Latanoprost 50 ug/mL
latanoprost · SOLUTION/ DROPS · Bausch & Lomb Incorporated
Latanoprost is a solution/ drops containing latanoprost at 50 ug/mL, taken ophthalmic. Manufactured by Bausch & Lomb Incorporated.
Key Facts
- Brand Name
- Latanoprost
- Generic Name
- latanoprost
- NDC Code (Product)
24208-463- Manufacturer
- Bausch & Lomb Incorporated
- Strength
- 50 ug/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- ANDA201006
- Drug Class
- Prostaglandin Analog [EPC]
- Marketing Start
- 03/22/2011
Recall History
Akorn, Inc.
Lack of assurance of sterility: product was found to be empty, under-filled, or leaking.
ImprimisRx NJ
Subpotent Drug
ImprimisRx CA, Inc., dba ImprimisRx
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
ImprimisRx NJ
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
ImprimisRx CA, Inc., dba ImprimisRx
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Release Testing: Out of specification for particulate matter test.
Clinical Specialties Compounding Pharmacy
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
ImprimisRx CA, Inc., dba ImprimisRx
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Apotex Inc
Lack of Assurance of Sterility: Failed at expiry for Preservative Effectiveness Test (PET), therefore the product may be susceptible to microbial growth before the expiry date.
ImprimisRx NJ
Subpotent Drug
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 Latanoprost ophthalmic solution is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprost ophthalmic solution is a prostaglandin F 2α analogue 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. If one dose is missed, treatment should continue with the next dose as normal. The dosage of latanoprost ophthalmic solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including latanoprost ophthalmic solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the IOP lowering effect or cause paradoxical elevations in IOP. Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours. Latanoprost ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower IOP. In vitro studies have shown that precipitation occurs when eye drops containing thimerosal are mixed with latanoprost ophthalmic solution. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Contact lenses should be removed prior to the administration of latanoprost ophthalmic solution, and may be reinsert…
Contraindications
4 CONTRAINDICATIONS Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. Known hypersensitivity to latanoprost, benzalkonium chloride, or any other ingredients in this product. (4)
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label: Iris pigmentation changes [see Warnings and Precautions (5.1) ] Eyelid skin darkening [see Warnings and Precautions (5.1) ] Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2) ] Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3) ] Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4) ] Most common adverse reactions (5-15%) from clinical trials are blurred vision, burning and stinging, conjunctival hyperemia, foreign body sensation, itching, increased pigmentation of the iris, and punctate keratitis. (6) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 609-250-7990 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, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the …
Frequently Asked Questions
What is Latanoprost used for?
Latanoprost contains latanoprost. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is Latanoprost a controlled substance?
Latanoprost is not classified as a controlled substance by the DEA.
What is the generic name for Latanoprost?
The generic name for Latanoprost is latanoprost. There are 5 other brand versions of latanoprost.
What is the NDC code for Latanoprost 50 ug/mL?
The NDC (National Drug Code) for Latanoprost 50 ug/mL is 24208-463, listed by Bausch & Lomb Incorporated.