Latanoprostene Bunod Ophthalmic Solution, 0.024%
Generic Name: latanoprostene bunod ophthalmic solution, 0.024%
Brand Names:
Latanoprostene Bunod Ophthalmic Solution, 0.024%
11 DESCRIPTION Latanoprostene bunod ophthalmic solution, 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. Latanoprostene bunod ophthalmic solution contains the active ingredient latanoprostene bunod 0.24 mg/mL, the preservative benzalkonium chloride 0.2 mg/mL, and the following inactive ingredients: polysorbate 80, glycerin, EDTA, and water. The formulation is buffered to pH 5.5 with citric acid/sodium citrate.
Overview
11 DESCRIPTION Latanoprostene bunod ophthalmic solution, 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. Latanoprostene bunod ophthalmic solution contains the active ingredient latanoprostene bunod 0.24 mg/mL, the preservative benzalkonium chloride 0.2 mg/mL, and the following inactive ingredients: polysorbate 80, glycerin, EDTA, and water. The formulation is buffered to pH 5.5 with citric acid/sodium citrate.
Uses
1 INDICATIONS AND USAGE Latanoprostene bunod ophthalmic solution, 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprostene bunod ophthalmic solution is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
Dosage
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the conjunctival sac of the affected eye(s) once daily in the evening. Do not administer latanoprostene bunod ophthalmic solution, 0.024% more than once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect. If latanoprostene bunod ophthalmic solution is to be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure, administer each drug product at least five (5) minutes apart. One drop in the affected eye(s) once daily in the evening.
Side Effects
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) ] • Bacterial Keratitis [ see Warnings and Precautions (5.5) ] • Use with Contact Lens [ see Warnings and Precautions (5.6 )] Most common ocular adverse reactions with incidence ≥ 2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at (609) 250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
5 WARNINGS AND PRECAUTIONS • Pigmentation: Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent. ( 5.1 ) • Eyelash changes: Gradual changes to eyelashes including increased length, increased thickness and number of eyelashes. Usually reversible upon discontinuation of treatment. ( 5.2 ) 5.1 Pigmentation Latanoprostene bunod ophthalmic solution, 0.024% may cause changes to pigmented tissues. The most frequently reported changes with prostaglandin analogs have been increased pigmentation of the iris and periorbital tissue (eyelid). Pigmentation is expected to increase as long as Latanoprostene bunod ophthalmic solution is administered. 4 CONTRAINDICATIONS None. None.
Pregnancy
8.1 Pregnancy Risk Summary There are no available human data for the use of Latanoprostene bunod ophthalmic solution during pregnancy to inform any drug associated risks. Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. Latanoprostene bunod was shown to be abortifacient and teratogenic when administered intravenously (IV) to pregnant rabbits at exposures ≥ 0.28 times the clinical dose. Doses ≥ 20 mcg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality.
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Latanoprostene bunod ophthalmic solution, 0.024% is supplied in low density polyethylene bottles with dropper tips and turquoise caps in the following sizes: 2.5 mL fill in a 4 mL white container - NDC 68083-563-01 5 mL fill in a 7 mL Natural container - NDC 68083-564-01 Storage: Unopened bottle should be stored refrigerated at 2º to 8ºC (36º to 46ºF).
Frequently Asked Questions
What is Latanoprostene Bunod Ophthalmic Solution, 0.024% used for?▼
1 INDICATIONS AND USAGE Latanoprostene bunod ophthalmic solution, 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Latanoprostene bunod ophthalmic solution is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
What are the side effects of Latanoprostene Bunod Ophthalmic Solution, 0.024%?▼
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) ] • Bacterial Keratitis [ see Warnings and Precautions (5.5) ] • Use with Contact Lens [ see Warnings and Precautions (5.6 )] Most common ocular adverse reactions with incidence ≥ 2% are conjunctival hyperemia (6%), eye irritation (4%), eye pain (3%), and instillation site pain (2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at (609) 250-7990 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Latanoprostene Bunod Ophthalmic Solution, 0.024% during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available human data for the use of Latanoprostene bunod ophthalmic solution during pregnancy to inform any drug associated risks. Latanoprostene bunod has caused miscarriages, abortion, and fetal harm in rabbits. Latanoprostene bunod was shown to be abortifacient and teratogenic when administered intravenously (IV) to pregnant rabbits at exposures ≥ 0.28 times the clinical dose. Doses ≥ 20 mcg/kg/day (23 times the clinical dose) produced 100% embryofetal lethality.
What are the important warnings for Latanoprostene Bunod Ophthalmic Solution, 0.024%?▼
5 WARNINGS AND PRECAUTIONS • Pigmentation: Increased pigmentation of the iris and periorbital tissue (eyelid) can occur. Iris pigmentation is likely to be permanent. ( 5.1 ) • Eyelash changes: Gradual changes to eyelashes including increased length, increased thickness and number of eyelashes. Usually reversible upon discontinuation of treatment. ( 5.2 ) 5.1 Pigmentation Latanoprostene bunod ophthalmic solution, 0.024% may cause changes to pigmented tissues. The most frequently reported changes with prostaglandin analogs have been increased pigmentation of the iris and periorbital tissue (eyelid). Pigmentation is expected to increase as long as Latanoprostene bunod ophthalmic solution is administered. 4 CONTRAINDICATIONS None. None.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.