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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 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.)
- 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 2022
- Label revision date
- July 17, 2023
- 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 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.)
- 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 2022
- Label revision date
- July 17, 2023
- Manufacturer
- Aurobindo Pharma Limited
- Registration number
- ANDA205537
- NDC root
- 65862-802
- FDA Insert
- Prescribing information, PDF file
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
If you are a consumer or patient please visit this version.
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 contains bimatoprost as its active ingredient, which works by enhancing the drainage of fluid from the eye. Managing IOP is crucial, as high levels can lead to serious eye conditions, including glaucoma. If you have concerns about your eye health or IOP, discussing treatment options with your healthcare provider is important.
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.
It's important to note that there are no reported teratogenic effects (which means it doesn't cause birth defects) or nonteratogenic effects associated with this medication. Always consult with your healthcare provider for personalized advice and information regarding your treatment options.
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 take this medication. If you have a hypersensitivity (an extreme allergic reaction) to any component of the drug, you should avoid using it altogether.
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 common side effects, with conjunctival hyperemia (redness of the eye) being the most frequent, affecting about 45% of users. Additionally, there is a possibility of pigmentation changes in the iris (the colored part of your eye), eyelids, and eyelashes, with iris pigmentation likely being permanent.
You might also notice changes in your eyelashes, such as increased length, thickness, and number, which are usually reversible. In some cases, hypersensitivity reactions may occur, so it's important to monitor how your body responds.
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 changes to your eyelashes, such as increased length, thickness, and number, are usually reversible.
There are no specific laboratory tests required for monitoring while using this medication. If you notice any concerning changes or have questions about your treatment, it’s important to reach out to your doctor for guidance.
Overdose
If you suspect an overdose of bimatoprost ophthalmic solution 0.03%, it's important to know that there is no specific information available about overdose effects in humans. In animal studies, very high doses did not show toxicity, but this does not guarantee safety in humans. If an overdose occurs, treatment should focus on relieving symptoms.
Signs of an overdose may not be clearly defined, so if you experience any unusual symptoms or have concerns, it’s best to seek medical advice promptly. Always contact a healthcare professional or poison control center for guidance on what to do next. If you or someone else is in distress, don’t hesitate to 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. 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 there are no well-controlled studies confirming its safety for nursing mothers. The possibility of this medication being passed into breast milk has not been established, which means we don't know how it might affect your baby.
Due to the uncertainty surrounding its effects, bimatoprost should only be used while breastfeeding if your healthcare provider believes that the benefits outweigh any potential risks to your infant. Always consult with your doctor before starting any new medication to ensure it’s safe for you and your baby.
Pediatric Use
It is important to be cautious when considering this medication for children under 16 years old. The use of this drug in younger patients is not recommended due to potential safety concerns, particularly the 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.
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 standard recommendations for medication use may apply to you, but it’s always best to consult with your healthcare provider for personalized advice. They can help ensure that any treatment you receive is safe and effective based on your kidney health.
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 provided information. This means that the medication may not have been studied in patients with liver impairment, and there are no special monitoring requirements or precautions outlined for you.
Always consult your healthcare provider for personalized advice and to ensure that any medication you take is safe and appropriate for your liver health. They can help you understand how your liver condition may affect your treatment.
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 more than one, make sure to wait at least five minutes between applications.
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 drops and wait about 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 temperatures between 2°C to 25°C (36°F 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 prevent contamination. Following these guidelines will help you use the product safely and effectively.
Additional Information
You should be aware that if you receive treatment with this medication, there is a possibility of increased pigmentation in your eyes. The long-term effects of this change are not fully understood, so it's important to have regular eye examinations if you notice any significant changes in your iris color. Additionally, if you wear contact lenses, make sure to remove them before using the bimatoprost ophthalmic solution 0.03%, and you can put them back in 15 minutes after applying the solution.
FAQ
What is Bimatoprost ophthalmic solution 0.03% used for?
Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
How does Bimatoprost work?
Bimatoprost is a prostaglandin analog that lowers intraocular pressure 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 adverse reaction is conjunctival hyperemia, 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. If using other topical ophthalmic drugs, administer them at least five minutes apart.
Can I use Bimatoprost if I wear contact lenses?
Yes, but you should remove your contact lenses before using Bimatoprost and can reinsert them 15 minutes after administration.
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 know about using Bimatoprost while breastfeeding?
The potential for Bimatoprost to be excreted in breast milk is not established, so it should be used during lactation only if the potential benefit justifies the risk to the infant.
What precautions should I take while using Bimatoprost?
Be aware of the possibility of increased pigmentation of the iris and eyelashes. Regular eye examinations are recommended if you notice significant changes.
What are the storage conditions for Bimatoprost?
Store Bimatoprost ophthalmic solution at 2°C to 25°C (36°F to 77°F). After opening, use it until the expiration date on the bottle.
Are there any contraindications for using Bimatoprost?
Yes, Bimatoprost is contraindicated in individuals with hypersensitivity to any of its components.
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 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.
The compound appears as a white to off-white powder, which is freely soluble in methanol and slightly soluble in water. Bimatoprost ophthalmic solution 0.03% is formulated as a clear, isotonic, colorless, sterile ophthalmic solution, with an osmolality of approximately 290 mOsmol/kg. Each milliliter of the solution contains 0.3 mg of bimatoprost as the active ingredient, along with inactive components including 0.05 mg/mL of benzalkonium chloride, citric acid monohydrate, disodium hydrogen phosphate heptahydrate, sodium chloride, and water for injection. The pH of the solution is adjusted with sodium hydroxide and/or hydrochloric acid, maintaining a range of 6.8 to 7.8 throughout 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.
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. This change is typically reversible; however, it is essential for healthcare providers to monitor patients for these effects and discuss any concerns with them.
Currently, there are no specific laboratory tests recommended for monitoring the effects of this medication. Healthcare professionals should remain vigilant and provide guidance to patients regarding any unusual symptoms or changes they may experience during treatment.
Side Effects
Most patients may experience conjunctival hyperemia, which has been reported in 45% of cases. Additionally, pigmentation changes can occur, affecting the iris, periorbital tissue (eyelid), and eyelashes, with iris pigmentation likely to be permanent.
Patients may also notice gradual changes to their eyelashes, including increased length, thickness, and number of lashes; these changes are usually reversible. Furthermore, hypersensitivity reactions have been observed in some patients.
Drug Interactions
Bimatoprost ophthalmic solution 0.03% may be safely administered alongside other topical ophthalmic drug products aimed at reducing intraocular pressure. When using 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, which can be absorbed by soft contact lenses, potentially leading to discoloration. Therefore, patients should remove their contact lenses prior to the instillation of bimatoprost ophthalmic solution 0.03% and may reinsert them 15 minutes after administration 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.
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 associated with 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 based on age alone.
However, healthcare providers should remain vigilant in monitoring geriatric patients for any potential age-related changes that may affect drug metabolism and response. It is essential to consider individual patient factors, including comorbidities and concurrent medications, when prescribing to elderly patients to ensure optimal therapeutic outcomes.
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, data from embryofetal developmental studies in pregnant mice and rats indicate potential risks. Administration of bimatoprost during organogenesis resulted in abortion and early delivery at oral doses that were at least 33 times (mice) or 94 times (rats) the human exposure at the recommended clinical dose, based on blood area under the curve (AUC) levels. No adverse effects were observed at lower doses, specifically at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended clinical dose.
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 oral 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 at the recommended clinical dose.
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 (47 times the human systemic exposure at the recommended human ophthalmic dose), while in mice, the NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure at the recommended human ophthalmic dose). No abnormalities were observed in fetuses from either species at doses up to 0.6 mg/kg/day.
Healthcare professionals should carefully consider the risks and benefits when prescribing bimatoprost to pregnant patients.
Lactation
There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% in nursing mothers. The potential for excretion of bimatoprost in breast milk has not been established. Due to the uncertainty regarding its effects, bimatoprost ophthalmic solution 0.03% should be administered to lactating mothers only if the potential benefit justifies the potential risk to the breastfed infant.
Renal Impairment
There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when treating patients with renal impairment.
Hepatic Impairment
There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, there are no dosage adjustments, special monitoring requirements, or precautions specified for individuals with compromised liver function. Healthcare professionals should exercise clinical judgment when considering the use of this medication in patients with liver problems, as the absence of data may necessitate careful monitoring and assessment of the patient's overall health status.
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 an entire bottle of bimatoprost ophthalmic solution 0.03% by a child weighing 10 kg. This suggests a significant margin of safety in the context of potential overdose scenarios.
Healthcare professionals are advised to monitor patients for any adverse effects and manage symptoms accordingly, given the lack of specific overdose data in humans.
Nonclinical Toxicology
Bimatoprost was evaluated for its carcinogenic potential in long-term studies conducted in mice and rats. The results indicated that Bimatoprost was not carcinogenic when administered via oral gavage for 104 weeks at doses of up to 2 mg/kg/day in mice and 1 mg/kg/day in rats. These doses correspond to at least 192 and 291 times the human systemic exposure at the recommended human dose (RHOD), respectively, 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 the in vivo mouse micronucleus tests.
Furthermore, Bimatoprost did not impair fertility in male or female rats when administered at doses up to 0.6 mg/kg/day, which is at least 103 times the human systemic exposure at the RHOD, based on blood AUC levels.
Postmarketing Experience
Postmarketing experience has identified several events reported voluntarily or through surveillance programs. There is a potential for increased brown pigmentation of the iris, which may be permanent. Additionally, there is a possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution 0.03%. Changes in eyelashes and vellus hair in the treated eye have also been observed during treatment with bimatoprost ophthalmic solution 0.03%. These changes may lead to disparities between eyes in terms of length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are generally reversible upon discontinuation of treatment.
Patient Counseling
Patients should be informed about the potential for increased brown pigmentation of the iris, which may be permanent. They should also 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%.
Additionally, it is 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°C to 25°C (36°F 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 kept tightly closed 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. The long-term effects of such pigmentation changes are currently unknown, and patients are advised to undergo regular examinations if they notice significant changes in iris color. Additionally, it is recommended that contact lenses be removed prior to the administration of the solution and may be reinserted 15 minutes after application.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Bimatoprost as submitted by Aurobindo Pharma Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.