Betimol 0.5% Ophthalmic Soln 5ml

Manufacturer AKORN 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.
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Drug Class
Antiglaucoma agent
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Pharmacologic Class
Beta-adrenergic blocker
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Pregnancy Category
Category C
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FDA Approved
Sep 1978
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Timolol eye drops are used to lower high pressure inside the eye, which can damage your vision if left untreated. It works by reducing the amount of fluid your eye makes.
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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 the medication as directed, even if your symptoms improve. Take the medication at the same time every day.

Administration Instructions

1. Use this medication for the eye only.
2. Remove contact lenses before using the medication. You can put them back in 15 minutes after administration, unless your eyes are irritated or infected.
3. Avoid touching the container tip to the eye, lid, or other skin, as this can contaminate the medication and lead to severe eye problems or vision loss.
4. Tilt your head back and drop the medication into the eye.
5. After administration, keep your eyes closed and apply gentle pressure to the inside corner of the eye for 1 to 2 minutes to help the medication stay in the eye.
6. Gently blot any excess solution from the eyelid.

Using Multiple Medications

If you are using more than one medication 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 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 the same time or use extra doses.
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Lifestyle & Tips

  • Wash hands thoroughly before and after using eye drops.
  • Do not touch the dropper tip to your eye or any other surface to prevent contamination.
  • Tilt your head back, pull down your lower eyelid to form a pouch, and instill one drop into the pouch.
  • Close your eye gently for 1-2 minutes and apply pressure to the inner corner of your eye (near the nose) to minimize systemic absorption.
  • If using other eye drops, wait at least 5-10 minutes between applications.
  • Remove contact lenses before instilling drops and wait at least 15 minutes before reinserting them.
  • Store at room temperature, away from light and moisture.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

initial_therapy: Start with 0.25% solution; if response is insufficient, increase to 0.5% solution.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution due to risk of systemic effects)
Infant: Not established (use with extreme caution due to risk of systemic effects)
Child: Not established (use with extreme caution due to risk of systemic effects)
Adolescent: Not established (use with caution, consider lower concentrations)
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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 due to minimal systemic absorption

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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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), whether or not accompanied by glaucoma. The precise mechanism of action in lowering IOP is not clearly established, but it is believed to be primarily due to a reduction of aqueous humor production. Some studies suggest a slight increase in aqueous humor outflow facility.
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Pharmacokinetics

Absorption:

Bioavailability: Low (systemic absorption occurs after ocular administration, but overall bioavailability from eye is low)
Tmax: Approximately 1-2 hours (for systemic absorption after ocular dose)
FoodEffect: Not applicable (ophthalmic administration)

Distribution:

Vd: Not available (for ophthalmic use, systemic Vd is approximately 1.7 L/kg)
ProteinBinding: Approximately 10% (systemic)
CnssPenetration: Limited (can cross blood-brain barrier, but ophthalmic systemic levels are low)

Elimination:

HalfLife: Approximately 4 hours (systemic, after oral administration; ocular half-life not well-defined but effect lasts 12-24 hours)
Clearance: Not available (systemic clearance is approximately 500 mL/min)
ExcretionRoute: Renal (metabolites and unchanged drug)
Unchanged: Approximately 20% (systemic, renally excreted unchanged)
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Pharmacodynamics

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

Safety & Warnings

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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. Call your doctor immediately if you experience:
+ Shortness of breath
+ Sudden weight gain
+ Swelling in the arms or legs
+ Bulging neck veins

Other Possible Side Effects

Most people taking this medication do not experience severe side effects, and some may not have any side effects at all. However, if you notice any of the following symptoms, contact your doctor or seek medical help if they bother you or do not go away:

Burning or stinging sensation
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 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe eye irritation, pain, or vision changes
  • Slow or irregular heartbeat
  • Dizziness or lightheadedness
  • Shortness of breath or wheezing
  • Swelling of the face, lips, tongue, or throat (signs of allergic reaction)
  • Unusual tiredness or weakness
  • Depression or mood changes
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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
+ Heart failure (weak heart)
+ Shock caused by heart problems
+ Slow heartbeat
* If you are currently taking another medication similar to this one. If you are unsure, consult your doctor or pharmacist.

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 other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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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 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 a higher 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, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.
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Overdose Information

Overdose Symptoms:

  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Bronchospasm (difficulty breathing, wheezing)
  • Acute cardiac failure
  • Dizziness
  • Headache

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For non-emergencies, call Poison Control at 1-800-222-1222. Management is supportive and symptomatic, potentially including atropine for bradycardia, beta-adrenergic stimulants for bronchospasm, or vasopressors for hypotension.

Drug Interactions

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Major Interactions

  • Oral beta-blockers (additive systemic effects, e.g., bradycardia, hypotension)
  • Calcium channel blockers (e.g., verapamil, diltiazem - increased risk of AV conduction disturbances, hypotension)
  • Catecholamine-depleting drugs (e.g., reserpine - additive hypotensive and/or bradycardic effects)
  • Digitalis (increased risk of bradycardia, AV block)
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Moderate Interactions

  • Quinidine (increased plasma levels of timolol due to CYP2D6 inhibition, leading to enhanced beta-blockade)
  • Clonidine (paradoxical hypertension upon clonidine withdrawal if timolol is co-administered)
  • Adrenergic psychotropic drugs (e.g., MAOIs - potential for hypertensive crisis)
  • Inhalation anesthetics (enhanced myocardial depression)
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Minor Interactions

  • NSAIDs (may reduce hypotensive effect of beta-blockers, though less significant for ophthalmic)

Monitoring

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Baseline Monitoring

Intraocular Pressure (IOP)

Rationale: To establish baseline and assess efficacy of treatment.

Timing: Before initiating therapy

Visual Acuity

Rationale: To establish baseline and monitor for changes.

Timing: Before initiating therapy

Heart Rate and Blood Pressure

Rationale: To assess for potential systemic beta-blockade effects (bradycardia, hypotension).

Timing: Before initiating therapy

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

Rationale: To identify contraindications or risk factors for bronchospasm.

Timing: Before initiating therapy

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Routine Monitoring

Intraocular Pressure (IOP)

Frequency: Every 2-4 weeks initially, then every 3-6 months once stable

Target: Individualized, typically <21 mmHg or target pressure to prevent progression

Action Threshold: IOP not adequately controlled, or signs of progression

Heart Rate and Blood Pressure

Frequency: Periodically, especially during dose titration or if systemic symptoms occur

Target: Normal limits for patient

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

Respiratory Symptoms (e.g., dyspnea, wheezing)

Frequency: Routinely inquire at follow-up visits

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

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Symptom Monitoring

  • Blurred vision
  • Eye irritation/discomfort
  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness)
  • Bronchospasm (wheezing, difficulty breathing)
  • Fatigue
  • Depression
  • Masking of hypoglycemia symptoms in diabetics

Special Patient Groups

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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.
Second Trimester: Potential for fetal exposure and effects.
Third Trimester: Increased risk of adverse effects in the neonate (bradycardia, hypoglycemia, respiratory depression) if used close to delivery.
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Lactation

L3 (Moderate Concern). Timolol is excreted in breast milk. Due to the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Infant Risk: Bradycardia, hypotension, respiratory depression, hypoglycemia.
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Pediatric Use

Use with extreme caution, especially in infants and young children, due to increased risk of systemic adverse effects (e.g., bradycardia, respiratory depression, apnea) from systemic absorption. Lower concentrations (0.25%) may be preferred if use is unavoidable. Not recommended for routine use in neonates.

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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 for decreased renal/hepatic function or polypharmacy. Monitor closely for systemic effects.

Clinical Information

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Clinical Pearls

  • Timolol ophthalmic can cause systemic beta-blockade effects, including bradycardia, hypotension, and bronchospasm, especially in susceptible individuals (e.g., those with asthma, COPD, heart block, or heart failure).
  • Patients should be instructed on proper instillation technique, including nasolacrimal occlusion (pressing on the inner corner of the eye for 1-2 minutes after instillation) to minimize systemic absorption.
  • Monitor intraocular pressure regularly to assess efficacy and systemic vital signs (heart rate, blood pressure) to monitor for systemic side effects.
  • Avoid abrupt discontinuation in patients with coronary artery disease, as it may exacerbate angina or precipitate myocardial infarction.
  • May mask signs of hyperthyroidism (e.g., tachycardia) or hypoglycemia in diabetic patients.
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Alternative Therapies

  • Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost)
  • Alpha-adrenergic agonists (e.g., brimonidine)
  • Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide)
  • Rho kinase inhibitors (e.g., netarsudil)
  • Cholinergic agonists (e.g., pilocarpine)
  • Laser trabeculoplasty
  • Surgical interventions (e.g., trabeculectomy)
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Cost & Coverage

Average Cost: $20 - $100 per 5ml bottle (0.5%)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (preferred generic)
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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 discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.