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Cromolyn Sodium (Gastrocrom)

Trade Name : Gastrocrom

Meda Pharmaceuticals

LIQUID

Strength 20 mg/mL

CROMOLYN SODIUM Decreased Histamine Release [PE],Mast Cell Stabilizer [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Cromolyn Sodium (Gastrocrom) which is also known as Gastrocrom and Manufactured by Meda Pharmaceuticals. It is available in strength of 20 mg/mL per ml. Read more

Cromolyn Sodium (Gastrocrom) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • 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 5,5u2019-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate]. The empirical formula is CHNaO; the molecular weight is 512.34. Its chemical structure is:
  • Pharmacologic Category: Mast cell stabilizer
  • Therapeutic Category:u00a0Antiallergic
  • 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 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.
  • 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.
  • GASTROCROM 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 GASTROCROM, 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 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 .
  • Other Adverse Events:u00a0
  • 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:
  • 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.
  • u00a0u00a0u00a0u00a0u00a0NDC 0037-0678-08u00a0u00a0u00a0u00a0u00a0u00a0u00a08 ampules x 5 mL
  • u00a0u00a0u00a0u00a0u00a0NDC 0037-0678-96u00a0u00a0u00a0u00a0u00a0u00a0u00a096 ampules x 5 mL
  • GASTROCROM Oral Concentrate should be stored between 15u00b0-30u00b0C (59u00b0-86u00b0F) 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:n n Somerset, New Jersey 08873-4120Gastrocrom is a registered trademark of Meda Pharma S.A.R.L., a Mylan Companyu00a9 2018 Mylan Specialty LP
  • Rev. 10/2018STW-ME7096-642R01IN-0678-02
  • Gastrocromn n- (cromolyn sodium, USP)n- Oral Concentrate
  • For Oral Use Only u2013 Not for Inhalation or Injection.
  • How to Use GASTROCROM:
  • The effect of GASTROCROM therapy is dependent upon its administration at REGULAR intervals, for as long as recommended by your physician.
  • Usual Starting Dose:n- Adults and Adolescents (13 Years and Older):
  • Children 2-12 Years:
  • Note:
  • Care & Storage:
  • 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:n n Somerset, New Jersey 08873-4120Gastrocrom is a registered trademark of Meda Pharma S.A.R.L., a Mylan Companyu00a9 2018 Mylan Specialty LP
  • Rev. 10/2018STW-ME7096-642R01IN-0678-02
  • NDC 0037-0678-96
  • Gastrocrom n (cromolyn sodium, USP)Oral Concentrate
  • FOR ORAL USE ONLY u2013NOT FOR INHALATION OR INJECTION.
  • Rx Only
  • 100 mg/5 mL96 Plastic Ampules
  • DESCRIPTION:
  • NOTE:
  • GASTROCROM Oral Concentrate shouldbe stored between 15u00ba-30u00baC (59u00ba-86u00baF)and protected from light. Do not use if itcontains a precipitate or becomesdiscolored. Keep out of the reach ofchildren.
  • Store ampules in foil pouch until readyto use
  • Rev. 10/2018STW-ME7096-442R01UC-0678-03
  • Distributed by:MEDAPHARMACEUTICALSn Somerset, New Jersey 08873-4120
  • Gastrocrom is a registered trademark of MedaPharma S.A.R.L., a Mylan Company.
  • u00a9 2018 Mylan Specialty LP

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