Timolol Maleate 0.25% Opht Sol 15ml
It is used to treat glaucoma.It is used to lower high eye pressure.
Drug Class
Antiglaucoma Agent
Pharmacologic Class
Non-selective Beta-Adrenergic Blocker
Pregnancy Category
Category C
FDA Approved
Sep 1978
DEA Schedule
Not Controlled
Overview
What is this medicine?
Timolol eye drops are used to lower high pressure inside your eye, which can be caused by conditions like glaucoma. It works by reducing the amount of fluid your eye makes.
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. Use this medication as directed, even if your symptoms improve. Take it at the same time every day.
Administration
This medication is for use in the eyes only. Before using, remove your contact lenses. You can put them back in 15 minutes after administering the medication, unless your eyes are irritated or infected.
To avoid contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
1. Tilt your head back and gently drop the medication into your eye.
2. After administration, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
3. Gently blot any excess solution from your eyelid.
If you are using multiple medications in the same eye, wait at least 5 minutes between each application.
Special Instructions
Some products are designed for morning use if taken once daily, while others have no specific timing requirements. Consult your pharmacist for guidance on using this medication.
Storage and Disposal
Store the medication in an upright position at room temperature, away from light. Do not freeze.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once or use extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Use this medication as directed, even if your symptoms improve. Take it at the same time every day.
Administration
This medication is for use in the eyes only. Before using, remove your contact lenses. You can put them back in 15 minutes after administering the medication, unless your eyes are irritated or infected.
To avoid contamination, do not touch the container tip to your eye, eyelid, or surrounding skin, as this can lead to bacterial infection, severe eye problems, or vision loss.
1. Tilt your head back and gently drop the medication into your eye.
2. After administration, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
3. Gently blot any excess solution from your eyelid.
If you are using multiple medications in the same eye, wait at least 5 minutes between each application.
Special Instructions
Some products are designed for morning use if taken once daily, while others have no specific timing requirements. Consult your pharmacist for guidance on using this medication.
Storage and Disposal
Store the medication in an upright position at room temperature, away from light. Do not freeze.
Missed Dose
If you miss a dose, take it as soon as you remember. If it is close to the time for your next dose, skip the missed dose and resume your regular schedule. Do not take two doses at once or use extra doses.
Lifestyle & Tips
- Follow your doctor's dosing instructions carefully.
- Wash your hands before applying the eye drops.
- Do not touch the dropper tip to your eye or any other surface to prevent contamination.
- Remove contact lenses before applying the drops and wait at least 15 minutes before reinserting them.
- If using other eye drops, wait at least 5-10 minutes between applications.
- Close your eye gently and apply pressure to the inner corner of your eye (near the nose) for 1-2 minutes after instilling the drop to minimize systemic absorption and maximize local effect.
Available Forms & Alternatives
Available Strengths:
- Timolol Maleate 10mg Tablets
- Timolol Maleate 20mg Tablets
- Timolol Maleate 0.25% Opht Sol 5ml
- Timolol Maleate 0.25% Opht Sol 10ml
- Timolol Maleate 0.25% Opht Sol 15ml
- Timolol Maleate 0.5% Ophth Soln 5ml
- Timolol Maleate 0.5% Ophth Sol 10ml
- Timolol Maleate 0.5% Ophth Sol 15ml
- Timolol Maleate 5mg Tablets
- Timolol 0.25% GF Ophth Soln 5ml
- Timolol 0.5% GF Opth Soln 5ml
- Timolol Mal 0.5% Op Sol-Once Daily
- Timolol Mal 0.5% Op Sol-Once Daily
- Timolol Mal 0.5% Ophth Sol 60s
- Timolol 0.25% Pf-Oph Sol 60's
- Timolol Hemi 0.5% Ophth Soln 5ml
- Timolol Hemi 0.5% Ophth Soln 10ml
- Timolol Hemi 0.5% Ophth Soln 15ml
Dosing & Administration
Adult Dosing
Standard Dose:
1 drop of 0.25% or 0.5% solution in the affected eye(s) twice daily
Dose Range:
0.25 - 0.5 mg
Condition-Specific Dosing:
initial_therapy:
0.25% solution twice daily; if response is not adequate, dosage may be increased to 0.5% solution twice daily.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution due to risk of systemic effects like apnea and bradycardia)
Infant:
Not established (use with extreme caution due to risk of systemic effects like apnea and bradycardia)
Child:
Not routinely recommended; if used, 0.25% once or twice daily with careful monitoring for systemic effects. Off-label use.
Adolescent:
Similar to adult dosing, 0.25% or 0.5% solution twice daily, with careful monitoring.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for ophthalmic use.
Moderate:
No specific adjustment needed for ophthalmic use; monitor for systemic effects if severe impairment.
Severe:
No specific adjustment needed for ophthalmic use; monitor for systemic effects due to potential for accumulation of systemically absorbed drug.
Dialysis:
Considerations: Low systemic absorption, but monitor for systemic effects.
Hepatic Impairment:
Mild:
No specific adjustment needed for ophthalmic use.
Moderate:
No specific adjustment needed for ophthalmic use; monitor for systemic effects if severe impairment.
Severe:
No specific adjustment needed for ophthalmic use; monitor for systemic effects due to potential for accumulation of systemically absorbed drug.
Confidence:
Medium
Pharmacology
Mechanism of Action
Timolol maleate is a non-selective beta-adrenergic receptor blocker. It reduces elevated and normal intraocular pressure (IOP) by decreasing the production of aqueous humor. The exact mechanism of action for reducing aqueous humor production is not precisely established but is thought to involve blockade of beta-2 receptors on the ciliary epithelium.
Pharmacokinetics
Absorption:
Bioavailability:
Low but variable systemic absorption after ocular administration (not precisely quantified for ophthalmic use, but systemic effects can occur).
Tmax:
Approximately 1-2 hours (for systemic plasma concentrations after ocular administration).
FoodEffect:
Not applicable for ophthalmic solution.
Distribution:
Vd:
Not precisely quantified for ophthalmic use; distributes widely in tissues after systemic absorption.
ProteinBinding:
Approximately 10% (low).
CnssPenetration:
Limited (for ophthalmic use, but systemic absorption can lead to CNS effects).
Elimination:
HalfLife:
Approximately 2-4 hours (systemic half-life).
Clearance:
Primarily renal clearance of metabolites.
ExcretionRoute:
Renal (primarily as metabolites).
Unchanged:
<20% (systemically absorbed drug).
Pharmacodynamics
OnsetOfAction:
Within 30 minutes.
PeakEffect:
1-2 hours.
DurationOfAction:
12-24 hours.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Eye problems, such as:
+ Change in eyesight
+ Eye pain
+ Severe eye irritation
Cardiovascular symptoms, such as:
+ Very bad dizziness or passing out
+ Slow heartbeat
+ Abnormal heartbeat
+ Chest pain
Muscle weakness
Heart failure, which can be life-threatening. If you experience any of the following, seek medical help immediately:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
+ Bulging neck veins
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 if they bother you or do not go away, contact your doctor:
Burning or stinging
Eye irritation
Dry eyes
Feeling of something in the eye
Dizziness or headache
Signs of a common cold
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Eye problems, such as:
+ Change in eyesight
+ Eye pain
+ Severe eye irritation
Cardiovascular symptoms, such as:
+ Very bad dizziness or passing out
+ Slow heartbeat
+ Abnormal heartbeat
+ Chest pain
Muscle weakness
Heart failure, which can be life-threatening. If you experience any of the following, seek medical help immediately:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
+ Bulging neck veins
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 if they bother you or do not go away, contact your doctor:
Burning or stinging
Eye irritation
Dry eyes
Feeling of something in the eye
Dizziness or headache
Signs of a common cold
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns, 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:
- Slow or irregular heartbeat
- Dizziness or lightheadedness
- Unusual tiredness or weakness
- Shortness of breath or wheezing
- Swelling of ankles or feet
- Severe eye irritation, pain, or vision changes
- Symptoms of depression (e.g., persistent sadness, loss of interest)
Before Using This Medicine
Before taking this medication, it is essential to inform your doctor about the following:
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
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 using another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine if the medications are similar.
It is crucial to note that this is not an exhaustive list of all potential interactions between this medication and other drugs or health conditions. Therefore, it is vital to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including all health problems
Before starting, stopping, or adjusting the dose of any medication, including this one, you must consult with your doctor to ensure your safety.
Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced as a result of the allergy.
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 using another medication similar to this one. If you are unsure, consult your doctor or pharmacist to determine if the medications are similar.
It is crucial to note that this is not an exhaustive list of all potential interactions between this medication and other drugs or health conditions. Therefore, it is vital to inform your doctor and pharmacist about:
All prescription and over-the-counter medications you are taking
Any natural products or vitamins you are using
Your complete medical history, including all health problems
Before starting, stopping, or adjusting the dose of any medication, including this one, you must consult with your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When performing tasks that require clear vision, such as driving, exercise caution to ensure your safety.
This medication may mask certain symptoms of low blood sugar, including 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, undergoing surgery, or experiencing nausea and vomiting. If you have any questions or concerns, consult your doctor.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. Additionally, follow your doctor's recommendations for regular eye pressure and vision checks.
Notify your doctor if you have an eye infection, eye injury, or are scheduled to undergo eye surgery. In rare cases, this medication has been associated with severe respiratory problems, which can be life-threatening, especially in individuals with asthma. If you have any questions, discuss them with your doctor.
This medication may also conceal symptoms of an overactive thyroid, 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 have a history of severe allergic reactions, inform your doctor, as you may be at risk of an even more severe reaction if you are re-exposed to the allergen. If you use epinephrine to treat severe allergic reactions, discuss this with your doctor, as the medication may be less effective while taking this drug.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
This medication may mask certain symptoms of low blood sugar, including 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, undergoing surgery, or experiencing nausea and vomiting. If you have any questions or concerns, consult your doctor.
If you have diabetes, it is crucial to closely monitor your blood sugar levels. Additionally, follow your doctor's recommendations for regular eye pressure and vision checks.
Notify your doctor if you have an eye infection, eye injury, or are scheduled to undergo eye surgery. In rare cases, this medication has been associated with severe respiratory problems, which can be life-threatening, especially in individuals with asthma. If you have any questions, discuss them with your doctor.
This medication may also conceal symptoms of an overactive thyroid, 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 have a history of severe allergic reactions, inform your doctor, as you may be at risk of an even more severe reaction if you are re-exposed to the allergen. If you use epinephrine to treat severe allergic reactions, discuss this with your doctor, as the medication may be less effective while taking this drug.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
Overdose Information
Overdose Symptoms:
- Severe bradycardia (very slow heart rate)
- Hypotension (very low blood pressure)
- Bronchospasm (difficulty breathing, wheezing)
- Acute cardiac failure
- Dizziness
- Fainting
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US). Management is supportive and symptomatic, potentially including atropine for bradycardia, beta-adrenergic stimulants for bronchospasm, and diuretics/digitalis for cardiac failure.
Drug Interactions
Contraindicated Interactions
- Bronchial asthma
- History of bronchial asthma
- Severe chronic obstructive pulmonary disease (COPD)
- Sinus bradycardia
- Second or third degree atrioventricular block
- Overt cardiac failure
- Cardiogenic shock
Major Interactions
- Oral beta-blockers (additive systemic effects)
- Calcium channel blockers (e.g., verapamil, diltiazem - additive effects on AV conduction or myocardial contractility)
- Digitalis (additive bradycardia)
- Quinidine (increased timolol plasma levels due to CYP2D6 inhibition)
- Clonidine (potential for paradoxical hypertension upon clonidine withdrawal)
- Reserpine and other catecholamine-depleting drugs (e.g., guanethidine - additive hypotensive and bradycardic effects)
Moderate Interactions
- General anesthetics (additive myocardial depression)
- Adrenergic psychotropics (e.g., MAOIs, TCAs - potential for exaggerated hypertensive response)
- Insulin and oral hypoglycemic agents (masking of hypoglycemia symptoms)
Minor Interactions
- Not specifically listed for ophthalmic timolol, but general caution with other ophthalmic preparations to avoid wash-out.
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess efficacy of treatment.
Timing: Before initiating therapy.
Heart Rate and Blood Pressure
Rationale: To assess baseline cardiovascular status due to potential for systemic absorption and beta-blocker effects.
Timing: Before initiating therapy.
Respiratory Status (History of Asthma/COPD)
Rationale: To identify contraindications or high-risk patients.
Timing: Before initiating therapy.
Cardiac History (Bradycardia, Heart Block, Heart Failure)
Rationale: To identify contraindications or high-risk patients.
Timing: Before initiating 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, typically 10-21 mmHg, or as determined by physician.
Action Threshold: IOP not adequately controlled, or significant fluctuations.
Heart Rate and Blood Pressure
Frequency: Periodically, especially if systemic symptoms occur or with concomitant use of other cardiovascular medications.
Target: Normal physiological range for the patient.
Action Threshold: Significant bradycardia (<50 bpm), hypotension, or symptomatic changes.
Respiratory Symptoms (e.g., shortness of breath, wheezing)
Frequency: Ongoing patient self-monitoring and clinician inquiry.
Target: Absence of new or worsening respiratory symptoms.
Action Threshold: Development of new or worsening respiratory symptoms, especially in patients with pre-existing respiratory conditions.
Symptom Monitoring
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Dizziness or lightheadedness
- Fatigue or weakness
- Bronchospasm (wheezing, shortness of breath, difficulty breathing)
- Blurred vision or other visual disturbances
- Eye irritation, redness, or discomfort
- Depression
- Masking of hypoglycemia symptoms (in diabetic patients)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, and there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm; avoid if possible.
Second Trimester:
Potential for fetal harm; avoid if possible.
Third Trimester:
Potential for fetal harm, including bradycardia, hypotension, and respiratory depression in the neonate if used close to delivery. Avoid if possible.
Lactation
Timolol is excreted in human milk. Due to the potential for serious adverse reactions in nursing infants 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:
Moderate risk (L3). Potential for bradycardia, hypotension, and respiratory depression in the infant due to systemic absorption.
Pediatric Use
Use with caution, especially in infants and young children, due to increased risk of systemic absorption and adverse effects (e.g., apnea, bradycardia, bronchospasm). Not recommended for neonates. Close monitoring for systemic effects is crucial if used off-label.
Geriatric Use
No specific dose adjustment is typically needed. However, elderly patients may be more sensitive to the systemic effects of beta-blockers, so monitor closely for bradycardia, hypotension, and respiratory symptoms.
Clinical Information
Clinical Pearls
- Despite being an eye drop, timolol can be systemically absorbed and cause systemic beta-blocker side effects, especially in susceptible individuals (e.g., those with asthma, COPD, heart block, or heart failure).
- Proper instillation technique, including nasolacrimal occlusion (pressing on the inner corner of the eye after instilling the drop), can help minimize systemic absorption and maximize local ocular effect.
- Timolol is often a first-line agent for open-angle glaucoma due to its efficacy and once or twice daily dosing.
- Patients should be advised to inform all healthcare providers about their timolol use, especially before surgery or if starting new medications, due to potential drug interactions.
- Regular monitoring of intraocular pressure is essential to ensure the drug's effectiveness.
Alternative Therapies
- Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost)
- Alpha-adrenergic agonists (e.g., brimonidine, apraclonidine)
- Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide)
- Miotics (e.g., pilocarpine)
- Rho kinase inhibitors (e.g., netarsudil)
- Laser trabeculoplasty
- Surgical interventions (e.g., trabeculectomy)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 15ml bottle of 0.25% solution
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Brand)
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 overdose, including the medication taken, the amount, and the time it occurred.