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latanoprostene bunod

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Overview

What is Vyzulta?

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.

Its chemical name is 4-(Nitrooxy)butyl (5Z)-7-{(1R,2R,3R,5S)-3,5-dihydroxy-2-[(3R)-3-hydroxy-5-phenylpentyl]cyclopentyl}hept-5-enoate. Its molecular formula is CHNO. Molecular weight: 507.62.

Its chemical structure is:

Latanoprostene bunod is a colorless to yellow oil.



What does Vyzulta look like?



What are the available doses of Vyzulta?

Topical ophthalmic solution: 0.24 mg/mL latanoprostene bunod (0.024%) ()

What should I talk to my health care provider before I take Vyzulta?

How should I use Vyzulta?

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.

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.


What interacts with Vyzulta?

Sorry No Records found


What are the warnings of Vyzulta?

Sorry No Records found


What are the precautions of Vyzulta?

Sorry No Records found


What are the side effects of Vyzulta?

Sorry No records found


What should I look out for while using Vyzulta?

None.


What might happen if I take too much Vyzulta?

Sorry No Records found


How should I store and handle Vyzulta?

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is supplied in a natural low density polyethylene, 7.5 mL bottle with dropper tip and a turquoise cap filled with a 5 mL fill volume (NDC 24208-504-05).Storage:During shipment, bottles may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.Protect from light. Protect from freezing.VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is supplied in a natural low density polyethylene, 7.5 mL bottle with dropper tip and a turquoise cap filled with a 5 mL fill volume (NDC 24208-504-05).Storage:During shipment, bottles may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.Protect from light. Protect from freezing.VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is supplied in a natural low density polyethylene, 7.5 mL bottle with dropper tip and a turquoise cap filled with a 5 mL fill volume (NDC 24208-504-05).Storage:During shipment, bottles may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.Protect from light. Protect from freezing.VYZULTA (latanoprostene bunod ophthalmic solution), 0.024% is supplied in a natural low density polyethylene, 7.5 mL bottle with dropper tip and a turquoise cap filled with a 5 mL fill volume (NDC 24208-504-05).Storage:During shipment, bottles may be maintained at temperatures up to 40°C (104°F) for a period not exceeding 14 days.Protect from light. Protect from freezing.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Latanoprostene bunod is thought to lower intraocular pressure by increasing outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes. Intraocular pressure is a major modifiable risk factor for glaucoma progression. Reduction of intraocular pressure reduces risk of glaucomatous visual field loss.

Non-Clinical Toxicology
None.

Studies to evaluate possible interactions between naltrexone hydrochloride and drugs other than opiates have not been performed. Consequently, caution is advised if the concomitant administration of naltrexone hydrochloride and other drugs is required.

The safety and efficacy of concomitant use of naltrexone hydrochloride and disulfiram is unknown, and the concomitant use of two potentially hepatotoxic medications is not ordinarily recommended unless the probable benefits outweigh the known risks.

Lethargy and somnolence have been reported following doses of naltrexone hydrochloride and thioridazine.

Patients taking naltrexone hydrochloride may not benefit from opioid containing medicines, such as cough and cold preparations, antidiarrheal preparations, and opioid analgesics. In an emergency situation when opioid analgesia must be administered to a patient receiving naltrexone hydrochloride, the amount of opioid required may be greater than usual, and the resulting respiratory depression may be deeper and more prolonged (see ).

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. The pigmentation change is due to increased melanin content in the melanocytes rather than to an increase in the number of melanocytes. After discontinuation of VYZULTA, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes are likely to be reversible in most patients. Patients who receive prostaglandin analogs, including VYZULTA, should be informed of the possibility of increased pigmentation, including permanent changes. The long-term effects of increased pigmentation are not known.

Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with VYZULTA™ (latanoprostene bunod ophthalmic solution), 0.024% can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly

The following adverse reactions are described elsewhere in the labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

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Interactions

Interactions

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