Product Elements:
Cromolyn sodium cromolyn sodium water cromolyn sodium cromolyn clear, colorless
Indications and Usage:
Indications and usage 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.
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.
Dosage and 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 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
Read more... (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.
Contraindications:
Contraindications cromolyn sodium oral solution (concentrate) 100 mg/5 ml is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium.
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 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 gastroin
Read more...testinal 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
Use in 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). 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.
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/m 2 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/m 2 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/m 2 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 cromolyn sodium oral solution (concentrate) 100 mg/5 ml 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.
Description:
Description 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 5,5â-[(2-hydroxytrimethylene)dioxy]bis[4-oxo-4h-1-benzopyran-2-carboxylate]. the molecular formula is c 23 h 14 na 2 o 11 ; the molecular weight is 512.34. its chemical structure is: pharmacologic category: mast cell stabilizer therapeutic category: antiallergic str-a
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%.
Carcinogenesis and Mutagenesis and 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/m 2 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
Read more...a mg/m 2 basis) and 100 mg/kg in females (less than the maximum recommended daily oral dose in adults on a mg/m 2 basis).
How Supplied:
How supplied 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
Spl Patient Package Insert:
Patient instructions cromolyn sodium oral solution (concentrate) 100 mg/5 ml for oral use only â 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 m
Read more...g/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 cromolynsodium-instr.jpg
Package Label Principal Display Panel:
Package label.principal display panel-5 ml fill in 5 ml container label ndc 42571-132-21 cromolyn sodium oral solution (concentrate) 100 mg/5 ml rx only 5 ml micro labs limited cromolynsodium-lbl.jpg
Package label.principal display panel-inner carton label 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 cromolynsodium-crtn.jpg
Package label.principal display panel- outer carton label 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 cromolynsodium-outrcrtn.jpg