Lacrisert (Ophthalmic)

LACRISERT (cellulose) , a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows:

NDC 25010-805-68 in packages containing 60 unit doses (each wrapped in an aluminum blister), two reusable applicators, and a plastic storage container to store the applicators after use.

Storage

Store below 30°C (86°F).

Distributed by: ATON PHARMA, INC. Lawrenceville, NJ 08648, USA. Manufactured by: Merck and Co., Inc. West Point, PA 19486 USA. Issued June 2007. FDA rev date: 2/21/2008

LACRISERT (cellulose) is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT (cellulose) is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions.

LACRISERT (cellulose) is also indicated for patients with:

Exposure keratitis
Decreased corneal sensitivity
Recurrent corneal erosions

One LACRISERT (cellulose) ophthalmic insert in each eye once daily is usually sufficient to relieve the symptoms associated with moderate to severe dry eye syndromes. Individual patients may require more flexibility in the use of LACRISERT (cellulose) ; some patients may require twice daily use for optimal results.

Clinical experience with LACRISERT (cellulose) indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.

LACRISERT (cellulose) is inserted into the inferior cul-de-sac of the eye beneath the base of the tarsus, not in apposition to the cornea, nor beneath the eyelid at the level of the tarsal plate. If not properly positioned, it will be expelled into the interpalpebral fissure, and may cause symptoms of a foreign body. Illustrated instructions are included in each package. While in the licensed practitioner's office, the patient should read the instructions, then practice insertion and removal of LACRISERT (cellulose) until proficiency is achieved.

NOTE: Occasionally LACRISERT (cellulose) is inadvertently expelled from the eye, especially in patients with shallow conjunctival fornices. The patient should be cautioned against rubbing the eye(s) containing LACRISERT (cellulose) , especially upon awakening, so as not to dislodge or expel the insert. If required, another LACRISERT (cellulose) ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove LACRISERT (cellulose) a few hours after insertion to avoid this. Another LACRISERT (cellulose) ophthalmic insert maybe inserted if needed.

If LACRISERT (cellulose) causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain LACRISERT (cellulose) is in the proper location, deep in the inferior cul-de-sac of the eye beneath the base of the tarsus. If these symptoms persist, LACRISERT (cellulose) should be removed and the patient should contact the practitioner.

LACRISERT (cellulose) is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.

WARNINGS

Instructions for inserting and removing LACRISERT (cellulose) should be carefully followed.

PRECAUTIONS

General

If improperly placed, LACRISERT (cellulose) may result in corneal abrasion (see DOSAGE AND ADMINISTRATION).

Information for Patients

Patients should be advised to follow the instructions for using LACRISERT (cellulose) which accompany the package.

Because this product may produce transient blurring of vision, patients should be instructed to exercise caution when operating hazardous machinery or driving a motor vehicle.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Feeding of hydroxypropyl cellulose to rats at levels up to 5% of their diet produced no gross or histopathologic changes or other deleterious effects.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

SIDE EFFECTS

The following adverse reactions have been reported in patients treated with LACRISERT (cellulose) , but were in most instances mild and transient:

Transient blurring of vision (See PRECAUTIONS)
 Ocular discomfort or irritation
 Matting or stickiness of eyelashes
 Photophobia
 Hypersensitivity
 Edema of the eyelids
 Hyperemia

DRUG INTERACTIONS

Application of hydroxypropyl cellulose ophthalmic inserts to the eyes of unanesthetized rabbits immediately prior to or two hours before instilling pilocarpine, proparacaine HCl (0.5%), or phenylephrine (5%) did not markedly alter the magnitude and/or duration of the miotic, local corneal anesthetic, or mydriatic activity, respectively, of these agents. Under various treatment schedules, the anti-inflammatory effect of ocularly instilled dexamethasone (0.1%) in unanesthetized rabbits with primary uveitis was not affected by the presence of hydroxypropyl cellulose inserts.

The following adverse reactions have been reported in patients treated with LACRISERT (cellulose) , but were in most instances mild and transient:

Transient blurring of vision (See PRECAUTIONS)
 Ocular discomfort or irritation
 Matting or stickiness of eyelashes
 Photophobia
 Hypersensitivity
 Edema of the eyelids
 Hyperemia

No information provided.