cromolyn sodium, inhaled (Rx)

Brand and Other Names:
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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

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Adverse Effects

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

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Warnings

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

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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.

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Pharmacology

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%)

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Images

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

Copyright © 2010 First DataBank, Inc.

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Patient Handout

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Patient Education
cromolyn ophthalmic (eye)

CROMOLYN - OPHTHALMIC

(CROW-mow-lin)

COMMON BRAND NAME(S): Opticrom

USES: This medication is used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). It prevents itching of the eyes that can occur with these conditions. Cromolyn is known as a mast cell stabilizer. It works by blocking certain natural substances (histamine, SRS-A) that cause allergic symptoms.

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.To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.It is best to avoid wearing contact lenses while using this medication.This medication is used in the affected eye(s), usually 4 times daily or as directed by your doctor. Treatment may be continued for as long as 3 months.Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over the eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of the eye near the nose and apply gentle pressure. This will prevent the medication from draining away from the eye. Try not to blink and do not rub the eye. Repeat these steps if your dose is for more than 1 drop and for the other eye if so directed.Do not rinse the dropper. Replace the dropper cap tightly after each use.If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed.It may take up to several days of continued use to see a relief in symptoms and up to 6 weeks for full benefit. If immediate relief of symptoms (itching) is needed, use other quick-relief medication (such as eye drops containing antihistamines, decongestants, or nonsteroidal anti-inflammatory drugs-NSAIDs) along with cromolyn as directed by your doctor. Tell your doctor if your condition persists or worsens.

SIDE EFFECTS: Burning or stinging of the eye may occur. If any of these effects persist or worsen, 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 using 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 (such as preservatives like benzalkonium chloride), 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: contact lens use.After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether 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: This medicine may be harmful if swallowed. 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: Avoid allergens that may be the cause of your allergies. Some common allergens that cause allergic eye conditions include pollen, grasses, weeds, dust mites, and pet dander.Do not share this medication with others.This medication has been prescribed for your current condition only. Do not use it later for another condition unless directed to do so by your doctor. A different medication may be necessary in that case.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

STORAGE: Store dropper bottle upright at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets. Discard any remaining solution after 4 weeks if directed to do so by the product manufacturer.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.

Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

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.

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Formulary

FormularyPatient Discounts

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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.

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