Cromolyn (ophthalmic): Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{KS}}
|genericName=cromolyn sodium
|aOrAn=a
|aOrAn=a
|indicationType=treatment
|indicationType=treatment
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
|fdaLIADAdult======Condition1=====
|fdaLIADAdult===Indications==
* Indicated in the treatment of vernal [[keratoconjunctivitis]], vernal [[conjunctivitis]], and vernal [[keratitis]].


* Dosing Information
==Dosing==
 
:* Dosage
 
=====Condition2=====
 
* Dosing Information
 
:* Dosage


=====Condition3=====
* The dose is 1 – 2 drops in each eye 4 – 6 times a day at regular intervals.


* Dosing Information
* One drop contains approximately 1.6 mg cromolyn sodium.


:* Dosage
* Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.


=====Condition4=====
* Symptomatic response to therapy (decreased [[itching]], [[tearing]], [[redness]], and [[discharge]]) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.


* Dosing Information
* If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.
 
:* Dosage
 
<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
|offLabelAdultGuideSupport======Condition1=====


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<!--Brand Names-->
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
|brandNames=* CROMOLYN SODIUM®<ref>{{Cite web | title =cromolyn sodium solution/ drops|url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5d8ed6be-ecc9-4e26-b6c1-4eaef46c0fa7 }}</ref>
 


<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>


<!--Drug Shortage Status-->
 
|drugShortage=
|drugShortage=
}}
}}

Revision as of 17:26, 5 May 2015

Cromolyn (ophthalmic)
Black Box Warning
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: Kiran Singh, M.D. [2]

Disclaimer

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Cromolyn (ophthalmic) is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosing

  • The dose is 1 – 2 drops in each eye 4 – 6 times a day at regular intervals.
  • One drop contains approximately 1.6 mg cromolyn sodium.
  • Patients should be advised that the effect of cromolyn sodium ophthalmic solution therapy is dependent upon its administration at regular intervals, as directed.
  • Symptomatic response to therapy (decreased itching, tearing, redness, and discharge) is usually evident within a few days, but longer treatment for up to six weeks is sometimes required. Once symptomatic improvement has been established, therapy should be continued for as long as needed to sustain improvement.
  • If required, corticosteroids may be used concomitantly with cromolyn sodium ophthalmic solution.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cromolyn (ophthalmic) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cromolyn (ophthalmic) in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding FDA-Labeled Use of Cromolyn (ophthalmic) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Cromolyn (ophthalmic) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Cromolyn (ophthalmic) in pediatric patients.

Contraindications

  • Condition1

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Cromolyn (ophthalmic) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Cromolyn (ophthalmic) in the drug label.

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Pregnancy Category


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Cromolyn (ophthalmic) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Cromolyn (ophthalmic) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Cromolyn (ophthalmic) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Cromolyn (ophthalmic) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Cromolyn (ophthalmic) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Cromolyn (ophthalmic) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Cromolyn (ophthalmic) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Cromolyn (ophthalmic) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Cromolyn (ophthalmic) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Cromolyn (ophthalmic) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Cromolyn (ophthalmic) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Cromolyn (ophthalmic) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Cromolyn (ophthalmic) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Cromolyn (ophthalmic) in the drug label.

Pharmacology

There is limited information regarding Cromolyn (ophthalmic) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Cromolyn (ophthalmic)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Cromolyn (ophthalmic) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Cromolyn (ophthalmic) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Cromolyn (ophthalmic) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Cromolyn (ophthalmic) in the drug label.

How Supplied

Storage

There is limited information regarding Cromolyn (ophthalmic) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Cromolyn (ophthalmic) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Cromolyn (ophthalmic) in the drug label.

Precautions with Alcohol

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

Brand Names

  • CROMOLYN SODIUM®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ "cromolyn sodium solution/ drops".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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