Cromolyn (nasal)

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Cromolyn (nasal)
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]

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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

Cromolyn (nasal) is a mast cell stabilizer that is FDA approved for the treatment of nasal symptoms due to hay fever and nasal allergies. Common adverse reactions include stinging, nosebleeds, and sores in the nose.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • To prevent and relieve nasal symptoms of hay fever and other nasal allergies:

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

There is limited information regarding Contraindications of Cromolyn (nasal) in pediatric patients.

Warnings

Do not use

  • If you are allergic to any of the ingredients

Ask a doctor before use if you have

  • Fever
  • Discolored nasal discharge
  • Sinus pain
  • Wheezing

When using this product

  • It may take several days of use to notice an effect. Your best effect may not be seen for 1 to 2 weeks.
  • Brief stinging or sneezing may occur right after use
  • Do not use it to treat sinus infection, asthma, or cold symptoms
  • Do not share this bottle with anyone else as this may spread germs

Stop use and ask a doctor if

  • Shortness of breath, wheezing, or chest tightness occurs
  • Hives or swelling of the mouth or throat occurs
  • Your symptoms worsen
  • You have new symptoms
  • Your symptoms do not begin to improve within two weeks
  • You need to use for more than 12 weeks

If pregnant or breast-feeding

  • Ask a health professional before use.

Keep out of reach of children.

  • If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Adverse Reactions

Clinical Trials Experience

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

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Drug Interactions of Cromolyn (nasal) in the drug label.

Use in Specific Populations

Pregnancy

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

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Nasal

Monitoring

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

IV Compatibility

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

Overdosage

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

Pharmacology

Template:Px
Template:Px
Cromolyn (nasal)
Systematic (IUPAC) name
5,5′-(2-hydroxypropane-1,3-diyl)bis(oxy)bis(4-oxo-4H-chromene-2-carboxylic acid)
Identifiers
CAS number 16110-51-3
ATC code A07EB01 D11AH03 (WHO) R01AC01 (WHO) R03BC01 (WHO) S01GX01 (WHO)
PubChem 2882
DrugBank DB01003
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 468.367 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability 1%
Metabolism ?
Half life 1.3 hours
Excretion ?
Therapeutic considerations
Licence data

US

Pregnancy cat.

B1(AU) B(US)

Legal status

Pharmacy Only (S2)(AU) inhaler POM, eye OTC(UK) nasal OTC, eye, inhaler Rx(US)

Routes topical: oral, nasal spray, inhaled, eye drops

Mechanism of Action

There is limited information regarding Mechanism of action of Cromolyn (nasal) in the drug label.

Structure

There is limited information regarding Structure of Cromolyn (nasal) in the drug label.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

There is limited information regarding Cromolyn (nasal) How Supplied in the drug label.

Storage

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

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.
This image is provided by the National Library of Medicine.

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Patient Counseling Information

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

Precautions with Alcohol

  • Alcohol-Cromolyn (nasal) 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 Cromolyn (nasal) 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. ↑ "cromolyn sodium spray, metered".

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