Cromolyn
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
CONTRAINDICATIONS GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium. WARNINGS The recommended dosage should be decreased in patients with decreased renal or hepatic function. Severe anaphylactic reactions may occur rarely in association with cromolyn sodium administration.
Preparation and administration
Maintenance Dose Once a therapeutic response has been achieved, the dose may be reduced to the minimum required to maintain the patient with a lower degree of symptomatology. To prevent relapses, the dosage should be maintained. Administration GASTROCROM should be administered as a solution at least 1/2 hour before meals and at bedtime after preparation according to the following directions: 1.
Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water. 2. Stir solution. 3. Drink all of the liquid.
Drug interactions
Check cromolyn against a medication listLabel text (2 paragraphs)
Drug Interaction During Pregnancy In pregnant mice, cromolyn sodium alone did not cause significant increases in resorptions or major malformations at subcutaneous doses up to 540 mg/kg (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis). Isoproterenol alone increased both resorptions and major malformations (primarily cleft palate) at a subcutaneous dose of 2.7 mg/kg (approximately 7 times the maximum recommended daily inhalation dose in adults on a mg/m 2 basis). The incidence of major malformations increased further when cromolyn sodium at a subcutaneous dose of 540 mg/kg was added to isoproterenol at a subcutaneous dose of 2.7 mg/kg.
No such interaction was observed in rats or rabbits.
Contraindications
CONTRAINDICATIONS GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for cromolyn. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
Pregnancy In reproductive studies in pregnant mice, rats, and rabbits, cromolyn sodium produced no evidence of fetal malformations at subcutaneous doses up to 540 mg/kg in mice (approximately equal to the maximum recommended daily oral dose in adults on a mg/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis) or at intravenous doses up to 485 mg/kg in rabbits (approximately 4 times the maximum recommended daily oral dose in adults on a mg/m 2 basis). There are, however, no adequate and well controlled studies in pregnant women.
Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Lactation
Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GASTROCROM is administered to a nursing woman.
Breastfeeding (LactMed)
Although no published data exist on the use of cromolyn during lactation, maternal milk levels are likely to be very low and it is expected to be poorly absorbed from the infant's gastrointestinal tract. An expert panel considers use of cromolyn to be acceptable during breastfeeding.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.