Latanoprost

LATANOPROST- latanoprost solution
Sandoz Inc

1 INDICATIONS AND USAGE

Latanoprost Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

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 as normal.

The dosage of Latanoprost Ophthalmic Solution should not exceed once daily; the combined use of two or more prostaglandins, or prostaglandin analogs including Latanoprost Ophthalmic Solution is not recommended. It has been shown that administration of these prostaglandin drug products more than once daily may decrease the intraocular pressure (IOP) lowering effect or cause paradoxical elevations in IOP.

Reduction of the IOP starts approximately 3 to 4 hours after administration and the maximum effect is reached after 8 to 12 hours.

Latanoprost Ophthalmic Solution 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. Contact lenses should be removed prior to the administration of Latanoprost Opthalmic Solution, and may be reinserted 15 minutes after administration

3 DOSAGE FORMS AND STRENGTHS

Sterile ophthalmic solution containing 50 mcg/mL latanoprost.

4 CONTRAINDICATIONS

Known hypersensitivity to latanoprost, benzalkonium chloride or any other ingredients in this product.

5 WARNINGS AND PRECAUTIONS

5.1 Pigmentation

Latanoprost ophthalmic solution has been reported to cause changes to pigmented tissues. The most 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 increase in the number of melanocytes. After discontinuation of latanoprost, pigmentation of the iris is likely to be permanent, while pigmentation of the periorbital tissue and eyelash changes have been reported to be reversible in some patients. Patients who receive treatment should be informed of the possibility of increased pigmentation. Beyond 5 years the effects of increased pigmentation are not known [see Clinical Studies (14.2)].

Iris color change may not be noticeable for several months to years. Typically, the brown pigmentation around the pupil spreads concentrically towards the periphery of the iris and the entire iris or parts of the iris become more brownish. Neither nevi nor freckles of the iris appear to be affected by treatment. While treatment with Latanoprost ophthalmic solution can be continued in patients who develop noticeably increased iris pigmentation, these patients should be examined regularly [see Patient Counseling Information (17)].

5.2 Eyelash Changes

Latanoprost ophthalmic solution may gradually change eyelashes and vellus hair in the treated eye; these changes include increased length, thickness, pigmentation, the number of lashes or hairs, and misdirected growth of eyelashes. Eyelash changes are usually reversible upon discontinuation of treatment [see Patient Counseling Information (17)].

5.3 Intraocular Inflammation

Latanoprost ophthalmic solution 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 because inflammation may be exacerbated.

5.4 Macular Edema

Macular edema, including cystoid macular edema, has been reported during treatment with Latanoprost ophthalmic solution. Latanoprost ophthalmic solution should be used with caution in aphakic patients, in pseudophakic patients with a torn posterior 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 ophthalmic solution. Latanoprost ophthalmic solution should be used with caution in patients with a history of herpetic keratitis. Latanoprost ophthalmic solution should be avoided in cases of active herpes simplex keratitis because inflammation may be exacerbated.

5.6 Bacterial Keratitis

There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, 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 Latanoprost ophthalmic solution, and may be reinserted 15 minutes after administration.

6 ADVERSE REACTIONS

The following adverse reactions were reported in postmarketing experience and are discussed in greater detail in other sections of the label:

Iris pigmentation changes [see Warnings and Precautions (5.1) ]
Eyelid skin darkening [see Warnings and Precautions (5.1) ]
Eyelash changes (increased length, thickness, pigmentation, and number of lashes) [see Warnings and Precautions (5.2) ]
Intraocular inflammation (iritis/uveitis) [see Warnings and Precautions (5.3) ]
Macular edema, including cystoid macular edema [see Warnings and Precautions (5.4) ]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Latanoprost ophthalmic solution was studied in three multicenter, randomized, controlled clinical trials. Patients received 50 mcg/mL Latanoprost ophthalmic solution once daily or 5 mg/mL active-comparator (timolol) twice daily. The patient population studied had a mean age of 65±10 years. Seven percent of patients withdrew before the 6-month endpoint.

Table 1: Ocular Adverse Reactions and Ocular Signs/Symptoms Reported by 5–15% of Patients Receiving Latanoprost

Symptom/Finding

Adverse Reactions (incidence (%))

Latanoprost

(n=460)

Timolol

(n=369)

Foreign body sensation

13

8

Punctate keratitis

10

9

Stinging

9

12

Conjunctival hyperemia

8

3

Blurred vision

8

8

Itching

8

8

Burning

7

8

Increased pigmentation of the Iris

7

0

Less than 1% of the patients treated with Latanoprost ophthalmic solution required discontinuation of therapy because of intolerance to conjunctival hyperemia.

Table 2: Adverse Reactions That Were Reported in 1–5% of Patients Receiving Latanoprost

Adverse Reactions (incidence (%))

Latanoprost

(n=460)

Timolol

(n=369)

Ocular Events/Signs and Symptoms

Excessive tearing

4

6

Eyelid discomfort/pain

4

2

Dry eye

3

3

Eye pain

3

3

Eyelid margin crusting

3

3

Erythema of the eyelid

3

2

Photophobia

2

1

Eyelid edema

1

3

Systemic Events

Upper respiratory tract infection/nasopharyngitis/influenza

3

3

Myalgia/arthralgia/back pain

1

0.5

Rash/allergic skin reaction

1

0.3

The ocular event/signs and symptoms of blepharitis have been identified as “commonly observed” through analysis of clinical trial data.

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