LATISSE .3 mg/mL
bimatoprost · SOLUTION/ DROPS · Allergan, Inc.
LATISSE is a solution/ drops containing bimatoprost at .3 mg/mL, taken ophthalmic. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- LATISSE
- Generic Name
- bimatoprost
- NDC Code (Product)
0023-3616- Manufacturer
- Allergan, Inc.
- Strength
- .3 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA022369
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 01/26/2009
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LATISSE ® (bimatoprost ophthalmic solution) 0.03% is indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. LATISSE ® is a prostaglandin analog, indicated to treat hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Ensure the face is clean, makeup and contact lenses are removed. Once nightly, place one drop of LATISSE ® (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 LATISSE ® . Do not apply to the lower eyelash line [see Warnings and Precautions ( 5.3 , 5.4 ) and Patient Counseling Information (17) ] . Additional applications of LATISSE ® 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 mar…
Contraindications
4 CONTRAINDICATIONS LATISSE ® is contraindicated in patients with hypersensitivity to bimatoprost or to any of the ingredients [ see Adverse Reactions (6.2) ]. Hypersensitivity. ( 4 )
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 AbbVie at 1-800-678-1605 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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-co…
Frequently Asked Questions
What is LATISSE used for?
LATISSE contains bimatoprost. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is LATISSE a controlled substance?
LATISSE is not classified as a controlled substance by the DEA.
What is the generic name for LATISSE?
The generic name for LATISSE is bimatoprost. There are 12 other brand versions of bimatoprost.
What is the NDC code for LATISSE .3 mg/mL?
The NDC (National Drug Code) for LATISSE .3 mg/mL is 0023-3616, listed by Allergan, Inc..