Timolol Hemi 0.5% Ophth Soln 10ml
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, Ophthalmic
Pregnancy Category
Category C
FDA Approved
Sep 1978
DEA Schedule
Not Controlled
Overview
What is this medicine?
Timolol eye drops are a medication used to lower high pressure inside the eye, which is often caused by glaucoma. It works by reducing the amount of fluid your eye produces. Lowering this pressure helps prevent damage to your optic nerve and can save your vision.
How to Use This Medicine
Proper Use of This Medication
To use this eye medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. Take the medication at the same time every day.
Administration Instructions
1. Remove your contact lenses before using this medication. You can put them back in 15 minutes after administration, unless your eyes are irritated or infected.
2. Avoid touching the container tip to your eye, lid, or skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
3. Tilt your head back and gently drop the medication into your eye.
4. After administration, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
5. Gently blot any excess solution from your eyelid.
Using Multiple Eye Medications
If you are using more than one eye medication, administer each medication at least 5 minutes apart.
Special Instructions
Some products are designed for morning use if taken once daily, while others do not have specific timing requirements. Consult with your pharmacist to determine the best schedule for your medication.
Storage and Disposal
Store the medication in an upright position at room temperature, away from light and freezing temperatures.
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 once or use extra doses.
To use this eye medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve. Take the medication at the same time every day.
Administration Instructions
1. Remove your contact lenses before using this medication. You can put them back in 15 minutes after administration, unless your eyes are irritated or infected.
2. Avoid touching the container tip to your eye, lid, or skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
3. Tilt your head back and gently drop the medication into your eye.
4. After administration, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
5. Gently blot any excess solution from your eyelid.
Using Multiple Eye Medications
If you are using more than one eye medication, administer each medication at least 5 minutes apart.
Special Instructions
Some products are designed for morning use if taken once daily, while others do not have specific timing requirements. Consult with your pharmacist to determine the best schedule for your medication.
Storage and Disposal
Store the medication in an upright position at room temperature, away from light and freezing temperatures.
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 once or use extra doses.
Lifestyle & Tips
- Wash hands thoroughly before and after applying eye drops.
- Tilt your head back, pull down your lower eyelid to form a pocket, and instill one drop into the pocket. Close your eye gently for 1-2 minutes, and apply gentle pressure to the inner corner of your eye (near the nose) to minimize systemic absorption.
- Avoid touching the dropper tip to your eye or any other surface to prevent contamination.
- If using other eye drops, wait at least 5-10 minutes between applications.
- Remove contact lenses before instilling the drops and wait at least 15 minutes before reinserting them.
- Do not stop using the eye drops without consulting your doctor, even if you feel well, as glaucoma is a chronic condition that requires continuous treatment.
- Inform your doctor about all other medications you are taking, including over-the-counter drugs, supplements, and herbal products, especially if you have heart or lung conditions.
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 0.5% solution in the affected eye(s) twice daily
Dose Range:
0.25 - 0.5 mg
Condition-Specific Dosing:
ocularHypertension:
1 drop of 0.5% solution in the affected eye(s) twice daily
openAngleGlaucoma:
1 drop of 0.5% solution in the affected eye(s) twice daily
Pediatric Dosing
Neonatal:
Not established, use with extreme caution due to potential for systemic effects (e.g., bradycardia, apnea). Lower concentrations (0.25%) and once daily dosing may be considered if absolutely necessary.
Infant:
Not established, use with extreme caution due to potential for systemic effects (e.g., bradycardia, apnea). Lower concentrations (0.25%) and once daily dosing may be considered if absolutely necessary.
Child:
Not established for routine use. If used, lower concentrations (0.25%) and once daily dosing are often preferred to minimize systemic absorption. Close monitoring for systemic adverse effects is crucial.
Adolescent:
Generally similar to adult dosing, but caution and monitoring for systemic effects are advised, especially in younger adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required for ophthalmic use due to minimal systemic absorption.
Moderate:
No specific adjustment required for ophthalmic use due to minimal systemic absorption.
Severe:
No specific adjustment required for ophthalmic use due to minimal systemic absorption, but caution is advised in patients with severe systemic renal impairment where even minimal absorption could be problematic.
Dialysis:
No specific adjustment required for ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment required for ophthalmic use due to minimal systemic absorption.
Moderate:
No specific adjustment required for ophthalmic use due to minimal systemic absorption.
Severe:
No specific adjustment required for ophthalmic use due to minimal systemic absorption, but caution is advised in patients with severe systemic hepatic impairment where even minimal absorption could be problematic.
Pharmacology
Mechanism of Action
Timolol is a non-selective beta-adrenergic receptor blocking agent. When applied topically to the eye, it reduces elevated and normal intraocular pressure (IOP) by reducing the production of aqueous humor. The exact mechanism of action for reducing aqueous humor formation is not precisely established but is thought to involve blockade of beta-2 receptors on the ciliary epithelium. It does not significantly affect aqueous humor outflow.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified for ophthalmic use, but systemic absorption occurs via conjunctival vessels and nasal mucosa.
Tmax:
1-2 hours (systemic plasma concentrations after ocular administration)
FoodEffect:
Not applicable for ophthalmic administration.
Distribution:
Vd:
Not available (for ophthalmic use)
ProteinBinding:
Approximately 10% (systemic)
CnssPenetration:
Limited (with ophthalmic use, but can occur with significant systemic absorption)
Elimination:
HalfLife:
Approximately 2-4 hours (systemic)
Clearance:
Not available (for ophthalmic use)
ExcretionRoute:
Primarily renal (as metabolites and unchanged drug)
Unchanged:
Approximately 20% (systemic, excreted unchanged in urine)
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
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 right away:
+ 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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency 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 right away:
+ 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
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe eye irritation, redness, or pain
- Blurred vision or other vision changes
- Very slow heart rate (bradycardia)
- Dizziness or lightheadedness
- Shortness of breath, wheezing, or difficulty breathing (especially if you have asthma or COPD)
- Chest pain
- Swelling of ankles or feet
- Unusual fatigue 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:
+ Breathing problems, such as 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.
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. They will help determine if 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 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:
+ Breathing problems, such as 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.
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. They will help determine if 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 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. 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 make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid 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 exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, discuss this with your doctor, as the medication may not be as effective while you are 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 make it more challenging to recognize symptoms of an overactive thyroid, such as a rapid heartbeat. If you have an overactive thyroid 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 exposed to the allergen again. If you use epinephrine to treat severe allergic reactions, discuss this with your doctor, as the medication may not be as effective while you are 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 (low blood pressure)
- Bronchospasm (difficulty breathing)
- Acute cardiac failure
- Dizziness
- Headache
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222. Treatment is supportive and symptomatic, and may include atropine for bradycardia, isoproterenol for bronchospasm, or cardiac pacing for severe heart block.
Drug Interactions
Contraindicated Interactions
- Patients with bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease (COPD)
- Sinus bradycardia
- Second or third degree atrioventricular block
- Overt cardiac failure
- Cardiogenic shock
Major Interactions
- Oral beta-adrenergic blocking agents (additive systemic effects, e.g., bradycardia, hypotension)
- Oral calcium channel blockers (e.g., verapamil, diltiazem) - potential for AV conduction disturbances, left ventricular failure, and hypotension
- Catecholamine-depleting drugs (e.g., reserpine, guanethidine) - potential for additive effects leading to hypotension and/or marked bradycardia
- Quinidine (increased plasma levels of timolol due to CYP2D6 inhibition, leading to enhanced systemic beta-blockade)
Moderate Interactions
- Digitalis glycosides (additive effects on AV conduction, leading to bradycardia)
- Clonidine (potential for rebound hypertension if clonidine is withdrawn abruptly while on a beta-blocker)
- Adrenergic psychotropic drugs (e.g., MAOIs, tricyclic antidepressants) - potential for exaggerated hypertensive response
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess efficacy of treatment.
Timing: Prior to initiation of therapy.
Visual Acuity and Visual Fields
Rationale: To establish baseline ocular function and monitor disease progression.
Timing: Prior to initiation of therapy.
Optic Nerve Head Examination
Rationale: To assess baseline optic nerve health and monitor for glaucomatous damage.
Timing: Prior to initiation of therapy.
Cardiac and Pulmonary History
Rationale: To identify contraindications or risk factors for systemic adverse effects (e.g., asthma, COPD, bradycardia, heart block).
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, typically 10-21 mmHg or lower depending on disease severity.
Action Threshold: IOP above target range, significant fluctuations, or progression of optic nerve damage/visual field loss.
Visual Fields
Frequency: Annually or more frequently if progression is suspected.
Target: Stable visual field.
Action Threshold: Progression of visual field defects.
Optic Nerve Head Examination (e.g., OCT)
Frequency: Annually or more frequently if progression is suspected.
Target: Stable optic nerve appearance.
Action Threshold: Progression of optic nerve damage.
Heart Rate and Blood Pressure
Frequency: Periodically, especially in patients with pre-existing cardiovascular conditions or symptoms.
Target: Within normal limits for the patient.
Action Threshold: Significant bradycardia (<50 bpm), hypotension, or new onset of cardiac symptoms.
Respiratory Status
Frequency: Periodically, especially in patients with pre-existing respiratory conditions.
Target: Normal breathing, no exacerbation of respiratory symptoms.
Action Threshold: New or worsening shortness of breath, wheezing, or other respiratory distress.
Symptom Monitoring
- Blurred vision
- Eye irritation (stinging, burning)
- Bradycardia (slow heart rate)
- Hypotension (low blood pressure)
- Dizziness
- Fatigue
- Bronchospasm (difficulty breathing, wheezing)
- Exacerbation of asthma or COPD symptoms
- Depression
- Headache
Special Patient Groups
Pregnancy
Timolol is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption can occur, and beta-blockers have been associated with adverse effects in the fetus/neonate (e.g., bradycardia, hypoglycemia, respiratory depression).
Trimester-Specific Risks:
First Trimester:
Limited data, but potential for fetal exposure. Use only if clearly needed.
Second Trimester:
Potential for fetal exposure. Monitor for fetal bradycardia and growth restriction.
Third Trimester:
Increased risk of neonatal bradycardia, hypoglycemia, and respiratory depression if used close to delivery. Monitor neonate closely for these effects.
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. Monitor the infant for signs of beta-blockade (e.g., bradycardia, lethargy, poor feeding).
Infant Risk:
L3 (Moderately Safe) - Potential for systemic effects in the infant, though risk is generally low with ophthalmic use. Monitor for bradycardia, hypotension, and respiratory depression.
Pediatric Use
Safety and efficacy in pediatric patients have not been established in controlled clinical trials. Use in pediatric patients, especially infants and neonates, should be approached with extreme caution due to the potential for increased systemic absorption and severe systemic adverse effects (e.g., bradycardia, apnea, central nervous system depression). Lower concentrations (0.25%) and once-daily dosing are often preferred, with close monitoring.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, elderly patients may be more susceptible to systemic adverse effects (e.g., bradycardia, hypotension) due to age-related physiological changes or co-morbidities. Use with caution and monitor for systemic effects, especially in those with pre-existing cardiac or pulmonary conditions.
Clinical Information
Clinical Pearls
- Timolol is a first-line agent for many forms of glaucoma due to its efficacy and relatively low cost.
- Always instruct patients on proper instillation technique to minimize systemic absorption and maximize ocular effect (e.g., nasolacrimal occlusion).
- Be aware of potential systemic side effects, especially in patients with a history of asthma, COPD, bradycardia, or heart block, even with ophthalmic use.
- If a patient experiences significant systemic side effects, consider switching to a more selective beta-blocker (e.g., betaxolol) or another class of IOP-lowering medication.
- Some formulations (e.g., Timoptic-XE) are gel-forming and allow for once-daily dosing, which can improve adherence.
- Regular monitoring of IOP is crucial, but also assess optic nerve and visual fields for disease progression.
Alternative Therapies
- Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost)
- Alpha-adrenergic agonists (e.g., brimonidine, apraclonidine)
- Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide, acetazolamide)
- Miotics (e.g., pilocarpine)
- Rho kinase inhibitors (e.g., netarsudil)
- Laser trabeculoplasty
- Glaucoma filtration surgery
Cost & Coverage
Average Cost:
$15 - $40 per 10ml bottle (0.5%)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.