Brand Name
Lacrisert
Generic Name
Hydroxypropyl
View Brand Information FDA approval date: June 01, 1981
Classification: Demulcent
Form: Insert
What is Lacrisert (Hydroxypropyl)?
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: Exposure keratitis Decreased corneal sensitivity Recurrent corneal erosions.
Approved To Treat
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Brand Information
Lacrisert (hydroxypropyl cellulose)
1DESCRIPTION
LACRISERT
The chemical name for hydroxypropyl cellulose is cellulose, 2-hydroxypropyl ether. It is an ether of cellulose in which hydroxypropyl groups (-CH
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.
2INDICATIONS AND USAGE
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:
- Exposure keratitis
3CONTRAINDICATIONS
LACRISERT is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.
4WARNINGS
Instructions for inserting and removing LACRISERT should be carefully followed.
5ADVERSE REACTIONS
The following adverse reactions have been reported in patients treated with LACRISERT, 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
To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6DOSAGE AND ADMINISTRATION
One LACRISERT 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; some patients may require twice daily use for optimal results.
Clinical experience with LACRISERT indicates that in some patients several weeks may be required before satisfactory improvement of symptoms is achieved.
LACRISERT 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 until proficiency is achieved.
NOTE: Occasionally LACRISERT 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, especially upon awakening, so as not to dislodge or expel the insert. If required, another LACRISERT ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove LACRISERT a few hours after insertion to avoid this. Another LACRISERT ophthalmic insert may be inserted if needed.
If LACRISERT causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain LACRISERT 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 should be removed and the patient should contact the practitioner.
7HOW SUPPLIED
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.
7.1Storage
Store below 30°C (86°F).
8PRINCIPAL DISPLAY PANEL - 5 mg Carton of 60
NDC24208-800-60
Rx only
LACRISERT
(hydroxypropyl cellulose
ophthalmic insert)
(hydroxypropyl cellulose
ophthalmic insert)
5 mg
FOR OPHTHALMIC USE ONLY
Carton also contains two sterile
applicators and a storage container.
applicators and a storage container.
CONTAINS NO PRESERVATIVE
60 STERILE OPHTHALMIC INSERTS
60 STERILE OPHTHALMIC INSERTS
BAUSCH + LOMB
9421104
9421104
