Lacrisert

Artificial Tears and Ocular Lubricants

Upon initial use, the health care provider should demonstrate the proper placement of the insert to the patient. While in the health care provider's office, the patient should carefully read the instructions, and then practice placement and removal of the insert until proficiency is achieved. Improper placement can result in corneal abrasion.
Before opening the package, wash your hands thoroughly with soap and water.
On a flat surface, open the blister pocket slowly and smoothly by peeling back the label area.
Open the applicator package with the label side up. Avoid touching the grooved tip of the applicator. Pick up applicator by the wide end and rinse the tip thoroughly under hot running tap water. Gently shake off any excess water.
Hold the applicator with the tip facing down and the forefinger on the top to guide and apply gentle pressure. Lightly press the grooved tip of the applicator onto the insert to have it adhere to the applicator.
Instruct the patient to look into a mirror. Starting with the right eye, have the patient turn their head to the right so that the colored part of the eye is close to their nose. Then, have the patient use their free hand to grasp the lower lid between the thumb and index finger. Pull the lid away from the eyeball and create a pocket between the white part of the eyeball and the lid.
Place the tip of the applicator containing the insert into the pocket. Avoid touching the colored part of the eye. Remove the applicator. It is important, after removing the applicator, to look down, then release the lower eyelid. The insert should remain deep in the lower pocket recess of the eye and not near the edge of the lower eyelid.
Repeat procedure with the left eye, instructing the patient to turn their head to the left so that the colored part of the eye is close to their nose.
Rinse the applicator thoroughly under hot running tap water after use. Gently shake off visible water droplets and promptly return it to the storage container.
Instruct patients to not rub their eyes, especially upon awakening, so as not to dislodge or expel the insert. If an insert is expelled, another insert may be administered if needed.
Because this product may cause transient blurred vision, instruct patients to use caution when operating hazardous machinery or driving a motor vehicle.
If the insert causes worsening of symptoms, or if new symptoms develop, instruct the patient to remove the insert and to contact their health care provider.
Should removal of the ophthalmic insert be necessary, instruct patient to follow these instructions: 1. Locate the insert by pulling the lid away from the eyeball while looking for the insert in a mirror. 2. Then close the eyelids. 3. When located, move the insert upward with their fingers through the closed eyelids. 4. Keep the lids against the eyeball and the insert should slip over the lid margin so that it can be removed with a clean facial tissue without touching the colored part of the eye.

edema / Delayed / Incidence not known
hyperemia / Delayed / Incidence not known
blurred vision / Early / Incidence not known
photophobia / Early / Incidence not known

ocular irritation / Rapid / Incidence not known

Lacrisert

Rx

Ophthalmic insert that acts to stabilize and thicken the precorneal tear film and prolong tear film breakup time
Used to reduce signs and symptoms resulting from moderate to severe dry eye syndromes
May produce transient blurring of vision; exercise caution when operating heavy machinery or driving

One 5 mg insert in each eye once daily. If needed, the dosing frequency may be increased to twice-daily in order to obtain optimal results. In some cases, several weeks may be required before clinical benefit is achieved.

Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

There are no drug interactions associated with Hydroxypropyl Cellulose products.

Lacrisert Ophthalmic Insert: 5mg

2 inserts per eye per day.

2 inserts per eye per day.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Safety and efficacy have not been established.

Hydroxypropyl cellulose helps to relieve moderate to severe dry eye syndromes by stabilizing and thickening the precorneal tear film and prolonging tear film breakup time. Hydroxypropyl cellulose also lubricates and protects the eyes.

Hydroxypropyl cellulose is administered ophthalmically. It is a physiologically inert substance available as an insert for administration into the inferior cul-de-sac of the eye. When fed orally to rats, hydroxypropyl cellulose was not metabolized and was excreted into the feces.

When orally administered to rats, hydroxypropyl cellulose was found not to be absorbed from the gastrointestinal tract.

Ophthalmic Route
Dissolution studies in rabbits showed the hydroxypropyl cellulose inserts becoming softer within 1 hour of being placed in the conjunctival sac. In most cases, the inserts completely dissolved within 14 to 18 hours; in all cases, the inserts had disappeared by 24 hours after placement. Dissolution was similar with prolonged use of the inserts up to 54 weeks.

There are no data regarding the use of hydroxypropyl cellulose ophthalmic inserts during pregnancy to assess the drug-associated risk for birth defects, miscarriages, or adverse maternal or fetal outcomes. Before administering the drug to pregnant women, consider the potential benefits of treatment against the possible risks to the mother and fetus.

It is not known whether hydroxypropyl cellulose is excreted in human milk. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally administered drug, health care providers are encouraged to report the adverse effect to the FDA.