Lumigan 0.01% Ophth Soln 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
Sep 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Bimatoprost eye drops are used to lower high pressure inside the eye, which can be caused by conditions like glaucoma or ocular hypertension. By lowering this pressure, it helps prevent vision loss.
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. This medication is for use in the eye only and should be applied in the evening.
Preparation and Administration
1. Wash your hands before and after using the medication.
2. Remove contact lenses before applying the medication. You can reinsert your lenses 15 minutes after application, unless your eyes are irritated or infected.
3. 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.
4. Tilt your head back and gently drop the medication into your eye.
5. After application, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Using Multiple Eye Medications
If you are using more than one medication in the same eye, apply each medication at least 5 minutes apart.
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. However, 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. This medication is for use in the eye only and should be applied in the evening.
Preparation and Administration
1. Wash your hands before and after using the medication.
2. Remove contact lenses before applying the medication. You can reinsert your lenses 15 minutes after application, unless your eyes are irritated or infected.
3. 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.
4. Tilt your head back and gently drop the medication into your eye.
5. After application, keep your eyes closed and apply pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.
Using Multiple Eye Medications
If you are using more than one medication in the same eye, apply each medication at least 5 minutes apart.
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. However, 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 drops once daily in the evening.
- If using other eye drops, wait at least 5 minutes between applications.
- Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them.
- Avoid touching the dropper tip to the eye or any other surface to prevent contamination.
- Wipe away any excess solution from the eyelid or cheek to minimize potential side effects like skin darkening or unwanted hair growth.
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:
glaucoma_ocular_hypertension:
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 specific adjustment needed for ophthalmic use due to low systemic absorption.
Moderate:
No specific adjustment needed for ophthalmic use due to low systemic absorption.
Severe:
No specific adjustment needed for ophthalmic use due to low systemic absorption.
Dialysis:
No specific adjustment needed for ophthalmic use due to low systemic absorption.
Hepatic Impairment:
Mild:
No specific adjustment needed for ophthalmic use due to low systemic absorption.
Moderate:
No specific adjustment needed for ophthalmic use due to low systemic absorption.
Severe:
No specific adjustment needed for ophthalmic use due to low systemic absorption.
Pharmacology
Mechanism of Action
Bimatoprost is a synthetic prostamide, structurally related to prostaglandin F2-alpha (PGF2Îą). It is believed to lower intraocular pressure (IOP) by increasing the outflow of aqueous humor through both the trabecular meshwork and uveoscleral pathways. The primary mechanism is thought to be increased uveoscleral outflow.
Pharmacokinetics
Absorption:
Bioavailability:
<1% (systemic after topical ocular administration)
Tmax:
Approximately 10 minutes (systemic)
FoodEffect:
Not applicable for ophthalmic solution.
Distribution:
Vd:
Not available (systemic volume of distribution is low due to rapid elimination)
ProteinBinding:
Approximately 88% (in vitro)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 45 minutes (systemic)
Clearance:
Not available
ExcretionRoute:
Renal (approximately 67%) and fecal (approximately 25%)
Unchanged:
Not available
Pharmacodynamics
OnsetOfAction:
Within 4 hours
PeakEffect:
Approximately 8-12 hours
DurationOfAction:
At least 24 hours
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. This change can occur months to years after starting the medication. If you notice any changes in your eye color, contact your doctor.
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
Darkening of the eyelids, which usually reverses after stopping the medication
Dry eyes
Feeling of something in the eye
Burning sensation
Symptoms of a common cold
Changes in eyelashes, such as darkening, thickening, or increased growth, which usually reverse 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
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. This change can occur months to years after starting the medication. If you notice any changes in your eye color, contact your doctor.
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
Darkening of the eyelids, which usually reverses after stopping the medication
Dry eyes
Feeling of something in the eye
Burning sensation
Symptoms of a common cold
Changes in eyelashes, such as darkening, thickening, or increased growth, which usually reverse 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:
- Sudden decrease in vision or vision loss
- Severe eye pain or discomfort
- Signs of eye infection (e.g., redness, swelling, discharge)
- Increased sensitivity to light
- New or worsening eye irritation
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 you experienced, including any symptoms that occurred.
If you have an eye infection or any other eye problems, as this may affect your ability to safely use this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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 you experienced, including any symptoms that occurred.
If you have an eye infection or any other eye problems, as this may affect your ability to safely use this medication.
This list is not exhaustive, and it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. They will help you determine if it is safe to take this medication in combination with your other medications and health conditions.
Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when driving or performing tasks that require clear vision, as it may affect your eyesight. Regularly schedule appointments with your doctor to monitor your eye pressure and vision, as advised. If you develop an eye infection, suffer an eye injury, or are scheduled to undergo eye surgery, promptly notify your doctor. 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:
- Unlikely with topical ophthalmic administration due to low systemic absorption.
- If accidentally ingested, symptoms might include gastrointestinal upset, but severe toxicity is not expected.
What to Do:
If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222). For ocular overdose, flush the eye with water.
Drug Interactions
Monitoring
Baseline Monitoring
Intraocular Pressure (IOP)
Rationale: To establish baseline and assess treatment efficacy.
Timing: Prior to initiation of therapy.
Ophthalmic Examination (including optic nerve head and visual fields)
Rationale: To assess the severity of glaucoma and monitor for progression.
Timing: Prior to initiation of therapy.
Routine Monitoring
Intraocular Pressure (IOP)
Frequency: Regularly, as determined by ophthalmologist (e.g., every 3-6 months or as needed)
Target: Individualized target IOP set by ophthalmologist.
Action Threshold: IOP above target range, or signs of disease progression.
Ophthalmic Examination (including iris color, eyelash changes, periorbital skin changes)
Frequency: Annually or as needed to monitor for known side effects.
Target: Not applicable
Action Threshold: Significant or bothersome changes in iris color, eyelash growth, or periorbital skin.
Symptom Monitoring
- Eye irritation
- Conjunctival hyperemia (redness)
- Eyelash changes (growth, thickness, number, pigmentation)
- Iris pigmentation changes (darkening)
- Periorbital skin darkening
- Macular edema (rare)
- Blurred vision
- Foreign body sensation
Special Patient Groups
Pregnancy
Category C. Studies in animals have shown adverse effects on the fetus. There are no adequate and well-controlled studies in pregnant women. Bimatoprost should be used 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.
Second Trimester:
Potential for developmental toxicity observed in animal studies.
Third Trimester:
Potential for developmental toxicity observed in animal studies.
Lactation
It is not known whether bimatoprost is excreted in human milk. Because many drugs are excreted in human milk, and because of the potential for serious adverse reactions in nursing infants from bimatoprost, 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:
Unknown; potential for serious adverse reactions.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.
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 can cause gradual changes to the eye, including increased brown pigmentation of the iris, darkening of the eyelid skin, and increased length, thickness, pigmentation, and number of eyelashes. These changes may be permanent.
- Advise patients to remove contact lenses prior to administration and wait 15 minutes before reinserting.
- To minimize systemic absorption and potential side effects, patients should apply pressure to the lacrimal sac area (inner corner of the eye) for one minute after instillation.
- If a dose is missed, the treatment should continue with the next dose as scheduled. Do not exceed one drop per day, as more frequent administration may decrease the IOP-lowering effect.
Alternative Therapies
- Other prostaglandin analogs (e.g., latanoprost, travoprost, tafluprost)
- Beta-blockers (e.g., timolol)
- Alpha-adrenergic agonists (e.g., brimonidine)
- Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide)
- Rho kinase inhibitors (e.g., netarsudil)
- Combination products (e.g., timolol/dorzolamide, timolol/brimonidine)
Cost & Coverage
Average Cost:
Varies, typically $200-$300 per 5ml bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (for brand-name Lumigan); Tier 1 (for generic bimatoprost)
General Drug Facts
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.