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hydroxypropyl cellulose
Overview
What is Lacrisert?
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 (-CHCHOHCH) 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.
What does Lacrisert look like?
What are the available doses of Lacrisert?
Sorry No records found.
What should I talk to my health care provider before I take Lacrisert?
Sorry No records found
How should I use Lacrisert?
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 keratitisDecreased corneal sensitivityRecurrent corneal erosions
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 maybe 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.
What interacts with Lacrisert?
LACRISERT is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.
What are the warnings of Lacrisert?
Carboplatin injection may cause fetal harm when administered to a pregnant woman. Carboplatin has been shown to be embryotoxic and teratogenic in rats. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.
What are the precautions of Lacrisert?
General
If improperly placed, LACRISERT may result in corneal abrasion (see ).
Information for Patients
Patients should be advised to follow the instructions for using LACRISERT 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.
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.
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.
What are the side effects of Lacrisert?
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 )Ocular discomfort or irritationMatting or stickiness of eyelashesPhotophobiaHypersensitivityEdema of the eyelidsHyperemia
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
What should I look out for while using Lacrisert?
LACRISERT is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.
Instructions for inserting and removing LACRISERT should be carefully followed.
What might happen if I take too much Lacrisert?
Sorry No Records found
How should I store and handle Lacrisert?
Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. Carboplatin injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation.Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. Carboplatin injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation.Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. Carboplatin injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation.Unopened vials of carboplatin injection are stable to the date indicated on the package when stored at 25°C (77°F); excursions permitted from 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].PROTECT FROM LIGHT. Carboplatin injection multidose vials maintain microbial, chemical, and physical stability for up to 14 days at 25°C following multiple needle entries.Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Solutions for infusion should be discarded 8 hours after preparation.LACRISERT, a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows:NDCLACRISERT, a sterile, translucent, rod-shaped, water-soluble, ophthalmic insert made of hydroxypropyl cellulose, 5 mg, is supplied as follows:NDC
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
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, halted, or sometimes reversed.
In a multicenter crossover study the 5 mg LACRISERT administered once a day during the waking hours was compared to artificial tears used four or more times daily. There was a prolongation of tear film breakup time and a decrease in foreign body sensation associated with dry eye syndrome in patients during treatment with inserts as compared to artificial tears; these findings were statistically significantly different between the treatment groups. Improvement, as measured by amelioration of symptoms, by slit lamp examination and by rose bengal staining of the cornea and conjunctiva, was greater in most patients with moderate to severe symptoms during treatment with LACRISERT. Patient comfort was usually better with LACRISERT than with artificial tears solution, and most patients preferred LACRISERT.
In most patients treated with LACRISERT for over one year, improvement was observed as evidenced by amelioration of symptoms generally associated with keratoconjunctivitis sicca such as burning, tearing, foreign body sensation, itching, photophobia and blurred or cloudy vision.
During studies in healthy volunteers, a thickened precorneal tear film was usually observed through the slit-lamp while LACRISERT was present in the conjunctival sac.
Non-Clinical Toxicology
LACRISERT is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.Instructions for inserting and removing LACRISERT should be carefully followed.
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.
If improperly placed, LACRISERT may result in corneal abrasion (see ).
Information for Patients
Patients should be advised to follow the instructions for using LACRISERT 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.
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 )Ocular discomfort or irritationMatting or stickiness of eyelashesPhotophobiaHypersensitivityEdema of the eyelidsHyperemia
To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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