Regulatory Information
HSA regulatory responsibility and product classification details
Regulatory Responsibility
Product Classification
Formulation Information
SOLUTION, STERILE
**2\. DOSAGE AND ADMINISTRATION** The recommended dosage is one drop in the affected eye(s) once daily in the evening. If one dose is missed, treatment should continue with the next dose in the evening. The dosage of ROCKLATAN should not exceed once daily. ROCKLATAN may be used concomitantly with other topical ophthalmic drug products to lower IOP. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart. Due to netarsudil’s vasodilating properties, other eye drops should be administered before latanoprost + netarsudil. Eye ointments should be administered last.
OPHTHALMIC
Medical Information
**1\. INDICATIONS AND USAGE** ROCKLATAN (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005% is a fixed dose combination of a Rho kinase inhibitor and a prostaglandin F2α analogue indicated for the reduction of elevated intraocular pressure (IOP) in patients with primary open-angle glaucoma or ocular hypertension for whom monotherapy with a prostaglandin F2α analogue or Rho kinase inhibitor provides insufficient IOP reduction.
**4\. CONTRAINDICATIONS** Hypersensitivity to the active substance(s) or to any of the excipients.
S01EE51
latanoprost and netarsudil
Manufacturer Information
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Aerie Pharmaceuticals Ireland, Limited
Active Ingredients
Documents
Package Inserts
Rocklatan Ophthalmic solution PI.pdf
Approved: July 4, 2023