Lumigan 0.01% Ophth Soln 2.5ml
It is used to treat glaucoma.It is used to lower high eye pressure.
Drug Class
Antiglaucoma agent
Pharmacologic Class
Prostaglandin F2-alpha analog
Pregnancy Category
Category C
FDA Approved
Oct 2008
DEA Schedule
Not Controlled
Overview
What is this medicine?
Lumigan 0.01% is an eye drop used to lower high pressure inside the eye, which can be caused by conditions like glaucoma or ocular hypertension. It works by helping fluid drain better from your eye.
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. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Apply this medication in the evening, only to the eye.
Wash your hands before and after use.
Remove contact lenses before applying the medication. You can put them back in 15 minutes after application, unless your eyes are irritated or infected.
Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
Tilt your head back, and gently drop the medication into your eye.
After application, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
If you are using multiple medications in the same eye, wait at least 5 minutes between applications.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed and store the container upright with the cap on.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not use two doses at the same time or take extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue using the medication as directed, even if your symptoms improve.
Administration Instructions
Apply this medication in the evening, only to the eye.
Wash your hands before and after use.
Remove contact lenses before applying the medication. You can put them back in 15 minutes after application, unless your eyes are irritated or infected.
Avoid touching the container tip to your eye, lid, or surrounding skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
Tilt your head back, and gently drop the medication into your eye.
After application, keep your eyes closed and apply pressure to the inner corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
If you are using multiple medications in the same eye, wait at least 5 minutes between applications.
Storage and Disposal
Store the medication at room temperature in a dry place, away from the bathroom.
Keep the lid tightly closed and store the container upright with the cap on.
Missed Dose
If you miss a dose, use it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular schedule.
Do not use two doses at the same time or take extra doses.
Lifestyle & Tips
- Administer one drop in the affected eye(s) once daily in the evening. Do not use more often than once daily, as more frequent use may decrease the IOP-lowering effect.
- If you use other eye drops, wait at least 5 minutes between applying Lumigan and other drops.
- Remove contact lenses before applying Lumigan and wait at least 15 minutes before reinserting them.
- Avoid touching the dropper tip to your eye or any other surface to prevent contamination.
- Be aware that this medication may cause gradual changes to your eye color (iris darkening), eyelid skin darkening, and increased growth, thickness, and darkness of eyelashes. These changes may be permanent and may occur only in the treated eye.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One drop in the affected eye(s) once daily in the evening.
Condition-Specific Dosing:
ocularHypertension:
One drop in the affected eye(s) once daily in the evening.
openAngleGlaucoma:
One drop in the affected eye(s) once daily in the evening.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Dialysis:
No specific considerations for topical ophthalmic use due to minimal systemic absorption.
Hepatic Impairment:
Mild:
No dosage adjustment necessary.
Moderate:
No dosage adjustment necessary.
Severe:
No dosage adjustment necessary.
Pharmacology
Mechanism of Action
Bimatoprost is a synthetic prostamide, structurally related to prostaglandin F2Ξ±. It is believed to lower intraocular pressure (IOP) in humans by increasing the outflow of aqueous humor through both the trabecular meshwork and uveoscleral pathways. The primary mechanism of action is thought to be increased uveoscleral outflow.
Pharmacokinetics
Absorption:
Bioavailability:
Low systemic absorption (Cmax ~0.08 ng/mL after topical ocular administration).
Tmax:
Approximately 10 minutes (ocular fluid); approximately 10 minutes (systemic plasma).
FoodEffect:
Not applicable for topical ophthalmic solution.
Distribution:
Vd:
Not well-characterized due to low systemic absorption.
ProteinBinding:
Approximately 88% in human plasma.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 45 minutes (systemic).
Clearance:
Not well-characterized due to low systemic absorption.
ExcretionRoute:
Primarily renal excretion of metabolites.
Unchanged:
Less than 1% of the administered dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Within 4 hours.
PeakEffect:
Approximately 8-12 hours.
DurationOfAction:
Approximately 24 hours.
Safety & Warnings
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
Changes in eyesight, eye pain, or severe eye irritation
Sensitivity to bright lights
Eye discharge
Eye color changes, which may turn brown and may not return to normal. If you notice any changes in eye color, contact your doctor. These changes can occur months to years after starting treatment.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Eye irritation
Dark eyelids, which usually return to normal after stopping the medication
Dry eyes
Feeling of something in the eye
Burning sensation
Signs of a common cold
Eyelash changes, such as darkening, thickening, or increased growth, which usually return to normal after stopping the medication
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
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
Changes in eyesight, eye pain, or severe eye irritation
Sensitivity to bright lights
Eye discharge
Eye color changes, which may turn brown and may not return to normal. If you notice any changes in eye color, contact your doctor. These changes can occur months to years after starting treatment.
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. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:
Eye irritation
Dark eyelids, which usually return to normal after stopping the medication
Dry eyes
Feeling of something in the eye
Burning sensation
Signs of a common cold
Eyelash changes, such as darkening, thickening, or increased growth, which usually return to normal after stopping the medication
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
Seek Immediate Medical Attention If You Experience:
- Severe eye pain or discomfort
- Sudden vision changes
- Signs of eye infection (e.g., discharge, swelling, redness)
- New or worsening eye redness or irritation
- Swelling around the eye
- Light sensitivity
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 allergic reaction and its symptoms.
If you have an eye infection or any other eye problems.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. This will help ensure your safety and the effectiveness of your treatment.
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 allergic reaction and its symptoms.
If you have an eye infection or any other eye problems.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor. This will help ensure your safety and the effectiveness of your treatment.
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. As directed by your doctor, regularly schedule check-ups to monitor your eye pressure and vision. If you experience an eye infection, suffer an eye injury, or are scheduled to undergo eye surgery, notify your doctor promptly. Be aware that the use of this medication has been associated with the development of cataracts. This medication is not intended for children under the age of 16. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Eye irritation
- Conjunctival hyperemia
What to Do:
If an overdose occurs, treatment should be symptomatic. Contact a poison control center or seek medical attention. Call 1-800-222-1222.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess the severity of glaucoma/ocular hypertension.
Timing: Prior to initiation of therapy.
Ophthalmic examination (slit lamp, fundoscopy)
Rationale: To assess ocular health and rule out other conditions.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, as determined by the ophthalmologist (e.g., 4-6 weeks after initiation, then every 3-6 months).
Target: Individualized target IOP set by ophthalmologist.
Action Threshold: If IOP is not adequately controlled or if there is evidence of disease progression.
Ophthalmic examination (e.g., iris color, conjunctival hyperemia, macular edema)
Frequency: Periodically, as determined by the ophthalmologist.
Target: Not applicable
Action Threshold: Development of significant ocular adverse effects (e.g., iris pigmentation, macular edema, severe hyperemia).
Symptom Monitoring
- Eye irritation
- Conjunctival hyperemia (redness)
- Eyelash changes (growth, thickening, darkening)
- Iris pigmentation changes (darkening)
- Periorbital skin darkening
- Blurred vision
- Foreign body sensation
- Dry eye
- Photophobia
Special Patient Groups
Pregnancy
Pregnancy Category C. There are no adequate and well-controlled studies of bimatoprost ophthalmic solution in pregnant women. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for developmental toxicity observed in animal studies at high systemic exposures, but human relevance is unknown due to low systemic absorption with ophthalmic use.
Second Trimester:
Potential for developmental toxicity observed in animal studies at high systemic exposures, but human relevance is unknown due to low systemic absorption with ophthalmic use.
Third Trimester:
Potential for developmental toxicity observed in animal studies at high systemic exposures, but human relevance is unknown due to low systemic absorption with ophthalmic use.
Lactation
It is not known whether bimatoprost is excreted in human milk. Caution should be exercised when Lumigan is administered to a nursing woman. Consider the developmental and health benefits of breastfeeding along with the motherβs clinical need for Lumigan and any potential adverse effects on the breastfed infant from Lumigan or from the underlying maternal condition.
Infant Risk:
Low risk due to minimal systemic absorption, but potential for unknown effects on infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
No overall differences in safety or effectiveness have been observed between elderly and younger patients. No dosage adjustment is necessary.
Clinical Information
Clinical Pearls
- Bimatoprost is a highly effective IOP-lowering agent, often used as first-line therapy for open-angle glaucoma and ocular hypertension.
- The most common and notable side effects include conjunctival hyperemia (redness), eyelash growth (longer, thicker, darker), and iris pigmentation changes (darkening of the iris, which may be permanent).
- Patients should be counselled on the potential for permanent iris color change, especially if treating only one eye.
- Periorbital skin darkening can also occur and may be reversible upon discontinuation.
- Administering the dose in the evening is important for optimal IOP reduction, as the peak effect occurs 8-12 hours post-dose.
- Avoid over-dosing (more than once daily) as it can lead to a paradoxical increase in IOP or reduced efficacy.
Alternative Therapies
- Other prostaglandin analogs (e.g., latanoprost, travoprost, tafluprost)
- Beta-blockers (e.g., timolol, betaxolol)
- Alpha-adrenergic agonists (e.g., brimonidine, apraclonidine)
- Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide, acetazolamide)
- Rho kinase inhibitors (e.g., netarsudil)
- Combination products (e.g., timolol/dorzolamide, timolol/brimonidine)
- Laser trabeculoplasty
- Surgical procedures (e.g., trabeculectomy, minimally invasive glaucoma surgery - MIGS)
Cost & Coverage
Average Cost:
$150 - $300 per 2.5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand), Tier 1 (Generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the substance taken, the amount, and the time it occurred.