Brimonid/timol 0.2/0.5% Op Sol 10ml
It is used to treat glaucoma.It is used to lower high eye pressure.
Drug Class
Antiglaucoma agents
Pharmacologic Class
Alpha-2 adrenergic agonist; Non-selective beta-adrenergic blocker
Pregnancy Category
Category C
FDA Approved
Sep 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is an eye drop that contains two different medicines, brimonidine and timolol. It is used to lower high pressure inside the eye, which can damage your vision and lead to a condition called glaucoma. It works by reducing the amount of fluid your eye makes and helping fluid drain better.
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. This medication is for use in the eyes only.
Preparation and Administration
1. Remove your contact lenses before using this medication. You can put them back in 15 minutes after administration, but only if your eyes are not irritated or infected.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
3. Wash your hands before and after using the medication.
4. Tilt your head back and gently drop the medication into your eye.
5. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
6. Gently blot any excess solution from your eyelid.
Using Multiple Eye Medications
If you are using more than one medication in the same eye, wait at least 5 minutes between each application.
Continuing Treatment
Continue using this medication as directed, even if your symptoms improve.
Checking the Medication
Do not use the medication if the solution has changed color, is cloudy, leaking, or contains particles.
Storage and Disposal
1. Store the medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
2. Keep all medications in a safe place, out of the reach of children and pets.
3. 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. Check with your pharmacist for guidance on disposal, and consider participating in a drug take-back program in your area.
Missing a Dose
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. This medication is for use in the eyes only.
Preparation and Administration
1. Remove your contact lenses before using this medication. You can put them back in 15 minutes after administration, but only if your eyes are not irritated or infected.
2. Avoid touching the container tip to your eye, lid, or surrounding skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
3. Wash your hands before and after using the medication.
4. Tilt your head back and gently drop the medication into your eye.
5. After administration, keep your eyes closed and apply gentle pressure to the inside corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
6. Gently blot any excess solution from your eyelid.
Using Multiple Eye Medications
If you are using more than one medication in the same eye, wait at least 5 minutes between each application.
Continuing Treatment
Continue using this medication as directed, even if your symptoms improve.
Checking the Medication
Do not use the medication if the solution has changed color, is cloudy, leaking, or contains particles.
Storage and Disposal
1. Store the medication at room temperature, protected from light and moisture. Do not store it in a bathroom.
2. Keep all medications in a safe place, out of the reach of children and pets.
3. 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. Check with your pharmacist for guidance on disposal, and consider participating in a drug take-back program in your area.
Missing a Dose
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 and after using eye drops.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- If you wear contact lenses, remove them before using the drops and wait at least 15 minutes before reinserting them.
- If you are using other eye drops, wait at least 5 minutes between applications.
- Apply pressure to the tear duct (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption and maximize local effect.
- Do not discontinue use without consulting your doctor, as this can lead to increased eye pressure and vision loss.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) twice daily, approximately 12 hours apart.
Pediatric Dosing
Neonatal:
Not established (contraindicated in infants <2 years due to risk of apnea and bradycardia)
Infant:
Not established (contraindicated in infants <2 years due to risk of apnea and bradycardia)
Child:
Not established (use with extreme caution in children 2-12 years due to high risk of systemic side effects)
Adolescent:
Not established (use with caution, consider lower systemic exposure in younger adolescents)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended for topical ophthalmic use.
Moderate:
No specific adjustment recommended for topical ophthalmic use.
Severe:
Use with caution; monitor for systemic adverse effects due to potential for increased systemic exposure.
Dialysis:
Use with caution; monitor for systemic adverse effects due to potential for increased systemic exposure.
Hepatic Impairment:
Mild:
No specific adjustment recommended for topical ophthalmic use.
Moderate:
No specific adjustment recommended for topical ophthalmic use.
Severe:
Use with caution; monitor for systemic adverse effects due to potential for increased systemic exposure.
Pharmacology
Mechanism of Action
Brimonidine is a highly selective alpha-2 adrenergic agonist that reduces aqueous humor production and increases uveoscleral outflow. Timolol is a non-selective beta-adrenergic receptor blocker that primarily reduces aqueous humor production.
Pharmacokinetics
Absorption:
Bioavailability:
Not well quantified for ocular administration; low systemic absorption for both components.
Tmax:
Brimonidine: ~1-4 hours (systemic); Timolol: ~1-3 hours (systemic)
FoodEffect:
Not applicable for ophthalmic solution.
Distribution:
Vd:
Not available (low systemic exposure)
ProteinBinding:
Brimonidine: ~29%; Timolol: ~60%
CnssPenetration:
Limited (from ocular administration)
Elimination:
HalfLife:
Brimonidine: ~2-3 hours (ocular), ~3 hours (systemic); Timolol: ~2.5-7 hours (systemic)
Clearance:
Not available
ExcretionRoute:
Renal (primarily)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 30 minutes
PeakEffect:
Approximately 1-2 hours
DurationOfAction:
Up to 12 hours
Safety & Warnings
Side Effects
Urgent 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
Slow heartbeat
Abnormal heartbeat
Chest pain
Dizziness or fainting
Muscle weakness
Heart problems, which can be rare but potentially deadly. If you experience:
+ Shortness of breath
+ Sudden 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 that bother you or do not go away, contact your doctor or seek medical help:
Eye irritation
Itching
* Burning or stinging
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
Slow heartbeat
Abnormal heartbeat
Chest pain
Dizziness or fainting
Muscle weakness
Heart problems, which can be rare but potentially deadly. If you experience:
+ Shortness of breath
+ Sudden 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 that bother you or do not go away, contact your doctor or seek medical help:
Eye irritation
Itching
* Burning or stinging
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 discomfort
- Sudden changes in vision
- Signs of an allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
- Signs of systemic effects: very slow heart rate, dizziness, fainting, unusual tiredness, shortness of breath, wheezing, swelling of ankles/feet.
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. Describe the symptoms you experienced during an allergic reaction.
Certain health conditions, including:
+ Respiratory problems 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 taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
Special Considerations for Children:
This medication is not suitable for children under 2 years of age. Do not administer this medication to a child 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.
Ensure it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.
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. Describe the symptoms you experienced during an allergic reaction.
Certain health conditions, including:
+ Respiratory problems 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 taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist.
Special Considerations for Children:
This medication is not suitable for children under 2 years of age. Do not administer this medication to a child 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.
Ensure it is safe to take this medication with all your other medications and health conditions before starting, stopping, or changing the dose of any medication. Always consult your doctor before making any changes to your medication regimen.
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 drug affects you.
This medication 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.
Regularly check your eye pressure and vision as instructed by your doctor. Additionally, notify your doctor if you have an eye infection, eye injury, or are scheduled for eye surgery.
Before consuming alcohol, marijuana, or other forms of cannabis, 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 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 risk for an even more severe reaction if exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult your doctor, as this medication may reduce the effectiveness of epinephrine.
This drug may also make it more challenging to recognize symptoms of hyperthyroidism, such as a rapid heartbeat. If you have hyperthyroidism and suddenly stop taking this medication, your condition may worsen and become life-threatening. Consult your doctor for guidance.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Before engaging in activities that require alertness or clear vision, such as driving, wait until you understand how this drug affects you.
This medication 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.
Regularly check your eye pressure and vision as instructed by your doctor. Additionally, notify your doctor if you have an eye infection, eye injury, or are scheduled for eye surgery.
Before consuming alcohol, marijuana, or other forms of cannabis, 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 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 risk for an even more severe reaction if exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, consult your doctor, as this medication may reduce the effectiveness of epinephrine.
This drug may also make it more challenging to recognize symptoms of hyperthyroidism, such as a rapid heartbeat. If you have hyperthyroidism and suddenly stop taking this medication, your condition may worsen and become life-threatening. Consult your doctor for guidance.
If you are pregnant, plan to become pregnant, or are breastfeeding, discuss the benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
Overdose Information
Overdose Symptoms:
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Bronchospasm (difficulty breathing)
- Heart failure
- Dizziness
- Fatigue
- Sedation
- Hypothermia
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine oxidase (MAO) inhibitors (due to brimonidine)
Major Interactions
- Oral beta-adrenergic blocking agents (additive systemic effects)
- Calcium channel blockers (additive hypotensive/bradycardic effects)
- Digitalis (additive bradycardic effects)
- Quinidine (can inhibit CYP2D6, increasing timolol levels)
- Reserpine and other catecholamine-depleting drugs (additive hypotensive/bradycardic effects)
Moderate Interactions
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Intraocular pressure (IOP)
Rationale: To establish baseline and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Ophthalmic examination (visual acuity, slit lamp, fundoscopy)
Rationale: To assess ocular health and rule out other conditions.
Timing: Prior to initiation of therapy.
Heart rate and blood pressure
Rationale: To assess baseline cardiovascular status, especially in patients with pre-existing cardiovascular disease, due to potential systemic absorption of timolol.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular pressure (IOP)
Frequency: Regularly, as determined by ophthalmologist (e.g., 2-4 weeks after initiation, then every 3-6 months)
Target: Individualized target IOP
Action Threshold: IOP above target range or signs of progression.
Heart rate and blood pressure
Frequency: Periodically, especially in patients with cardiovascular or pulmonary disease.
Target: Normal physiological range for the patient
Action Threshold: Significant bradycardia, hypotension, or signs of heart failure.
Ocular examination
Frequency: Annually or as clinically indicated.
Target: Stable ocular health
Action Threshold: Signs of ocular irritation, inflammation, or vision changes.
Symptom Monitoring
- Ocular irritation (redness, stinging, burning, itching)
- Blurred vision
- Dry mouth
- Fatigue
- Dizziness
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Bronchospasm (difficulty breathing, wheezing)
- Depression
- Insomnia
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Timolol has been associated with adverse effects in animal studies and has been detected in human breast milk. Brimonidine has shown some reproductive toxicity in animal studies.
Trimester-Specific Risks:
First Trimester:
Potential for fetal exposure; risk of adverse effects not fully established.
Second Trimester:
Potential for fetal exposure; risk of adverse effects not fully established.
Third Trimester:
Potential for fetal exposure; risk of adverse effects not fully established. Systemic beta-blocker effects (e.g., bradycardia, hypoglycemia) in the neonate are possible if used near term.
Lactation
Both brimonidine and timolol are excreted in human milk. Due to the potential for serious adverse reactions in nursing infants (especially bradycardia, hypotension, and apnea from timolol), 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:
High (L3 - Moderately Safe, but significant risk of adverse effects, especially in neonates/infants, due to systemic absorption of timolol).
Pediatric Use
Contraindicated in infants under 2 years of age due to the potential for increased risk of respiratory depression and bradycardia associated with timolol. Use with extreme caution in children 2-12 years of age due to high incidence and severity of systemic side effects (e.g., somnolence, bradycardia, hypothermia, apnea, hypotension).
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, greater sensitivity of some older individuals to systemic effects (e.g., cardiovascular, CNS) cannot be ruled out. Monitor for systemic adverse effects.
Clinical Information
Clinical Pearls
- This combination product offers the convenience of two medications in one drop, potentially improving patient adherence and providing enhanced IOP reduction compared to monotherapy.
- Despite being topical, systemic absorption can occur, leading to systemic side effects, particularly those associated with beta-blockade (e.g., bradycardia, hypotension, bronchospasm).
- Proper instillation technique, including nasolacrimal occlusion, can help minimize systemic absorption and maximize local drug concentration.
- Patients should be advised about potential for fatigue, drowsiness, or dizziness, especially at the start of therapy, and cautioned about driving or operating machinery.
- The preservative benzalkonium chloride (BAK) can be absorbed by soft contact lenses; patients should be advised to remove lenses before instillation and wait 15 minutes before reinserting.
Alternative Therapies
- Prostaglandin analogs (e.g., Latanoprost, Travoprost, Bimatoprost)
- Carbonic anhydrase inhibitors (e.g., Dorzolamide, Brinzolamide)
- Alpha-adrenergic agonists (e.g., Brimonidine monotherapy)
- Beta-adrenergic blockers (e.g., Timolol monotherapy, Betaxolol)
- Rho kinase inhibitors (e.g., Netarsudil)
- Miotics (e.g., Pilocarpine)
- Laser trabeculoplasty
- Glaucoma filtration surgery
Cost & Coverage
Average Cost:
Price varies widely by pharmacy and generic/brand per 10ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often preferred 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 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.