LUMIGAN .1 mg/mL
bimatoprost · SOLUTION/ DROPS · Allergan, Inc.
LUMIGAN is a solution/ drops containing bimatoprost at .1 mg/mL, taken ophthalmic. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- LUMIGAN
- Generic Name
- bimatoprost
- NDC Code (Product)
0023-3205- Manufacturer
- Allergan, Inc.
- Strength
- .1 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA022184
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 09/10/2010
Recall History
Allergan Sales, LLC
Failed Impurities/Degradation Specifications.
Allergan Sales, LLC
Failed Impurities/Degradation Specifications
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE LUMIGAN ® (bimatoprost ophthalmic solution) 0.01% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. LUMIGAN ® 0.01% is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. LUMIGAN ® (bimatoprost ophthalmic solution) 0.01% should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect. Reduction of the intraocular pressure starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours. LUMIGAN ® 0.01% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. One drop in the affected eye(s) once daily in the evening. ( 2 )
Contraindications
4 CONTRAINDICATIONS LUMIGAN ® 0.01% 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: Pigmentation including blepharal pigmentation and iris hyperpigmentation [see Warnings and Precautions (5.1) ] Eyelash Changes [see Warnings and Precautions (5.2) ] Intraocular Inflammation [see Warnings and Precautions (5.3) ] Macular Edema [see Warnings and Precautions (5.4) ] Hypersensitivity [see Contraindications (4) ] Most common adverse reaction (31%) is conjunctival hyperemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial s 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. In a 12-month clinical study with bimatoprost ophthalmic solutions 0.01%, the most common adverse reaction was conjunctival hyperemia (31%). Approximately 1.6% of patients discontinued therapy due to conjunctival hyperemia. Other adverse drug reactions (reported in 1 to 4% of patients) with L…
Frequently Asked Questions
What is LUMIGAN used for?
LUMIGAN contains bimatoprost. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is LUMIGAN a controlled substance?
LUMIGAN is not classified as a controlled substance by the DEA.
What is the generic name for LUMIGAN?
The generic name for LUMIGAN is bimatoprost. There are 12 other brand versions of bimatoprost.
What is the NDC code for LUMIGAN .1 mg/mL?
The NDC (National Drug Code) for LUMIGAN .1 mg/mL is 0023-3205, listed by Allergan, Inc..