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Bimatoprost

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Active ingredient
Bimatoprost 0.3 mg/1 mL
Other brand names
Drug class
Prostaglandin Analog
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 2021
Label revision date
September 26, 2024
FDA Insert
Prescribing information, PDF file
Active ingredient
Bimatoprost 0.3 mg/1 mL
Other brand names
Drug class
Prostaglandin Analog
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 2021
Label revision date
September 26, 2024
Manufacturer
Micro Labs Limited
Registration number
ANDA202505
NDC root
42571-128
FDA Insert
Prescribing information, PDF file
Packaging Info (3 NDCs)
Packaging & NDC Codes (3)

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Drug Overview

Bimatoprost ophthalmic solution 0.03% is a synthetic medication that helps lower elevated intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. It works by mimicking the effects of natural substances called prostamides, which help increase the outflow of fluid from the eye. By enhancing this fluid drainage, Bimatoprost can reduce the risk of optic nerve damage and visual field loss associated with high IOP.

This clear, colorless solution contains Bimatoprost as its active ingredient, along with a preservative and other inactive components. It is designed to be easy to use and is an important option for managing eye pressure in those at risk for glaucoma.

Uses

Bimatoprost ophthalmic solution 0.03% is used to help lower high eye pressure in people who have open-angle glaucoma or ocular hypertension. By reducing this pressure, it can help protect your vision and maintain eye health.

If you have concerns about your eye pressure or conditions like glaucoma, it's important to talk to your healthcare provider about how this treatment may benefit you.

Dosage and Administration

To use this medication, you will need to apply one drop directly into the affected eye or eyes. It's important to do this once daily, and the best time to apply it is in the evening. This routine helps ensure that the medication works effectively to address your condition. Remember to follow this schedule consistently for the best results.

What to Avoid

It's important to be aware of certain situations where you should not use this medication. If you have a hypersensitivity (an extreme allergic reaction) to any component of the drug, you should avoid taking it.

Additionally, this medication is classified as a controlled substance, which means it has the potential for abuse or misuse. Be cautious, as using it improperly can lead to dependence (a condition where your body becomes reliant on the drug). Always follow your healthcare provider's instructions and do not take this medication if you have any of the contraindications mentioned.

Side Effects

You may experience some side effects while using this medication. The most common reaction is conjunctival hyperemia, which occurs in about 45% of users. Additionally, you might notice changes in pigmentation, including darkening of the iris (the colored part of your eye), eyelids, and eyelashes. It's important to know that iris pigmentation is likely to be permanent.

You may also see gradual changes in your eyelashes, such as increased length, thickness, and number, which are usually reversible. Some individuals may experience hypersensitivity, which is an allergic reaction. If you have any concerns about these side effects, please consult your healthcare provider.

Warnings and Precautions

You should be aware that using this medication may lead to changes in the color of your iris (the colored part of your eye), eyelids, and eyelashes. The change in iris color is likely to be permanent, while the increase in the length, thickness, and number of your eyelashes is usually reversible.

There are no specific laboratory tests required for safe use of this medication. If you experience any unusual symptoms or have concerns while using it, it's important to consult your doctor for guidance.

Overdose

If you suspect an overdose of bimatoprost ophthalmic solution (a medication used for eye conditions), it's important to know that there is no specific information available about overdose effects in humans. If an overdose occurs, treatment should focus on relieving symptoms rather than a specific antidote.

In studies with mice and rats, doses much higher than what a child might accidentally ingest did not show any harmful effects. For example, a dose of 100 mg/kg/day is significantly higher than what would be found in one bottle of the solution. However, if you notice unusual symptoms or have concerns, it’s always best to seek medical advice promptly. If you or someone else experiences severe symptoms, such as difficulty breathing or extreme drowsiness, seek immediate medical help.

Pregnancy Use

There are currently no well-controlled studies on the use of bimatoprost ophthalmic solution 0.03% in pregnant women, but based on available data, there is no evidence of an increased risk of major birth defects or miscarriages. However, animal studies have shown that high doses of bimatoprost can lead to abortion and early delivery in pregnant mice and rats. These adverse effects were not seen at lower doses, which were significantly below those that would be expected in humans using the recommended clinical dose.

Given that animal studies may not always predict human outcomes, it is important to use bimatoprost during pregnancy only if the potential benefits outweigh the risks to the fetus. If you are pregnant or planning to become pregnant, consult your healthcare provider to discuss the best options for your situation.

Lactation Use

If you are breastfeeding and considering the use of bimatoprost ophthalmic solution 0.03%, it's important to know that it is unclear whether this eye treatment can enter your breast milk in significant amounts. In studies with lactating rats, bimatoprost was found in their milk after receiving a much higher dose than what is typically used in humans. However, there is no specific data on how it behaves at doses relevant to your treatment.

When making decisions about using this medication, weigh the benefits of breastfeeding against your need for bimatoprost and any potential risks to your baby. Always consult with your healthcare provider to ensure the best choice for both you and your child.

Pediatric Use

It is important to be cautious when considering this medication for children. The use of this drug in patients under 16 years old is not recommended due to potential safety concerns. Specifically, there is a risk of increased pigmentation (darkening of the skin) that may occur with long-term use.

If you are a parent or caregiver, it’s best to consult with a healthcare professional to discuss safe treatment options for your child. Always prioritize their health and well-being when making decisions about medications.

Geriatric Use

As an older adult or caregiver, it's reassuring to know that there are no significant differences in safety or effectiveness when using this medication compared to younger adults. This means that you can expect similar results and side effects as other adults, which can help you feel more confident in managing your health.

However, it's always important to discuss any specific health concerns or conditions with your healthcare provider, as individual needs may vary. They can provide personalized advice and ensure that the medication is appropriate for you or your loved one.

Renal Impairment

If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring requirements mentioned for your condition in the provided information. This means that the medication may not have tailored instructions for individuals with renal impairment (kidney issues).

Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your kidney health. They can provide guidance based on your specific situation and any other health considerations you may have.

Hepatic Impairment

If you have liver problems, it's important to know that there are no specific guidelines or dosage adjustments mentioned for your condition in the available information. This means that the standard recommendations apply, but you should always consult your healthcare provider for personalized advice. They can help determine the best approach for your treatment and monitor your liver function as needed.

Make sure to keep your doctor informed about your liver health, as they may need to conduct regular tests to ensure your safety while using any medication. Your well-being is a priority, so don't hesitate to ask questions or express any concerns you may have.

Drug Interactions

It's important to talk to your healthcare provider about any medications you are using, including bimatoprost ophthalmic solution 0.03%. This eye drop can be safely used with other eye drops to help lower eye pressure, but if you are using multiple eye medications, make sure to space them out by at least five minutes to ensure they work effectively.

Additionally, bimatoprost contains a substance called benzalkonium chloride, which can discolor soft contact lenses. To avoid this, you should remove your contact lenses before using the eye drops and wait at least 15 minutes before putting them back in. Always consult with your healthcare provider to ensure you are using your medications safely and effectively.

Storage and Handling

To ensure the best results with your bimatoprost ophthalmic solution 0.03%, store it in a cool, dry place at a temperature between 2° to 25°C (36° to 77°F). This helps maintain the effectiveness of the solution. Once you open the bottle, you can continue to use it until the expiration date printed on the label, so be sure to check that date before use.

When handling the solution, make sure to keep the dropper tip clean and avoid touching it to any surfaces, including your eye, to maintain its sterility (the absence of germs). Proper storage and handling will help ensure that you get the most benefit from your treatment.

Additional Information

You should be aware that treatment with this medication may lead to increased pigmentation, particularly in the iris (the colored part of your eye). If you notice any significant changes in your eye color, it's important to have regular check-ups with your healthcare provider.

Additionally, if you wear contact lenses, make sure to remove them before using the bimatoprost ophthalmic solution 0.03%. You can put your lenses back in about 15 minutes after applying the solution.

FAQ

What is Bimatoprost ophthalmic solution 0.03%?

Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog used to reduce elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

How does Bimatoprost work?

Bimatoprost mimics naturally occurring substances called prostamides and lowers intraocular pressure by increasing the outflow of aqueous humor through specific routes in the eye.

What are the common side effects of Bimatoprost?

The most common side effect is conjunctival hyperemia (redness of the eye), occurring in about 45% of patients. Other effects may include pigmentation changes in the iris and eyelashes.

How should I use Bimatoprost ophthalmic solution?

You should instill one drop in the affected eye(s) once daily in the evening. Make sure to remove contact lenses before use and wait 15 minutes before reinserting them.

Are there any contraindications for using Bimatoprost?

Yes, Bimatoprost is contraindicated in individuals with hypersensitivity to any of its components.

Can I use Bimatoprost during pregnancy?

Bimatoprost should only be used during pregnancy if the potential benefits justify the risks, as animal studies have shown adverse effects at high doses.

What should I do if I notice increased pigmentation while using Bimatoprost?

If you notice increased pigmentation of the iris or eyelashes, you should consult your doctor for regular examinations.

What is the storage requirement for Bimatoprost?

Bimatoprost should be stored at 2° to 25°C (36° to 77°F) and can be used until the expiration date printed on the bottle after opening.

Packaging Info

The table below lists all NDC Code configurations of Bimatoprost, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bimatoprost.
Details

FDA Insert (PDF)

This is the full prescribing document for Bimatoprost, 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.

View FDA-approved insert (PDF)

Description

Bimatoprost ophthalmic solution 0.03% is a synthetic prostamide analog exhibiting ocular hypotensive activity. The chemical name of bimatoprost is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-(1E,3S)-3-hydroxy-5-phenyl-1-pentenylcyclopentyl]-5-N-ethylheptenamide, with a molecular weight of 415.58 and a molecular formula of C25H37NO4. This compound is presented as a clear, colorless solution that is practically free from particles, with an osmolality of approximately 290 mOsmol/kg.

The formulation contains bimatoprost at a concentration of 0.3 mg/mL as the active ingredient, along with benzalkonium chloride at 0.05 mg/mL as a preservative. Inactive ingredients include sodium chloride, disodium hydrogen phosphate heptahydrate, citric acid monohydrate, and water for injection. The pH of the solution is adjusted with sodium hydroxide and/or hydrochloric acid, maintaining a range of 6.9 to 7.6 throughout its shelf life. Bimatoprost is a powder that demonstrates high solubility in ethyl alcohol and methyl alcohol, with slight solubility in water.

Uses and Indications

Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

There are no teratogenic or nonteratogenic effects associated with this medication.

Dosage and Administration

The recommended dosage for administration is one drop in the affected eye(s) once daily in the evening. Healthcare professionals should instruct patients to ensure proper technique when administering the drop to maximize efficacy and minimize potential contamination. It is advised to avoid touching the dropper tip to any surface, including the eye, to maintain sterility.

Contraindications

Use of this product is contraindicated in individuals with a known hypersensitivity to any of its components.

Warnings and Precautions

Pigmentation of the iris, periorbital tissue (eyelid), and eyelashes may occur with the use of this medication. It is important to note that iris pigmentation is likely to be permanent. Healthcare professionals should inform patients about this potential side effect to ensure they are adequately prepared for any changes.

Patients may also experience a gradual change in their eyelashes, which can include increased length, thickness, and number of lashes. These changes are typically reversible; however, monitoring for any unexpected or prolonged effects is advisable.

Currently, there are no specific laboratory tests recommended for the safe use of this medication. Healthcare providers should remain vigilant and assess patients regularly for any adverse effects or changes in their condition.

In the event of any concerning symptoms or side effects, patients are advised to seek medical attention promptly. Additionally, if patients experience any significant changes or have concerns regarding their treatment, they should be encouraged to consult their healthcare provider for further guidance.

Side Effects

In clinical trials, the most common adverse reaction observed was conjunctival hyperemia, reported in 45% of patients.

Additional adverse reactions include pigmentation changes, which may affect the iris, periorbital tissue (eyelids), and eyelashes. Notably, iris pigmentation is likely to be permanent. Patients may also experience changes in their eyelashes, characterized by a gradual increase in length, thickness, and number of lashes; these changes are usually reversible.

Hypersensitivity reactions have also been reported among participants, warranting careful monitoring.

Drug Interactions

Bimatoprost ophthalmic solution 0.03% may be administered concurrently with other topical ophthalmic products aimed at reducing intraocular pressure. When utilizing multiple topical ophthalmic medications, it is recommended that they be applied at least five (5) minutes apart to ensure optimal efficacy and minimize potential interactions.

It is important to note that bimatoprost ophthalmic solution 0.03% contains benzalkonium chloride, a preservative that can be absorbed by soft contact lenses, potentially leading to discoloration. Therefore, patients should remove their contact lenses prior to the application of bimatoprost ophthalmic solution 0.03%. Contact lenses may be reinserted 15 minutes after the administration of the solution to avoid any adverse effects related to lens discoloration.

Packaging & NDC

The table below lists all NDC Code configurations of Bimatoprost, the U.S. brand-name prescription product. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Bimatoprost.
Details

Pediatric Use

Use in pediatric patients below the age of 16 years is not recommended due to potential safety concerns. Specifically, there is an increased risk of pigmentation changes following long-term chronic use in this population. Healthcare professionals should exercise caution when considering treatment options for children and adolescents under 16 years of age.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, have not demonstrated any overall clinical differences in safety or effectiveness compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population.

However, healthcare providers should remain vigilant in monitoring elderly patients for any potential adverse effects, as individual responses may vary. It is essential to consider the overall health status and comorbidities of geriatric patients when prescribing, as these factors may influence treatment outcomes.

Pregnancy

There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% in pregnant women. Based on postmarketing experience, there is no increase in the risk of major birth defects or miscarriages associated with its use. However, animal studies have shown that administration of bimatoprost during organogenesis in pregnant mice and rats resulted in abortion and early delivery at oral doses significantly higher than the recommended clinical dose, specifically at least 33 times the human exposure in mice and 94 times in rats (based on blood area under the curve AUC levels). No adverse effects were observed at lower doses, specifically at 2.6 times the human exposure in mice and 47 times in rats.

In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis through lactation resulted in reduced gestation length, increased fetal and pup mortality, and decreased fetal body weight at doses at least 41 times the human systemic exposure at the recommended clinical dose. No adverse effects were noted in rat offspring at exposures estimated at 14 times the human exposure.

Due to the potential risks observed in animal studies, bimatoprost ophthalmic solution 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. The No Observed Adverse Effect Level (NOAEL) for abortion in rats was determined to be 0.3 mg/kg/day (47 times the human systemic exposure), while in mice, the NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure). No abnormalities were observed in fetuses at doses up to 0.6 mg/kg/day in both species.

Healthcare professionals should carefully consider the risks and benefits when prescribing this medication to pregnant patients.

Lactation

It is not known whether topical ocular treatment with bimatoprost ophthalmic solution 0.03% could result in sufficient systemic absorption to produce detectable quantities in human milk. In animal studies, bimatoprost has been shown to be present in the breast milk of lactating rats at an intravenous dose (1 mg/kg) 324 times the recommended human oral dose (RHOD) on a mg/m² basis; however, no animal data is available at clinically relevant doses.

The developmental and health benefits of breastfeeding should be considered alongside the mother’s clinical need for bimatoprost ophthalmic solution 0.03% and any potential adverse effects on the breastfed infant from this treatment.

Renal Impairment

There is no information available regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with reduced kidney function.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population.

Overdosage

In the event of an overdose with bimatoprost ophthalmic solution, 0.03%, there is currently no available information regarding overdosage in humans. Should an overdose occur, the recommended course of action is to provide symptomatic treatment as necessary.

Toxicity studies conducted in mice and rats via oral administration (by gavage) have demonstrated that doses up to 100 mg/kg/day did not result in any observable toxicity. Notably, this dosage, when converted to mg/m², is at least 70 times greater than the accidental ingestion of a single bottle of bimatoprost ophthalmic solution, 0.03%, by a child weighing 10 kg. This data suggests a significant margin of safety; however, healthcare professionals should remain vigilant and manage any overdose cases with appropriate symptomatic care.

Nonclinical Toxicology

Bimatoprost was evaluated for its carcinogenic potential in both mice and rats. In these studies, it was administered via oral gavage for a duration of 104 weeks at doses of up to 2 mg/kg/day in mice and 1 mg/kg/day in rats. The results indicated that bimatoprost was not carcinogenic, with the doses tested representing at least 192 and 291 times the human systemic exposure at the recommended human dose (RHOD), based on blood area under the curve (AUC) levels.

Additionally, bimatoprost was assessed for mutagenicity and clastogenicity through various tests, including the Ames test, the mouse lymphoma test, and in vivo mouse micronucleus tests. The findings demonstrated that bimatoprost was neither mutagenic nor clastogenic.

Furthermore, the effects of bimatoprost on fertility were investigated in male and female rats. The results showed that bimatoprost did not impair fertility at doses up to 0.6 mg/kg/day, which corresponds to at least 103 times the human systemic exposure at the RHOD, based on blood AUC levels.

Postmarketing Experience

No specific postmarketing experience details are available. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Patients should be informed about the potential for increased brown pigmentation of the iris, which may be permanent. Additionally, they should be made aware of the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution 0.03%.

It is important to discuss with patients the potential changes in eyelashes and vellus hair in the treated eye during the course of treatment with bimatoprost ophthalmic solution 0.03%. These changes may lead to differences between the eyes in terms of length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Patients should be reassured that eyelash changes are typically reversible upon discontinuation of treatment.

Healthcare providers should instruct patients to avoid allowing the tip of the dispensing container to come into contact with the eye, surrounding structures, fingers, or any other surface. This precaution is essential to prevent contamination of the solution by common bacteria that can cause ocular infections, which may lead to serious damage to the eye and potential loss of vision.

Patients should be advised to seek immediate medical advice if they develop any intercurrent ocular condition, such as trauma or infection, undergo ocular surgery, or experience any ocular reactions, particularly conjunctivitis and eyelid reactions, regarding the continued use of bimatoprost ophthalmic solution 0.03%.

It is also crucial to inform patients that bimatoprost ophthalmic solution 0.03% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Patients should be instructed to remove their contact lenses prior to instillation of the solution and may reinsert them 15 minutes after administration.

Finally, if patients are using more than one topical ophthalmic drug, they should be advised to administer the drugs at least five (5) minutes apart to ensure proper absorption and effectiveness.

Storage and Handling

Bimatoprost ophthalmic solution 0.03% is supplied in a container that allows for easy dispensing. It should be stored at a temperature range of 2° to 25°C (36° to 77°F) to maintain its efficacy.

Once opened, the solution can be used until the expiration date indicated on the bottle. It is important to handle the product with care to ensure its integrity and effectiveness throughout its use.

Additional Clinical Information

Patients receiving treatment with bimatoprost ophthalmic solution 0.03% should be informed about the potential for increased pigmentation, particularly regarding the iris. Regular examinations are recommended for patients who notice a significant change in iris pigmentation. Additionally, it is advised that contact lenses be removed before the administration of the solution and can be reinserted 15 minutes after application.

FDA Insert (PDF)

This document is the official FDA-approved prescribing information for Bimatoprost as submitted by Micro Labs Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.

View full prescribing information (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Bimatoprost, retrieved by a validated AI data-extraction workflow.

All FDA-approved dosage forms and strengths are listed in the Packaging & NDC Codes section above. Regulatory status, pharmacologic class (EPC), and mechanism of action (MoA) were cross-checked against the FDA Orange Book (ANDA202505) and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

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Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.