Gastrocrom 20 mg/mL

cromolyn sodium · LIQUID · Viatris Specialty LLC

No Recall HistoryCurrently in Shortage

Plain English

Gastrocrom is a liquid containing cromolyn sodium at 20 mg/mL, taken oral. Manufactured by Viatris Specialty LLC.

Key Facts

Brand Name: Gastrocrom
Generic Name: cromolyn sodium
NDC Code (Product): 0037-0678
Manufacturer: Viatris Specialty LLC
Strength: 20 mg/mL
Dosage Form: LIQUID
Route: ORAL
Marketing Status
Application #: NDA020479
Marketing Start: 05/01/2015

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

treatment failure1,004 reports

drug ineffective288 reports

fatigue182 reports

nausea173 reports

headache152 reports

diarrhoea142 reports

off label use136 reports

urticaria135 reports

dyspnoea120 reports

anaphylactic reaction114 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

INDICATIONS AND USAGE GASTROCROM is indicated in the management of patients with mastocytosis. Use of this product has been associated with improvement in diarrhea, flushing, headaches, vomiting, urticaria, abdominal pain, nausea, and itching in some patients.

Dosage & Administration

DOSAGE AND ADMINISTRATION NOT FOR INHALATION OR INJECTION. SEE DIRECTIONS FOR USE. The usual starting dose is as follows: Adults and Adolescents (13 Years and Older) Two ampules four times daily, taken one-half hour before meals and at bedtime. Children 2-12 Years One ampule four times daily, taken one-half hour before meals and at bedtime. Pediatric Patients Under 2 Years Not recommended. If satisfactory control of symptoms is not achieved within two to three weeks, the dosage may be increased but should not exceed 40 mg/kg/day. Patients should be advised that the effect of GASTROCROM therapy is dependent upon its administration at regular intervals, as directed. 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…

Warnings

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.

Contraindications

CONTRAINDICATIONS GASTROCROM is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.

Drug Interactions

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.

Adverse Reactions

ADVERSE REACTIONS Most of the adverse events reported in mastocytosis patients have been transient and could represent symptoms of the disease. The most frequently reported adverse events in mastocytosis patients who have received GASTROCROM during clinical studies were headache and diarrhea, each of which occurred in 4 of the 87 patients. Pruritus, nausea, and myalgia were each reported in 3 patients and abdominal pain, rash, and irritability in 2 patients each. One report of malaise was also recorded. To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-877-999-8406 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Other Adverse Events: Additional adverse events have been reported during studies in other clinical conditions and from worldwide postmarketing experience. In most cases the available information is incomplete and attribution to the drug cannot be determined. The majority of these reports involve the gastrointestinal system and include: diarrhea, nausea, abdominal pain, constipation, dyspepsia, flatulence, glossitis, stomatitis, vomiting, dysphagia, esophagospasm. Other less commonly reported events (the majority representing only a single rep…

Frequently Asked Questions

What is Gastrocrom used for?

Gastrocrom contains cromolyn sodium. It is a liquid taken oral. Consult your doctor for specific uses.

Is Gastrocrom a controlled substance?

Gastrocrom is not classified as a controlled substance by the DEA.

What is the generic name for Gastrocrom?

The generic name for Gastrocrom is cromolyn sodium. There are 11 other brand versions of cromolyn sodium.

What is the NDC code for Gastrocrom 20 mg/mL?

The NDC (National Drug Code) for Gastrocrom 20 mg/mL is 0037-0678, listed by Viatris Specialty LLC.

Product NDC

0037-0678

Package NDC

0037-0678-96

Other Cromolyn Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)