Timolol Hemi 0.5% Ophth Soln 15ml

Manufacturer SOMERSET THERAPEUTICS Active Ingredient Timolol Eye Drops (Bottle)(TIM oh lol) Pronunciation TIM-oh-lol
It is used to treat glaucoma.It is used to lower high eye pressure.
đŸˇī¸
Drug Class
Antiglaucoma agent
đŸ§Ŧ
Pharmacologic Class
Non-selective beta-adrenergic blocker
🤰
Pregnancy Category
Category C
✅
FDA Approved
Sep 1978
âš–ī¸
DEA Schedule
Not Controlled

Overview

â„šī¸

What is this medicine?

Timolol eye drops are used to lower high pressure inside your eyes, which can help prevent vision loss from 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 and potentially cause severe eye problems or vision loss.

Tilt your head back and gently drop the medication into your eye. 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. Use a tissue to 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. Some products are designed for morning use if taken once daily, while others may not have 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 the medication.

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 make up for a missed dose.
💡

Lifestyle & Tips

  • Wash hands thoroughly before and after use.
  • Do not touch the dropper tip to any surface (eye, finger, etc.) to avoid contamination.
  • Tilt head back, pull down lower eyelid, and look up. Gently squeeze one drop into the eye. Close eye gently for 1-2 minutes.
  • Apply gentle pressure to the inner corner of the eye (nasolacrimal occlusion) for 1-2 minutes after instillation to minimize systemic absorption and side effects.
  • If using other eye drops, wait at least 5-10 minutes between medications.
  • Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.

Dosing & Administration

đŸ‘¨â€âš•ī¸

Adult Dosing

Standard Dose: 1 drop in the affected eye(s) twice daily
Dose Range: 0.25 - 0.5 mg

Condition-Specific Dosing:

initial_therapy: 0.25% solution, if response is insufficient, may increase to 0.5% solution.
đŸ‘ļ

Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with extreme caution due to increased risk of systemic side effects)
Child: Not established
Adolescent: Not established
âš•ī¸

Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed for ophthalmic use
Moderate: No adjustment typically needed for ophthalmic use
Severe: No adjustment typically needed for ophthalmic use, but monitor for systemic effects if significant renal impairment is present
Dialysis: No specific adjustment for ophthalmic use; systemic absorption is minimal but monitor for systemic effects

Hepatic Impairment:

Mild: No adjustment typically needed for ophthalmic use
Moderate: No adjustment typically needed for ophthalmic use
Severe: No adjustment typically needed for ophthalmic use, but monitor for systemic effects if significant hepatic impairment is present

Pharmacology

đŸ”Ŧ

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. A slight increase in aqueous outflow may also contribute to the IOP-lowering effect.
📊

Pharmacokinetics

Absorption:

Bioavailability: Variable systemic absorption from ophthalmic administration (estimated 50-70% of applied dose can be absorbed systemically)
Tmax: Systemic Tmax: Approximately 1-2 hours after oral administration; not well-defined for ophthalmic systemic absorption but IOP reduction peaks around 1-2 hours.
FoodEffect: Not applicable for ophthalmic formulation

Distribution:

Vd: Approximately 1.7 L/kg (systemic)
ProteinBinding: Approximately 10%
CnssPenetration: Limited (systemic absorption can lead to CNS effects, but direct penetration from ophthalmic use is low)

Elimination:

HalfLife: Approximately 2-4 hours (systemic)
Clearance: Approximately 500 mL/min (systemic)
ExcretionRoute: Renal (primarily as metabolites, some unchanged drug)
Unchanged: Approximately 20% (systemic)
âąī¸

Pharmacodynamics

OnsetOfAction: Within 30 minutes
PeakEffect: 1-2 hours
DurationOfAction: 12-24 hours

Safety & Warnings

âš ī¸

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 help immediately:
+ Shortness of breath
+ Significant 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:

  • Slow or irregular heartbeat
  • Dizziness or lightheadedness, especially when standing up
  • Shortness of breath, wheezing, or difficulty breathing
  • Chest pain
  • Severe eye irritation, redness, or pain
  • Sudden vision changes
  • Signs of allergic reaction (rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
📋

Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, 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.
âš ī¸

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, particularly in individuals with asthma. If you have any questions or concerns, 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, potentially leading to life-threatening consequences. Consult your doctor for guidance.

If you have a history of severe allergic reactions, inform your doctor, as you may be at increased risk of a more severe reaction if you are re-exposed to the allergen. Furthermore, 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 potential 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 (very slow heart rate)
  • Hypotension (very low blood pressure)
  • Bronchospasm (difficulty breathing, wheezing)
  • Acute cardiac failure
  • Dizziness
  • Fainting

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For accidental ingestion or overdose, contact a poison control center (e.g., 1-800-222-1222 in the US).

Drug Interactions

đŸšĢ

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)
  • Calcium channel blockers (e.g., verapamil, diltiazem) (risk of AV conduction disturbances, left ventricular failure, hypotension)
  • Catecholamine-depleting drugs (e.g., reserpine, guanethidine) (additive hypotensive effects, bradycardia)
  • Digitalis and calcium antagonists (additive effects on AV conduction time)
  • Quinidine (increased plasma levels of timolol)
  • Clonidine (potential for rebound hypertension upon withdrawal of clonidine while on beta-blocker)
🟡

Moderate Interactions

  • Adrenergic psychostimulants (e.g., amphetamines) (reduced effect of stimulant)
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (may reduce hypotensive effect of beta-blockers)
  • Insulin and oral hypoglycemic agents (beta-blockers may mask signs of hypoglycemia)
đŸŸĸ

Minor Interactions

  • Not available

Monitoring

đŸ”Ŧ

Baseline Monitoring

Intraocular Pressure (IOP)

Rationale: To establish baseline and assess efficacy of treatment

Timing: Before initiation of therapy

Heart Rate and Blood Pressure

Rationale: To monitor for systemic beta-blockade effects (bradycardia, hypotension)

Timing: Before initiation of therapy

Respiratory Status (e.g., lung auscultation, history of asthma/COPD)

Rationale: To identify contraindications or risk of bronchospasm

Timing: Before 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 (e.g., 10-21 mmHg, or lower depending on disease severity)

Action Threshold: IOP above target range, or signs of disease progression

Heart Rate and Blood Pressure

Frequency: Periodically (e.g., annually or as clinically indicated)

Target: Normal physiological range (e.g., HR > 50 bpm, SBP > 90 mmHg)

Action Threshold: Significant bradycardia (<50 bpm), hypotension, or symptomatic changes

Ocular Examination (e.g., slit lamp, fundoscopy)

Frequency: Regularly, as determined by ophthalmologist

Target: Not applicable

Action Threshold: Signs of ocular irritation, inflammation, or disease progression

đŸ‘ī¸

Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness, fainting)
  • Bronchospasm (shortness of breath, wheezing, difficulty breathing)
  • Fatigue
  • Depression
  • Blurred vision
  • Eye irritation, burning, stinging, itching
  • Dry eyes
  • Conjunctivitis

Special Patient Groups

🤰

Pregnancy

Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been shown to be embryotoxic in rabbits at doses 100 times the maximum recommended human oral dose and fetotoxic in rats at doses 1000 times the maximum recommended human oral dose.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity based on animal studies; human data limited.
Second Trimester: Potential for fetal bradycardia, growth restriction; human data limited.
Third Trimester: Potential for neonatal bradycardia, hypotension, respiratory depression, and hypoglycemia if exposed near term due to systemic absorption.
🤱

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: Risk of systemic beta-blockade effects in the infant (e.g., bradycardia, hypotension, respiratory depression, hypoglycemia). Monitor infant for these signs.
đŸ‘ļ

Pediatric Use

Safety and efficacy in pediatric patients have not been established. Use with extreme caution in infants and young children due to increased systemic absorption and higher risk of systemic adverse effects (e.g., bradycardia, apnea, central nervous system depression).

👴

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. However, caution is advised in elderly patients with pre-existing cardiac or pulmonary conditions due to the potential for systemic beta-blockade effects.

Clinical Information

💎

Clinical Pearls

  • Always instruct patients on proper instillation technique, including nasolacrimal occlusion, to minimize systemic absorption and potential side effects.
  • Timolol can mask the signs and symptoms of acute hypoglycemia in diabetic patients and hyperthyroidism (e.g., tachycardia).
  • Patients with a history of severe cardiac or pulmonary disease should be carefully evaluated before initiating timolol ophthalmic due to the risk of systemic effects.
  • If a patient is already on an oral beta-blocker, monitor closely for additive systemic effects when initiating timolol ophthalmic.
  • Withdrawal of systemic beta-blockers should be gradual; while ophthalmic absorption is less, abrupt discontinuation of timolol ophthalmic in patients with severe coronary artery disease may exacerbate angina, myocardial infarction, or ventricular arrhythmia.
🔄

Alternative Therapies

  • Prostaglandin analogs (e.g., latanoprost, bimatoprost, travoprost)
  • 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
  • Surgical procedures (e.g., trabeculectomy)
💰

Cost & Coverage

Average Cost: Varies widely (e.g., $15-$50) per 5ml or 15ml bottle
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
📚

General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it is a good idea to consult with your pharmacist to confirm. If you have any questions or concerns about your medication, do not hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information about the medication taken, the quantity, and the time it occurred, as this will help healthcare professionals provide the most effective treatment.