ROCKLATAN(netarsudil and latanoprost ophthalmic solution)0.02%/0.005%, for topical ophthalmic(二)
N 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.
3. DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing netarsudil 0.20 mg/mL and latanoprost 0.05 mg/mL.
4. CONTRAINDICATIONS
None.
5. WARNINGS AND PRECAUTIONS
5.1 Pigmentation
ROCKLATAN contains latanoprost which has been reported to cause changes to pigmented tissues. Themost frequently reported changes have been increased pigmentation of the iris, periorbital tissue (eyelid),and eyelashes. Pigmentation is expected to increase as long as latanoprost is administered.
The pigmentation change is due to increased melanin content in the melanocytes rather than to an increasein the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to bepermanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to bereversible in some patients. Patients who receive treatment should be informed of the possibility oincreased pigmentation. Beyond 5 years the effects of increased pigmentation are not known.
Iris color change may not be noticeable for several months to years. Typically, the brown pigmentationaround the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of theiris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. Whiletreatment with ROCKLATAN can be continued in patients who develop noticeably increased irispigmentation, these patients should be examined regularly [see Patient Counseling Information (17)].
5.2 Eyelash Changes
ROCKLATAN contains latanoprost which may gradually change eyelashes and vellus hair in the treatedeye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, andmisdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment[see Patient Counseling Information (17)].
5.3 Intraocular Inflammation
ROCKLATAN contains latanoprost which should be used with caution in patients with a history ofintraocular inflammation (iritis/uveitis) and should generally not be used in patients with active intraocularinflammation because it may exacerbate inflammation.
5.4 Macular Edema
Macular edema, including cystoid macular edema, has been reported during treatment with latanoprost.
ROCKLATAN should be used with caution in aphakic patients, in pseudophakic patients with a tornposterior lens capsule, or in patients with known risk factors for macular edema.
5.5 Herpetic Keratitis
Reactivation of Herpes Simplex keratitis has been reported during treatment with latanoprost.
ROCKLATAN should be used with caution in patients with a history of herpetic keratitis. ROCKLATANshould be avoided in cases of active herpes simplex keratitis because it may exacerbate inflammation.
5.6 Bacterial Keratitis
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topicalophthalmic products. These containers had been inadvertently contaminated by patients who, in mostcases, had a concurrent corneal disease or a disruption of the ocular epithelial surface [see Patient
Counseling Information (17)].
5.7 Use with Contact Lenses
Contact lenses should be removed prior to the administration of ROCKLA |
