Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) contains 100 mg cromolyn sodium, USP, in Water for Injection. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is clear, colorless, and sterile. It is intended for oral use.

Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The molecular formula is C 23H 14Na 2O 11; the molecular weight is 512.34. Its chemical structure is:

 



Pharmacologic Category: Mast cell stabilizer



Therapeutic Category: Antiallergic

In vitro and in vivo animal studies have shown that cromolyn sodium inhibits the release of mediators from sensitized mast cells. Cromolyn sodium acts by inhibiting the release of histamine and leukotrienes (SRS-A) from the mast cell.



Cromolyn sodium has no intrinsic vasoconstrictor, antihistamine, or glucocorticoid activity.



Cromolyn sodium is poorly absorbed from the gastrointestinal tract. No more than 1% of an administered dose is absorbed by humans after oral administration, the remainder being excreted in the feces. Very little absorption of cromolyn sodium was seen after oral administration of 500 mg by mouth to each of 12 volunteers. From 0.28 to 0.50% of the administered dose was recovered in the first 24 hours of urinary excretion in 3 subjects. The mean urinary excretion of an administered dose over 24 hours in the remaining 9 subjects was 0.45%.

Four randomized, controlled clinical trials were conducted with Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL in patients with either cutaneous or systemic mastocytosis; two of which utilized a placebo-controlled crossover design, one utilized an active-controlled (chlorpheniramine plus cimetidine) crossover design, and one utilized a placebo-controlled parallel group design. Due to the rare nature of this disease, only 36 patients qualified for study entry, of whom 32 were considered evaluable. Consequently, formal statistical analyses were not performed. Clinically significant improvement in gastrointestinal symptoms (diarrhea, abdominal pain) were seen in the majority of patients with some improvement also seen for cutaneous manifestations (urticaria, pruritus, flushing) and cognitive function. The benefit seen with Cromolyn sodium 200 mg QID was similar to chlorpheniramine (4 mg QID) plus cimetidine (300 mg QID) for both cutaneous and systemic symptoms of mastocytosis.



Clinical improvement occurred within 2 to 6 weeks of treatment initiation and persisted for 2 to 3 weeks after treatment withdrawal. Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL did not affect urinary histamine levels or peripheral eosinophilia, although neither of these variables appeared to correlate with disease severity. Positive clinical benefits were also reported for 37 of 51 patients who received Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL in United States and foreign humanitarian programs.

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 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.

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.

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.

In view of the biliary and renal routes of excretion of Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL, consideration should be given to decreasing the dosage of the drug in patients with impaired renal or hepatic function.

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) 100 mg/5 mL 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.



T o report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 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 report) include the following:



Skin: pruritus, rash, urticaria/angioedema, erythema/ burning, photosensitivity

Musculoskeletal: arthralgia, myalgia, stiffness/weakness of legs

Neurologic: headache, dizziness, hypoesthesia, paresthesia, migraine, convulsions, flushing

Psychiatric: psychosis, anxiety, depression, hallucinations, behavior change, insomnia, nervousness

Heart Rate: tachycardia, premature ventricular contractions (PVCs), palpitations

Respiratory: pharyngitis, dyspnea

Miscellaneous: fatigue, edema, unpleasant taste, chest pain, postprandial lightheadedness and lethargy, dysuria, urinary frequency, purpura, hepatic function test abnormal, polycythemia, neutropenia, pancytopenia, tinnitus, lupus erythematosus (LE) syndrome

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 to 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) 100 mg/5 mL 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) 100 mg/5 mL should be administered as a solution at least ½ 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.

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL is supplied in a BFS (Blow Fill Seal) ampules as follows:  5 mL fill in 5 mL BFS ampule, with 8 ampules in one partitioned inner carton and such 12 inner cartons in one outer carton.

5 mL fill in 5 mL BFS Ampule                                                                       NDC 42571-132-21

Inner Carton of 8 x 5 mL BFS Ampules                                                        NDC 42571-132-51

Outer Carton of 96 x 5 mL (12 inner cartons of 8 x 5 mL BFS Ampules)      NDC 42571-132-52

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL should be stored between 15° to 30°C (59° to 86°F) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.

Manufactured by:

Micro Labs Limited

Bangalore-560 099, INDIA.



Manufactured for:

Micro Labs USA, Inc.

Somerset, NJ 08873



Rev. 06/2022

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL  

For Oral Use Only – Not for Inhalation or Injection.

MUST BE DILUTED  

How to Use Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL:  

As with all prescription drugs, follow the directions for dosage that your physician recommends.

The effect of Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician.

Usual Starting Dose:

Adults and Adolescents (13 Years and Older):  

Two ampules four times daily, taken one-half hour before meals and at bedtime.

Children 2 to 12 Years:  

One ampule four times daily, taken one-half hour before meals and at bedtime.

Note:  

Your physician may decide to increase OR decrease your dosage to achieve optimum results with Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL. However, do not change your dose or stop taking Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL without first consulting your physician.

Care & Storage:  

Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL should be stored between 15° to 30°C (59° to 86°F) and protected from light. Do not use if it contains a precipitate or becomes discolored. Keep out of the reach of children.

Store in carton until time of use.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Directions for Use:

Manufactured by:

Micro Labs Limited

Bangalore-560 099, INDIA.



Manufactured for:

Micro Labs USA, Inc.

Somerset, NJ 08873



Rev. 06/2022

NDC 42571-132-21

Cromolyn Sodium

Oral Solution

(Concentrate)

100 mg/5 mL

Rx Only

5 mL

MICRO LABS LIMITED

NDC 42571-132-51

Rx Only

Cromolyn Sodium

Oral Solution (Conncentrate)

100 mg/5 mL

FOR ORAL USE ONLY - NOT FOR INHALATION OR INJECTION

8 Ampoules

MICRO LABS LIMITED

NDC 42571-132-52

Rx Only

Cromolyn Sodium

Oral Solution (Concentrate)

100 mg/5 mL

FOR ORAL USE ONLY - NOT FOR INHALATION OR INJECTION

96 Ampoules

MICRO LABS