Betimol 0.25% Ophth Soln 5ml

Manufacturer THEA PHARMA 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
Non-selective beta-adrenergic blocker
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Pregnancy Category
Not available
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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. It works by reducing the amount of fluid your eye makes. This medicine is commonly used to treat glaucoma or ocular hypertension.
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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. 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 administration.

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 administration 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 applying eye drops.
  • Do not touch the dropper tip to your eye or any other surface to avoid contamination.
  • If using other eye drops, wait at least 5-10 minutes between applications.
  • Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them.
  • Apply pressure to the tear duct (inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption and side effects.
  • Inform your doctor about all medications you are taking, especially oral beta-blockers or heart medications.

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: 0.25% solution, 1 drop twice daily. If response is not adequate, dosage may be increased to 0.5% solution, 1 drop twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended for ophthalmic use, but monitor for systemic effects.
Moderate: No specific adjustment recommended for ophthalmic use, but monitor for systemic effects.
Severe: No specific adjustment recommended for ophthalmic use, but monitor for systemic effects.
Dialysis: No specific adjustment recommended for ophthalmic use, but monitor for systemic effects.

Hepatic Impairment:

Mild: No specific adjustment recommended for ophthalmic use, but monitor for systemic effects.
Moderate: No specific adjustment recommended for ophthalmic use, but monitor for systemic effects.
Severe: No specific adjustment recommended for ophthalmic use, but monitor for systemic effects.

Pharmacology

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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 reducing the production of aqueous humor. The exact mechanism of action for reducing aqueous humor production is not fully established, but it is thought to involve blockade of beta-2 receptors on the ciliary epithelium.
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Pharmacokinetics

Absorption:

Bioavailability: Systemic absorption occurs after ocular administration, but specific ophthalmic bioavailability is not well-quantified.
Tmax: Plasma concentrations peak approximately 1-2 hours after ocular administration.
FoodEffect: Not applicable for ophthalmic solution.

Distribution:

Vd: Not specifically quantified for ophthalmic use, but widely distributed in tissues.
ProteinBinding: Approximately 10% to plasma proteins.
CnssPenetration: Limited, but can cross the blood-brain barrier to some extent, leading to CNS side effects in susceptible individuals.

Elimination:

HalfLife: Approximately 4 hours (systemic).
Clearance: Not specifically quantified for ophthalmic use.
ExcretionRoute: Primarily renal excretion of metabolites and unchanged drug.
Unchanged: Approximately 20% of an oral dose is excreted unchanged in urine.
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Pharmacodynamics

OnsetOfAction: Within 30 minutes after single dose.
PeakEffect: 1-2 hours after single dose.
DurationOfAction: Up to 24 hours, allowing for twice-daily dosing.

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 medical attention immediately:

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

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe eye irritation, redness, or pain
  • Changes in vision
  • Slow heart rate (bradycardia)
  • Dizziness or fainting
  • Shortness of breath, wheezing, or difficulty breathing
  • Chest pain
  • Swelling of ankles or feet
  • Unusual fatigue or weakness
  • Symptoms of depression
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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:
+ Respiratory problems like asthma or chronic obstructive pulmonary disease (COPD)
+ Heart block or heart failure (a weakened 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.

Please note that this is not an exhaustive list of all potential interactions between this medication and other substances or health conditions.

To ensure your safety, it is crucial to discuss the following with your doctor and pharmacist:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your overall health status

Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to confirm that it is safe to do so in conjunction with your other medications and health conditions.
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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 or concerns, 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 risk of 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 potential benefits and risks of this medication with your doctor to ensure the best possible outcome for you and your baby.
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Overdose Information

Overdose Symptoms:

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

What to Do:

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

Drug Interactions

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Major Interactions

  • Oral beta-blockers (additive systemic effects)
  • Calcium channel blockers (e.g., verapamil, diltiazem - risk of AV conduction disturbances, bradycardia, hypotension)
  • Catecholamine-depleting drugs (e.g., reserpine - risk of hypotension, bradycardia)
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Moderate Interactions

  • Digitalis (additive effects on AV conduction)
  • Quinidine (can inhibit CYP2D6, increasing timolol plasma levels)
  • Clonidine (rebound hypertension upon withdrawal of clonidine while on beta-blocker)
  • Adrenergic psychotropic drugs (e.g., MAOIs, tricyclic antidepressants - potential for exaggerated hypertensive response)

Monitoring

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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 systemic beta-blockade effects.

Timing: Before initiating therapy.

Respiratory Function (e.g., spirometry)

Rationale: To assess for underlying respiratory conditions (e.g., asthma, COPD) due to potential for bronchospasm.

Timing: Before initiating therapy, especially in patients with history of respiratory disease.

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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, typically <21 mmHg or target pressure to prevent progression.

Action Threshold: If IOP remains elevated or continues to progress, consider dose adjustment or alternative therapy.

Heart Rate and Blood Pressure

Frequency: Periodically, especially during initial therapy or dose changes.

Target: Within normal limits for the patient.

Action Threshold: Significant bradycardia (<50 bpm) or hypotension; consider discontinuation or dose reduction.

Ocular Examination (e.g., visual acuity, slit lamp)

Frequency: Regularly, as determined by ophthalmologist.

Target: Stable or improved ocular health.

Action Threshold: New or worsening ocular symptoms, signs of irritation or allergic reaction.

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Symptom Monitoring

  • Blurred vision
  • Ocular irritation (burning, stinging, itching)
  • Dry eyes
  • Bradycardia (slow heart rate)
  • Hypotension (dizziness, lightheadedness)
  • Bronchospasm (wheezing, shortness of breath)
  • Fatigue
  • Depression
  • Masking of hypoglycemia symptoms in diabetics

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Timolol has been shown to cross the placenta. Neonates exposed to beta-blockers in utero may be at risk for bradycardia, hypotension, and hypoglycemia.

Trimester-Specific Risks:

First Trimester: Limited data, but systemic absorption occurs. Potential for fetal bradycardia.
Second Trimester: Potential for fetal bradycardia, hypotension, and hypoglycemia.
Third Trimester: Increased risk of neonatal bradycardia, hypotension, respiratory depression, and hypoglycemia. Monitor neonates for signs of beta-blockade for the first few days of life.
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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 bradycardia, hypotension, and other systemic beta-blockade effects in the infant. Monitor infant for signs of beta-blockade.
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use with caution due to potential for increased systemic absorption and adverse effects, especially in infants and young children.

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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 due to decreased renal or hepatic function, or concomitant medications. Use with caution and monitor closely.

Clinical Information

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Clinical Pearls

  • Timolol ophthalmic solution can cause systemic beta-blockade effects, including bradycardia, hypotension, and bronchospasm, especially in patients with pre-existing cardiac or respiratory conditions.
  • Advise patients to occlude the nasolacrimal duct (press on the inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption.
  • Patients with a history of asthma, severe COPD, sinus bradycardia, or heart block should generally avoid timolol ophthalmic.
  • Monitor diabetic patients closely as beta-blockers can mask symptoms of hypoglycemia.
  • Inform patients that the full IOP-lowering effect may take a few weeks to stabilize.
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Alternative Therapies

  • Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost)
  • Alpha-adrenergic agonists (e.g., brimonidine, apraclonidine)
  • Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide, acetazolamide)
  • Rho kinase inhibitors (e.g., netarsudil)
  • Miotic agents (e.g., pilocarpine)
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Cost & Coverage

Average Cost: Not available Not available
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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'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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.