LACRISERT- hydroxypropyl cellulose insert

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P) (HYDROXYPROPYL CELLULOSE (1600000 WAMW) - UNII:RFW2ET671P)

Available from:

Bausch & Lomb Incorporated

INN (International Name):

HYDROXYPROPYL CELLULOSE - UNII:RFW2ET671P)

Composition:

HYDROXYPROPYL CELLULOSE (TYPE H) 5 mg

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

LACRISERT is indicated in patients with moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. LACRISERT is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions. LACRISERT is also indicated for patients with: LACRISERT is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose. Clinical experience with LACRISERT indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved. Two applicators (one spare) are supplied with each package. Preparing to Insert LACRISERT Before opening the package of LACRISERT, wash your hands thoroughly with soap and water. STEP 1: On a flat surface, open blister pocket slowly and smoothly by peeling back label area. Each blister pocket contains one LACRISERT ophthalmic insert. STEP 2: Open applicator package with label side up. Avoid touching 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 excess water. STEP 3: Hold applicator with tip facing down and with forefinger on top to guide and apply gentle pressure. Lightly press the grooved tip of the applicator onto the LACRISERT ophthalmic insert and it will adhere to the applicator. It is important to follow STEPS 4 and 5 carefully or you might experience difficulty in keeping LACRISERT (hydroxypropyl cellulose ophthalmic insert) in your eye. STEP 4: Look into a mirror. Starting with the right eye, turn your head to the right so that the colored part of the eye is close to your nose. Use your 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. STEP 5: Place the tip of the applicator containing LACRISERT 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. LACRISERT (hydroxypropyl cellulose ophthalmic insert) should remain deep in the lower pocket recess of the eye and not near the edge of the lower eyelid. Repeat procedure with left eye, turning head to the left so that the colored part of the eye is close to your 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. Note that the storage container provides space for a strip of two LACRISERT ophthalmic inserts next to the applicator storage compartment. IMPORTANT If LACRISERT causes worsening of symptoms, or if new symptoms develop, it should be removed and your prescriber contacted. Should the removal of the LACRISERT ophthalmic insert be necessary, follow these instructions. CAUTION: Because this product may produce transient blurring of vision, you should exercise caution when operating hazardous machinery or driving a motor vehicle. Store below 86°F (30°C) Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Renaissance Lakewood, LLC, Lakewood, NJ 08701 USA This Instructions for Use has been approved by the U.S. Food and Drug Administration. LACRISERT is a trademark of Bausch & Lomb Incorporated or its affiliates. © 2019 Bausch & Lomb Incorporated or its affiliates 9421304 Revised: 10/2019

Product summary:

LACRISERT, a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows: NDC 24208-800-60 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. Store below 30°C (86°F).

Authorization status:

New Drug Application

Summary of Product characteristics

LACRISERT- HYDROXYPROPYL CELLULOSE INSERT
BAUSCH & LOMB INCORPORATED
----------
LACRISERT
(HYDROXYPROPYL CELLULOSE OPHTHALMIC INSERT)
STERILE OPHTHALMIC INSERT
5 MG
DESCRIPTION
LACRISERT (hydroxypropyl cellulose ophthalmic insert) is a sterile,
translucent, rod-shaped, water
soluble, ophthalmic insert made of hydroxypropyl cellulose, for
administration into the inferior cul-de-
sac of the eye.
The chemical name for hydroxypropyl cellulose is cellulose,
2-hydroxypropyl ether. It is an ether of
cellulose in which hydroxypropyl groups (-CH CHOHCH ) are attached to
the hydroxyls present in
the anhydroglucose rings of cellulose by ether linkages. A
representative structure of the monomer is:
The molecular weight is typically 1 × 10 .
Hydroxypropyl cellulose is an off-white, odorless, tasteless powder.
It is soluble in water below
38°C, and in many polar organic solvents such as ethanol, propylene
glycol, dioxane, methanol,
isopropyl alcohol (95%), dimethyl sulfoxide, and dimethyl formamide.
Each LACRISERT is 5 mg of hydroxypropyl cellulose. LACRISERT contains
no preservatives or
other ingredients. It is about 1.27 mm in diameter by about 3.5 mm
long.
LACRISERT is supplied in packages of 60 units, together with
illustrated instructions and a special
applicator for removing LACRISERT from the unit dose blister and
inserting it into the eye. A spare
applicator is included in each package.
CLINICAL PHARMACOLOGY
_PHARMACODYNAMICS_
LACRISERT acts to stabilize and thicken the precorneal tear film and
prolong the tear film breakup time
which is usually accelerated in patients with dry eye states.
LACRISERT also acts to lubricate and
protect the eye.
LACRISERT usually reduces the signs and symptoms resulting from
moderate to severe dry eye
syndromes, such as conjunctival hyperemia, corneal and conjunctival
staining with rose bengal,
exudation, itching, burning, foreign body sensation, smarting,
photophobia, dryness and blurred or
cloudy vision. Progressive visual deterioration which occurs in some
patients may be retarded, h