Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1012
| Predicate | Object |
|---|---|
| rdf:type | |
| rdfs:label |
Cromolyn Sodium (Solution)
|
| dailymed-instance:dosage |
The dose is 1-2 drops in each eye 4-6 times a day at regular
intervals. One drop contains approximately 1.6 mg cromolyn sodium. Patients
should be advised that the effect of Cromolyn Sodium Ophthalmic Solution,
4% therapy is dependent upon its administration at regular intervals, as directed. Symptomatic
response to therapy (decreased itching, tearing, redness, and discharge) is
usually evident within a few days, but longer treatment for up to six weeks
is sometimes required. Once symptomatic improvement has been established,
therapy should be continued for as long as needed to sustain improvement. If required, corticosteroids may be used concomitantly
with Cromolyn Sodium Ophthalmic Solution, USP 4%.
|
| dailymed-instance:descripti... |
Cromolyn Sodium Ophthalmic Solution, USP 4% is a clear,
colorless, sterile solution intended for topical ophthalmic use. Cromolyn
sodium is represented by the following structural formula: Chemical
Name: disodium 5-5' - [(2-hydroxytrimethylene) dioxy] bis [4-oxo-4H-1-benzopyran-2-carboxylate]. Pharmacologic
Category: Mast cell stabilizer Each mL contains: Active: Cromolyn sodium 40 mg (4%); Preservative:Benzalkonium chloride 0.01%; lnactives: Edetate disodium 0.1% and purified water. It has a pH of 4.0 to
7.0.
|
| dailymed-instance:clinicalP... |
In vitro and in vivo animal studies have shown that cromolyn
sodium inhibits the degranulation of sensitized mast cells which occurs after
exposure to specific antigens. Cromolyn sodium acts by inhibiting the release
of histamine and SRS-A (slow-reacting substance of anaphylaxis) from the mast
cell. Another activity demonstrated in vitro is the
capacity of cromolyn sodium to inhibit the degranulation of non-sensitized
rat mast cells by phospholipase A and the subsequent release of chemical mediators.
Another study showed that cromolyn sodium did not inhibit the enzymatic activity
of released phospholipase A on its specific substrate. Cromolyn
sodium has no intrinsic vasoconstrictor, antihistamine, or anti-inflammatory
activity. Cromolyn sodium is poorly absorbed. When
multiple doses of cromolyn sodium ophthalmic solution are instilled into normal
rabbit eyes, less than 0.07% of the administered dose of cromolyn sodium is
absorbed into the systemic circulation (presumably by way of the eye, nasal
passages, buccal cavity, and gastrointestinal tract). Trace amounts (less
than 0.01%) of the cromolyn sodium dose penetrate into the aqueous humor and
clearance from this chamber is virtually complete within 24 hours after treatment
is stopped. In normal volunteers, analysis of drug
excretion indicates that approximately 0.03% of cromolyn sodium is absorbed
following administration to the eye.
|
| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Cromolyn Sodium Ophthalmic Solution, USP 4% is contraindicated
in those patients who have shown hypersensitivity to cromolyn sodium or to
any of the other ingredients.
|
| dailymed-instance:supply |
Cromolyn Sodium Ophthalmic Solution, USP 4% is supplied
as 10 mL of solution in an opaque polyethylene eye drop bottle. 10
mL NDC 60793-075-10 Store at Controlled Room Temperature
20���25��C (68���77��F). Protect from light���store
in original carton. Keep tightly closed and out of the reach of children. Rx only. Manufactured by: King
Pharmaceuticals, Inc., Bristol, TN 37620 Rev 05/99
|
| dailymed-instance:activeMoi... | |
| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
General: Patients may experience a transient stinging or burning
sensation following application of Cromolyn Sodium Ophthalmic Solution, USP
4%. The recommended frequency of administration should
not be exceeded (see DOSAGE AND ADMINISTRATION).<br/>Information for Patients: Patients should be advised to follow the patient instructions
listed on the Information for Patients sheet. Users
of contact lenses should refrain from wearing lenses while exhibiting the
signs and symptoms of vernal keratoconjunctivitis, vernal conjunctivitis,
or vernal keratitis. Do not wear contact lenses during treatment with Cromolyn
Sodium Ophthalmic Solution, USP 4%.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Long term studies of cromolyn sodium in mice (12 months
intraperitoneal administration at doses up to 150 mg/kg three days per week),
hamsters (intraperitoneal administration at doses up to 52.6 mg/kg three days
per week for 15 weeks followed by 17.5 mg/kg three days per week for 37 weeks),
and rats (18 months subcutaneous administration at doses up to 75 mg/kg six
days per week) showed no neoplastic effects. The average daily maximum dose
levels administered in these studies were 192.9 mg/mfor mice,
47.2 mg/mfor hamsters and 385.8 mg/mfor rats. These
doses correspond to approximately 6.8, 1.7, and 14 times the maximum daily
human dose of 28 mg/m. Cromolyn sodium
showed no mutagenic potential in the Ames Salmonella/microsome plate assays, mitotic gene conversion in Saccharomyces
cerevisiae and in an in vitro cytogenetic
study in human peripheral lymphocytes. No evidence
of impaired fertility was shown in laboratory reproduction studies conducted
subcutaneously in rats at the highest doses tested, 175 mg/kg/day (1050 mg/m)
in males and 100 mglkg/day (600 mg/m) in females. These doses
are approximately 37 and 21 times the maximum daily human dose, respectively,
based on mg/m.<br/>Pregnancy:<br/>Teratogenic Effects: Pregnancy Category B.: Reproduction studies with cromolyn sodium administered subcutaneously
to pregnant mice and rats at the maximum daily doses of 540 mg/kg (1620 mg/m)
and 164 mg/kg (984 mg/m), respectively, and intravenously to rabbits
at a maximum daily dose of 485 mg/kg (5820 mg/m) produced no evidence
of fetal malformation. These doses represent approximately 57, 35, and 205
times the maximum daily human dose, respectively, on a mg/mbasis.
Adverse fetal effects (increased resorption and decreased fetal weight) were
noted only at the very high parenteral doses that produced maternal toxicity.
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.<br/>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 Cromolyn Sodium Ophthalmic Solution, USP 4% is administered to a nursing
woman.<br/>Pediatric Use: Safety and effectiveness in children below the age of 4
years have not been established.
|
| dailymed-instance:genericMe... |
cromolyn sodium
|
| dailymed-instance:fullName |
Cromolyn Sodium (Solution)
|
| dailymed-instance:adverseRe... |
The most frequently reported adverse reaction attributed
to the use of Cromolyn Sodium Ophthalmic Solution, USP 4%, on the basis of
reoccurrence following readministration, is transient ocular stinging or
burning upon instillation. The following adverse reactions
have been reported as infrequent events. It is unclear whether they are attributedto the drug: Conjunctival infection; watery eyes; itchy
eyes; dryness around the eye; puffy eyes; eye irritation; and styes. Immediate
hypersensitivity reactions been reported rarely and include dyspnea edema,
and rash.
|
| dailymed-instance:indicatio... |
Cromolyn Sodium Ophthalmic Solution, USP 4% is indicated
in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and
vernal keratitis.
|
| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Cromolyn Sodium
|