before putting them back in. However, if your eyes are irritated or infected, do not put your contact lenses back in.
Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
Wash your hands before and after using this medication.
Tilt your head back, drop the medication into your eye, and then keep your eyes closed.
Apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Gently blot any excess solution from your eyelid.
Using Multiple Medications
If you are using more than one medication in the same eye, wait at least 5 minutes between applications.
Continuing Treatment
Continue using this medication as directed, even if your symptoms improve.
Checking the Medication
Do not use this medication if the solution has changed color, is cloudy, leaking, or contains particles.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture.
Keep it in a dry place, away from bathrooms.
Store all medications in a safe location, out of the reach of children and pets.
* 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. Consult your pharmacist for guidance on disposal, and consider participating in local drug take-back programs.
Missed Doses
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. For optimal results, use this medication as directed.
Administration
Apply this medication to the eye only.
Remove contact lenses before using this medication and wait 15 minutes after application before putting them back in. However, if your eyes are irritated or infected, do not put your contact lenses back in.
Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria into the medication and potentially cause severe eye problems or vision loss.
Wash your hands before and after using this medication.
Tilt your head back, drop the medication into your eye, and then keep your eyes closed.
Apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Gently blot any excess solution from your eyelid.
Using Multiple Medications
If you are using more than one medication in the same eye, wait at least 5 minutes between applications.
Continuing Treatment
Continue using this medication as directed, even if your symptoms improve.
Checking the Medication
Do not use this medication if the solution has changed color, is cloudy, leaking, or contains particles.
Storage and Disposal
Store this medication at room temperature, protected from light and moisture.
Keep it in a dry place, away from bathrooms.
Store all medications in a safe location, out of the reach of children and pets.
* 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. Consult your pharmacist for guidance on disposal, and consider participating in local drug take-back programs.
Missed Doses
If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Wash hands thoroughly before administering eye drops.
- Do not touch the dropper tip to any surface, including the eye, to avoid contamination.
- If you wear contact lenses, remove them before instilling the drops and wait at least 15 minutes before reinserting them.
- If you are using other eye drops, wait at least 5 minutes between each medication.
- Close your eye gently after instilling the drop and apply pressure to the inner corner of your eye for 1-2 minutes to help reduce systemic absorption and increase local effect.
- Store at room temperature, away from light and moisture.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) twice daily, approximately 12 hours apart.
Condition-Specific Dosing:
glaucoma:
One drop in the affected eye(s) twice daily, approximately 12 hours apart.
Pediatric Dosing
Neonatal:
Not established (Contraindicated in children under 2 years of age due to potential for apnea and bradycardia).
Infant:
Not established (Contraindicated in children under 2 years of age due to potential for apnea and bradycardia).
Child:
Not established (Use with caution in children 2-17 years of age due to potential for systemic adverse effects such as somnolence, bradycardia, and hypothermia).
Adolescent:
One drop in the affected eye(s) twice daily, approximately 12 hours apart (use with caution, monitor for systemic effects).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure.
Moderate:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure.
Severe:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure.
Dialysis:
Considerations: Systemic exposure may be increased. Monitor closely for adverse effects.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure.
Moderate:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure.
Severe:
No specific dose adjustment recommended, but use with caution due to potential for increased systemic exposure.
Pharmacology
Mechanism of Action
Brimonidine is an alpha-2 adrenergic agonist that reduces aqueous humor production and increases uveoscleral outflow. Timolol is a non-selective beta-adrenergic blocker that reduces aqueous humor production. The combination results in additive intraocular pressure (IOP) lowering effects.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption for both components after ocular administration.
Tmax:
Brimonidine: Systemic Tmax is approximately 1-4 hours. Timolol: Systemic Tmax is approximately 1-2 hours.
FoodEffect:
Not applicable for ophthalmic solution.
Distribution:
Vd:
Not available for ophthalmic use; systemic Vd for timolol is approximately 1.7 L/kg.
ProteinBinding:
Brimonidine: Approximately 29%. Timolol: Approximately 60%.
CnssPenetration:
Limited (systemic absorption can lead to CNS effects, especially with brimonidine in children).
Elimination:
HalfLife:
Brimonidine: Approximately 3 hours (terminal elimination half-life can be longer). Timolol: Approximately 2.5-7 hours.
Clearance:
Not available for ophthalmic use; systemic clearance for timolol is approximately 0.5 L/kg/hr.
ExcretionRoute:
Primarily renal for both components.
Unchanged:
Not available (low percentage of unchanged drug excreted systemically).
Pharmacodynamics
OnsetOfAction:
Approximately 30 minutes
PeakEffect:
Approximately 2 hours
DurationOfAction:
Approximately 12 hours
Safety & Warnings
Side Effects
Urgent 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 or seek immediate 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
Changes in eyesight, eye pain, or severe eye irritation
Slow heartbeat
Abnormal heartbeat
Chest pain
Dizziness or fainting
Muscle weakness
Heart problems, which can be rare but potentially deadly. Seek immediate medical attention if you experience:
+ Shortness of breath
+ Sudden significant weight gain
+ Swelling in the arms or legs
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, contact your doctor for advice:
Eye irritation
Itching
Burning or stinging
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website 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 immediate 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
Changes in eyesight, eye pain, or severe eye irritation
Slow heartbeat
Abnormal heartbeat
Chest pain
Dizziness or fainting
Muscle weakness
Heart problems, which can be rare but potentially deadly. Seek immediate medical attention if you experience:
+ Shortness of breath
+ Sudden significant weight gain
+ Swelling in the arms or legs
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, contact your doctor for advice:
Eye irritation
Itching
Burning or stinging
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor.
Reporting Side Effects
To report side effects, you can:
Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
Visit the FDA's MedWatch website at https://www.fda.gov/medwatch
Seek Immediate Medical Attention If You Experience:
- Severe eye pain or discomfort
- Sudden changes in vision
- Signs of eye infection (e.g., discharge, swelling, severe redness)
- Severe dizziness or lightheadedness
- Very slow heart rate
- Difficulty breathing or wheezing
- Unusual fatigue or weakness
- Signs of allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
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 to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
Certain health conditions, including:
+ Respiratory issues like asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (weak heart)
+ Shock caused by heart problems
+ Slow heartbeat
* If you are currently using a similar medication, consult your doctor or pharmacist to confirm.
Special Considerations for Children:
If the patient is under 2 years of age, do not administer this medication. It is not recommended for children younger than 2 years old.
Additional Guidance:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction you experienced, such as symptoms and signs.
Certain health conditions, including:
+ Respiratory issues like asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (weak heart)
+ Shock caused by heart problems
+ Slow heartbeat
* If you are currently using a similar medication, consult your doctor or pharmacist to confirm.
Special Considerations for Children:
If the patient is under 2 years of age, do not administer this medication. It is not recommended for children younger than 2 years old.
Additional Guidance:
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. Verify that it is safe to take this medication with your existing treatments and health conditions. Never start, stop, or adjust the dosage of any medication without 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.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this medication affects you.
This drug may mask certain symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia. This risk is particularly elevated in individuals with diabetes, children, and those who are fasting, including people undergoing surgery, experiencing abnormal eating patterns, or vomiting. If you have concerns, consult your doctor.
As directed by your doctor, regularly have your eye pressure and vision checked. Additionally, notify your doctor if you have an eye infection, suffer an eye injury, or are scheduled for eye surgery.
Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
Although rare, severe respiratory problems have occurred in individuals taking this medication, sometimes with fatal outcomes, particularly in people with asthma. If you have questions or concerns, consult your doctor.
If you have a history of severe allergic reactions, inform your doctor, as you may be at increased risk of a more severe reaction upon re-exposure to the allergen. Furthermore, if you rely on epinephrine to treat severe allergic reactions, discuss this with your doctor, as this medication may reduce the effectiveness of epinephrine.
This drug may also obscure symptoms of hyperthyroidism, such as a rapid heartbeat. If you have hyperthyroidism and abruptly stop taking this medication, your condition may worsen, potentially becoming life-threatening. Consult your doctor for guidance.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for both you and your baby.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this medication affects you.
This drug may mask certain symptoms of low blood sugar, such as a rapid heartbeat, which can increase the risk of severe or prolonged hypoglycemia. This risk is particularly elevated in individuals with diabetes, children, and those who are fasting, including people undergoing surgery, experiencing abnormal eating patterns, or vomiting. If you have concerns, consult your doctor.
As directed by your doctor, regularly have your eye pressure and vision checked. Additionally, notify your doctor if you have an eye infection, suffer an eye injury, or are scheduled for eye surgery.
Prior to consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, discuss the potential risks with your doctor.
Although rare, severe respiratory problems have occurred in individuals taking this medication, sometimes with fatal outcomes, particularly in people with asthma. If you have questions or concerns, consult your doctor.
If you have a history of severe allergic reactions, inform your doctor, as you may be at increased risk of a more severe reaction upon re-exposure to the allergen. Furthermore, if you rely on epinephrine to treat severe allergic reactions, discuss this with your doctor, as this medication may reduce the effectiveness of epinephrine.
This drug may also obscure symptoms of hyperthyroidism, such as a rapid heartbeat. If you have hyperthyroidism and abruptly stop taking this medication, your condition may worsen, potentially becoming life-threatening. Consult your doctor for guidance.
If you are pregnant, planning to become pregnant, or breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for both you and your baby.
Overdose Information
Overdose Symptoms:
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Bronchospasm (difficulty breathing)
- Acute cardiac failure
- Dizziness
- Somnolence (drowsiness)
- Hypothermia
- Apnea (especially in infants/children)
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222. Management is supportive and symptomatic, including atropine for bradycardia, vasopressors for hypotension, and bronchodilators for bronchospasm.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) (due to brimonidine component)
- Patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD) (due to timolol component)
- Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock (due to timolol component)
Major Interactions
- Oral beta-blockers (additive systemic effects, e.g., bradycardia, hypotension)
- Calcium channel blockers (additive effects on AV conduction and left ventricular function)
- Cardiac glycosides (additive effects on AV conduction)
- Antiarrhythmics (e.g., amiodarone, quinidine) (additive effects on heart rate and conduction)
- CNS depressants (e.g., alcohol, barbiturates, opiates, sedatives) (additive CNS depression with brimonidine)
- Tricyclic antidepressants (may blunt the IOP-lowering effect of brimonidine)
- Adrenergic psychotropic drugs (e.g., chlorpromazine, methylphenidate, reserpine) (potential for additive effects or potentiation of systemic effects)
Moderate Interactions
- Cimetidine, quinidine, fluoxetine, paroxetine (CYP2D6 inhibitors, may increase timolol systemic levels)
- Clonidine (potential for additive hypotensive effects)
- General anesthetics (potential for additive hypotensive effects and myocardial depression)
Minor Interactions
- Not specifically documented for minor severity with significant clinical impact.
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess efficacy of treatment.
Timing: Prior to initiation of therapy.
Heart Rate and Blood Pressure
Rationale: To assess for systemic beta-blocker effects.
Timing: Prior to initiation of therapy.
Ocular Examination
Rationale: To assess overall eye health and rule out other conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, as determined by ophthalmologist (e.g., every 3-6 months or as needed).
Target: Individualized target IOP based on disease severity and progression.
Action Threshold: If IOP is not adequately controlled or shows progression, consider treatment adjustment.
Heart Rate and Blood Pressure
Frequency: Periodically, especially in patients with pre-existing cardiovascular conditions.
Target: Within normal limits for the patient.
Action Threshold: Significant bradycardia (<50 bpm), hypotension, or new onset of cardiac symptoms.
Ocular Examination (e.g., slit lamp, fundoscopy)
Frequency: Annually or as clinically indicated.
Target: Stable ocular health.
Action Threshold: New or worsening ocular symptoms, signs of inflammation, or changes in optic nerve.
Symptom Monitoring
- Ocular irritation (burning, stinging, itching, foreign body sensation)
- Ocular dryness
- Blurred vision
- Conjunctival hyperemia (redness)
- Allergic conjunctivitis
- Dizziness
- Fatigue
- Bradycardia
- Hypotension
- Somnolence (especially in children)
- Respiratory symptoms (e.g., bronchospasm, dyspnea)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects on the fetus with both components at high systemic doses. Systemic absorption occurs after ocular administration.
Trimester-Specific Risks:
First Trimester:
Potential risk, avoid if safer alternatives exist.
Second Trimester:
Potential risk, monitor closely if use is necessary.
Third Trimester:
Potential risk, especially for systemic effects on the fetus (e.g., bradycardia, hypotension) due to timolol.
Lactation
Not recommended. Timolol is excreted in human milk and has the potential for serious adverse reactions in nursing infants. It is unknown whether brimonidine is excreted in human milk, but systemic absorption occurs. A decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Risk of bradycardia, hypotension, respiratory depression, and other systemic beta-blocker effects from timolol. Risk of somnolence and apnea from brimonidine, especially in neonates/infants.
Pediatric Use
Contraindicated in children under 2 years of age due to the potential for apnea and bradycardia associated with brimonidine. Use with caution in children 2-17 years of age due to potential for systemic adverse effects such as somnolence, bradycardia, and hypothermia. Close monitoring is required.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution should be exercised in patients with a history of cardiovascular disease due to the potential for systemic beta-blocker effects.
Clinical Information
Clinical Pearls
- This combination product is designed to simplify dosing and improve adherence compared to using two separate drops.
- Patients should be instructed on proper ophthalmic administration technique to maximize efficacy and minimize systemic absorption.
- Advise patients to remove contact lenses before administration and wait 15 minutes before reinserting.
- Monitor for systemic side effects, especially bradycardia, hypotension, and CNS depression, particularly in susceptible patients (e.g., elderly, those with cardiovascular or respiratory conditions).
- Contraindicated in infants and young children due to significant risk of systemic adverse effects.
Alternative Therapies
- Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost)
- Beta-blockers (e.g., timolol, betaxolol, levobunolol)
- Alpha-2 adrenergic agonists (e.g., brimonidine, apraclonidine)
- Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide, acetazolamide)
- Cholinergic agonists (e.g., pilocarpine)
- Rho kinase inhibitors (e.g., netarsudil)
Cost & Coverage
Average Cost:
Varies widely, typically $100-$300+ per 15ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand), Tier 1 (for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to 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. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.