Nedocromil

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Nedocromil
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: Adeel Jamil, M.D. [2]

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Overview

Nedocromil is a mast cell stabilizer, ophthalmologic agent that is FDA approved for the treatment of allergic conjunctivitis. Common adverse reactions include headache, ocular burning, irritation and stinging, unpleasant taste, nasal congestion, conjunctivitis, eye redness, photophobia, and rhinitis..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

  • ALOCRIL® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.

Dosing Information

  • The recommended dosage is one or two drops in each eye twice a day. ALOCRIL® ophthalmic solution should be used at regular intervals.
  • Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

  • ALOCRIL® ophthalmic solution is indicated for Allergic conjunctivitis age 3 yr and older.

Dosing Information

  • 1 to 2 drops in each eye twice daily

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • ALOCRIL® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

Warnings

There is limited information regarding Warnings of Nedocromil in the drug label.

Adverse Reactions

Clinical Trials Experience

  • The most frequently reported adverse experience was headache (~40%).
  • Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.
  • Some of these events were similar to the underlying ocular disease being studied.

Postmarketing Experience

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

Drug Interactions

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

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): B

  • Reproduction studies performed in mice, rats and rabbits using a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum human daily ocular dose on a mg/kg basis) revealed no evidence of teratogenicity or harm to the fetus due to nedocromil sodium. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, ALOCRIL® ophthalmic solution should be used during pregnancy only if clearly needed.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

  • After intravenous administration to lactating rats, nedocromil was excreted in milk. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ALOCRIL® ophthalmic solution is administered to a nursing woman.

Pediatric Use

  • Safety and effectiveness in children below the age of 3 years 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 Nedocromil with respect to specific gender populations.

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Ophthalmic solution

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

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

Pharmacology

Nedocromil.png
Nedocromil
Systematic (IUPAC) name
9-ethyl-4,6-dioxo-10-propyl-6,9-dihydro-4H-pyrano[3,2-g]quinoline-2,8-dicarboxylic acid
Identifiers
CAS number 69049-73-6
ATC code R01AC07 R03BC03, S01GX04
PubChem 50294
DrugBank DB00716
Chemical data
Formula C19H17NO7 
Mol. mass 371.341 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability  ?
Protein binding 89%
Metabolism not metabolized
Half life ~3.3 hours
Excretion excreted unchanged
Therapeutic considerations
Pregnancy cat.

?

Legal status

POM(UK) -only(US)

Routes Inhalation and eye drops

Mechanism of Action

  • Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.
  • In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.

Structure

  • ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.
  • Nedocromil sodium is represented by the following structural formula:
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

  • Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).

Nonclinical Toxicology

  • A two-year inhalation carcinogenicity study of nedocromil sodium at a dose of 24 mg/kg/day (approximately 400 times the maximum recommended human daily ocular dose on a mg/kg basis) in Wistar rats showed no carcinogenic potential.
  • Nedocromil sodium showed no mutagenic potential in the Ames Salmonella/microsome plate assay, mitotic gene conversion in Saccharomyces cerevisiae, mouse lymphoma forward mutation and mouse micronucleus assays.
  • Reproduction and fertility studies in mice and rats showed no effects on male and female fertility at a subcutaneous dose of 100 mg/kg/day (more than 1600 times the maximum recommended human daily ocular dose).

Clinical Studies

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

How Supplied

ALOCRIL® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:

5 mL in 10 mL bottle NDC 0023-8842-05

Rx only

Revised: 12/2012

© 2013 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. Made in the U.S.A.

71761US12

Storage

  • Storage: Store at 2º–25º C (36º–77º F).

Images

Drug Images

Package and Label Display Panel

PRINCIPAL DISPLAY PANEL

NDC 0023-8842-05

Alocril® (nedocromil sodium

ophthalmic solution) 2%

STERILE

For topical application in the eye

5 mL

ALLERGAN

This image is provided by the National Library of Medicine.

Patient Counseling Information

  • Patients should be advised to follow the patient instructions listed on the Information for Patients sheet.
  • Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.
  • Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

Precautions with Alcohol

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

Brand Names

  • Alocril®

Look-Alike Drug Names

There is limited information regarding Nedocromil 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.


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