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'''Hypromellose''', short for '''hydroxypropyl methylcellulose''' (HPMC), is a semisynthetic, inert, viscoelastic [[polymer]] used as an ophthalmic lubricant, as well as an [[excipient]] and controlled-delivery component in oral medicaments, found in a variety of commercial products.<ref>de Silva ''et al'', "[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16052145&query_hl=8&itool=pubmed_docsum  Hydroxypropyl methylcellulose (HPMC) lubricant facilitates insertion of porous spherical orbital implants.]" ''Ophthal Plast Reconstr Surg''. 2005 Jul;21(4):301-2.</ref><ref>Williams ''et al'', "[http://www.aapspharmscitech.org/view.asp?art=pt020208 Method to Recover a Lipophilic Drug From Hydroxypropyl Methylcellulose Matrix Tablets.]" ''AAPS PharmSciTech''. 2001; 2(2): article 8.</ref>
{{DrugProjectFormSinglePage
|authorTag={{RB}}
==Opthalmic applications==
|OTC=Yes
Hypromellose solutions were patented as a semisynthetic substitute for tear-film.<ref>[http://patft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=5,679,713.PN.&OS=PN/5,679,713&RS=PN/5,679,713 US Pat. No. 5,679,713]</ref> Its molecular structure is predicated upon a base celluloid compound that is highly water soluble. Post-application, celluloid attributes of good water solubility reportedly aids in visual clarity. When applied, a hypromellose solution acts to swell and absorb water, thereby expanding the thickness of the tear-film. Hypromellose augmentation therefore results in extended lubricant time presence on the cornea, which theoretically results in decreased eye irritation, especially in dry climates, home, or work environments.<ref>Koroloff ''et al'', "[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=15014864&query_hl=8&itool=pubmed_docsum A randomised controlled study of the efficacy of hypromellose and Lacri-Lube combination versus polyethylene/Cling wrap to prevent corneal epithelial breakdown in the semiconscious intensive care patient]", ''Intensive Care Med''. 2004 Jun;30(6):1122-6. Epub 2004 Mar 10.</ref> On a molecular level, this polymer contains beta-linked D-glucose units that remain metabolically intact for days to weeks. On a manufacturing note, since hypromellose is a vegetarian substitute for gelatin, it is slightly more expensive to produce due to semisynthetic manufacturing processes. Aside from its widespread commercial and retail availability [[Over-the-counter drugs|over the counter]] in a variety of products, Hypromellose 2% solution has been documented to be used during surgery to aid in corneal protection and during orbital surgery.
|genericName=Hypromellose
|aOrAn=a
|drugClass=ophthalmic solution
|indicationType=treatment
|indication=[[dryness of the eye]] and prevent further irritation
|adverseReactions=[[eye pain]], [[changes in vision]]
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult=*Relieves [[dryness of the eye]].
*Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun.
*As a protectant against further irritation.
====Dosage====
*Put 1 or 2 drops in the affected eye(s) as needed.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


==Excipient/Tableting ingredient==
<!--Pediatric Indications and Dosage-->
In addition to its use in opthalmic liquids, hypromellose has been used as an ingredient in oral tablet and capsule formulations, where it functions to delay the release of a medicinal compound into the digestive tract.


==References==
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<references/>
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


[[Category:Excipients]]
 
[[da:Hydroxypropylmethylcellulose]]
 
[[de:Hydroxypropylmethylzellulose]]
<!--Guideline-Supported Use (Pediatric)-->
[[nl:Hydroxypropylmethylcellulose]]
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
{{WikiDoc Sources}}
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|warnings=* For external use only.
* Do not use if sealed bottle tip is broken or punctured.
* If solution changes color or becomes cloudy, do not use.
====When using this product====
* To avoid contamination, do not touch tip of container to any surface.
* Replace cap after using.
====Stop use and ask a physician====
* If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.
 
 
<!--Adverse Reactions-->
 
<!--Clinical Trials Experience-->
|clinicalTrials=* [[eye pain]]
* [[changes in vision]]
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|useInPregnancyAUS=There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Ophthalmic solution
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|overdose=There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacology-->
 
<!--Drug box 2-->
|drugBox={{Chembox2
| verifiedrevid = 451585076
| ImageFile = Hypromellose Wiki Structure.png
| ImageSize = 200px
| IUPACName =
| OtherNames = Hydroxypropyl methylcellulose; hydroxypropyl methyl cellulose; HPMC; E464
| Section1 = {{Chembox Identifiers
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 21241863
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 36SFW2JZ0W
| InChI = 1/C36H70O19.C20H38O11/c1-19(37)9-45-17-27-29(47-11-21(3)39)31(48-12-22(4)40)34(51-15-25(7)43)36(54-27)55-30-28(18-46-10-20(2)38)53-35(52-16-26(8)44)33(50-14-24(6)42)32(30)49-13-23(5)41;1-21-9-11-13(23-3)15(24-4)18(27-7)20(30-11)31-14-12(10-22-2)29-19(28-8)17(26-6)16(14)25-5/h19-44H,9-18H2,1-8H3;11-20H,9-10H2,1-8H3/t19?,20?,21?,22?,23?,24?,25?,26?,27-,28-,29-,30-,31+,32+,33-,34-,35-,36+;11-,12-,13-,14-,15+,16+,17-,18-,19-,20+/m11/s1
| InChIKey = PUSNGFYSTWMJSK-GSZQVNRLBE
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C36H70O19.C20H38O11/c1-19(37)9-45-17-27-29(47-11-21(3)39)31(48-12-22(4)40)34(51-15-25(7)43)36(54-27)55-30-28(18-46-10-20(2)38)53-35(52-16-26(8)44)33(50-14-24(6)42)32(30)49-13-23(5)41;1-21-9-11-13(23-3)15(24-4)18(27-7)20(30-11)31-14-12(10-22-2)29-19(28-8)17(26-6)16(14)25-5/h19-44H,9-18H2,1-8H3;11-20H,9-10H2,1-8H3/t19?,20?,21?,22?,23?,24?,25?,26?,27-,28-,29-,30-,31+,32+,33-,34-,35-,36+;11-,12-,13-,14-,15+,16+,17-,18-,19-,20+/m11/s1
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = PUSNGFYSTWMJSK-GSZQVNRLSA-N
| CASNo_Ref = {{cascite|correct|CAS}}
| CASNo = 9004-65-3
| PubChem =
| ATCCode_prefix = S01
| ATCCode_suffix = KA02
| SMILES = }}
| Section2 = {{Chembox Properties
| Formula = variable
| MolarMass = variable
| Appearance =
| Density =
| MeltingPt =
| BoilingPt =
| Solubility = }}
| Section3 = {{Chembox Hazards
| MainHazards =
| FlashPt =
| Autoignition = }}
}}
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
 
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
 
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 
<!--How Supplied-->
|storage=* Store at room temperature 15°-30°C (59°-86°F).
* Do not freeze.
* Keep box for complete information.
|packLabel=====Principal display panel====
: [[File:Hypromellose Principal Display panel.png|none|600px]]
====Ingredients and Appearance====
: [[File:Hypromellose Ingredients and Appearance.png|none|600px]]
|fdaPatientInfo=* When using this product do not touch tip of container to any surface. Replace cap after using.
* Stop use and ask a doctor if you experience any of the following:
:* eye pain
:* changes in vision
:* continued redness or irritation of the eye
:* condition worsens or persists for more than 72 hours
* If swallowed, get medical help or contact a Poison Control Center right away.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
<!--Brand Names-->
|brandNames=* GenTeal®<ref>{{Cite web | title = Hypromellose | url = http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=3c4ea323-2407-4f9d-b44f-eebf127924ba }}</ref>
|drugShortage=
}}
<!--Pill Image-->
 
 
 
<!--Label Display Image-->
 
 
 
 
 
<!--Category-->
 
[[Category:Drug]]

Latest revision as of 15:28, 24 February 2015

Hypromellose
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: Rabin Bista, M.B.B.S. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Overview

Hypromellose is a ophthalmic solution that is FDA approved for the treatment of dryness of the eye and prevent further irritation. Common adverse reactions include eye pain, changes in vision.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • Relieves dryness of the eye.
  • Temporarily relieves discomfort due to minor irritations of the eye or from exposure to wind and sun.
  • As a protectant against further irritation.

Dosage

  • Put 1 or 2 drops in the affected eye(s) as needed.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Hypromellose in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Hypromellose Contraindications in the drug label.

Warnings

  • For external use only.
  • Do not use if sealed bottle tip is broken or punctured.
  • If solution changes color or becomes cloudy, do not use.

When using this product

  • To avoid contamination, do not touch tip of container to any surface.
  • Replace cap after using.

Stop use and ask a physician

  • If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours, discontinue use and consult a doctor.

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Hypromellose in the drug label.

Drug Interactions

There is limited information regarding Hypromellose Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

There is no FDA guidance on the use of Hypromellose with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Hypromellose with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Hypromellose with respect to geriatric patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Ophthalmic solution

Monitoring

There is limited information regarding Monitoring of Hypromellose in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Hypromellose in the drug label.

Overdosage

There is limited information regarding Chronic Overdose of Hypromellose in the drug label.

Pharmacology

Template:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox entryTemplate:Chembox E numberTemplate:Chembox Supplement
Template:Chembox header2 | Hypromellose
Identifiers
ChemSpider
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).
UNII
Properties
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 Hypromellose Mechanism of Action in the drug label.

Structure

There is limited information regarding Hypromellose Structure in the drug label.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Hypromellose in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Hypromellose in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Hypromellose in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Hypromellose in the drug label.

How Supplied

There is limited information regarding Hypromellose How Supplied in the drug label.

Storage

  • Store at room temperature 15°-30°C (59°-86°F).
  • Do not freeze.
  • Keep box for complete information.

Images

Drug Images

{{#ask: Page Name::Hypromellose |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

Principal display panel

Ingredients and Appearance

{{#ask: Label Page::Hypromellose |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

  • When using this product do not touch tip of container to any surface. Replace cap after using.
  • Stop use and ask a doctor if you experience any of the following:
  • eye pain
  • changes in vision
  • continued redness or irritation of the eye
  • condition worsens or persists for more than 72 hours
  • If swallowed, get medical help or contact a Poison Control Center right away.

Precautions with Alcohol

  • Alcohol-Hypromellose interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

Look-Alike Drug Names

There is limited information regarding Hypromellose Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "Hypromellose".
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