Cromolyn sodium inhaled dosing, indications, interactions, adverse effects, and more

Sections

Sections cromolyn sodium, inhaled
Dosing & Uses
Adverse Effects
Warnings
Pregnancy
Pharmacology
Images
Patient Handout
Formulary

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

nebulization solution

10mg/mL (2mL/vial)

Asthma

20 mg inhaled via nebulization QID; may decrease to BID/TID once stabilized

Bronchospasm Prophylaxis (Exercise Induced or Allergen)

Administer 20 mg as single dose 10-15 min prior to exercise or allergen exposure but no longer than 1 hr

Mastocytosis (Orphan)

Orphan designation for treatment of mastocytosis

Sponsor

Patara Pharma, LLC; 11455 El Camino Real, Suite 460; San Diego, California 92130

Idiopathic Pulmonary Fibrosis (Orphan)

Orphan designation for treatment of idiopathic pulmonary fibrosis

Orphan sponsor

Respivant Sciences, Inc; 11455 El Camino Real, Suite 460; San Diego, California 92130

Dosage Forms & Strengths

nebulization solution

10mg/mL (2mL/vial)

Asthma

<2 years: Safety and efficacy not established

≥2 years: 20 mg inhaled via nebulization QID; may decrease to BID/TID once stabilized

Bronchospasm Prophylaxis (Exercise Induced or Allergen)

<2 years: Safety and efficacy not established

&ge2 years: Administer 20 mg as single dose 10-15 min prior to exercise or allergen exposure but no longer than 1 hr

Frequency Not Defined

Cough

Flushing

Palpitation

Chest pain

Nasal congestion

Nausea

Fatigue

Migraine

Sneezing

Wheezing

Psychosis

Pruritus

Dysphagia

Esophagospasm

Pancytopenia

Polycythemia

Tinnitus

Pharyngitis

Lupus erythematosus

Contraindications

Hypersensitivity; acute asthma attack

Cautions

Not for status asthmaticus

Use caution in patients with a history of cardiac arryhthmias

Use caution in renal or hepatic impairment; may require dose adjustment

Some reports of bronchospasm or cough after administration

Not useful in acute situations

Symptoms may reoccur while withdrawing or tapering the dose

Pregnancy & Lactation

Pregnancy Category: B

Lactation: Unknown whether distributed in breast milk; likely compatible

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Mast cell stabilizer; inhibits release of histamine, leukotrienes, and slow-reacting substance of anaphylaxis from mast cell by inhibiting degranulation following exposure to reactive antigens

Pharmacokinetics

Absorption: 8%

Peak plasma time: 15 min

Peak plasma concentration: 9 ng/mL

Half-life: 80-90 min

Onset: 2-6 weeks (PO)

Duration: 6 hr

Excretion: Feces (98%, unabsorbed drugs); urine (<0.5%)

BRAND	FORM.	UNIT PRICE	PILL IMAGE
cromolyn nasal -	5.2 mg/spray (4 %) aerosol
cromolyn inhalation -	20 mg/2 mL nebulizer soln
cromolyn ophthalmic (eye) -	4 % drops
cromolyn ophthalmic (eye) -	4 % drops
cromolyn oral -	100 mg/5 mL liquid
cromolyn oral -	100 mg/5 mL liquid
cromolyn oral -	100 mg/5 mL liquid
cromolyn oral -	100 mg/5 mL liquid
Nasalcrom nasal -	5.2 mg/spray (4 %) aerosol
Gastrocrom oral -	100 mg/5 mL liquid
Gastrocrom oral -	100 mg/5 mL liquid

Patient Handout

Select a drug:

CROMOLYN LIQUID - ORAL

(CROW-mow-lin)

COMMON BRAND NAME(S): Gastrocrom

USES: This medication is used to treat mastocytosis, a disease that occurs when the body has too many mast cells. These normal body cells release substances (such as histamines) that are needed for normal body defense and healing, but when too many mast cells are present, they release too much of these substances. This can lead to symptoms such as diarrhea, stomach/abdominal pain, itching, rash, and flushing. Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing mast cells from releasing the substances that can cause these skin and gut problems.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using cromolyn and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth 30 minutes before meals and at bedtime, usually 4 times daily or as directed by your doctor. If you are using this drug to prevent a food allergy or for inflammatory bowel disease, your doctor may direct you to take it 15-20 minutes before meals.Do not swallow the ampules. The contents of the ampules are used to make a solution. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. To make the solution, break open the ampule(s) and squeeze the liquid into a glass of water. Do not mix with fruit juice, soda, milk, or any fluid except plain water. Stir the solution well. Drink all of the solution right away. Do not mix it ahead of time. Do not take the ampules out of their foil pouch until right before using.Dosage is based on your medical condition and response to therapy.This medication does not work right away. You need to use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. It may take 2-3 weeks before you see a benefit from this medication. Your doctor may change your dose to find the best dose for you.Do not use this form of cromolyn for inhalation (such as in a nebulizer), in the nose, or by injection. It is for oral use (swallowing) only. It does not work to treat breathing problems, nasal/seasonal allergies, or other allergic reactions.Inform your doctor if your symptoms do not improve or if they worsen.

SIDE EFFECTS: Headache, muscle aches, and diarrhea may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking cromolyn, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, take it as soon as you remember. If you have already had your meal, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Keep the ampules in their foil pouches at room temperature away from heat and light until ready for use. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

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Adding plans allows you to:

View the formulary and any restrictions for each plan.
Manage and view all your plans together – even plans in different states.
Compare formulary status to other drugs in the same class.
Access your plan list on any device – mobile or desktop.

The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

View explanations for tiers and restrictions

Tier	Description
1	This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2	This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6	This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC	NOT COVERED – Drugs that are not covered by the plan.

Code	Definition
PA	Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL	Quantity Limits Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST	Step Therapy Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR	Other Restrictions Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.

Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.

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