ZOLYMBUS .1 mg/g
bimatoprost · GEL · Thea Pharma Inc.
ZOLYMBUS is a gel containing bimatoprost at .1 mg/g, taken ophthalmic. Manufactured by Thea Pharma Inc..
Key Facts
- Brand Name
- ZOLYMBUS
- Generic Name
- bimatoprost
- NDC Code (Product)
82584-010- Manufacturer
- Thea Pharma Inc.
- Strength
- .1 mg/g
- Dosage Form
- GEL
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA217307
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 02/26/2026
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 ZOLYMBUS™ is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. ZOLYMBUS™ is a prostaglandin analog indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) once daily in the evening. ZOLYMBUS should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the IOP lowering effect. Reduction of the IOP starts approximately 4 hours after the first administration with maximum effect reached within approximately 8 to 12 hours. ZOLYMBUS may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. If one dose is missed, treatment should continue with the next dose as normal. The gel from one single-dose container is to be used immediately after opening for administration to one or both eyes. Since sterility cannot be maintained after the single-dose container is opened, discard the open container and the remaining contents immediately after administration. One drop in the affected eye(s) once daily in the evening.
Contraindications
4 CONTRAINDICATIONS ZOLYMBUS 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 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 reactions (≥10%) are conjunctival hyperemia (14%) and eye irritation (11%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Thea Pharma Inc. at 1-833-838-4028 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 the two clinical trials conducted with ZOLYMBUS (bimatoprost ophthalmic gel) 0.01% comparing it to preserved bimatoprost ophthalmic solution 0.01%, the most frequently reported ocular adverse reactions were conjunctival hyperemia (14%), eye irrita…
Frequently Asked Questions
What is ZOLYMBUS used for?
ZOLYMBUS contains bimatoprost. It is a gel taken ophthalmic. Consult your doctor for specific uses.
Is ZOLYMBUS a controlled substance?
ZOLYMBUS is not classified as a controlled substance by the DEA.
What is the generic name for ZOLYMBUS?
The generic name for ZOLYMBUS is bimatoprost. There are 11 other brand versions of bimatoprost.
What is the NDC code for ZOLYMBUS .1 mg/g?
The NDC (National Drug Code) for ZOLYMBUS .1 mg/g is 82584-010, listed by Thea Pharma Inc..