Brimonidine tartrate/ Timolol maleate

Combigan

Combigan eye drops, a combination of brimonidine tartrate and timolol maleate, are FDA-approved for reducing intraocular pressure in individuals with glaucoma or ocular hypertension. This dual-action medication helps prevent serious vision issues by decreasing fluid production and enhancing fluid drainage in the eye, thus effectively managing eye pressure. Suitable for adults and children over two years, Combigan should be administered as one drop in the affected eyes twice daily, about 12 hours apart. While Combigan is generally safe, it can cause side effects such as eye irritation, dry eyes, and fatigue. More serious effects like respiratory or heart-related issues may also occur. Users must follow their healthcare provider’s instructions precisely and report any severe symptoms. Combigan should be stored at room temperature, away from light and moisture, and kept out of reach of children. It is essential to adhere to dosing schedules and consult a healthcare provider for any concerns.

Product Overview

Combigan eye drops, containing brimonidine tartrate and timolol maleate, are a powerful dual-action medication approved by the FDA to lower intraocular pressure in patients suffering from glaucoma or ocular hypertension. These conditions can lead to serious vision problems if not adequately managed. Brimonidine tartrate functions as an alpha-2 adrenergic receptor agonist, which reduces the production of aqueous humor, while timolol maleate, a beta-blocker, decreases fluid production and enhances fluid drainage from the eye. Together, they effectively reduce the pressure inside the eye, helping to prevent potential damage and vision loss.

Available in a standard strength of 0.2%/0.5%, Combigan is prescribed as one drop in the affected eye(s) twice daily, about 12 hours apart. It is suitable for adults and children under two years under close medical supervision. The unique combination of ingredients works synergistically to significantly reduce eye pressure.

While generally safe, Combigan can cause side effects such as eye irritation, dry eyes, fatigue, and, in rare cases, more severe effects like respiratory problems or heart-related issues. Users should be cautious about potential interactions with other CNS depressants and cardiovascular drugs. If a dose is missed, apply it as soon as possible unless it’s near the time for the next dose. For accidental ingestion or overdose, immediate medical attention is necessary. Store the eye drops at room temperature, away from light and moisture, and ensure they are out of reach of children. Patients should follow their healthcare provider’s instructions closely and promptly report any severe side effects or symptoms. This comprehensive approach ensures Combigan’s safe and effective use, providing essential relief for those managing elevated intraocular pressures.

Uses of Combigan

• Glaucoma
• Eye Pressure

How to Use Combigan?

Dosage

• 5 mL of 0.2%/0.5% solution
• 10 mL of 0.2%/0.5% solution
• 15 mL of 0.2%/0.5% solution

Recommended Dosage for Different Patients

Adults

• Standard Dosage: The typical dosage for adults is one drop of Combigan in the affected eye(s) twice daily, approximately 12 hours apart.

Children

• Ages 2 and Older: The safety and efficacy of Combigan in children younger than 2 years have not been established. For children aged 2 years and older, the dosage is generally the same as for adults: one drop in the affected eye(s) twice daily. However, use in children should be closely monitored by a healthcare provider.

Elderly

• Standard Dosage: Elderly patients are usually prescribed the exact dosage as younger adults: one drop in the affected eye(s) twice daily. Due to potential systemic absorption and sensitivity to beta-blockers, elderly patients should be monitored for systemic side effects.

Special Considerations

• Patients with Renal or Hepatic Impairment: Patients with liver or kidney problems should use Combigan cautiously. The drug’s effects on this population are not well studied, and such conditions may alter the medication’s metabolism and excretion.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

How to Take It?

• Wash Your Hands: Always start by washing your hands thoroughly with soap and water to prevent contamination of the dropper tip and your eye.
• Prepare the Bottle: Shake the bottle gently if instructed. Remove the cap without touching the dropper tip to any surface, including your eye or hands.
• Tilt Your Head Back: Tilt your head slightly and pull down your lower eyelid to create a small pocket.
• Administer the Drops: Hold the dropper directly over your eye and place one drop into the conjunctival sac, the space between your lower eyelid and the eye. Be careful not to let the dropper touch your eye or eyelashes, as this can contaminate the solution.
• Close Your Eyes: After applying the drop, close your eyes for 1 to 2 minutes. Do not blink or rub your eyes. This helps to keep the medicine in your eye.
• Apply Pressure to the Corner of Your Eye: To prevent the medication from draining away too quickly, gently press on the corner of your eye (near the nose) for about 1 minute. This technique is called punctal occlusion.
• Repeat if Necessary: If your prescription is for more than one drop in the same eye, wait at least 5 minutes before applying the next drop. This prevents the second drop from washing out the first.
• Replace the Cap: After use, immediately put the cap back on the bottle, ensuring it is closed tightly.
• Rewash Your Hands: Wash your hands to remove any medication.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

How Does Combigan Work?

Combigan is an ophthalmic medication to lower intraocular pressure in glaucoma or ocular hypertension patients. It combines two active ingredients: brimonidine tartrate and timolol maleate. Brimonidine tartrate is an alpha-2 adrenergic receptor agonist which reduces the amount of fluid (aqueous humor) the eye produces. At the same time, timolol maleate, a beta-blocker, slows fluid production and improves fluid drainage from the eye. By decreasing fluid production and increasing drainage, Combigan effectively lowers the pressure inside the eye, helping to prevent further eye damage and potential vision loss associated with elevated intraocular pressure.

Important Safety Information

Side Effects

Common side effects of this medication may include:

• Eye discomfort/irritation
• Eye redness
• Itchy eyes
• Dry eyes
• Blurred vision
• Headache
• Fatigue or drowsiness
• Dizziness
• Taste disturbances

Serious side effects of this medication may include:

• Allergic reactions: Some individuals may experience severe allergic reactions to the components of Combigan, characterized by swelling of the face, lips, tongue, or throat, severe itching, redness, trouble breathing, or hives.
• Respiratory problems: Because timolol is a beta-blocker, it can cause respiratory issues, including worsening of pre-existing asthma or causing new onset of breathing difficulties.
• Heart-related issues: Timolol can affect heart function, potentially leading to slowed heart rate, chest pain, palpitations, or irregular heartbeats. It may also worsen symptoms in patients with heart diseases such as congestive heart failure.
• Eye-related complications: In addition to common mild eye irritation, more severe reactions can include eye pain, swelling, redness, or changes in vision that could indicate a significant problem that requires prompt medical attention.
• Central nervous system effects: The components of Combigan might trigger depression, confusion, or mood changes.
• Reduction in blood pressure: Timolol can cause a drop in blood pressure, which can lead to dizziness, fainting, or fatigue.
• Severe skin reactions: Although rare, severe skin reactions like Stevens-Johnson syndrome may occur.
• Hypersensitivity reactions: Combigan can cause a localized or generalized rash, urticaria, or pruritus, which indicates a hypersensitivity reaction.

[Note: This list may not cover all possible side effects. Always consult with your healthcare provider for medical advice about side effects.]

Warnings

• • Warnings for Lung Conditions: Though uncommon for eye drops, Combigan (brimonidine/timolol) can be systemically absorbed and may adversely interact with medications for respiratory conditions. This could potentially worsen breathing problems and may be life-threatening. Inform your healthcare provider if you have respiratory conditions like asthma or COPD to consider an alternative treatment.
  • Heart Failure Caution: Inform your healthcare provider about any pre-existing heart conditions such as heart failure, irregular heartbeats, or slow heartbeats. Combigan may exacerbate these conditions by affecting heart function. Even individuals without prior heart issues may develop cardiac complications with long-term use. Report any symptoms such as shortness of breath, reduced exercise capacity, fatigue, or swelling in your legs and ankles to your healthcare provider immediately.

• Risk of Masked Hypoglycemia: The beta-blocker component (timolol) in Combigan can mask symptoms of hypoglycemia (low blood sugar). If you have diabetes, monitor your blood sugar levels frequently. Be aware of how to recognize and manage low blood sugar. Seek immediate medical attention if you experience dizziness, sweating, or confusion.

• Hidden Symptoms of Hyperthyroidism: Combigan may mask signs of high thyroid hormone levels, such as an elevated heart rate. Ensure your healthcare provider monitors your thyroid function while using this medication. Alert your provider if you experience irregular heartbeats or symptoms like shakiness or sweating worsen.

Precautions

• Allergy Information: Inform your doctor or pharmacist if you are allergic to clobetasol or other corticosteroids like hydrocortisone or prednisone or if you have other allergies. This product may contain inactive ingredients that could cause allergic reactions.
• Medical History: Share your medical history with your healthcare provider, especially if you have poor blood circulation, immune system problems, or certain skin conditions such as rosacea or perioral dermatitis.
• Skin Infections: Avoid using clobetasol on infected skin or with open sores.
• Response to Stress: Long-term or widespread use of corticosteroids may reduce your body’s ability to respond to physical stress. Inform your doctor or dentist that you are using clobetasol or have used it in the past few months if you are about to undergo surgery, receive emergency treatment, or have a severe illness/injury.
• Impact on Child’s Growth: Prolonged use of this medication may slow down a child’s growth. Regular medical checks of your child’s height are recommended if clobetasol is used for extended periods.
• Use During Pregnancy: Clobetasol should only be used during pregnancy when necessary. Discuss the potential risks and benefits with your doctor.
• Breastfeeding: It is unknown if clobetasol passes into breast milk when applied topically. Although similar oral medications can pass into breast milk, consult your doctor before breastfeeding.

Contraindications

• Bronchial Asthma or History of Asthma: Patients with a history of bronchial asthma should not use Combigan.
• Severe Chronic Obstructive Pulmonary Disease (COPD): Individuals with severe COPD should avoid Combigan.
• Sinus Bradycardia: Patients with sinus bradycardia (slow heart rate) should not use this medication.
• Second or Third-Degree Atrioventricular (AV) Block: Combigan is contraindicated in patients with these heart rhythm abnormalities.
• Overt Cardiac Failure: Individuals with overt cardiac failure should avoid Combigan.
• Cardiogenic Shock: Patients in cardiogenic shock should not use this medication.
• Neonates and Infants (Under the Age of 2 Years): Combigan is contraindicated in this age group.

Missed Dose

If you forget to take a dose, apply it as soon as you remember. However, if it’s close to the time for your next dose, just skip the missed dose and continue with your regular schedule. Do not apply extra medication to make up for the missed dose.

[Note: If you have missed a medication dose and are unsure when to take the next one, consult your doctor or pharmacist immediately.]

Overdose 

If ingested, this medication can be dangerous. In the event of an overdose where someone shows severe symptoms like unconsciousness or difficulty breathing, immediately call 911. Signs of an overdose can include slowed breathing and a reduced heart rate.

[Note: If you consumed more than the recommended dose, get medical help immediately or call the Poison Help line at 1-800-222-1222.]

Storage

• Keep the bottle at room temperature, away from extreme heat and cold. The ideal storage temperature is between 15°C to 25°C (59°F to 77°F).
• Store the bottle in a place protected from light and moisture. Do not store it in the bathroom, as the humidity could affect the medication.
• Ensure the bottle’s cap is tightly closed when not in use to prevent contamination or leakage.
• Store Combigan out of reach and in the sight of children to prevent accidental ingestion or misuse.
• Do not freeze the medication, which can alter its chemical stability and effectiveness.
• Discard the bottle of Combigan after the expiration date or when the prescribed treatment period is over, even if there is still some solution. Follow local regulations to dispose of medications, and do not pour them down the drain unless instructed.

[Note: Discuss with your healthcare professional the proper disposal of unused medicine and any questions you may have regarding its storage.]

Combigan Interactions

• Central Nervous System Depressants: Combigan may enhance the effects of agents such as alcohol, barbiturates, opiates, sedatives, or anesthetics, which can increase sedation and drowsiness.
• Antihypertensives/Beta-Blockers: Since Combigan includes a beta-blocker, using it with other systemic beta-blockers (like those used for high blood pressure) can enhance cardiovascular effects such as reduced heart rate and blood pressure.
• Calcium Channel Blockers: Using Combigan with certain calcium channel blockers, particularly those like verapamil and diltiazem, can potentially lead to a significant drop in heart rate and blood pressure.
• Digitalis: When used with digitalis (digoxin), there is an increased risk of a slowed heart rate.
• MAO Inhibitors: Combigan should be used cautiously with monoamine oxidase (MAO) inhibitors, as it can potentially increase the systemic effect of brimonidine.
• Antidepressants: Certain antidepressants, especially those that affect the serotonin and noradrenaline systems (like SSRIs and SNRIs), may affect the effectiveness and systemic absorption of brimonidine.
• CYP2D6 Inhibitors: Timolol is metabolized by the enzyme CYP2D6. Drugs that inhibit CYP2D6 (such as quinidine, SSRIs, and antipsychotics) may increase timolol levels, leading to enhanced beta-blockade effects.

[Note: This isn’t a complete list, and there could be other drugs that interact with Combigan. Make sure to tell your doctor about any prescription, over-the-counter medicines, and herbal products you’re taking.]

Combigan Alternatives

• Latanoprost (latanoprost)
• Xalatan (latanoprost)
• Travatan Z (travoprost)
• Lumigan (bimatoprost)
• Timolol (timolol maleate)
• Dorzolamide-Timolol (dorzolamide hydrochloride and timolol maleate)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may 8cause serious side effects.] 

Frequently Asked Questions

Is it safe to use Combigan while wearing contact lenses?

You should remove your contact lenses before applying Combigan (brimonidine / timolol), as the preservatives in the eye drops can harm the lenses. Allow at least 15 minutes after application before reinserting your contact lenses.

Can Combigan (brimonidine/timolol) impact blood pressure?

Combigan (brimonidine/timolol) can be absorbed into the bloodstream, potentially affecting your blood pressure and causing it to drop to unsafe levels. If you experience dizziness or faintness while using Combigan, it’s essential to inform your healthcare provider.

How long does a bottle of Combigan typically last?

A bottle of Combigan eye drops is generally intended to last about one month. If you find yourself running low before it’s time for a refill, contact your healthcare provider. After one month, the effectiveness of the preservatives in the eye drops may diminish, potentially allowing bacteria to grow, so it is recommended to use a new bottle.

How quickly does Combigan begin to reduce eye pressure?

Combigan rapidly lowers eye pressure within 1 to 2 hours of application. However, it’s crucial to continue using the eye drops for the duration your healthcare provider prescribes. They will advise you when to stop using Combigan based on regular testing to monitor your eye pressure levels.

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