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Bimatoprost
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This product has been discontinued
- Active ingredient
- Bimatoprost 0.3 mg/1 mL
- Other brand names
- 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.)
- 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 2018
- Label revision date
- March 7, 2022
- FDA Insert
- Prescribing information, PDF file
- Active ingredient
- Bimatoprost 0.3 mg/1 mL
- Other brand names
- 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.)
- 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 2018
- Label revision date
- March 7, 2022
- Manufacturer
- Akorn
- Registration number
- ANDA203299
- NDC root
- 50383-908
- 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 used 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 a fluid called aqueous humor through specific pathways in the eye, 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 is designed to be easy to use. If you have concerns about your eye pressure or conditions like glaucoma, bimatoprost may be a treatment option to discuss with your healthcare provider.
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, as using it inappropriately 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 concerns about these issues.
Side Effects
You may experience some common side effects, such as conjunctival hyperemia, which is a redness of the eye that occurs in about 45% of users. Additionally, there are some important changes to be aware of. You might notice pigmentation changes in the iris (the colored part of your eye), eyelids, and eyelashes, with iris pigmentation likely being permanent. Changes to your eyelashes, including increased length, thickness, and number, can also occur, but these are usually reversible. Some individuals may also experience hypersensitivity, which is an allergic reaction. If you notice any of these effects, it's a good idea to discuss them 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. While the change in iris color is likely to be permanent, any changes to your eyelashes, such as increased length, thickness, and number, are usually reversible.
It's important to monitor these changes and consult your doctor if you have any concerns. While there are no specific laboratory tests required for this medication, staying informed about your health is always a good practice. If you experience any unexpected symptoms or reactions, don't hesitate to reach out to your healthcare provider 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 overdosing 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. However, based on available data, there is no evidence to suggest an increased risk of major birth defects or miscarriages associated with its use. Animal studies have shown that high doses of bimatoprost can lead to adverse effects such as abortion and early delivery, but these effects were not observed at lower doses that are closer to human exposure levels.
If you are pregnant or planning to become pregnant, it is important to discuss the use of bimatoprost with your healthcare provider. The potential benefits of using this medication should be carefully weighed against any possible risks to your fetus. Always prioritize open communication with your doctor to ensure the best outcomes for you and your baby.
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 data available 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's important to be cautious when considering this medication for children. If your child is under 16 years old, it's not recommended to use this drug due to potential safety concerns. Specifically, long-term use may lead to increased pigmentation, which means changes in skin color that could be permanent. Always consult with your healthcare provider for the best options for your child's health and safety.
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 the treatment can be just as beneficial for you or your loved one, without added risks specific to age.
However, it's always important to discuss any concerns with your healthcare provider, especially regarding any other health conditions or medications that may be involved. Your doctor can help ensure that the treatment is appropriate for your individual needs.
Renal Impairment
If you have kidney problems, it's important to know that there are no specific guidelines, dosage adjustments, or monitoring recommendations provided for your condition in the available information. This means that the standard instructions do not address how your kidney health might affect the use of this medication.
Always consult your healthcare provider for personalized advice and to ensure that any treatment plan is safe and effective for you, especially if you have renal impairment (kidney issues). Your doctor can help determine the best approach based on your individual health needs.
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 for the medication do not change based on liver impairment. However, it’s always a good idea to discuss your liver health with your healthcare provider, as they can offer personalized advice and monitor your condition appropriately.
Make sure to keep your doctor informed about any liver issues you may have, as they can help ensure that your treatment is safe and effective for you.
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 wait at least five minutes between each application.
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 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, store it in its original container at a temperature between 2º to 25ºC (36º to 77ºF). This helps maintain the solution's effectiveness. Always check the expiration date stamped on the bottle before use, as it indicates until when the product is safe to 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 sterility (the state of being free from bacteria or other living microorganisms). 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% 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 should I use Bimatoprost Ophthalmic Solution?
You should instill one drop in the affected eye(s) once daily in the evening.
What are the common side effects of Bimatoprost?
Common side effects include conjunctival hyperemia (redness of the eye) and changes in eyelash appearance, such as increased length and thickness.
Can Bimatoprost cause pigmentation changes?
Yes, Bimatoprost can cause pigmentation of the iris, periorbital tissue (eyelid), and eyelashes, with iris pigmentation likely being permanent.
Is Bimatoprost safe to use during pregnancy?
Bimatoprost should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus, as there are no adequate studies in pregnant women.
What should I do if I wear contact lenses?
You should remove your contact lenses before using Bimatoprost and may reinsert them 15 minutes after administration.
Are there any contraindications for using Bimatoprost?
Yes, Bimatoprost is contraindicated in individuals with hypersensitivity to any of its components.
How should Bimatoprost be stored?
Bimatoprost ophthalmic solution should be stored in the original container at temperatures between 2º to 25ºC (36º to 77ºF).
Can Bimatoprost be used with other eye medications?
Yes, Bimatoprost can be used with other topical ophthalmic drug products, but they should be administered at least five minutes apart.
What should I be aware of regarding eyelash changes?
You may experience gradual changes to your eyelashes, including increased length, thickness, and number, which are usually reversible.
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 — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not 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.
This formulation is presented as a clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost is a powder that demonstrates high solubility in ethyl alcohol and methyl alcohol, while being slightly soluble in water. The solution contains bimatoprost at a concentration of 0.3 mg/mL as the active ingredient, along with inactive components including benzalkonium chloride (0.05 mg/mL), citric acid, purified water, sodium chloride, and sodium phosphate, dibasic. The pH of the solution is adjusted with hydrochloric acid and/or sodium hydroxide, 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 that patients tilt their head back, pull down the lower eyelid to create a pocket, and instill the drop without touching the eye or eyelid with the dropper tip. After administration, patients should close their eyes gently and may apply pressure to the inner corner of the eye to prevent drainage.
Contraindications
Use of this product is contraindicated in patients with hypersensitivity to any component of the formulation. Due to the potential for severe allergic reactions, administration in such cases may pose significant health risks.
Warnings and Precautions
Pigmentation changes may occur with the use of this medication, specifically affecting 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 upon discontinuation of the medication. Monitoring for these effects is advisable to assess the patient's response and to provide appropriate guidance.
No specific laboratory tests are recommended for monitoring the use of this medication. However, healthcare providers should remain vigilant for any adverse effects and maintain open communication with patients regarding their treatment experience.
Side Effects
In clinical trials, the most common adverse reaction observed was conjunctival hyperemia, which occurred in 45% of patients.
Additional adverse reactions of note include pigmentation changes, which may affect the iris, periorbital tissue (eyelid), and eyelashes. It is important to note that 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 has also been reported as an adverse reaction in some patients.
Drug Interactions
Bimatoprost ophthalmic solution, 0.03% may be safely administered in conjunction with other topical ophthalmic drug products aimed at reducing intraocular pressure. When utilizing multiple topical ophthalmic medications, it is recommended that these agents be applied with a minimum interval of five (5) minutes between administrations 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, leading to discoloration. Therefore, it is advised that contact lenses be removed 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.
Details | ||||
|---|---|---|---|---|
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not Marketed. FDA record dates for this NDC:
Active ingredients
Inactive ingredients
| ||||
| Solution/ Drops | 0.3 mg/1 mL | ||
Product details Regulatory status — Discontinued NSDE (NDC Directory) reports this NDC as Not 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 when compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population.
Healthcare providers should continue to monitor 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. However, based on postmarketing experience, there is no observed increase in the risk of major birth defects or miscarriages associated with its use.
Embryofetal developmental studies in pregnant mice and rats have shown that 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, as determined by blood area under the curve (AUC) levels. Notably, these adverse effects were not observed at lower doses, specifically at 2.6 times (mice) and 47 times (rats) the human exposure at the recommended clinical dose.
In pre- and 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 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.
Due to the limitations of animal reproductive studies in predicting human response, bimatoprost ophthalmic solution, 0.03%, should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. In an embryofetal development study in rats, abortion was observed at an oral dose of 0.6 mg/kg/day (94 times the human systemic exposure at the recommended human ophthalmic dose), with a No Observed Adverse Effect Level (NOAEL) for abortion identified at 0.3 mg/kg/day (47 times the human systemic exposure). Similarly, in a mouse study, abortion and early delivery occurred at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure), with a NOAEL for these effects at 0.1 mg/kg/day (2.6 times the human systemic exposure). No abnormalities were observed in fetuses from either species at doses up to 0.6 mg/kg/day.
In summary, while there is no direct evidence of teratogenic effects in humans, the potential risks associated with bimatoprost use during pregnancy necessitate careful consideration and should only be undertaken when the benefits outweigh the risks.
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 (RHOD) on a m2g/m 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%, as well as any potential adverse effects on the breastfed child 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
There is no available information 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 caution and consider the lack of data when prescribing this medication to patients with liver problems.
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 information may provide some reassurance regarding the safety margin associated with potential accidental overdoses in pediatric populations.
Healthcare professionals are advised to monitor patients for any adverse effects and manage symptoms accordingly, as specific antidotes or treatments for bimatoprost overdose have not been established.
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 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 is 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. 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. 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. This is crucial for determining the continued use of bimatoprost ophthalmic solution, 0.03%.
Additionally, patients should be informed that bimatoprost ophthalmic solution, 0.03% contains benzalkonium chloride, which can be absorbed by soft contact lenses. Therefore, contact lenses should be removed prior to the instillation of the solution and may be reinserted 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 is supplied in its original container to ensure stability and efficacy. It should be stored at a temperature range of 2º to 25ºC (36º to 77ºF). The product remains usable until the expiration date indicated on the bottle. Proper storage conditions are essential to maintain the integrity of the solution.
Additional Clinical Information
Patients receiving treatment with bimatoprost ophthalmic solution, 0.03%, should be informed about the potential for increased pigmentation, particularly in the iris. Regular examinations are recommended for those who notice significant changes in iris pigmentation. Additionally, it is advised that patients remove contact lenses before instilling the solution and may reinsert them 15 minutes after administration.
FDA Insert (PDF)
This document is the official FDA-approved prescribing information for Bimatoprost as submitted by Akorn. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.