Nesudil Plus (Netarsudil INN 0.02% & Latanoprost USP 0.005%)

Therapeutic Group : Opthalmic eye drops

Presentation:

Nesudil Plus Ophthalmic Solution: Each ml contains Netarsudil Dimesylate INN equivalent to Netarsudil 0.20 mg and Latanoprost USP 0.05 mg.

Pharmacology:

Nesudil Plus is a fixed-dose combination of a Rho kinase inhibitor and a Prostaglandin F2? analogue. Netarsudil is a Rho kinase inhibitor, works at the cellular level within the trabecular outflow pathway to relax actin-myosin. This causes relaxation within the trabecular meshwork and the inner wall of Schlemm\\\’s canal, and decrease episcleral venous pressure (EVP).
Latanoprost is a selective FP receptor agonist which reduces the intraocular pressure (IOP) by increasing the outflow of aqueous humor through uveoscleral outflow.

Indications:

Nesudil Plus is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

Dosage & Administration:

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

Contrainidications:

This eye drops is 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 or to any surface
Should be used with caution in patients with active intraocular inflammation (e.g., iritis/uveits)
May cause changes to pigmented tissues, gradually change eyelashes and vellus hair in the treated eye
Cystoid macular edema, has been reported during treatment with Latanoprost. Reactivation of Herpes Simplex keratitis may occur
Netarsudil & Latanoprost combination can be used with other topical eye drug products, but they should be administered at least 5 minutes apart from each other
Use in special group:
Pregnancy: There are no adequate and well-controlled studies of Netarsudil & Latanoprost combination in pregnant women to inform any drug associated risk.
Lactation: There are no data on the presence of Netarsudil or Latanoprost in human milk, the effects on the breastfed infant, or the effects on milk production.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Use in elderly patients: No overall differences in safety and effectiveness have been observed between elderly and other adult patients.

Side effects:

The most common ocular adverse reaction observed in controlled clinical studies with Netarsudil & Latanoprost was conjunctival hyperemia, instillation site pain, corneal verticillata, instillation site discomfort, foreign body sensation and blurred visions were reported in few patients.

Storage:

Store at 2°-8°C in a dry place, protect from light until opened. After opening the product may be kept at 2°-25°C for upto 6 weeks. Keep out of the reach of children.

Packing:

Nesudil Plus Ophthalmic Solution: Each LDPE dropper bottle contains 3 ml Sterile Eye Drops.