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ROCKLATAN OPHTHALMIC SOLUTION, 0.02% W/V / 0.005% W/V

Prescription Only
Drug type: Therapeutic
ATC code: S01EE51
Dosage form: SOLUTION, STERILE
Route of administration: OPHTHALMIC
Active ingredient: Latanoprost; Netarsudil mesylate eqv Netarsudil; LATANOPROST; NETARSUDIL MESYLATE EQV NETARSUDIL

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.

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.

Registrant
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
Approval Date
2023-07-04
Approval Number
SIN16818P
Manufacturer
Aerie Pharmaceuticals Ireland, Limited
Licence Holder
SANTEN PHARMACEUTICAL ASIA PTE. LTD.
ROCKLATAN OPHTHALMIC SOLUTION, 0.02% W/V / 0.005% W/V | MedPath