Latanoprostene Bunod is a landmark breakthrough, a first-in-class monotherapy eye drop that simultaneously increases TRABECULAR AND UVEOSCLERAL OUTFLOW for effective Glaucoma management. It is Indicated for the treatment of Primary open-angle glaucoma or ocular hypertension. Apart from reducing IOP, it provides neuroprotection. Latanoprostene Bunod approved by USFDA on November, 2017.

Description

Latanoprostene Bunod (Zultan) represents a novel approach in glaucoma treatment due to its dual mechanism of action, targeting both the uveoscleral and trabecular meshwork outflow pathways to effectively lower intraocular pressure. It is a prescription-only medication designed for topical application to the eyes. The medication is metabolized into two relevant moieties upon administration: (1) Latanoprost acid, and (2) Butanediol mononitrate

 

  1. Latanoprost Acid: After application, Latanoprostene Bunod is metabolized to latanoprost acid, a prostaglandin F2α analog. Latanoprost acid increases the outflow of aqueous humor from the eye, particularly through the uveoscleral pathway, which helps to reduce intraocular pressure.

 

  1. Butanediol Mononitrate: The second component, Butanediol Mononitrate, releases Nitric Oxide. Nitric oxide helps to relax the trabecular meshwork and Schlemm’s canal, enhancing the conventional outflow of aqueous humor, and further reducing intraocular pressure.

 

Dosage & Administration: The recommended dosage is one drop in the affected eye(s) once daily in the evening.

Presentation

    Zultan Ophthalmic Solution: Each ml contains Latanoprostene Bunod INN 0.24 mg

Indications

    Zultan ophthalmic solution is indicated for the reduction of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Dosage & Administration

    The recommended dosage is one drop in the conjunctival sac of the affected eye(s) once daily in the evening.

Contrainidications

    Latanoprostene Bunod eye drops are contraindicated in patients who are hypersensitive to any component of this preparation.

Warning & Precautions

    • For ophthalmic use only.
    • To avoid possible contamination of the drops, do not touch the dropper tip.
    • Should be used with caution in patients with a history of intraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocular inflammation.
    • May cause changes to pigmented tissues, and gradually change eyelashes and vellus hair in the treated eye.
    • Contact lenses should be removed before the administration of Latanoprostene Bunod and may be reinserted 15 minutes after administration.
    • Latanoprostene Bunod can be used with other topical eye drug products, but they should be administered at least 5 minutes apart from each other.
    • Do not administer Latanoprostene Bunod ophthalmic solution more than once daily since it has been shown that more frequent administration of prostaglandin analogs may lessen the intraocular pressure lowering effect.

Side effects

    The reported most common ocular adverse reaction is: Pigmentation, Eyelash Changes, Intraocular Inflammation, Macular Edema, Bacterial Keratitis etc.

Drug interaction

Use in special groups

    Use in Pregnancy: There is no available human data for using Latanoprostene Bunod during pregnancy to inform of any drug-associated risks.
    Lactation: There are no data on the presence of Latanoprostene Bunod in human milk, the effects on the breastfed infant, or the effects on milk production.
    Use in the Paediatric population: Paediatric patients aged 16 years and younger are not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use.
    Use in Geriatric Patients: No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.

Packing

    Zultan Ophthalmic Solution: Each LDPE dropper bottle contains 3 ml of Sterile Eye Drops.