Dosing & Uses
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
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
Warnings
Contraindications
Hypersensitivity
Cautions
Not for status asthmaticus
Use caution in patients with a history of cardiac arrhythmias
Use caution in renal or hepatic impairment; may require dose adjustment
Some reports of bronchospasm or cough after administration
Patients who develop bronchospasm may not be able to continue therapy despite prior bronchodilator administration; rarely, very severe bronchospasm has been encountered
Not useful in acute situations
Symptoms of asthma may recur if cromolyn sodium reduced below recommended dosage or discontinued
Because it is preventive medication, may take up to four weeks before patient experiences maximum benefit
Stability and safety when mixed with other drugs in a nebulizer not established
Should be administered in a power-driven nebulizer with an adequate airflow rate equipped with a suitable face mask or mouthpiece
Pregnancy & Lactation
Pregnancy
No adequate and well-controlled studies in pregnant women
Animal data
- Reproduction studies with drug administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg and 164 mg/kg, respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg produced no evidence of fetal malformations; the doses represent approximately 27, 17, and 98 times, respectively, the maximum recommended adult human daily inhalation dose on a mg/m2 basis; adverse fetal effects (increased resorption and decreased fetal weight) were noted only at very high parenteral doses that produced maternal toxicity
Lactation
Not known whether this drug is excreted in human milk; because many drugs are excreted in human milk, exercise caution when cromolyn sodium administered to a nursing woman
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.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%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| cromolyn nasal - | 5.2 mg/spray (4 %) aerosol |  | |
| cromolyn ophthalmic (eye) - | 4 % drops |  | |
| cromolyn ophthalmic (eye) - | 4 % drops |  | |
| cromolyn inhalation - | 20 mg/2 mL nebulizer soln |  | |
| cromolyn inhalation - | 20 mg/2 mL nebulizer soln |  | |
| 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 |  | |
| Gastrocrom oral - | 100 mg/5 mL liquid |  | |
| Gastrocrom oral - | 100 mg/5 mL liquid |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
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 if available from your pharmacist before you start using cromolyn and each time you get a refill. If you have any questions, ask 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.Use this medication in the affected eye(s) as directed by your doctor, usually 4 times daily. 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 (such as 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 lasts or gets worse.
SIDE EFFECTS: Burning or stinging of the eye 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 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 can do it 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 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: 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. Discard any remaining solution after 4 weeks if directed to do so by the product manufacturer. 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 July 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.
Formulary
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