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Lumigan
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- Active ingredient
- Bimatoprost 0.3 mg/1 mL
- Other brand names
- Bimatoprost (by Akorn)
- Bimatoprost (by Akorn)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Amneal Pharmaceuticals Ny Llc)
- Bimatoprost (by Apotex Corp.)
- Bimatoprost (by Aurobindo Pharma Limited)
- Bimatoprost (by Fosun Pharma Usa Inc.)
- Bimatoprost (by Gland Pharma Limited)
- Bimatoprost (by Micro Labs Limited)
- Bimatoprost (by Sandoz Inc)
- Bimatoprost (by Somerset Therapeutics, Llc)
- Durysta (by Allergan, Inc.)
- Latisse (by Allergan, Inc.)
- Lumigan (by Allergan, Inc.)
- View full label-group details →
- Dosage form
- Solution/ Drops
- Route
- Ophthalmic
- Prescription status
- Rx (prescription)
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2001
- Label revision date
- December 7, 2018
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Bimatoprost 0.3 mg/1 mL
- Other brand names
- Bimatoprost (by Akorn)
- Bimatoprost (by Akorn)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Amneal Pharmaceuticals Ny Llc)
- Bimatoprost (by Apotex Corp.)
- Bimatoprost (by Aurobindo Pharma Limited)
- Bimatoprost (by Fosun Pharma Usa Inc.)
- Bimatoprost (by Gland Pharma Limited)
- Bimatoprost (by Micro Labs Limited)
- Bimatoprost (by Sandoz Inc)
- Bimatoprost (by Somerset Therapeutics, Llc)
- Durysta (by Allergan, Inc.)
- Latisse (by Allergan, Inc.)
- Lumigan (by Allergan, Inc.)
- View full label-group details →
- Dosage form
- Solution/ Drops
- Route
- Ophthalmic
- Prescription status
- Rx (prescription)
- CSA schedule
- Not a scheduled drug
- Pregnancy
- See Pregnancy Use Section
- Lactation
- See Lactation Use Section
- Marketed in the U.S.
- Since 2001
- Label revision date
- December 7, 2018
- Manufacturer
- Allergan, Inc.
- NDC root
- 0023-9187
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
LUMIGAN® is a prescription eye drop solution that contains bimatoprost (a medication used to lower eye pressure). It is formulated as a sterile ophthalmic solution with a concentration of 0.03%. LUMIGAN® is primarily used to treat increased intraocular pressure in individuals with conditions such as glaucoma or ocular hypertension, helping to protect your vision by reducing pressure in the eye.
This medication is provided in a 3 mL bottle and is manufactured by Allergan. If you have concerns about your eye health or pressure, LUMIGAN® may be a treatment option to discuss with your healthcare provider.
Uses
LUMIGAN® (bimatoprost ophthalmic solution) is used to help lower high pressure inside the eye, which can occur in conditions like open-angle glaucoma or ocular hypertension. By reducing this pressure, LUMIGAN® can help protect your vision and maintain eye health. If you have been diagnosed with either of these conditions, your healthcare provider may recommend this treatment to manage your intraocular pressure effectively.
Dosage and Administration
To use this medication, you will apply it directly to your eyes as an ophthalmic (eye) solution. The active ingredient in this solution is bimatoprost, which is present at a concentration of 0.3 mg in every 1 mL of the solution.
Make sure to follow the instructions provided by your healthcare provider regarding how often to use the drops. It's important to apply the solution correctly to ensure you receive the full benefit of the medication. If you have any questions about how to use it or how often to apply it, don’t hesitate to ask your doctor or pharmacist for guidance.
What to Avoid
It seems that the specific details regarding what to avoid while using this medication are not provided. However, it's important to remember that certain medications can have restrictions based on your health history or other medications you may be taking. Always consult with your healthcare provider before starting any new medication to ensure it is safe for you.
If you have concerns about potential misuse, dependence (which means relying on a substance to function normally), or if you should avoid using the medication altogether, your doctor can provide guidance tailored to your situation. Always prioritize open communication with your healthcare team to ensure your safety and well-being.
Side Effects
You may experience some common side effects, such as redness in the eyes, irritation, itching, dry eyes, and changes in eyelash growth. Less frequently, you might notice ocular pain, a sensation of having something in your eye, sensitivity to light, eye discharge, or changes in the pigmentation of your iris and eyelids.
In rare cases, more serious reactions can occur, including macular edema (swelling in the central part of the retina), uveitis (inflammation of the eye), and allergic reactions like angioedema (swelling under the skin) or urticaria (hives). If you have asthma, be aware that your symptoms may worsen. Always consult your healthcare provider if you experience any concerning symptoms.
Warnings and Precautions
There are no specific warnings, precautions, or instructions regarding laboratory tests, emergency help, or when to stop taking the medication and call your doctor provided in the information available.
It's always a good practice to stay informed about your health and any medications you are taking. If you have any concerns or experience unusual symptoms while using this medication, please consult your healthcare provider for guidance.
Overdose
If you accidentally use too much LUMIGAN (bimatoprost ophthalmic solution), there isn't a lot of information available about what might happen. However, if you experience an overdose, the first step is to flush your eye gently with warm water. This can help remove any excess solution.
If you happen to swallow the solution, it's important to contact a poison control center or seek medical help right away. Being aware of these steps can help ensure your safety and well-being.
Pregnancy Use
If you are pregnant or planning to become pregnant, it's important to know that there is no specific information available about the use of LUMIGAN (bimatoprost ophthalmic solution) during pregnancy. This means that safety concerns, dosage adjustments, or special precautions for pregnant individuals have not been established.
Before using this medication, you should discuss it with your healthcare provider to ensure it is safe for you and your baby. Always prioritize open communication with your doctor about any medications you are considering during pregnancy.
Lactation Use
If you are breastfeeding and considering the use of LUMIGAN (bimatoprost ophthalmic solution), you can feel reassured that there are no specific warnings or recommendations regarding its use during nursing. This means that, based on the available information, it is not expected to pose risks to you or your nursing infant. However, as with any medication, it's always a good idea to discuss your options with your healthcare provider to ensure the best care for both you and your baby.
Pediatric Use
When considering LUMIGAN (bimatoprost) for your child, it's important to know that its use in children has not been established. This means that the safety and effectiveness of this medication for pediatric patients (children) have not been determined. As a parent or caregiver, you should consult with your child's healthcare provider to discuss any concerns and explore appropriate treatment options.
Geriatric Use
When considering Lumigan (bimatoprost) for older adults, it's important to note that specific studies on its use in this age group have not been conducted. Fortunately, no changes to the dosage are required for elderly patients. However, you should be aware that older adults may be more sensitive to the side effects of this medication.
If you or a loved one has reduced kidney function, extra caution is advised when using Lumigan. Always consult with a healthcare provider to ensure safe and effective use, especially if there are any concerns about kidney health or potential side effects.
Renal Impairment
If you have kidney issues, you can take this medication without needing any specific dosage adjustments. The information provided does not indicate any special monitoring or safety considerations for patients with renal impairment. However, it's always a good idea to discuss your individual health situation with your healthcare provider to ensure the best care.
Hepatic Impairment
If you have liver problems, it's important to know that the insert for LUMIGAN (bimatoprost ophthalmic solution) does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no established guidelines for how your liver health might affect the use of this medication.
Always consult your healthcare provider for personalized advice and to discuss any concerns you may have regarding your liver condition and the use of LUMIGAN. They can help ensure that your treatment is safe and effective based on your individual health needs.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. In this case, there are no known drug interactions or laboratory test interactions associated with the medication. However, your healthcare provider can help ensure that your overall treatment plan is safe and effective, taking into account all the medications and tests you may be using. Always feel free to ask questions and share your complete health history to get the best care possible.
Storage and Handling
To ensure the best performance of your product, store it in a cool, dry place at a temperature between 20°C to 25°C (68°F to 77°F). It's important to keep the product protected from light to maintain its effectiveness. Once you open the product, please remember to discard it after use to ensure safety and prevent contamination. Following these guidelines will help you use the product safely and effectively.
Additional Information
No further information is available.
FAQ
What is LUMIGAN®?
LUMIGAN® is an ophthalmic solution containing the active ingredient bimatoprost, indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
How should I use LUMIGAN®?
Administer LUMIGAN® as prescribed by your healthcare provider, typically one drop in the affected eye(s) once daily in the evening.
What are the common side effects of LUMIGAN®?
Common side effects include conjunctival hyperemia, eye irritation, itching of the eye, dry eye, and eyelash growth.
Are there any rare side effects associated with LUMIGAN®?
Rare side effects may include macular edema, uveitis, iris cysts, and ocular inflammation.
What precautions should I take when using LUMIGAN®?
Caution should be exercised when administering LUMIGAN® to elderly patients, particularly those with reduced kidney function, as they may exhibit increased sensitivity to side effects.
Is LUMIGAN® safe to use during pregnancy?
There is no specific information regarding the use of LUMIGAN® during pregnancy, including safety concerns or dosage modifications.
How should I store LUMIGAN®?
Store LUMIGAN® at 20°C to 25°C (68°F to 77°F), protect it from light, and discard it after opening.
Can LUMIGAN® be used in pediatric patients?
Pediatric use of LUMIGAN® has not been established, and safety and effectiveness in this population have not been determined.
Packaging Info
The table below lists all NDC Code configurations of Lumigan (bimatoprost), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
FDA Insert (PDF)
This is the full prescribing document for Lumigan, submitted to the U.S. Food and Drug Administration (FDA). It contains official information for healthcare providers, including how to use the medication, possible side effects, and safety warnings.
Description
LUMIGAN® is a sterile ophthalmic solution containing bimatoprost at a concentration of 0.03%. It is supplied in a 3 mL bottle and is available by prescription only (Rx only).
Uses and Indications
LUMIGAN® (bimatoprost ophthalmic solution) is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Limitations of Use: There are no specific teratogenic or nonteratogenic effects associated with the use of LUMIGAN® as noted in the available data.
Dosage and Administration
The active ingredient, bimatoprost, is formulated as an ophthalmic solution with a concentration of 0.3 mg per 1 mL. This medication is intended for administration via the ophthalmic route.
Healthcare professionals should instruct patients to apply the solution as directed, ensuring proper technique to maximize efficacy and minimize potential contamination. It is essential to follow the prescribed dosing regimen, which may vary based on individual patient needs and clinical judgment.
Patients should be advised to avoid touching the dropper tip to any surface, including the eye, to prevent contamination. If a dose is missed, the patient should administer it as soon as they remember, unless it is almost time for the next scheduled dose. In such cases, the patient should skip the missed dose and resume the regular dosing schedule.
Healthcare providers should monitor patients for therapeutic response and any adverse effects, adjusting the dosing as necessary based on clinical evaluation.
Contraindications
There are no specific contraindications provided for this product. It is essential for healthcare professionals to evaluate individual patient circumstances and consider any potential risks associated with the use of this product.
Warnings and Precautions
There are currently no specific warnings or precautions associated with the use of this medication. Healthcare professionals are advised to remain vigilant and monitor patients for any unforeseen reactions or complications that may arise during treatment.
As there are no recommended laboratory tests or specific instructions for emergency medical assistance or discontinuation of the medication, it is essential for healthcare providers to exercise clinical judgment and consider individual patient circumstances when prescribing this therapy. Regular follow-up and patient assessment are encouraged to ensure safe and effective use.
Side Effects
Patients may experience a range of adverse reactions associated with the use of this medication. Common adverse reactions include conjunctival hyperemia, eye irritation, itching of the eye, dry eye, and eyelash growth.
Less common adverse reactions reported include ocular pain, foreign body sensation in the eye, photophobia, eye discharge, increased pigmentation of the iris, eyelid darkening, and changes in eyelash characteristics, such as increased length, thickness, and number.
Rare adverse reactions have also been observed, including macular edema, uveitis, iris cysts, periorbital skin darkening, and ocular inflammation.
Postmarketing experience has revealed additional adverse reactions, such as allergic reactions, which may include severe manifestations like anaphylaxis, as well as asthma exacerbation and respiratory symptoms. Systemic effects, including headache and dizziness, have also been reported. Notably, patients with a history of asthma may be at an increased risk for exacerbation of their condition.
Severe allergic reactions, including angioedema and urticaria, have been documented, highlighting the importance of monitoring for these serious events. Changes in eyelash characteristics, including increased length, thickness, and pigmentation, may occur and should be considered when evaluating treatment outcomes.
Drug Interactions
No drug interactions or drug and laboratory test interactions have been identified in the available data. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.
Packaging & NDC
The table below lists all NDC Code configurations of Lumigan (bimatoprost), the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.
Details | ||||
|---|---|---|---|---|
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Marketed All current FDA data sets list this NDC as actively marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
Pediatric Use
Pediatric use of LUMIGAN (bimatoprost) has not been established, and safety and effectiveness in pediatric patients have not been determined. Therefore, caution is advised when considering the use of this medication in children and adolescents.
Geriatric Use
Clinical studies have not specifically evaluated the use of Lumigan (bimatoprost) in geriatric patients. However, no dosage adjustments are necessary for elderly patients.
It is important to note that elderly patients may demonstrate increased sensitivity to the side effects associated with bimatoprost. Therefore, caution should be exercised when administering Lumigan to this population, especially in those with compromised kidney function. Regular monitoring for adverse effects is recommended to ensure patient safety and optimal therapeutic outcomes.
Pregnancy
There is no specific information available regarding the use of LUMIGAN (bimatoprost ophthalmic solution) during pregnancy. As such, the safety of this medication in pregnant patients has not been established. Healthcare professionals should consider the potential risks and benefits when prescribing LUMIGAN to women of childbearing potential. Due to the lack of data on dosage modifications or special precautions for use during pregnancy, it is recommended that healthcare providers exercise caution and discuss alternative treatment options with pregnant patients or those planning to become pregnant.
Lactation
There are no specific warnings or recommendations regarding nursing mothers or lactation for LUMIGAN (bimatoprost ophthalmic solution). The available data does not indicate whether bimatoprost is excreted in human breast milk or its effects on breastfed infants. Healthcare professionals should consider the potential risks and benefits when prescribing this medication to lactating mothers.
Renal Impairment
Patients with renal impairment do not require specific dosage adjustments based on the information provided. Additionally, there are no special monitoring or safety considerations indicated for patients with reduced kidney function.
Hepatic Impairment
Patients with hepatic impairment have not been specifically studied in relation to LUMIGAN (bimatoprost ophthalmic solution). Consequently, there are no dosage adjustments, special monitoring requirements, or precautions outlined for this population. It is recommended that healthcare providers exercise caution when prescribing LUMIGAN to patients with compromised liver function, given the lack of data on its safety and efficacy in this group.
Overdosage
In cases of overdosage with LUMIGAN (bimatoprost ophthalmic solution), clinical experience is limited. However, appropriate management steps should be taken to mitigate potential adverse effects.
Ocular Overdosage Management If an overdose occurs in the eye, it is recommended to flush the affected eye with warm water. This action may help to remove excess solution and reduce the risk of irritation or other complications.
Ingestion of the Solution In the event that the solution is ingested, it is crucial to contact a poison control center or seek immediate medical attention. Prompt intervention is essential to ensure the safety and well-being of the patient.
Healthcare professionals should remain vigilant and monitor for any symptoms that may arise from overdosage, although specific symptoms have not been extensively documented.
Nonclinical Toxicology
In animal studies, no teratogenic effects were observed with bimatoprost. However, adverse developmental outcomes were noted in the offspring of rats administered bimatoprost during pregnancy. Additionally, there was no increase in fetal malformations associated with bimatoprost treatment in these studies.
Postmarketing Experience
Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include conjunctival hyperemia, eye irritation, and changes in eyelash characteristics, such as increased length, thickness, and pigmentation.
Additional adverse reactions reported consist of headache, dizziness, and various skin reactions, including rash and pruritus. There have also been reports of increased pigmentation of the iris, eyelid, and eyelashes.
Rare cases of macular edema, including cystoid macular edema, have been documented, particularly in patients with a history of ocular surgery or pre-existing conditions.
Patient Counseling
Patients should be advised to use LUMIGAN exactly as prescribed by their healthcare provider. It is important for patients to understand that LUMIGAN is intended for ophthalmic use only and should not be injected or ingested.
Patients should be instructed to wash their hands thoroughly before using LUMIGAN to minimize the risk of contamination. Additionally, they should be advised to remove contact lenses prior to administration of LUMIGAN and to wait at least 15 minutes before reinserting them.
Patients should be informed that LUMIGAN may cause darkening of the iris, eyelid, and eyelashes, which may be permanent. They should also be made aware that LUMIGAN may lead to increased eyelash growth and changes in eyelash pigmentation.
It is essential for patients to be informed about the potential for ocular side effects, including eye irritation, redness, and dryness. Patients should be advised to report any changes in vision or eye discomfort to their healthcare provider promptly.
Patients should be instructed to store LUMIGAN at room temperature and to protect it from light. Furthermore, they should be advised to discard the bottle 4 weeks after opening, even if there is solution remaining, to ensure safety and efficacy.
Storage and Handling
The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F) to maintain its efficacy. It is essential to protect the product from light to prevent degradation. Additionally, the product must be discarded after opening to ensure safety and effectiveness.
Additional Clinical Information
No further data are available.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Lumigan as submitted by Allergan, Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.