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Drug overview for GASTROCROM (cromolyn sodium):
Generic name: CROMOLYN SODIUM (CROW-mow-lin)
Drug class: Mast-Cell Stabilizer-Type Anti-allergy Systemic Agents
Therapeutic class: Antineoplastics
Cromolyn sodium has been described as a mast-cell stabilizer.
No enhanced Uses information available for this drug.
Generic name: CROMOLYN SODIUM (CROW-mow-lin)
Drug class: Mast-Cell Stabilizer-Type Anti-allergy Systemic Agents
Therapeutic class: Antineoplastics
Cromolyn sodium has been described as a mast-cell stabilizer.
No enhanced Uses information available for this drug.
DRUG IMAGES
GASTROCROM 100 MG/5 ML CONC
The following indications for GASTROCROM (cromolyn sodium) have been approved by the FDA:
Indications:
Systemic mastocytosis
Professional Synonyms:
Systemic mast cell disease
Indications:
Systemic mastocytosis
Professional Synonyms:
Systemic mast cell disease
The following dosing information is available for GASTROCROM (cromolyn sodium):
The oral aerosol inhaler delivers 800 mcg of cromolyn sodium per metered spray from the mouthpiece. The commercially available aerosol containing 8.1 or 14.2
g of drug delivers at least 112 or 200 metered sprays, respectively; the canister should be discarded after the labeled number of actuations have been used since the correct drug dose per inhalation cannot be assured if used for additional doses.
Although cromolyn sodium is only minimally absorbed (up to 1%) following oral administration, the absorbed portion undergoes renal and biliary elimination. Severe anaphylactic reactions may occur rarely in patients receiving cromolyn sodium, and the manufacturer states that oral dosage of the drug should be reduced in patients with impaired renal or hepatic function. Dosage reduction of cromolyn sodium given via oral inhalation also should be considered in patients with renal or hepatic impairment.
g of drug delivers at least 112 or 200 metered sprays, respectively; the canister should be discarded after the labeled number of actuations have been used since the correct drug dose per inhalation cannot be assured if used for additional doses.
Although cromolyn sodium is only minimally absorbed (up to 1%) following oral administration, the absorbed portion undergoes renal and biliary elimination. Severe anaphylactic reactions may occur rarely in patients receiving cromolyn sodium, and the manufacturer states that oral dosage of the drug should be reduced in patients with impaired renal or hepatic function. Dosage reduction of cromolyn sodium given via oral inhalation also should be considered in patients with renal or hepatic impairment.
Cromolyn sodium is administered orally and via oral inhalation. The oral concentrate of the drug in ampuls should not be used for oral inhalation therapy nor injected. Proper administration of cromolyn sodium is necessary to obtain optimum results, and it is important that the patient receive careful instruction on the particular dosage form employed.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| GASTROCROM 100 MG/5 ML CONC | Maintenance | Adults take 200 mg (2 ampules) and squeeze contents into a glass of water and stir by oral route 4 times per day 30 min before meals and at bedtime |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| CROMOLYN 100 MG/5 ML ORAL CONC | Maintenance | Adults take 200 mg (2 ampules) and squeeze contents into a glass of water and stir by oral route 4 times per day 30 min before meals and at bedtime |
The following drug interaction information is available for GASTROCROM (cromolyn sodium):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for GASTROCROM (cromolyn sodium):
Drug contraindication overview.
No enhanced Contraindications information available for this drug.
No enhanced Contraindications information available for this drug.
There are 0 contraindications.
There are 2 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Disease of liver |
| Kidney disease with reduction in glomerular filtration rate (GFr) |
There are 0 moderate contraindications.
The following adverse reaction information is available for GASTROCROM (cromolyn sodium):
Adverse reaction overview.
No enhanced Common Adverse Effects information available for this drug.
No enhanced Common Adverse Effects information available for this drug.
There are 10 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Pruritus of skin Skin rash Urticaria |
| Rare/Very Rare |
|---|
|
Allergic dermatitis Anaphylaxis Angioedema Bronchospastic pulmonary disease Dyspnea Eosinophilic pneumonia Laryngeal edema |
There are 7 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Diarrhea Headache disorder |
None. |
| Rare/Very Rare |
|---|
|
Abdominal pain with cramps Insomnia Irritability Myalgia Nausea |
The following precautions are available for GASTROCROM (cromolyn sodium):
No enhanced Pediatric Use information available for this drug.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
In animal studies, cromolyn has produced adverse effects on the fetus (e.g., increased resorption, decreased fetal weight) only in very high parenteral doses. Healthy infants have been born to women who received cromolyn throughout pregnancy; nevertheless, there is insufficient evidence to establish the safety of cromolyn in pregnancy. Cromolyn sodium should be used during pregnancy only when clearly needed.
Since it is not known if cromolyn is distributed into milk in humans, the drug should be used with caution in nursing women. Clinicians should weigh the potential benefits to the mother against the potential risks to the infant when considering cromolyn sodium therapy in nursing women.
No enhanced Geriatric Use information available for this drug.
The following prioritized warning is available for GASTROCROM (cromolyn sodium):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for GASTROCROM (cromolyn sodium)'s list of indications:
| Systemic mastocytosis | |
| C96.21 | Aggressive systemic mastocytosis |
| D47.02 | Systemic mastocytosis |
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