ADD CONDITION
Bimatoprost
Last content change checked dailysee data sync status
- Active ingredient
- Bimatoprost 0.3 mg/1 mL
- Other brand names
- Bimatoprost (by Akorn)
- Bimatoprost (by Akorn)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Inc.)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Alembic Pharmaceuticals Limited)
- Bimatoprost (by Amneal Pharmaceuticals Ny Llc)
- Bimatoprost (by Apotex Corp.)
- Bimatoprost (by Aurobindo Pharma Limited)
- Bimatoprost (by Fosun Pharma Usa Inc.)
- Bimatoprost (by 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 2019
- Label revision date
- April 12, 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 Fosun Pharma Usa Inc.)
- 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 2019
- Label revision date
- April 12, 2022
- Manufacturer
- Gland Pharma Limited
- Registration number
- ANDA210126
- NDC roots
- 68083-295, 68083-296, 68083-439
- 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 synthetic medication designed to help 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 effectively reduces IOP, which is important for preventing damage to the optic nerve and maintaining healthy vision.
This clear, sterile solution is applied directly to the eye and is formulated to be safe and effective for managing conditions associated with high eye pressure. If you have concerns about your eye health or IOP, 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. Elevated intraocular pressure can lead to serious eye problems, so this medication is important for managing your eye health.
If you have any concerns about your eye pressure or the use of this medication, it's always a good idea to discuss them with your healthcare provider. They can provide you with more information tailored to your specific situation.
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 affects about 45% of users and involves redness of the eye. Additionally, you might notice changes in pigmentation, which can affect the iris (the colored part of your eye), the skin around your eyes (periorbital tissue), and your eyelashes. It's important to note that any changes to the iris pigmentation are 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. Some individuals may experience hypersensitivity (an allergic reaction), so it's essential to monitor how you feel while using this medication.
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 for monitoring while using this medication. If you experience any concerning symptoms 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 (a medication used for eye conditions), it's important to know that there is no specific information available about overdoses 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, doses up to 100 mg/kg/day were tested, which is significantly more than what would be found in a single bottle of the solution. However, if you notice unusual symptoms or have concerns, it’s always best to seek immediate medical help. Signs of overdose can vary, so if you are unsure, contacting a healthcare professional is the safest course of action.
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 significant increase in the 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 do not always predict human outcomes, bimatoprost should only be used during pregnancy if the potential benefits outweigh the risks to the fetus. If you are pregnant or planning to become pregnant, it is essential to discuss any medications with your healthcare provider to ensure the safest options for you and your baby.
Lactation Use
If you are breastfeeding or planning to breastfeed, it's important to know that there are no well-controlled studies on the use of bimatoprost ophthalmic solution, 0.03% in pregnant women. Animal studies have shown that administering this medication to pregnant rats can lead to reduced gestation length, lower fetal body weight, and increased mortality among fetuses and pups at doses much higher than what humans would typically receive. However, no adverse effects were noted in rat offspring at lower exposure levels.
Given that animal studies may not always predict how humans will respond, bimatoprost should only be used during pregnancy if the potential benefits outweigh the risks to the fetus. Always consult with your healthcare provider to discuss any concerns and to ensure the best choices 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 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 others, regardless of age.
However, it's always important to discuss any specific health concerns or conditions with your healthcare provider, as individual needs may vary. Staying informed and communicating openly with your doctor can help ensure the best care tailored to your situation.
Renal Impairment
It appears that there is no specific information regarding renal impairment (kidney problems) in the provided text. This means there are no dosage adjustments, special monitoring, or safety considerations outlined 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, who can offer personalized guidance based on your individual situation.
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 medications you take are safe for your liver health. They can provide guidance tailored to your specific situation.
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 medications, but if you are using more than one, make sure to wait at least five minutes between applying them.
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 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, it's important to store it properly. Keep the solution at a temperature between 2° to 25°C (36° to 77°F). This helps maintain its effectiveness. Once you open the bottle, you can continue to use the solution until the expiration date printed on the bottle, so be sure to check that date before use.
When handling the solution, always make sure to wash your hands thoroughly to maintain cleanliness and avoid contamination. This is especially important since the solution is used in your eyes. If you have any questions about disposal or further handling instructions, please consult your healthcare provider for guidance.
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.
When using bimatoprost ophthalmic solution, 0.03%, make sure to remove your contact lenses before applying the drops. You can put them back in about 15 minutes after using the medication.
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 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.
Can I use Bimatoprost with other eye medications?
Yes, Bimatoprost can be used with other topical ophthalmic drugs, but they should be administered at least five minutes apart.
What should I do if I wear contact lenses?
Remove your contact lenses before using Bimatoprost ophthalmic solution, and you 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 are the storage conditions for Bimatoprost?
Store Bimatoprost ophthalmic solution at 2° to 25°C (36° to 77°F). After opening, it can be used until the expiration date on the bottle.
What precautions should I take regarding pigmentation?
You should be informed about the possibility of increased pigmentation of the iris and eyelashes, and regular eye examinations are recommended if noticeable changes occur.
Are there any contraindications for using Bimatoprost?
Yes, Bimatoprost is contraindicated in individuals with hypersensitivity to any of its components.
What is the recommended dosage for Bimatoprost?
The recommended dosage is one drop in the affected eye(s) once daily in the evening.
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. This formulation is presented as a clear, isotonic, colorless, sterile ophthalmic solution, characterized by an osmolality of approximately 290 mOsmol/kg.
The active ingredient, bimatoprost, is present at a concentration of 0.3 mg/mL. Inactive components include benzalkonium chloride (0.05 mg/mL), disodium hydrogen phosphate heptahydrate, citric acid monohydrate, 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. 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 that patients tilt their head back, pull down the lower eyelid to create a small pocket, and instill the drop into this pocket without touching the dropper tip to any surface, including the eye. After administration, patients should close their eyes gently and avoid blinking or squeezing the eyelids to facilitate absorption.
Contraindications
Use of this product is contraindicated in individuals with a known hypersensitivity to any of its components.
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, and healthcare professionals should inform patients of this potential outcome.
Patients may also experience gradual changes in their eyelashes, which can include increased length, thickness, and number of lashes. These changes are typically reversible upon discontinuation of the medication.
While no specific laboratory tests are required for monitoring, healthcare providers should remain vigilant for any signs of adverse effects related to pigmentation changes. It is essential for healthcare professionals to maintain open communication with patients regarding any concerns or side effects experienced during treatment.
Side Effects
In clinical trials, the most common adverse reaction observed among participants was conjunctival hyperemia, reported in 45% of subjects.
Additional adverse reactions include pigmentation changes, which may affect the iris, periorbital tissue (eyelids), and eyelashes. Notably, iris pigmentation is likely to be permanent. Participants may also experience changes in eyelashes, characterized by a gradual increase in length, thickness, and number of lashes; these changes are usually reversible.
Hypersensitivity reactions have also been reported, indicating the need for monitoring in patients who may be susceptible to such responses.
Drug Interactions
Bimatoprost ophthalmic solution, 0.03% can be safely used in conjunction with other topical ophthalmic medications aimed at reducing intraocular pressure. When multiple topical ophthalmic products are prescribed, it is recommended that they be administered with an interval of at least five (5) minutes between applications 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 may be absorbed by soft contact lenses, 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.
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 when compared to younger adult patients. Therefore, no specific dosage adjustments are necessary for this population.
However, healthcare providers should remain vigilant in monitoring geriatric patients for any potential age-related changes that may influence individual responses to treatment. It is essential to consider the overall health status and comorbidities of elderly patients when prescribing, as these factors may impact the therapeutic outcomes and safety profile.
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- 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.
Given that animal reproductive studies may not always predict human responses, 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 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 at doses up to 0.6 mg/kg/day in both species.
Healthcare professionals should carefully consider the risks and benefits when prescribing bimatoprost to pregnant patients.
Lactation
Bimatoprost ophthalmic solution, 0.03% has not been studied in adequate and well-controlled trials in lactating mothers. In pre/postnatal development studies involving pregnant rats, administration of bimatoprost from organogenesis through the end of 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 (based on blood AUC levels). However, no adverse effects were observed in rat offspring at exposures estimated to be 14 times the human exposure at the recommended clinical dose.
Due to the lack of human data and the potential risks indicated by animal studies, bimatoprost ophthalmic solution, 0.03% should be administered to lactating mothers only if the potential benefits outweigh the risks to the nursing infant.
Renal Impairment
There is no information available regarding renal impairment, dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider individual patient factors when treating patients with renal impairment, as specific guidelines or recommendations are not provided in the current data.
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 specific guidance necessitates careful evaluation of the patient's overall health status and liver function.
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 underscores the relative safety of the product at levels significantly above typical exposure.
Healthcare professionals are advised to monitor patients for any adverse effects and manage symptoms accordingly in the event of an overdose.
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 a lack of mutagenic or clastogenic effects in several assays, including the Ames test, the mouse lymphoma test, and in vivo mouse micronucleus tests.
Furthermore, Bimatoprost did not exhibit any impairment of fertility in male or female rats 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. 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 may 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, 0.03% is supplied in a suitable container that ensures product integrity. It should be stored at a temperature range of 2° to 25°C (36° to 77°F).
Once opened, the solution remains stable and can be used until the expiration date indicated on the bottle. Proper storage conditions are essential to maintain the efficacy and safety 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 in the iris. Regular examinations are recommended for those 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 Gland Pharma Limited. It includes detailed information about indications, dosage, contraindications, warnings, and clinical pharmacology.