bimatoprost .3 mg/mL Solution/ Drops — NDC 62332-511-03 (Billing 62332-0511-03)
This is a package of bimatoprost .3 mg/mL Solution/ Drops from Alembic Pharmaceuticals Inc., marketed since Jan 2020 and currently FDA-listed; retail pharmacies pay about $26.27 per mL (NADAC). It is the main listing for this product, which comes in 2 package sizes.
NDC database record
One package, one record: these facts belong to NDC 62332-511-03 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 62332 labeler · 511 product · 03 package
- Package marketed since
- Mar 20, 2020
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 6233251103 7
- Medicaid fills, this package
- 24 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 064746
- GCN: 16219
- GPI-14 (Medi-Span): 90734020002020
- HICL (First Databank): 022000
- AHFS class code: 52:40.28.00
- RxCUI (RxNorm): 1041495
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Prostaglandin Analog class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Topical bimatoprost is used to treat hypotrichosis (less than the normal amount of hair) of the eyelashes by promoting the growth of longer, thicker, and darker lashes. Topical bimatoprost is in a class of medications called prostaglandin analogs. It works by increasing the number of eyelash hairs that grow and the amount of time that they grow.
Read the full MedlinePlus article ↗- It depends on the product you have. Lumigan, Zolymbus and Durysta lower high eye pressure in open-angle glaucoma or ocular hypertension. Latisse and generic bimatoprost 0.03% are f...
- Lumigan and Zolymbus are one drop in the eye once daily in the evening. Latisse and generic bimatoprost 0.03% go on the upper eyelid margin once nightly with a fresh sterile applic...
- Red, itchy or dry eyes are common, and you may notice lash growth or darker skin around the eye. Most of these are mild. Call me or your doctor if you have eye pain, vision changes...
- Yes. It can make the iris more brown, and this is likely to be permanent. It may take months or years to notice. Your doctor can talk with you about this.
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Bimatoprost — tap one for details:
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 3, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $26.274 | $78.82 / 3 ml |
| Medicaid paysCMS SDUD · 12 mo | $16.35 | $49.05 / 3 ml |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Marketing end | Status |
|---|---|---|---|---|---|---|
| 62332-0511-03 You're viewing this Main listing | 1 BOTTLE in 1 CARTON / 3 mL in 1 BOTTLE | $26.27 / mL | $78.82 | 2020-03-20 | — | Active |
| 62332-0511-05 62332-511-05 | 1 BOTTLE in 1 CARTON / 5 mL in 1 BOTTLE | $20.65 / mL | $103.25 | 2020-01-21 | — | Active |
Per mL, this pack runs about 27% above the cheapest pack (NDC 62332-0511-05, $20.65 vs $26.27 NADAC).
Pack size FAQ
What quantity is in this package?
What NDC number is used to bill for this package of bimatoprost .3 mg/mL Solution/ Drops?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Bimatoprost .3 mg/mL 72266-0241-01 | Fosun | 1 bottle | $4.207 | AT | Availability likely | save 84% |
| Bimatoprost .3 mg/mL 70069-0403-01 | Somerset | 1 bottle | $4.207 | AT | Availability likely | save 84% |
| Bimatoprost .3 mg/mL 70069-0401-01 | Somerset | 1 bottle | $6.969 | AT | Availability likely | save 73% |
| Bimatoprost .3 mg/mL 72266-0139-01 | Fosun | 1 bottle | $6.969 | AT | Availability likely | save 73% |
| Bimatoprost .3 mg/mL 65862-0802-05 | Aurobindo | 1 bottle | $8.852 | AT | Availability likely | save 66% |
| Bimatoprost .3 mg/mL 72266-0140-01 | Fosun | 1 bottle | $8.852 | AT | Availability likely | save 66% |
| Bimatoprost .3 mg/mL 60505-0583-01 | Apotex | 1 bottle | $8.852 | AT | Availability likely | save 66% |
| Bimatoprost .3 mg/mL 62332-0507-05 | Alembic | 1 bottle | $8.852 | AT | Availability likely | save 66% |
| Bimatoprost .3 mg/mL 42571-0128-21 | Micro | 1 bottle | $8.852 | AT | Availability likely | save 66% |
| Bimatoprost .3 mg/mL 70069-0402-01 | Somerset | 1 bottle | $8.852 | AT | Availability likely | save 66% |
| Bimatoprost .3 mg/mL 00781-6206-75 | Sandoz | 1 bottle | $20.649 | AT | Availability likely | save 21% |
| bimatoprost .3 mg/mLthis 62332-0511-03 | Alembic | 1 bottle | $26.274 | AT | Availability likely | — |
| Latisse .3 mg/mL 00023-3616-05 | Allergan, | 1 bottle | $31.491 | AT | Availability likely | +20% |
| Bimatoprost .3 mg/mL 68083-0295-01 | Gland | 1 bottle | — | AT | FDA listed | — |
| Bimatoprost .3 mg/mL 68083-0296-01 | Gland | 1 bottle | — | AT | FDA listed | — |
| Bimatoprost .3 mg/mL 68083-0439-01 | Gland | 1 bottle | — | AT | FDA listed | — |
| Bimatoprost .3 mg/mL 46708-0507-05 | Alembic | 1 bottle | — | AT | FDA listed | — |
| bimatoprost .3 mg/mL 46708-0511-03 | Alembic | 1 bottle | — | AT | FDA listed | — |
| Bimatoprost .3 mg/mL 68071-3590-05 | NuCare | 1 bottle | — | AT | FDA listed | — |
| Bimatoprost .3 mg/mL 68071-3612-05 | NuCare | 1 bottle | — | AT | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII F5UM2KM3W7
Benzalkonium chloride is a chemical compound that works as a preservative and antimicrobial agent in medications. It prevents bacterial and fungal growth in liquid formulations to keep the product safe during storage and use.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
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UNII 451W47IQ8X
Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
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UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 70WT22SF4B
A mineral salt that acts as a buffer to maintain the pH balance of the medication. It helps stabilize the drug's potency and prevents unwanted chemical changes during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 3, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
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Manufacturer & labeler
More NDCs from Alembic Pharmaceuticals Inc. labeler code 62332
- OLOPATADINE HYDROCHLORIDE 2 mg/mL Solution/ Drops NDC 62332-502-03
- Moxifloxacin ophthalmic solution 5 mg/mL Solution/ Drops NDC 62332-505-03
- Azelastine Hydrochloride Ophthalmic Solution 0.05% .5 mg/mL Solution/ Drops NDC 62332-506-06
- Bimatoprost .3 mg/mL Solution/ Drops NDC 62332-507-05
- Bromfenac Ophthalmic Solution 0.09% 1.035 mg/mL Solution/ Drops NDC 62332-508-17
- Travoprost Ophthalmic Solution USP, 0.004% .04 mg/mL Solution/ Drops NDC 62332-510-05
- Treprostinil 20 mg/20mL Injection, Solution NDC 62332-514-20
- Treprostinil 50 mg/20mL Injection, Solution NDC 62332-515-20
- Treprostinil 100 mg/20mL Injection, Solution NDC 62332-516-20
- Treprostinil 200 mg/20mL Injection, Solution NDC 62332-517-20
- Tobramycin Ophthalmic Solution 3 mg/mL Solution/ Drops NDC 62332-518-05
- Dorzolamide Hydrochloride 20 mg/mL Solution/ Drops NDC 62332-519-10
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Bimatoprost ophthalmic solution, 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. Bimatoprost ophthalmic solution, for topical ophthalmic use is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of bimatoprost ophthalmic solution, 0.03% on the disposable sterile applicator supplied with the package and apply evenly along the skin of the upper eyelid margin at the base of the eyelashes. The upper lid margin in the area of lash growth should feel lightly moist without runoff.
Blot any excess solution runoff outside the upper eyelid margin with a tissue or other absorbent cloth. Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.
Do not reuse applicators and do not use any other brush/applicator to apply bimatoprost ophthalmic solution 0.03%. Do not apply to the lower eyelash line [ see Warnings and Precautions (5.3, 5.4 ] and Patient Counseling Information (17)]. Additional applications of bimatoprost ophthalmic solution 0.03% will not increase the growth of eyelashes.
Upon discontinuation of treatment, eyelash growth is expected to return to its pre-treatment level. Apply nightly directly to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying applicators. Blot any excess solution beyond the eyelid margin.
Dispose of the applicator after one use. Repeat for the opposite eyelid margin using a new sterile applicator.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Ophthalmic solution containing bimatoprost 0.3 mg/mL. Ophthalmic solution containing bimatoprost 0.3 mg/mL.
⛔ Contraindications ▾
4 CONTRAINDICATIONS Bimatoprost ophthalmic solution, 0.03% is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [ see Adverse Reactions 6.2) ]. Hypersensitivity
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Concurrent administration of Bimatoprost ophthalmic solution, for topical ophthalmic use and intraocular pressure (IOP)-lowering prostaglandin analogs in ocular hypertensive patients may decrease the IOP-lowering effect. Patients using these products concomitantly should be closely monitored for changes to their IOP. ( 5.1 ) Pigmentation of the eyelids and iris may occur. Iris pigmentation is likely to be permanent. ( 5.2, 5.3 )
5.1Effects on Intraocular Pressure Bimatoprost ophthalmic solution (LUMIGAN ® ) lowers intraocular pressure (IOP) when instilled directly to the eye in patients with elevated IOP. In clinical trials, in patients with or without elevated IOP, bimatoprost ophthalmic solution 0.03% lowered IOP, however, the magnitude of the reduction was not cause for clinical concern. In ocular hypertension studies with LUMIGAN ® , it has been shown that exposure of the eye to more than one dose of bimatoprost daily may decrease the intraocular pressure lowering effect.
In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution 0.03% may interfere with the desired reduction in IOP. Patients using prostaglandin analogs including LUMIGAN ® for IOP reduction should only use bimatoprost ophthalmic solution 0.03% after consulting with their physician and should be monitored for changes to their intraocular pressure.
5.2Iris Pigmentation Increased iris pigmentation has occurred when bimatoprost solution was administered. Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent [see Adverse Reactions (6.2] . The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes.
The long term effects of increased pigmentation are not known. Iris color changes seen with administration of bimatoprost ophthalmic solution may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish.
Neither nevi nor freckles of the iris appear to be affected by treatment. Treatment with bimatoprost ophthalmic solution 0.03% can be continued in patients who develop noticeably increased iris pigmentation.
5.3Lid Pigmentation Bimatoprost has been reported to cause pigment changes (darkening) to periorbital pigmented tissues and eyelashes. The pigmentation is expected to increase as long as bimatoprost is administered, but has been reported to be reversible upon discontinuation of bimatoprost in most patients.
5.4Hair Growth Outside the Treatment Area There is the potential for hair growth to occur in areas where bimatoprost ophthalmic solution 0.03% comes in repeated contact with the skin surface. It is important to apply bimatoprost ophthalmic solution 0.03% only to the skin of the upper eyelid margin at the base of the eyelashes using the accompanying sterile applicators, and to carefully blot any excess bimatoprost ophthalmic solution 0.03% from the eyelid margin to avoid it running onto the cheek or other skin areas.
5.5Intraocular Inflammation Bimatoprost ophthalmic solution 0.03% should be used with caution in patients with active intraocular inflammation (e.g., uveitis) because the inflammation may be exacerbated.
5.6Macular Edema Macular edema, including cystoid macular edema, has been reported during treatment with bimatoprost ophthalmic solution (LUMIGAN®) for elevated IOP. Bimatoprost ophthalmic solution 0.03% should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.
5.7Contamination of bimatoprost ophthalmic solution 0.03% or Applicator The Bimatoprost ophthalmic solution 0.03% bottle must be kept intact during use… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Effects on Intraocular Pressure [see Warnings and Precautions (5.1)] Iris Pigmentation [see Warnings and Precautions (5.2)] Lid Pigmentation [see Warnings and Precautions (5.3)] Hair Growth Outside the Treatment Area [see Warnings and Precautions (5.4)] Intraocular Inflammation [see Warnings and Precautions (5.5)] Macular Edema [see Warnings and Precautions (5.6)] Hypersensitivity [see Contraindications (4)] Most common adverse reactions (incidence approximately 3% to 4%) are eye pruritus, conjunctival hyperemia, and skin hyperpigmentation.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceutical Inc. at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The following information is based on clinical trial results from a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The most frequently reported adverse reactions were eye pruritus, conjunctival hyperemia, skin hyperpigmentation, ocular irritation, dry eye symptoms, and periorbital erythema.
These reactions occurred in less than 4% of patients. Additional adverse reactions seen in clinical trials experience include foreign body sensation, hair growth abnormal, and iris hyperpigmentation. Additional adverse reactions reported with bimatoprost ophthalmic solution (LUMIGAN ® ) for the reduction of intraocular pressure include, ocular dryness, visual disturbance, ocular burning, eye pain, blepharitis, cataract, superficial punctate keratitis, eye discharge, tearing, photophobia, allergic conjunctivitis, asthenopia, conjunctival edema, iritis, infections (primarily colds and upper respiratory tract infections), headaches, and asthenia.
6.2Postmarketing Experience The following adverse reactions have been identified during postapproval use of bimatoprost ophthalmic solution 0.03%. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The reactions include dry skin of the eyelid and/or periocular area, eye swelling, eyelid edema, hordeolum, hypersensitivity (local allergic reactions), lacrimation increased, madarosis and trichorrhexis (temporary loss of a few lashes to loss of sections of eyelashes, and temporary eyelash breakage, respectively), periorbital and lid changes associated with periorbital fat atrophy and skin tightness resulting in deepening of eyelid sulcus and eyelid ptosis, rash (including macular and erythematous), skin discoloration (periorbital), skin exfoliation of the eyelid and/or periorbital area, trichiasis, and vision blurred.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC).
These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.
No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily , based on AUC).
The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily , based on AUC).
The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC) . No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day.
These effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). The NOAEL for postnatal development and mating performance of the offspring wa… [Excerpted — this section continues on DailyMed.]
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary There are no adequate and well-controlled studies of bimatoprost ophthalmic solution 0.03% administration in pregnant women. There is no increase in the risk of major birth defects or miscarriages based on bimatoprost postmarketing experience. In embryofetal development studies, administration of bimatoprost to pregnant mice and rats during organogenesis resulted in abortion and early delivery at oral doses at least 33 times (mice) or 94 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on the area under the curve (AUC).
These adverse effects were not observed at 2.6 times (mice) and 47 times (rats) the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. In pre/postnatal development studies, administration of bimatoprost to pregnant rats from organogenesis to the end of lactation resulted in reduced gestation length and fetal body weight, and increased fetal and pup mortality at oral doses at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC.
No adverse effects were observed in rat offspring at exposures estimated at 14 times the human exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC. Because animal reproductive studies are not always predictive of human response bimatoprost ophthalmic solution 0.03% should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. Data Animal Data In an embryofetal development rat study, abortion was observed in pregnant rats administered bimatoprost orally during organogenesis at 0.6 mg/kg/day (94 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily , based on AUC).
The No Observed Adverse Effect Level (NOAEL) for abortion was 0.3 mg/kg/day (estimated at 47 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on AUC). No abnormalities were observed in rat fetuses at doses up to 0.6 mg/kg/day. In an embryofetal development mouse study, abortion and early delivery were observed in pregnant mice administered bimatoprost orally during organogenesis at doses greater than or equal to 0.3 mg/kg/day (33 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily , based on AUC).
The NOAEL for abortion and early delivery was 0.1 mg/kg/day (2.6 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC) . No abnormalities were observed in mouse fetuses at doses up to 0.6 mg/kg/day (72 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). In a pre/postnatal development study, treatment of pregnant rats with bimatoprost orally from gestation day 7 to lactation day 20 resulted in reduced gestation length, increased late resorptions, fetal deaths, and postnatal pup mortality, and reduced pup body weight at doses greater than or equal to 0.3 mg/kg/day.
These effects were observed at exposures at least 41 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily, based on AUC). The NOAEL for postnatal development and mating performance of the offspring was 0.1 mg/kg/day (estimated at… [Excerpted — this section continues on DailyMed.]
🧒 Pediatric Use ▾
8.4Pediatric Use Use of bimatoprost ophthalmic solution 0.03% was evaluated in a sixteen-week double-masked, randomized, vehicle-controlled study conducted in pediatric patients who were post-chemotherapy or had alopecia areata, and adolescents who had hypotrichosis with no associated medical condition. No new safety issues were observed. The results of the Global Eyelash Assessment (GEA) are provided in Table 1.
Table 1. Number (%) of subjects with at least a 1-grade increase from baseline at month 4 in Global Eyelash Assessment Age Range (years) Bimatoprost ophthalmic solution 0.03% Vehicle Difference (95% CI) Adolescents with hypotrichosis (N=40) 15-17 19/26 (73%) 1/14 (7%) 66% (44%, 88%) Post Chemotherapy Pediatric Patients (N=16) 5-17 11/13 (85%) 3/3 (100%) -15% (-35%, 4%) Alopecia Areata Pediatric Patients (N=15) 5-17 4/9 (44%) 2/6 (33%) 11% (-39%, 61%)
🧓 Geriatric Use ▾
8.5Geriatric Use No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown, the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.
12.3Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C max and AUC 0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng●hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing.
There was no significant systemic drug accumulation over time. Distribution Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of
0.67L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.
Elimination Metabolism Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation. Bimatoprost then undergoes oxidation, N-deethylation, and glucuronidation to form a diverse variety of metabolites. Excretion Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes.
The total blood clearance of bimatoprost was
1.5L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.
🧬 Mechanism of Action ▾
12.1Mechanism of Action Bimatoprost is a structural prostaglandin analog. Although the precise mechanism of action is unknown, the growth of eyelashes is believed to occur by increasing the percent of hairs in, and the duration of the anagen or growth phase.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Bimatoprost ophthalmic solution, 0.03% is supplied sterile in opaque white low-density polyethylene round screw neck bottle and tips with high density polyethylene turquoise opaque screw cap accompanied by sterile, disposable applicators: 5 mL in a 5 mL bottle with 140 applicators NDC 62332-511-05 3 mL in a 5 mL bottle with 70 applicators NDC 62332-511-03 Storage: Store at 2° to 25°C (36° to 77°F).
📋 Description ▾
11 DESCRIPTION Bimatoprost ophthalmic solution, 0.03% is a synthetic prostaglandin analog. Its chemical name is (Z)-7-[( 1R, 2R, 3R, 5S )-3, 5-Dihydroxy-2-[(1E, 3S)-3-hydroxy-5-phenyl-1pentenyl] cyclopentenyl]-5-N-ethylheptenamide, and its molecular weight is 415.58. Its molecular formula is C 25 H 37 NO 4 .
Its chemical structure is: Bimatoprost is a powder, which is soluble in methanol and alcohol. Bimatoprost ophthalmic solution 0.03% is clear, isotonic, colorless, sterile ophthalmic solution with an osmolality of approximately 290 mOsmol/kg. Bimatoprost Ophthalmic Solution 0.03% contains: Active : bimatoprost 0.3 mg/mL; Preservative : benzalkonium chloride 0.05 mg/mL; Inactives : sodium chloride; sodium phosphate, dibasic; citric acid; and water for injection.
Sodium hydroxide and/or hydrochloric acid may be added to adjust pH. The pH during its shelf-life ranges from 6.8 to7.8. bimatoprost-struc
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information) Nightly Application Inform patients that bimatoprost ophthalmic solution, 0.03% should be applied every night using only the accompanying sterile applicators. They should start by ensuring their face is clean, all makeup is removed, and their contact lenses removed (if applicable). Then, carefully place one drop of bimatoprost ophthalmic solution, 0.03% on the disposable sterile applicator and brush cautiously along the skin of the upper eyelid margin at the base of the eyelashes.
If any bimatoprost ophthalmic solution, 0.03% gets into the eye proper, it will not cause harm. The eye should not be rinsed. Additional applications of bimatoprost ophthalmic solution, 0.03% will not increase the growth of eyelashes.
Inform patients not to apply to the lower eyelash line. Any excess solution outside the upper eyelid margin should be blotted with a tissue or other absorbent material. The onset of effect is gradual but is not significant in the majority of patients until 2 months.
Counsel patients that the effect is not permanent and can be expected to gradually return to the original level upon discontinuation of treatment with bimatoprost ophthalmic solution, 0.03%. Handling the Bottle and Applicator Instruct patients that the bimatoprost ophthalmic solution, 0.03% bottle must be maintained intact and to avoid allowing the tip of the bottle or applicator to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination of the bottle or applicator by common bacteria known to cause ocular infections.
Instruct patients to only use the applicator supplied with the product once and then discard since reuse could result in using a contaminated applicator. Serious infections may result from using contaminated solutions or applicators. Potential for Intraocular Pressure Effects Bimatoprost ophthalmic solution, 0.03% may lower intraocular pressure although not to a level that will cause clinical harm.
In patients using LUMIGAN ® or other prostaglandin analogs for the treatment of elevated intraocular pressure, the concomitant use of bimatoprost ophthalmic solution, 0.03% may interfere with the desired reduction in IOP. Patients using prostaglandin analogs for IOP reduction should only use bimatoprost ophthalmic solution, 0.03% after consulting with their physician. Potential for Eyelid Skin Darkening Inform patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of bimatoprost ophthalmic solution, 0.03%.
Potential for Iris Darkening Advise patients about the potential for increased brown iris pigmentation which is likely to be permanent. Increased iris pigmentation has occurred when bimatoprost solution was administered. Potential for Unexpected Hair Growth or Eyelash Changes Inform patients of the possibility of hair growth occurring outside of the target treatment area if bimatoprost ophthalmic solution, 0.03% repeatedly touches the same area of skin outside the treatment area.
They should also be informed of the possibility of disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are likely reversible upon discontinuation of treatment. When to Seek Physician Advice Advise patients that if they develop a new ocular condition (e.g., trauma or infection), experience a sudden decrease in visual acuity, have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician’s advice concerning the continued use of bimatoprost ophthalmic solution, 0.03%.
Patients on IOP-lowering medications should not use bimatoprost ophthalmic solution, 0.03% without prior consultation with their physician. Contact Lens Use Advise patients that bimatoprost ophthalmic solution, 0.03% contain… [Excerpted — this section continues on DailyMed.]
🍼 Nursing Mothers ▾
8.2Lactation Risk Summary 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 breast milk of lactating rats at an intravenous dose (i.e., 1 mg/kg) 324 times the recommended human ophthalmic dose (on a mg/m 2 basis), however no animal data is available at clinically relevant doses. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for bimatoprost ophthalmic solution 0.03% and any potential adverse effects on the breastfed child from bimatoprost ophthalmic solution 0.03%.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption After one drop of bimatoprost ophthalmic solution 0.03% was administered once daily into both eyes (cornea and/or conjunctival sac) of 15 healthy subjects for two weeks, blood concentrations peaked within 10 minutes after dosing and were below the lower limit of detection (0.025 ng/mL) in most subjects within 1.5 hours after dosing. Mean C max and AUC 0-24hr values were similar on days 7 and 14 at approximately 0.08 ng/mL and 0.09 ng●hr/mL, respectively, indicating that steady state was reached during the first week of ocular dosing.
There was no significant systemic drug accumulation over time. Distribution Bimatoprost is moderately distributed into body tissues with a steady-state volume of distribution of
0.67L/kg. In human blood, bimatoprost resides mainly in the plasma. Approximately 12% of bimatoprost remains unbound in human plasma.
Elimination Metabolism Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation. Bimatoprost then undergoes oxidation, N-deethylation, and glucuronidation to form a diverse variety of metabolites. Excretion Following an intravenous dose of radiolabeled bimatoprost (3.12 mcg/kg) to six healthy subjects, the maximum blood concentration of unchanged drug was 12.2 ng/mL and decreased rapidly with an elimination half-life of approximately 45 minutes.
The total blood clearance of bimatoprost was
1.5L/hr/kg. Up to 67% of the administered dose was excreted in the urine while 25% of the dose was recovered in the feces.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES Bimatoprost ophthalmic solution, 0.03% was evaluated for its effect on overall eyelash prominence in a multicenter, double-masked, randomized, vehicle-controlled, parallel study including 278 adult patients for four months of treatment. The primary efficacy endpoint in this study was an increase in overall eyelash prominence as measured by at least a 1-grade increase on the 4-point Global Eyelash Assessment (GEA) scale, from baseline to the end of the treatment period (week 16). Bimatoprost ophthalmic solution, 0.03% was more effective than vehicle as measured by the GEA score, with statistically significant differences seen at 8-week, 12-week, and 16-week ( primary endpoint ) treatment durations.
Table 2 Number (%) of subjects with at least a 1-grade increase from baseline in Global Eyelash Assessment (Primary Efficacy Endpoint – Week 16) Week Bimatoprost ophthalmic solution, 0.03% N=137 N (%) Vehicle N= 141 N (%) 1 7 (5%) 3 (2%) 4 20 (15%) 11 (8%) 8 69 (50%) 21 (15%) 12 95 (69%) 28 (20%) 16 107 (78%) 26 (18%) 20 103 (79%) 27 (21%) In this study, patients were also evaluated for the effect of bimatoprost ophthalmic solution, 0.03% on the length, thickness and darkness of their eyelashes. Improvements from baseline in eyelash growth as measured by digital image analysis assessing eyelash length, fullness/thickness, and darkness were statistically significantly more pronounced in the bimatoprost group at weeks 8, 12, and 16.
Table 3 Efficacy endpoint at Week 16 (Mean Change from Baseline) Bimatoprost ophthalmic solution 0.03% Vehicle Eyelash growth (length) (mm; % increase) N=137 1.4; 25% N=141 0.1; 2% Fullness/thickness (mm 2 ; % increase) N=136 0.7; 106% N=140 0.1; 12% Eyelash darkness (intensity*; % increase in darkness) N=135 -20.2; -18% N=138 -3.6;-3% * a negative value is representative of eyelash darkening After the 16-week treatment period, a 4-week post-treatment period followed during which the effects of bimatoprost started to return toward baseline.
The effect on eyelash growth is expected to abate following longer term discontinuation.
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis and Mutagenesis and Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (approximately 192 and 291 times the human systemic exposure following topical administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels). Mutagenesis Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.
Impairment of Fertility Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day(103 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels).
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis and Mutagenesis and Impairment of Fertility Carcinogenesis Bimatoprost was not carcinogenic in either mice or rats when administered by oral gavage for 104 weeks at doses of up to 2 mg/kg/day and 1 mg/kg/day respectively (approximately 192 and 291 times the human systemic exposure following topical administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels). Mutagenesis Bimatoprost was not mutagenic or clastogenic in the Ames test, in the mouse lymphoma test, or in the in vivo mouse micronucleus tests.
Impairment of Fertility Bimatoprost did not impair fertility in male or female rats up to doses of 0.6 mg/kg/day(103 times the human systemic exposure following topical ophthalmic administration of bimatoprost 0.03% to the cornea or conjunctival sac bilaterally once daily based on blood AUC levels).
📄 Patient Package Insert ▾
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📄 Package Label / Principal Display Panel ▾
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 5 mL-Gland: B imatoprost ophthalmic solution 0.03% Topical - Carton label - 5mL-Gland: Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 3 mL-Gland: Bimatoprost ophthalmic solution 0.03% Topical - Carton label - 3 mL-Gland: Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 5 mL - Alembic: B imatoprost ophthalmic solution 0.03% Topical - Carton label - 5mL - Alembic : Bimatoprost ophthalmic solution 0.03% Topical - Bottle label - 3 mL - Alembic : B imatoprost ophthalmic solution 0.03% Topical - Carton label - 3mL - Alembic : bimatoprost-bottle-5ml bimatoprost-carton-5ml bimatoprost-bottle-3ml bimatoprost-carton-3ml bimatoprost-bottle-5ml-alembic bimatoprost-carton-3ml-alembic bimatoprost-bottle-3ml-alembic bimatoprost-carton-5ml-alembic