AdultPediatricDosage 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 Category: B Lactation: Unknown whether distributed in breast milk; likely compatiblePregnancy 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 inhalation- 20 mg/2 mL nebulizer solncromolyn inhalation- 20 mg/2 mL nebulizer solncromolyn inhalation- 20 mg/2 mL nebulizer solncromolyn ophthalmic (eye)- 4 % dropscromolyn ophthalmic (eye)- 4 % dropscromolyn oral- 100 mg/5 mL liquidcromolyn oral- 100 mg/5 mL liquidcromolyn oral- 100 mg/5 mL liquidcromolyn oral- 100 mg/5 mL liquidcromolyn nasal- 5.2 mg/spray (4 %) aerosolNasalcrom nasal- 5.2 mg/spray (4 %) aerosolGastrocrom oral- 100 mg/5 mL liquidGastrocrom oral- 100 mg/5 mL liquidCopyright © 2010 First DataBank, Inc.Select a drug:cromolyn inhalationcromolyn ophthalmic (eye)cromolyn nasalcromolyn oralPrint Patient Educationcromolyn inhalation CROMOLYN NEBULIZER SOLUTION - INHALATION (KROE-mo-lin) COMMON BRAND NAME(S): Intal USES: This medication is used to prevent symptoms (wheezing and shortness of breath) caused by asthma. It is also used to prevent wheezing and shortness of breath caused by exercise, cold/dry/polluted air, or allergens such as pollen. Controlling breathing problems may decrease time lost from work or school. If you use this medication you may not need to use other asthma drugs (such as corticosteroids) as often.Cromolyn belongs to a class of medications called mast cell stabilizers. It works by preventing release of certain natural chemicals (such as histamines) that may cause swelling of the airways and breathing problems.This medication must be used regularly to prevent asthma symptoms. It does not work right away and should not be used to relieve sudden asthma attacks. If an asthma attack occurs, use your quick-relief inhaler as prescribed. HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using cromolyn and each time you get a refill. Follow the illustrated directions for the proper use of this medication. If you have any questions, ask your doctor or pharmacist.This product is used with special breathing equipment (power nebulizer with face mask or mouthpiece). Make sure you understand how to use the machine and how to properly clean it to prevent infections. A parent or other responsible adult should supervise a child who is using this type of machine. Ask your doctor, pharmacist, or respiratory therapist about the proper use of the equipment with this medication.Before using, check this product visually for particles or discoloration. If either is present, do not use the solution. Do not mix this medication with other solutions or products in the nebulizer.Inhale this medication by mouth as directed by your doctor, usually 4 times daily. If you are using this medication to prevent breathing problems related to exercise, cold/dry air, or allergens, use it within 10 to 15 minutes, but not more than 60 minutes, before exposure.If you are using other inhaled medications, ask your doctor when to use each of the medications and in what order you should use them.Learn which of your inhalers/medications you should use every day (controller drugs) and which you should use if your breathing suddenly worsens (quick-relief drugs). Ask your doctor ahead of time what you should do if you have new or worsening cough or shortness of breath, wheezing, increased sputum, worsening peak flow meter readings, waking up at night with trouble breathing, if you use your quick-relief inhaler more often (more than 2 days a week), or if your quick-relief inhaler does not seem to be working well. Learn when you can treat sudden breathing problems by yourself and when you must get medical help right away.Use this medication regularly in order to get the most benefit from it. This medication works best if always used at evenly spaced intervals. To help you remember, use it at the same times each day. Do not increase your dose, use it more often, or stop using this medication without first asking your doctor. Dosage is based on your medical condition, your age, response to treatment, and use of other asthma medications. Your doctor may lower your dose once the medication starts to work. Follow your doctor's instructions carefully.It may take up to 4 weeks of regular use before the full benefit of this drug takes effect. SIDE EFFECTS: Coughing, stuffy nose, sneezing, headache, nausea, or tearing 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.Tell your doctor right away if you have any serious side effects, including: dizziness, painful/frequent urination, joint swelling/pain, swollen glands around the cheek (parotid gland), muscle weakness, heartburn.Rarely, this medication may cause severe sudden worsening of breathing problems/asthma immediately after use. If you have sudden worsening of breathing, use your quick-relief inhaler and get medical help right away.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, 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: liver problems, kidney problems.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 unknown 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.Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow/red range, increased use of quick-relief inhalers).Avoid substances that can worsen breathing problems by causing irritation or allergic reaction, such as smoke, pollen, pet dander, dust, and mold.Because the flu virus can worsen breathing problems, ask your doctor or pharmacist if you should have a flu shot every year. MISSED DOSE: If you miss a dose, use it as soon as you remember. Use the remaining doses for that day at evenly spaced intervals. Do not double the dose to catch up. STORAGE: Store at room temperature in the foil pouches away from light and moisture. 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. Information last revised May 2023. Copyright(c) 2023 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. FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding 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