NDC 0037-0678 Gastrocrom

Cromolyn Sodium

NDC Product Code 0037-0678

NDC CODE: 0037-0678

Proprietary Name: Gastrocrom What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Cromolyn Sodium What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat certain allergic eye conditions (vernal keratoconjunctivitis, vernal conjunctivitis, vernal keratitis). It prevents itching of the eyes that can occur with these conditions. Cromolyn is known as a mast cell stabilizer. It works by blocking certain natural substances (histamine, SRS-A) that cause allergic symptoms.

NDC Code Structure

  • 0037 - Meda Pharmaceuticals

NDC 0037-0678-96

Package Description: 12 POUCH in 1 CARTON > 8 AMPULE in 1 POUCH (0037-0678-08) > 5 mL in 1 AMPULE

NDC Product Information

Gastrocrom with NDC 0037-0678 is a a human prescription drug product labeled by Meda Pharmaceuticals. The generic name of Gastrocrom is cromolyn sodium. The product's dosage form is liquid and is administered via oral form.

Labeler Name: Meda Pharmaceuticals

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Gastrocrom Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CROMOLYN SODIUM 20 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Decreased Histamine Release - [PE] (Physiologic Effect)
  • Mast Cell Stabilizer - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Meda Pharmaceuticals
Labeler Code: 0037
FDA Application Number: NDA020479 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: NDA - A product marketed under an approved New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 05-01-2015 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Gastrocrom Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

DESCRIPTION: Each 5 mL ampule of GASTROCROM contains 100 mg cromolyn sodium, USP, in purified water. Cromolyn sodium is a hygroscopic, white powder having little odor. It may leave a slightly bitter aftertaste. GASTROCROM (cromolyn sodium, USP) Oral Concentrate 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 empirical formula is C23H14Na2O11; the molecular weight is 512.34. Its chemical structure is:Pharmacologic Category: Mast cell stabilizerTherapeutic Category: Antiallergic

Clinical Pharmacology

CLINICAL PHARMACOLOGY: 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%.

Clinical Studies

CLINICAL STUDIES: Four randomized, controlled clinical trials were conducted with GASTROCROM 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 GASTROCROM 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 2-6 weeks of treatment initiation and persisted for 2-3 weeks after treatment withdrawal. GASTROCROM 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 GASTROCROM in United States and foreign humanitarian programs.

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.

Contraindications

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

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.

Precautions

PRECAUTIONS: In view of the biliary and renal routes of excretion of GASTROCROM, consideration should be given to decreasing the dosage of the drug in patients with impaired renal or hepatic function.

Carcinogenesis & Mutagenesis & Impairment Of Fertility

Carcinogenesis, Mutagenesis, and Impairment of Fertility: In carcinogenicity studies in mice, hamsters, and rats, cromolyn sodium had no neoplastic effects at intraperitoneal doses up to 150 mg/kg three days per week for 12 months in mice, at intraperitoneal doses up to 53 mg/kg three days per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks in hamsters, and at subcutaneous doses up to 75 mg/kg six days per week for 18 months in rats. These doses in mice, hamsters, and rats are less than the maximum recommended daily oral dose in adults and children on a mg/m2 basis.Cromolyn sodium showed no mutagenic potential in Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces cerevisiae and in an in vitro cytogenetic study in human peripheral lymphocytes. In rats, cromolyn sodium showed no evidence of impaired fertility at subcutaneous doses up to 175 mg/kg in males (approximately equal to the maximum recommended daily oral dose in adults on a mg/m2 basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m2 basis).

Pregnancy

Pregnancy: Pregnancy Category B. 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/m2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m2 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/m2 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.

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/m2 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/m2 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.

Nursing Mothers

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.

Pediatric Use

Pediatric Use: In adult rats no adverse effects of cromolyn sodium were observed at oral doses up to 6144 mg/kg (approximately 25 times the maximum recommended daily oral dose in adults on a mg/m2 basis). In neonatal rats, cromolyn sodium increased mortality at oral doses of 1000 mg/kg or greater (approximately 9 times the maximum recommended daily oral dose in infants on a mg/m2 basis) but not at doses of 300 mg/kg or less (approximately 3 times the maximum recommended daily oral dose in infants on a mg/m2 basis). Plasma and kidney concentrations of cromolyn after oral administration to neonatal rats were up to 20 times greater than those in older rats. In term infants up to six months of age, available clinical data suggest that the dose should not exceed 20 mg/kg/day. The use of this product in pediatric patients less than two years of age should be reserved for patients with severe disease in which the potential benefits clearly outweigh the risks.

Geriatric Use

Geriatric Use: Clinical studies of GASTROCROM did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

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 legsNeurologic: 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

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:Break open ampule(s) and squeeze liquid contents of ampule(s) into a glass of water.Stir solution.Drink all of the liquid.

How Supplied

HOW SUPPLIED: GASTROCROM Oral Concentrate is an unpreserved, colorless solution supplied in a low density polyethylene plastic unit dose ampule with 8 ampules per foil pouch. Each 5 mL ampule contains 100 mg cromolyn sodium, USP, in purified water.     NDC 0037-0678-08       8 ampules x 5 mL     NDC 0037-0678-96       96 ampules x 5 mLGASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-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 ampules in foil pouch until ready for use.Distributed by:Meda Pharmaceuticals®Somerset, New Jersey 08873-4120
MEDA PHARMACEUTICALS and GASTROCROM are registered trademarks of Meda AB or a related entity.
© 2013 Meda Pharmaceuticals Inc.
Rev. 4/2013
STW-ME7096-642R00
IN-0678-01

Patient Instructions

Gastrocrom®
(cromolyn sodium, USP)
Oral Concentrate
For Oral Use Only – Not for Inhalation or Injection.How to Use GASTROCROM: As with all prescription drugs, follow the directions for dosage that your physician recommends.The effect of GASTROCROM 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 2-12 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 GASTROCROM. However, do not change your dose or stop taking GASTROCROM without first consulting your physician.Care & Storage: GASTROCROM Oral Concentrate should be stored between 15°-30°C (59°-86°F) and protected from light. Do not use if it contains a precipitate (particles or cloudiness) or becomes discolored. Keep out of the reach of children. Store ampules in foil pouch until ready for use.Recycling Information: GASTROCROM Oral Concentrate ampules are made with a low density polyethylene plastic (recycling material code: LDPE).Directions for Use:1. Open foil pouch by tearing at serrated edge as shown.2. Remove ampule(s) from the strip.3. Open the ampule by twisting off the tabbed top section.4. Squeeze liquid contents into a glass of water. Stir solution. Drink all of the liquid. Discard the empty ampule.Distributed by:Meda Pharmaceuticals®
Somerset, New Jersey 08873-4120
MEDA PHARMACEUTICALS and GASTROCROM are registered trademarks of Meda AB or a related entity.
© 2013 Meda Pharmaceuticals Inc.      Rev. 4/2013
STW-ME7096-642R00IN-0678-01

Prinicipal Display Panel - Pouch Label

NDC 0037-0678-08
Rx Only
Gastrocrom®
(cromolyn sodium, USP)
Oral Concentrate
100 mg / 5 mL
8 Ampules
Store between 15°-30°C (59°-86°F) and protect from light.
Do not us if it contains a precipitate or becomes discolored.
Keep out of the reach of children.
Store ampules in foil pouch until ready to use.
Distributed by:
MEDA Pharmaceuticals®
Somerset, New Jersey 08873-4120
MEDA PHARMACEUTICALS and GASTROCROM are registered trademarks of Meda AB or a related entity.
© 2013 Meda Pharmaceuticals Inc.
Open by tearing at serrated edge along seam.
Rev. 4/2013
STW-ME7096-801R00
LP-0678-01

* Please review the disclaimer below.