Cromolyn Sodium
Generic Name: cromolyn sodium
Brand Names:
Cromolyn Sodium
DESCRIPTION: Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) 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. Cromolyn Sodium Oral Solution (Concentrate) is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate].
Overview
DESCRIPTION: Each 5 mL ampule of Cromolyn Sodium Oral Solution (Concentrate) 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. Cromolyn Sodium Oral Solution (Concentrate) is clear, colorless, and sterile. It is intended for oral use. Chemically, cromolyn sodium is disodium 5,5’-[(2-hydroxy-trimethylene) dioxy]bis[4-oxo-4H-1-benzopyran-2-carboxylate].
Uses
INDICATIONS AND 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
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 Cromolyn Sodium Oral Solution (Concentrate) therapy is dependent upon its administration at regular intervals, as directed.
Side Effects
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 Omnivium Pharmaceuticals LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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: Cromolyn Sodium Oral Solution (Concentrate) is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
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/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 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/m 2 basis).
Storage
HOW SUPPLIED: Cromolyn Sodium Oral Solution (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.
Frequently Asked Questions
What is Cromolyn Sodium used for?▼
INDICATIONS AND 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.
What are the side effects of 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 Omnivium Pharmaceuticals LLC at 1-888-514-4727 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Cromolyn Sodium during 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/m 2 basis) and 164 mg/kg in rats (less than the maximum recommended daily oral dose in adults on a mg/m 2 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/m 2 basis).
What are the important warnings for Cromolyn Sodium?▼
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.
Related Medications
Apis Mellifica, Argentum Nitricum, Badiaga, Belladonna, Cantharis, Causticum, Chimaphila Umbellata, Colocynthis, Cubeba Officinalis, Cucurbita Citrullus, Cucurbita Pepo Flower, Echinacea Angustifolia, Equisetum Hyemale, Eryngium Aquaticum, Ferrum Phosphoricum, Mitchella Repens, Oleum Santali, Petroselinum Sativum, Piper Methysticum, Populus Tremuloides Bark, Sarsaparilla, Terebinthina, Uva Ursi
apis mellifica, argentum nitricum, badiaga, belladonna, cantharis, causticum, chimaphila umbellata, colocynthis, cubeba officinalis, cucurbita citrullus, cucurbita pepo flower, echinacea angustifolia, equisetum hyemale, eryngium aquaticum, ferrum phosphoricum, mitchella repens, oleum santali, petroselinum sativum, piper methysticum, populus tremuloides bark, sarsaparilla, terebinthina, uva ursi
Standardized Insect Venom Allergenic Extract [EPC]
Uses: For temporary relief of minor: frequent urination* bladder discomfort* backache* swollen ankles and feet* *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Cyclosporine A
cyclosporine a
Dosage form: POWDER. Active ingredients: CYCLOSPORINE (1 g/g). Category: BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING.
Aquilegia, Avena, Chamomilla, Coffea Cruda, Cypripedium, Humulus, Kali Phos, Passiflora, Valeriana, Zinc Met
aquilegia, avena, chamomilla, coffea cruda, cypripedium, humulus, kali phos, passiflora, valeriana, zinc met
Non-Standardized Food Allergenic Extract [EPC]
PURPOSE: Temporarily relieves the common symptoms of sleeplessness, including: ° wakefulness ° restlessness ° emotional stress and anxiety ° caffeine sensitivity ° natural ° gluten free ° no artifical flavors or colors ° vegan ° no known negative side effects ° no known negative drug interactions
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.