Timolol 0.25% Pf-Oph Sol 60's
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 the eye, which can damage your vision if not treated. 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, but avoid doing so if your eyes are irritated or infected.
To administer the medication:
1. Tilt your head back and gently drop the medication into your eye.
2. After use, 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 do not have specific timing requirements. Consult your pharmacist for guidance on using this medication.
Disposal
After administering the medication, discard any remaining balance. Store the foil pouch at room temperature and throw away any unused portion of an opened pouch after 30 days. Keep unused containers in their foil pouches until use. Do not freeze the medication.
Missed Dose
If you miss a dose, take 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 take two doses at the same time or use extra doses.
Important Safety Precautions
To avoid contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, lid, or other skin.
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, but avoid doing so if your eyes are irritated or infected.
To administer the medication:
1. Tilt your head back and gently drop the medication into your eye.
2. After use, 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 do not have specific timing requirements. Consult your pharmacist for guidance on using this medication.
Disposal
After administering the medication, discard any remaining balance. Store the foil pouch at room temperature and throw away any unused portion of an opened pouch after 30 days. Keep unused containers in their foil pouches until use. Do not freeze the medication.
Missed Dose
If you miss a dose, take 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 take two doses at the same time or use extra doses.
Important Safety Precautions
To avoid contamination and potential severe eye problems or vision loss, do not touch the container tip to your eye, lid, or other skin.
Lifestyle & Tips
- Wash hands thoroughly before administering eye drops.
- Do not touch the dropper tip to any surface (eye, finger, etc.) to avoid contamination.
- If using other eye drops, wait at least 5-10 minutes between applications.
- After instilling the drop, close your eye gently and apply pressure to the inner corner of your eye (near the nose) for 1-2 minutes to minimize systemic absorption and maximize local effect.
- Remove contact lenses before administration and wait at least 15 minutes before reinserting (if not preservative-free). Preservative-free formulations can be used with contacts, but consult your eye care professional.
- Store at room temperature, away from light and moisture.
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) once or twice daily.
Dose Range:
0.25 - 0.5 mg
Condition-Specific Dosing:
initialTherapy:
Start with 0.25% solution once daily. If IOP is not adequately controlled, increase to 0.5% solution once daily. If still not controlled, consider twice daily dosing or alternative/adjunctive therapy.
Pediatric Dosing
Neonatal:
Not established (use with extreme caution, risk of apnea and bradycardia)
Infant:
Not established (use with extreme caution, risk of apnea and bradycardia)
Child:
Dosing is individualized and off-label for many pediatric uses. Typically 0.25% solution once or twice daily, with careful monitoring for systemic effects.
Adolescent:
Similar to adult dosing, 0.25% or 0.5% solution once or twice daily, with careful monitoring.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Dialysis:
No specific considerations for ophthalmic use.
Hepatic Impairment:
Mild:
No adjustment needed (minimal systemic absorption)
Moderate:
No adjustment needed (minimal systemic absorption)
Severe:
No adjustment needed (minimal systemic absorption)
Pharmacology
Mechanism of Action
Timolol maleate is a non-selective beta-adrenergic receptor blocking agent. When applied topically to the eye, it reduces elevated and normal intraocular pressure (IOP), primarily 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-receptors on the ciliary epithelium.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for ophthalmic, but systemic absorption occurs.
Tmax:
Plasma concentrations peak approximately 1-2 hours after ophthalmic administration.
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not precisely quantified for ophthalmic, but widely distributed after systemic absorption.
ProteinBinding:
Approximately 60% (systemic)
CnssPenetration:
Limited (after ophthalmic administration, but systemic absorption can lead to CNS effects).
Elimination:
HalfLife:
Approximately 2.5-5 hours (systemic, after ophthalmic administration).
Clearance:
Approximately 15 L/hr (systemic).
ExcretionRoute:
Renal (primarily as metabolites, some unchanged drug).
Unchanged:
Approximately 20% (systemic).
Pharmacodynamics
OnsetOfAction:
Within 30 minutes after single dose.
PeakEffect:
1-2 hours after single dose.
DurationOfAction:
Up to 24 hours (IOP reduction).
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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
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 attention 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, contact your doctor or seek medical help if they bother you or do not go away:
Burning or stinging
Eye irritation
Dry eyes
Feeling that something is in the eye
Dizziness or headache
* Signs of a common cold
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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 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
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 attention 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, contact your doctor or seek medical help if they bother you or do not go away:
Burning or stinging
Eye irritation
Dry eyes
Feeling that something is in the eye
Dizziness or headache
* Signs of a common cold
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 changes
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- Very slow heart rate or irregular heartbeat
- Severe dizziness or fainting
- Shortness of breath, wheezing, or difficulty breathing (especially in patients with asthma or COPD)
- Swelling of ankles or feet
- Unusual tiredness or weakness
- Depression or mood changes
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. Be sure to describe the symptoms you experienced.
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 a similar medication. If you are unsure, consult your doctor or pharmacist.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Never start, stop, or change the dose of any medication without first consulting 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. Be sure to describe the symptoms you experienced.
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 a similar medication. If you are unsure, consult your doctor or pharmacist.
Please note that this is not an exhaustive list of all potential interactions with this medication. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all medications you are taking, including prescription and over-the-counter drugs, natural products, and vitamins.
Discuss all your health problems with your doctor and pharmacist.
Verify that it is safe to take this medication with all your other medications and health conditions.
* Never start, stop, or change the dose of any medication without first 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. 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. Although rare, 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 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 have a history of severe allergic reactions, inform your doctor, as you may be at risk for an even more severe reaction if you are re-exposed to the allergen. If you use epinephrine to treat severe allergic reactions, consult your doctor, as this medication may reduce the effectiveness of epinephrine.
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 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. Although rare, 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 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 have a history of severe allergic reactions, inform your doctor, as you may be at risk for an even more severe reaction if you are re-exposed to the allergen. If you use epinephrine to treat severe allergic reactions, consult your doctor, as this medication may reduce the effectiveness of epinephrine.
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 you and your baby.
Overdose Information
Overdose Symptoms:
- Severe bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Bronchospasm (difficulty breathing)
- Acute cardiac failure
- Dizziness
- Headache
- Nausea
- Vomiting
What to Do:
If overdose is suspected, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Atropine for bradycardia, isoproterenol for severe bradycardia/heart block, glucagon for refractory bradycardia, bronchodilators for bronchospasm, diuretics for cardiac failure.
Drug Interactions
Major Interactions
- Oral beta-blockers (additive systemic effects, e.g., bradycardia, hypotension)
- Calcium channel blockers (e.g., verapamil, diltiazem - risk of AV conduction disturbances, left ventricular failure, hypotension)
- Catecholamine-depleting drugs (e.g., reserpine - risk of additive hypotensive and/or bradycardic effects)
- Digitalis (risk of additive bradycardia and AV block)
Moderate Interactions
- Quinidine (can inhibit timolol metabolism via CYP2D6, leading to increased plasma levels and systemic beta-blockade)
- Clonidine (potential for rebound hypertension upon clonidine withdrawal if beta-blocker is not also withdrawn gradually)
- Adrenergic psychotropic drugs (e.g., MAOIs, TCAs - theoretical risk of exaggerated pressor response)
- Inhalation anesthetics (potential for exaggerated hypotension)
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess treatment efficacy.
Timing: Before initiating therapy.
Heart Rate and Blood Pressure
Rationale: To assess for potential systemic beta-blockade effects.
Timing: Before initiating therapy.
Respiratory Status (e.g., lung sounds, history of asthma/COPD)
Rationale: To identify patients at risk for bronchospasm.
Timing: Before initiating therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, typically 2-4 weeks after initiation/dose change, then every 3-6 months or as clinically indicated.
Target: Individualized, typically <21 mmHg or target reduction from baseline.
Action Threshold: If IOP is not adequately controlled, consider dose increase or adjunctive therapy.
Heart Rate and Blood Pressure
Frequency: Periodically, especially during initial therapy or dose changes.
Target: Maintain within normal limits for the patient.
Action Threshold: Significant bradycardia (<50 bpm) or hypotension (systolic <90 mmHg) may warrant dose reduction or discontinuation.
Signs/Symptoms of Systemic Beta-blockade (e.g., fatigue, dizziness, dyspnea)
Frequency: At each follow-up visit.
Target: Absence of significant symptoms.
Action Threshold: Presence of concerning symptoms may require re-evaluation of therapy.
Symptom Monitoring
- Blurred vision
- Eye irritation (stinging, burning, itching)
- Dry eyes
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Dizziness or lightheadedness
- Fatigue or weakness
- Dyspnea (shortness of breath) or wheezing
- Depression
- Masking of hypoglycemia symptoms in diabetics
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Systemic absorption occurs, and beta-blockers can cause adverse effects in the fetus/neonate (e.g., bradycardia, hypoglycemia, respiratory depression).
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for fetal exposure due to systemic absorption.
Second Trimester:
Potential for fetal exposure; monitor for fetal bradycardia.
Third Trimester:
Increased risk of adverse effects in the neonate (bradycardia, hypoglycemia, respiratory depression) if exposed near term. Monitor neonates for signs of beta-blockade.
Lactation
Timolol is excreted in human milk. Use with caution. The American Academy of Pediatrics considers timolol to be compatible with breastfeeding, but monitor the infant for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding).
Infant Risk:
Low to moderate risk. Potential for bradycardia, hypotension, and hypoglycemia in the infant, especially with higher maternal doses or in premature infants. Monitor infant closely.
Pediatric Use
Use with extreme caution, especially in infants and young children, due to increased risk of systemic adverse effects (e.g., apnea, bradycardia, bronchospasm, CNS depression) from systemic absorption. Dosing must be carefully individualized and monitored. Not recommended for routine use in neonates and infants.
Geriatric Use
Generally well-tolerated. However, elderly patients may be more susceptible to systemic adverse effects (e.g., bradycardia, hypotension, CNS effects) due to potential age-related decreases in renal or hepatic function, or concomitant medications. Start with lower doses and monitor closely.
Clinical Information
Clinical Pearls
- Timolol ophthalmic is a non-selective beta-blocker; therefore, it can cause systemic side effects similar to oral beta-blockers, including bradycardia, hypotension, and bronchospasm.
- Patients with a history of asthma, severe COPD, sinus bradycardia, second- or third-degree AV block, or overt cardiac failure should generally avoid timolol ophthalmic or use it with extreme caution.
- To minimize systemic absorption and maximize local effect, instruct patients to perform punctal occlusion (gently press on the inner corner of the eye for 1-2 minutes) after instilling the drop.
- Preservative-free formulations (like the 60's unit dose) are beneficial for patients with ocular surface disease or contact lens wearers, as preservatives can cause irritation.
- Monitor diabetic patients closely, as beta-blockers can mask symptoms of hypoglycemia (e.g., tachycardia).
Alternative Therapies
- Prostaglandin analogs (e.g., Latanoprost, Travoprost, Bimatoprost)
- Alpha-2 adrenergic agonists (e.g., Brimonidine)
- Carbonic anhydrase inhibitors (e.g., Dorzolamide, Brinzolamide)
- Rho kinase inhibitors (e.g., Netarsudil)
- Cholinergic agonists (e.g., Pilocarpine - less common first-line)
Cost & Coverage
Average Cost:
$30 - $100 per 60 single-use vials (0.25% or 0.5%)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (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 your 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.