Timolol Maleate 0.5% Ophth Sol 15ml

Timolol maleate is a non-selective beta-adrenergic receptor antagonist. 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 formation is not fully elucidated but is thought to involve blockade of beta-2 receptors on the ciliary epithelium.

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 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 rare but potentially deadly. Seek immediate medical attention 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 contact your doctor or seek medical help if you notice any of the following:

Burning or stinging sensations
Eye irritation
Dry eyes
Feeling of something 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.

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.

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 regimen. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.

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, including fatal cases in individuals with asthma. If you have any questions, discuss them with your doctor.

This medication may also obscure 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 increased risk of a more severe reaction if 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, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

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

• Digitalis glycosides (increased risk of bradycardia, AV block)
• Quinidine (inhibition of timolol metabolism via CYP2D6, leading to increased systemic levels and effects)
• Fluoxetine, Paroxetine (CYP2D6 inhibitors, potential for increased timolol systemic exposure)
• Clonidine (rebound hypertension upon withdrawal of clonidine may be exacerbated by beta-blockers)
• Epinephrine (mydriasis may occur)

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

• Blurred vision
• Eye irritation/discomfort
• Bradycardia (slow heart rate)
• Hypotension (low blood pressure)
• Dizziness
• Fatigue
• Shortness of breath
• Wheezing
• Depression
• Headache

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).

L3 (Moderate risk). Timolol is excreted in breast milk. Potential for serious adverse reactions in the breastfed infant (e.g., bradycardia, respiratory depression). 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.

Use with caution, especially in infants and young children, due to increased systemic absorption and potential for severe systemic adverse effects (e.g., apnea, bradycardia, bronchospasm). Lower concentrations (0.25%) are often preferred initially. Close monitoring for systemic effects is crucial.

Generally well-tolerated. However, elderly patients may be more susceptible to systemic adverse effects (e.g., bradycardia, hypotension, CNS effects) due to age-related changes in renal/hepatic function or concomitant cardiovascular conditions. Monitor closely.

• Timolol is a non-selective beta-blocker; therefore, it is contraindicated in patients with bronchial asthma, severe COPD, sinus bradycardia, second or third-degree AV block, overt cardiac failure, or cardiogenic shock.
• Even though it's an eye drop, significant systemic absorption can occur, leading to systemic beta-blocker side effects.
• Patients should be instructed on proper instillation technique, including nasolacrimal occlusion (applying pressure to the inner corner of the eye) for 1-2 minutes after instillation to minimize systemic absorption.
• Monitor for signs of systemic beta-blockade, especially in patients with pre-existing cardiac or respiratory conditions.
• If switching from another glaucoma medication, continue the previous medication for one day while starting timolol, then discontinue the previous medication.

• Prostaglandin analogs (e.g., Latanoprost, Travoprost, Bimatoprost)
• Alpha-2 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)

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 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 medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.