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Bimatoprost
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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 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.)
- Lumigan (by Allergan, Inc.)
- View full label-group details →
- 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 2020
- Label revision date
- June 9, 2022
- 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 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.)
- Lumigan (by Allergan, Inc.)
- View full label-group details →
- 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 2020
- Label revision date
- June 9, 2022
- Manufacturer
- Fosun Pharma USA Inc.
- Registration number
- ANDA210126
- NDC roots
- 72266-139, 72266-140, 72266-241
- FDA Insert
- Prescribing information, PDF file
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Drug Overview
Bimatoprost ophthalmic solution, 0.03% is a medication designed to help lower elevated intraocular pressure (IOP) in individuals with open-angle glaucoma or ocular hypertension. It is a synthetic prostamide analog, which means it mimics the effects of natural substances in the body that help regulate eye pressure. By increasing the outflow of aqueous humor (the fluid in the eye) through specific pathways, bimatoprost effectively reduces IOP, thereby helping to protect against potential damage to the optic nerve and loss of vision.
This clear, sterile solution is applied directly to the eye and works by enhancing the drainage of fluid, which is crucial for maintaining healthy eye pressure. Managing IOP is important, as higher levels can lead to serious eye conditions, including glaucoma.
Uses
Bimatoprost ophthalmic solution, 0.03%, is used to help lower high pressure inside the eye, specifically for individuals with open-angle glaucoma or ocular hypertension. This medication works by increasing the outflow of fluid from the eye, which can help prevent damage to the optic nerve and maintain your vision.
It's important to note that there are no reported teratogenic effects (which means it does not cause birth defects) or nonteratogenic effects associated with this medication. If you have any concerns or questions about using this treatment, be sure to discuss them with your healthcare provider.
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 and follow your healthcare provider's instructions closely to prevent any issues related to dependence (a condition where your body becomes reliant on a substance). Always prioritize your safety and consult with your doctor if you have any concerns.
Side Effects
You may experience some side effects while using this medication. The most common reaction is conjunctival hyperemia, which affects about 45% of users and involves redness of the eye. Additionally, you might notice changes in pigmentation, particularly in 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, but these changes are usually reversible. Lastly, some individuals may experience hypersensitivity reactions, which are allergic responses that can vary in severity. If you notice any unusual symptoms, it's best to consult with 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 changes to your eyelashes, such as increased length, thickness, and number, are usually reversible.
There are no specific laboratory tests required while using this medication, but it's important to monitor any changes you notice. If you experience any unexpected side effects or have concerns, please stop using the medication and 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 about overdose effects in humans. However, if an overdose occurs, treatment should focus on relieving symptoms.
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 a 10 kg child would get from one bottle of the solution.
If you notice unusual symptoms or have concerns about an overdose, it's best to seek medical advice immediately. Always err on the side of caution and contact a healthcare professional if you are unsure.
Pregnancy Use
There are currently no well-controlled studies on the use of bimatoprost ophthalmic solution 0.03% in pregnant women. However, based on available data, there is no evidence of an increased risk of major birth defects or miscarriages. Animal studies have shown that high doses of bimatoprost can lead to abortion and early delivery in pregnant mice and rats, but these effects were not seen at lower doses that are closer to human exposure levels.
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. While studies in lactating rats have shown that bimatoprost can be found in breast milk at much higher doses than what humans would typically use, there is no data available on its effects at doses relevant to human use.
When making decisions about using this medication, weigh the benefits of breastfeeding against your need for bimatoprost and any potential risks to your nursing child. Always consult with your healthcare provider to ensure the best choice for both you and your baby.
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 by seeking expert advice.
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 your treatment plan.
However, it's always important to discuss any specific health concerns or conditions with your healthcare provider, as they can provide personalized advice tailored to your needs.
Renal Impairment
It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. Therefore, there are no guidelines, dosage adjustments, or monitoring instructions to share for patients with kidney issues. If you have concerns about how your kidney health may affect your treatment, it's important to discuss this with your healthcare provider for personalized advice and recommendations.
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, and there are no special monitoring requirements or precautions outlined for patients with liver impairment.
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe for your liver health. They can provide guidance based on your individual situation and help monitor your liver function as needed.
Drug Interactions
It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.
Always feel free to ask questions and share your complete list of medications and any lab tests you may be undergoing. This way, you can receive the best possible care tailored to your needs.
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). Following these guidelines will help you use the product safely and effectively.
Additional Information
You should be aware that treatment with bimatoprost ophthalmic solution, 0.03% may lead to increased pigmentation of your eyes. If you notice any significant changes in the color of your iris, it's important to have regular check-ups with your healthcare provider.
Before using the eye drops, make sure to remove your contact lenses. You can put them back in about 15 minutes after applying the drops.
FAQ
What is Bimatoprost ophthalmic solution, 0.03%?
Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog used to lower elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
How does Bimatoprost work?
Bimatoprost lowers intraocular pressure (IOP) by increasing the outflow of aqueous humor through the trabecular meshwork and uveoscleral routes.
What are the common side effects of Bimatoprost?
The most common side effect is conjunctival hyperemia (45%). Other effects include pigmentation of the iris and eyelash changes.
Can Bimatoprost cause changes in eye pigmentation?
Yes, Bimatoprost can cause permanent pigmentation of the iris and periorbital tissue, as well as changes in eyelashes.
How should I use Bimatoprost ophthalmic solution?
You should instill one drop in the affected eye(s) once daily in the evening.
Is Bimatoprost safe to use during pregnancy?
There are no adequate studies in pregnant women, so Bimatoprost should only be used if the potential benefit justifies the potential risk to the fetus.
What should I do if I wear contact lenses?
Remove your contact lenses before using Bimatoprost and wait 15 minutes before reinserting them.
What are the storage conditions for Bimatoprost?
Store Bimatoprost at 2° to 25°C (36° to 77°F) and use it until the expiration date after opening.
Are there any contraindications for using Bimatoprost?
Yes, Bimatoprost is contraindicated in individuals with hypersensitivity to any of its components.
Is Bimatoprost recommended for children?
Bimatoprost is not recommended for pediatric patients below the age of 16 due to potential safety concerns.
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.
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
| ||||
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.
Description
Bimatoprost ophthalmic solution, 0.03% is a synthetic prostamide analog with ocular hypotensive activity. Its chemical name is (Z)-7-[(1R,2R,3R,5S)-3,5-Dihydroxy-2-(1E,3S)-3-hydroxy-5-phenyl-1-pentenylcyclopentyl]-5-N-ethylheptenamide, and it has a molecular weight of 415.58 and a molecular formula of C25H37NO4. Bimatoprost is presented as a powder that is very soluble in ethyl alcohol and methyl alcohol, and slightly soluble in water.
The ophthalmic solution is clear, isotonic, colorless, and sterile, with an osmolality of approximately 290 mOsmol/kg. It contains active bimatoprost at a concentration of 0.3 mg/mL. Inactive ingredients include benzalkonium chloride at 0.05 mg/mL, disodium hydrogen phosphate heptahydrate, citric acid monohydrate, sodium chloride, and water for injection. Sodium hydroxide and/or hydrochloric acid may be added to adjust the pH, which ranges from 6.8 to 7.8 during its shelf life.
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. Due to the potential for severe allergic reactions, administration in such cases may pose significant health risks.
Warnings and Precautions
Pigmentation changes may occur in the iris, periorbital tissue (eyelids), and eyelashes. 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.
In addition to pigmentation changes, patients may experience a gradual alteration in their eyelashes, which may include increased length, thickness, and number of lashes. These changes are typically reversible; however, monitoring for any unexpected or concerning effects is advisable.
Currently, there are no specified laboratory tests required for the safe use of this treatment. Healthcare providers should remain vigilant and provide appropriate guidance to patients regarding any changes they may observe during the course of treatment.
Side Effects
In clinical trials, the most common adverse reaction observed was conjunctival hyperemia, reported in 45% of patients. Additionally, pigmentation changes may occur, affecting the iris, periorbital tissue (eyelid), and eyelashes, with iris pigmentation 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. Furthermore, hypersensitivity reactions have been noted among participants, indicating a potential for allergic responses.
Drug Interactions
There are currently no documented drug interactions associated with this medication. Additionally, there are no known interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are necessary at this time.
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.
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
| ||||
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, it is essential for healthcare providers to remain vigilant when prescribing to geriatric patients, considering the potential for altered pharmacokinetics and increased sensitivity to medications in this age group. Regular monitoring and assessment of therapeutic outcomes are recommended to ensure optimal safety and efficacy in elderly patients.
Pregnancy
There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% in pregnant women. Postmarketing experience does not indicate an increased risk of major birth defects or miscarriages associated with bimatoprost. However, animal studies have demonstrated potential risks. In embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis 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. No adverse effects were observed at lower doses, specifically 2.6 times the human exposure in mice and 47 times in rats.
Further, in pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis through lactation resulted in reduced gestation length, decreased fetal body weight, and increased fetal and pup mortality 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.
Given that animal reproductive studies may not always predict human responses, bimatoprost ophthalmic solution 0.03% should be used during pregnancy only if the potential benefits justify the potential risks to the fetus. The No Observed Adverse Effect Level (NOAEL) for abortion in rats was determined to be 0.3 mg/kg/day, which corresponds to approximately 47 times the human systemic exposure at the recommended human ophthalmic dose. Similarly, in mice, the NOAEL for abortion and early delivery was 0.1 mg/kg/day, equating to about 2.6 times the human systemic exposure at the recommended dose. No abnormalities were observed in fetuses at doses up to 0.6 mg/kg/day in both species.
Healthcare professionals should carefully consider these findings when prescribing bimatoprost 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) that is 324 times the recommended human oral dose (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 child from this medication.
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 are no established 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. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.
Overdosage
In the event of an overdose with bimatoprost ophthalmic solution, 0.03%, there is currently no available information regarding overdosage in humans. However, if an overdose occurs, the recommended course of action is to provide symptomatic treatment.
Toxicity studies conducted in oral mice and rats have demonstrated that doses up to 100 mg/kg/day did not result in any observable toxicity. It is important to note that this dose is significantly higher—at least 70 times greater—than the accidental ingestion of an entire bottle of bimatoprost ophthalmic solution, 0.03%, by a child weighing 10 kg.
Healthcare professionals should remain vigilant for any potential symptoms of overdose and manage the situation accordingly, focusing on symptomatic relief as necessary.
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 for mice and 1 mg/kg/day for 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 oral dose (RHOD), based on blood area under the curve (AUC) levels.
In terms of mutagenicity, bimatoprost demonstrated no mutagenic or clastogenic effects in several assays, including the Ames test, the mouse lymphoma test, and in vivo mouse micronucleus tests.
Additionally, bimatoprost did not impair fertility in male or female rats when administered 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 have been reported. As such, there are no additional adverse events or rare case reports to summarize at this time.
Patient Counseling
Healthcare providers should advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Patients should also be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution, 0.03%.
It is important to inform patients of 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. Healthcare providers should reassure patients that eyelash changes are typically reversible upon discontinuation of treatment.
Patients should be instructed to avoid allowing the tip of the dispensing container to come into contact with the eye, surrounding structures, fingers, or any other surface to prevent contamination of the solution by common bacteria that can cause ocular infections. Serious damage to the eye and potential loss of vision may result from the use of contaminated solutions.
Healthcare providers should advise patients to seek immediate medical advice if they develop an 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%.
Patients should also be informed that bimatoprost ophthalmic solution, 0.03% contains benzalkonium chloride, which may be absorbed by soft contact lenses. Therefore, contact lenses should be removed prior to the instillation of bimatoprost ophthalmic solution, 0.03%, and may be reinserted 15 minutes after administration.
Finally, healthcare providers should advise patients that if they are using more than one topical ophthalmic drug, the drugs should be administered with an interval of at least five (5) minutes between applications.
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 ensure that the container is properly sealed when not in use to prevent contamination and preserve the integrity of the product.
Additional Clinical Information
Patients receiving treatment with bimatoprost ophthalmic solution, 0.03% should be informed about the potential for increased pigmentation, particularly of the iris. Regular examinations are recommended for patients who notice significant changes 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 Fosun Pharma USA Inc.. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.