Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5mL
Cromolyn Sodium Oral Solution (Concentrate) · SOLUTION, CONCENTRATE · Ritedose Pharmaceuticals, LLC
Cromolyn Sodium Oral Solution (Concentrate) is a prescription solution, concentrate containing cromolyn sodium oral solution (concentrate) at 100 mg/5mL, taken oral. Manufactured by Ritedose Pharmaceuticals, LLC.
Key Facts
- Brand Name
- Cromolyn Sodium Oral Solution (Concentrate)
- Generic Name
- Cromolyn Sodium Oral Solution (Concentrate)
- NDC Code (Product)
76204-025- Manufacturer
- Ritedose Pharmaceuticals, LLC
- Strength
- 100 mg/5mL
- Dosage Form
- SOLUTION, CONCENTRATE
- Route
- ORAL
- Marketing Status
- HUMAN PRESCRIPTION DRUG
- Application #
- ANDA209264
- Drug Class
- Decreased Histamine Release [PE]; Mast Cell Stabilizer [EPC]
- Marketing Start
- 12/01/2021
Recall History
The Ritedose Corporation
CGMP deviation: product released prior to supplier approval.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
Cromolyn Sodium Oral Solution (Concentrate) 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
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 Cromolyn Sodium Oral Solution (Concentrate) 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: Cromolyn Sodium Oral Solution (Concentrate) 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.…
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
Cromolyn Sodium Oral Solution (Concentrate) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
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 Cromolyn Sodium Oral Solution (Concentrate) 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 Ritedose Pharmaceuticals, LLC at 1-855-806-3300 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…
Frequently Asked Questions
What is Cromolyn Sodium Oral Solution (Concentrate) used for?
Cromolyn Sodium Oral Solution (Concentrate) contains Cromolyn Sodium Oral Solution (Concentrate). It is a solution, concentrate taken oral. Consult your doctor for specific uses.
Is Cromolyn Sodium Oral Solution (Concentrate) a controlled substance?
Cromolyn Sodium Oral Solution (Concentrate) is not classified as a controlled substance by the DEA.
What is the generic name for Cromolyn Sodium Oral Solution (Concentrate)?
The generic name for Cromolyn Sodium Oral Solution (Concentrate) is Cromolyn Sodium Oral Solution (Concentrate). There are no other listed brand versions of Cromolyn Sodium Oral Solution (Concentrate).
What is the NDC code for Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5mL?
The NDC (National Drug Code) for Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5mL is 76204-025, listed by Ritedose Pharmaceuticals, LLC.
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)