Latanoprostene Bunod
Generic Name: latanoprostene bunod
Brand Names:
Vyzulta
11 DESCRIPTION VYZULTA ® (latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. VYZULTA 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 VYZULTA ® (latanoprostene bunod ophthalmic solution), 0.024% is a prostaglandin analog formulated as a sterile topical ophthalmic solution. VYZULTA 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 VYZULTA ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
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 VYZULTA (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 VYZULTA 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. ( 2 )
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 Bausch & Lomb Incorporated at 1-800-553-5340 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 VYZULTA (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. ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary There are no available human data for the use of VYZULTA 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 VYZULTA ® (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 24208-504-02 5 mL fill in a 7.5 mL natural container - NDC 24208-504-05 Storage: Unopened bottle should be stored refrigerated at 2°C to 8°C (36°F to...
Frequently Asked Questions
What is Latanoprostene Bunod used for?▼
1 INDICATIONS AND USAGE VYZULTA ® (latanoprostene bunod ophthalmic solution) 0.024% is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. VYZULTA is a prostaglandin analog indicated for the reduction of intraocular pressure in patients with open-angle glaucoma or ocular hypertension. ( 1 )
What are the side effects of Latanoprostene Bunod?▼
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 Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Latanoprostene Bunod during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available human data for the use of VYZULTA 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?▼
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 VYZULTA (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. ( 4 )
Related Medications
Zinc Monoethylfumarate Micronized
zinc monoethylfumarate micronized
Dosage form: POWDER. Active ingredients: ZINC MONOETHYLFUMARATE (1 kg/kg). Category: BULK INGREDIENT.
Ibrutinib (form-c)
ibrutinib (form-c)
Dosage form: POWDER. Active ingredients: IBRUTINIB (1 kg/kg). Category: BULK INGREDIENT.
Pramoxine Hydrochloride And Zinc Acetate
pramoxine hydrochloride and zinc acetate
Active ingredients Purposes Pramoxine Hydrochloride (1.0%) Topical analgesic Zinc Acetate (0.1%) Skin protectant
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.