Hydroxypropyl cellulose

Hydroxypropyl cellulose
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Turky Alkathery, M.D. [2]

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Overview

Hydroxypropyl cellulose is a derivative of cellulose that is FDA approved for the treatment of moderate to severe dry eye syndromes, including keratoconjunctivitis sicca. Hydroxypropyl cellulose is indicated especially in patients who remain symptomatic after an adequate trial of therapy with artificial tear solutions.. Common adverse reactions include transient blurring of vision , ocular discomfort or irritation, matting or stickiness of eyelashes Photophobia, hypersensitivity, edema of the eyelids and hyperemia.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

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

Hydroxypropyl cellulose is also indicated for patients with:

Exposure keratitis.
Decreased corneal sensitivity.
Recurrent corneal erosions.

Dosage

One hydroxypropyl 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 hydroxypropyl cellulose; some patients may require twice daily use for optimal results.

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

Hydroxypropyl 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 hydroxypropyl cellulose until proficiency is achieved.

NOTE: Occasionally hydroxypropyl 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 hydroxypropyl cellulose, especially upon awakening, so as not to dislodge or expel the insert. If required, another hydroxypropyl cellulose ophthalmic insert may be inserted. If experience indicates that transient blurred vision develops in an individual patient, the patient may want to remove hydroxypropyl cellulose a few hours after insertion to avoid this. Another hydroxypropyl cellulose ophthalmic insert maybe inserted if needed.

If hydroxypropyl cellulose causes worsening of symptoms, the patient should be instructed to inspect the conjunctival sac to make certain hydroxypropyl 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, hydroxypropyl cellulose should be removed and the patient should contact the practitioner.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxypropyl cellulose in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxypropyl cellulose in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Safety and effectiveness in pediatric patients have not been established.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Hydroxypropyl cellulose in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Hydroxypropyl cellulose in pediatric patients.

Contraindications

hydroxypropyl cellulose is contraindicated in patients who are hypersensitive to hydroxypropyl cellulose.

Warnings

Instructions for inserting and removing hydroxypropyl cellulose should be carefully followed.

Precautions

General

If improperly placed, hydroxypropyl cellulose may result in corneal abrasion.

Information for Patients

Patients should be advised to follow the instructions for using hydroxypropyl 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.

Adverse Reactions

Clinical Trials Experience

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

Transient blurring of vision.
Ocular discomfort or irritation.
Matting or stickiness of eyelashes.
Photophobia.
Hypersensitivity.
Edema of the eyelids.
Hyperemia.

Postmarketing Experience

There is limited information regarding Postmarketing Experience.

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.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Hydroxypropyl cellulose in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Hydroxypropyl cellulose in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Hydroxypropyl cellulose during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Hydroxypropyl cellulose in women who are nursing.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatic Use

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

Gender

There is no FDA guidance on the use of Hydroxypropyl cellulose with respect to specific gender populations.

Race

There is no FDA guidance on the use of Hydroxypropyl cellulose with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Hydroxypropyl cellulose in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Hydroxypropyl cellulose in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Hydroxypropyl cellulose in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Hydroxypropyl cellulose in patients who are immunocompromised.

Administration and Monitoring

Administration

Ophthalmic.

Monitoring

There is limited information regarding drug monitoring.

IV Compatibility

There is limited information regarding IV compatibility.

Overdosage

There is limited information regarding drug overdose.

Pharmacology

Template:Chembox header2 \| Hydroxypropyl cellulose
Identifiers
CAS Number	9004-64-2^Y
ChEMBL	ChEMBL1201471^N
ChemSpider	NA^Y
DrugBank	DB00840^Y
ECHA InfoCard	Lua error in Module:Wikidata at line 879: attempt to index field 'wikibase' (a nil value). Lua error in Module:Wikidata at line 879: attempt to index field 'wikibase' (a nil value).
Properties
Chemical formula	variable
Molar mass	variable
Template:Chembox header2 \| Except where noted otherwise, data are given for materials in their standard state (at 25 °C, 100 kPa) Infobox disclaimer and references

Mechanism of Action

There is limited information regarding Hydroxypropyl cellulose Mechanism of Action in the drug label.

Structure

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 (-CH2CHOHCH3) are attached to the hydroxyls present in the anhydroglucose rings of cellulose by ether linkages. A representative structure of the monomer is:

This image is provided by the National Library of Medicine.

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 hydroxypropyl cellulose is 5 mg of hydroxypropyl cellulose. hydroxypropyl cellulose contains no preservatives or other ingredients. It is about 1.27 mm in diameter by about 3.5 mm long.

Hydroxypropyl cellulose is supplied in packages of 60 units, together with illustrated instructions and a special applicator for removing hydroxypropyl cellulose from the unit dose blister and inserting it into the eye. A spare applicator is included in each package.

Pharmacodynamics

Hydroxypropyl cellulose 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. hydroxypropyl cellulose also acts to lubricate and protect the eye.

Hydroxypropyl cellulose 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 hydroxypropyl cellulose 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 hydroxypropyl cellulose. Patient comfort was usually better with hydroxypropyl cellulose than with artificial tears solution, and most patients preferred hydroxypropyl cellulose.

In most patients treated with hydroxypropyl cellulose 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 hydroxypropyl cellulose was present in the conjunctival sac.

Pharmacokinetics

Hydroxypropyl cellulose is a physiologically inert substance. In a study of rats fed hydroxypropyl cellulose or unmodified cellulose at levels up to 5% of their diet, it was found that the two were biologically equivalent in that neither was metabolized.

Studies conducted in rats fed 14C-labeled hydroxypropyl cellulose demonstrated that when orally administered, hydroxypropyl cellulose is not absorbed from the gastrointestinal tract and is quantitatively excreted in the feces.

Dissolution studies in rabbits showed that hydroxypropyl cellulose inserts became softer within 1 hour after they were placed in the conjunctival sac. Most of the inserts dissolved completely in 14 to 18 hours; with a single exception, all had disappeared by 24 hours after insertion. Similar dissolution of the inserts was observed during prolonged administration (up to 54 weeks).

Nonclinical Toxicology

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.

Clinical Studies

There is limited information regarding Clinical Studies.

How Supplied

LACRISERT, 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).

Images

Drug Images

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