bimatoprost .3 mg/mL
bimatoprost · SOLUTION/ DROPS · Alembic Pharmaceuticals Inc.
Bimatoprost is an eye drop medication that belongs to a class of drugs called prostaglandin analogs, used to treat high eye pressure in glaucoma and ocular hypertension. It works by increasing fluid drainage from the eye to help lower pressure inside the eye.
Key Facts
- Brand Name
- bimatoprost
- Generic Name
- bimatoprost
- NDC Code (Product)
62332-511- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- .3 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA210515
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 01/21/2020
Recall History
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Medisca Inc.
CGMP Deviations
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: OOS results observed in any other individual impurity and total impurities.
Allergan Sales, LLC
Failed Impurities/Degradation Specifications.
Aspen Biopharma Labs Pvt., Ltd.
CGMP Deviations
Sandoz Inc
Labeling: Incorrect or missing package insert.
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 Bimatoprost ophthalmic solution 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost ophthalmic solution 0.03% 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. Bimatoprost ophthalmic solution 0.03% 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. Bimatoprost ophthalmic solution 0.03% 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 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.
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: • Pigmentation [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 (45%) is conjunctival hyperemia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials 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 clinical trials, the most frequent events associated with the use of bimatoprost ophthalmic solution 0.03% occurring in approximately 15% to 45% of patients, in descending order of incidence, included conjunctival hyperemia, growth of eyelashes, and ocular pruritus. Approximately 3% of patients discontinued therapy due…
Frequently Asked Questions
What is bimatoprost used for?
Bimatoprost is an eye drop medication that belongs to a class of drugs called prostaglandin analogs, used to treat high eye pressure in glaucoma and ocular hypertension. It works by increasing fluid drainage from the eye to help lower pressure inside the eye.
Is bimatoprost a controlled substance?
bimatoprost is not classified as a controlled substance by the DEA.
What is the generic name for bimatoprost?
The generic name for bimatoprost is bimatoprost. There are 11 other brand versions of bimatoprost.
What is the NDC code for bimatoprost .3 mg/mL?
The NDC (National Drug Code) for bimatoprost .3 mg/mL is 62332-511, listed by Alembic Pharmaceuticals Inc..