Betimol 0.5% Ophthalmic Soln 15ml

Manufacturer THEA PHARMA Active Ingredient Timolol Eye Drops (Bottle)(TIM oh lol) Pronunciation TYE-moe-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
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. It works by reducing the amount of fluid your eye makes. This medication is a type of medicine called a beta-blocker.
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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 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, severe eye problems, or vision loss.

1. Tilt your head back and gently drop the medication into your eye.
2. After administration, keep your eyes closed and apply gentle 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 have no 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. 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 administering eye drops.
  • Do not touch the dropper tip to your eye or any other surface to avoid contamination.
  • If you wear contact lenses, remove them before applying the drops and wait at least 15 minutes before reinserting them.
  • If using other eye drops, wait at least 5-10 minutes between applications.
  • Close your eye gently and apply pressure to the inner corner of your eye (near the nose) for 1-2 minutes after instilling the drop to minimize systemic absorption and maximize local effect.
  • Do not stop using the drops without consulting your doctor, even if you feel well, as eye pressure can increase again.
  • Inform your doctor about all other medications you are taking, especially oral beta-blockers, heart medications, or asthma medications.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

ocularHypertension: 1 drop of 0.25% or 0.5% solution in the affected eye(s) twice daily
openAngleGlaucoma: 1 drop of 0.25% or 0.5% solution in the affected eye(s) twice daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with extreme caution due to potential for systemic adverse effects)
Child: Not established (use with extreme caution due to potential for systemic adverse effects)
Adolescent: Similar to adult dosing, but with caution and close monitoring for systemic effects
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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: Considerations: Systemic absorption can occur; monitor for systemic beta-blockade 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 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 in reducing aqueous humor formation is not precisely established but is thought to involve blockade of beta-2 receptors on the ciliary epithelium.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (significant systemic absorption can occur after ophthalmic administration)
Tmax: Approximately 1-2 hours (for systemic effects after ophthalmic dose)
FoodEffect: Not applicable for ophthalmic solution

Distribution:

Vd: Not available (systemic distribution occurs)
ProteinBinding: Low (approximately 10%)
CnssPenetration: Yes (can cross the blood-brain barrier)

Elimination:

HalfLife: Approximately 2.5-5 hours (systemic)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites)
Unchanged: Approximately 20% (renal excretion of unchanged drug)
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Pharmacodynamics

OnsetOfAction: Within 30 minutes (IOP reduction)
PeakEffect: 1-2 hours (IOP reduction)
DurationOfAction: Up to 24 hours (IOP reduction)

Safety & Warnings

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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, including:
+ 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 right away if you experience:
+ 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 or any other unusual symptoms, contact your doctor or seek medical help:

Burning or stinging sensations
Eye irritation
Dry eyes
Feeling of something 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 dizziness or fainting
  • Very slow heart rate (bradycardia)
  • Shortness of breath, wheezing, or difficulty breathing (especially if you have asthma or COPD)
  • Swelling of ankles or feet, unusual weight gain (signs of heart failure)
  • Chest pain
  • Severe eye pain or vision changes
  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
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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 issues 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 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 medications you are taking
Any natural products or vitamins you are using
Your overall health status

Before starting, stopping, or adjusting 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 hypoglycemia (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 concerns or questions, 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, including fatal cases in individuals with asthma. If you have any questions or concerns, discuss them with your doctor.

This medication may also obscure symptoms of hyperthyroidism (an overactive thyroid), 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 increased risk of a 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:

  • Severe bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Bronchospasm (difficulty breathing, wheezing)
  • Acute cardiac failure
  • Dizziness, lightheadedness
  • Syncope (fainting)

What to Do:

Seek immediate medical attention. Call 911 or your local emergency number. For poison control, call 1-800-222-1222.

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, left ventricular failure, hypotension)
  • Catecholamine-depleting drugs (e.g., reserpine, guanethidine - risk of additive hypotensive and/or marked bradycardia)
  • Digitalis (risk of additive bradycardia and AV block)
  • Quinidine (may increase plasma levels of timolol due to CYP2D6 inhibition, leading to increased systemic beta-blockade)
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Moderate Interactions

  • Clonidine (potential for rebound hypertension upon clonidine withdrawal if beta-blocker is not tapered)
  • Adrenergic psychotropic drugs (e.g., MAOIs, tricyclic antidepressants - potential for exaggerated hypertensive response)
  • Inhalation anesthetics (e.g., halothane, isoflurane - risk of myocardial depression and hypotension)
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Minor Interactions

  • NSAIDs (may attenuate the hypotensive effect of beta-blockers)

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 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

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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 target IOP (e.g., <21 mmHg or lower, based on disease severity)

Action Threshold: IOP not adequately controlled, or significant fluctuations

Heart Rate and Blood Pressure

Frequency: Periodically, especially during initial therapy or dose changes

Target: Within normal limits for the patient, or as clinically appropriate

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

Ocular Examination (e.g., visual acuity, optic nerve assessment)

Frequency: Regularly, as determined by ophthalmologist

Target: Stable or improved

Action Threshold: Worsening vision, optic nerve changes, or other signs of disease progression

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Symptom Monitoring

  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Bronchospasm (wheezing, shortness of breath, difficulty breathing)
  • Exacerbation of asthma or COPD symptoms
  • Symptoms of heart failure (e.g., edema, dyspnea on exertion)
  • Dizziness, lightheadedness, syncope
  • Fatigue, weakness
  • Depression
  • Ocular irritation (burning, stinging, itching, redness)
  • Blurred vision

Special Patient Groups

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Pregnancy

Timolol is classified as Pregnancy Category C. Studies in animals have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Systemic absorption can occur, and beta-blockade effects in the fetus (e.g., bradycardia, hypoglycemia) are possible.

Trimester-Specific Risks:

First Trimester: Potential for developmental toxicity observed in animal studies; human data limited.
Second Trimester: Risk of fetal bradycardia and growth restriction.
Third Trimester: Risk of neonatal bradycardia, hypoglycemia, and respiratory depression if exposed near term.
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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. Monitor breastfed infants for signs of beta-blockade (e.g., bradycardia, lethargy).

Infant Risk: Risk L3 (Moderate concern - possible adverse effects on infant, but not severe; monitor infant).
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Pediatric Use

Use in pediatric patients is generally not recommended due to the potential for serious systemic adverse reactions (e.g., bradycardia, respiratory depression, apnea), especially in infants and neonates. If used, extreme caution, close monitoring, and the lowest effective concentration should be employed. Safety and efficacy have not been fully established.

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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 (e.g., bradycardia, hypotension) due to age-related decreases in renal and hepatic function, and polypharmacy. Monitor closely for systemic effects.

Clinical Information

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Clinical Pearls

  • Timolol is a non-selective beta-blocker; therefore, it should be used with extreme caution or avoided in patients with bronchial asthma, severe COPD, sinus bradycardia, second or third-degree AV block, overt cardiac failure, or cardiogenic shock.
  • Systemic absorption of ophthalmic timolol can lead to significant systemic beta-blockade effects. Always remind patients to occlude the nasolacrimal duct (punctal occlusion) for 1-2 minutes after instillation to minimize systemic absorption.
  • Patients should be advised about the potential for masked symptoms of hypoglycemia in diabetic patients and masked signs of hyperthyroidism.
  • Timolol can cause transient blurred vision or other visual disturbances; caution patients about driving or operating machinery until vision is clear.
  • Regular monitoring of intraocular pressure, heart rate, and blood pressure is crucial, especially during the initial phase of treatment.
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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)
  • Cholinergic agonists (e.g., pilocarpine)
  • Surgical interventions (e.g., laser trabeculoplasty, trabeculectomy)
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Cost & Coverage

Average Cost: Varies, typically $15-$50 per 15mL bottle of 0.5% solution
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 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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.