 |
drug-information.ru |
|Cromolyn Cromolyn Ophthalmic Solution |
| Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home CromolynGeneric Name: Cromolyn sodium Dosage Form: Ophthalmic solution DescriptionCromolyn 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. Clinical PharmacologyIn 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. Indications and UsageCromolyn Sodium Ophthalmic Solution, USP 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. ContraindicationsCromolyn Sodium Ophthalmic Solution, USP 4% is contraindicated in those patients who have shown hypersensitivity to Cromolyn sodium or to any of the other ingredients. PrecautionsGeneralPatients 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). Information for PatientsPatients 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%. Carcinogenesis, Mutagenesis, Impairment of FertilityLong 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/m2 for mice, 47.2 mg/m2 for hamsters and 385.8 mg/m2 for rats. These doses correspond to approximately 6.8, 1.7, and 14 times the maximum daily human dose of 28 mg/m2. 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/m2) in males and 100 mglkg/day (600 mg/m2) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m2. PregnancyTeratogenic 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/m2) and 164 mg/kg (984 mg/m2), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m2) produced no evidence of fetal malformation. These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m2 basis. 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. Nursing MothersIt 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. Pediatric UseSafety and effectiveness in children below the age of 4 years have not been established. Adverse ReactionsThe 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. Dosage and AdministrationThe 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%. How SuppliedCromolyn 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 Information for the PatientCromolyn Sodium Ophthalmic Solution, USP 4% Sterile It is important to use Cromolyn Sodium Ophthalmic Solution, USP 4% regularly, as directed by your physician.
Special Tips
Manufactured by: King Pharmaceuticals, Inc. Bristol, TN 37620 Rev 05/99
Revised: 10/2006 Where can I get more information about Cromolyn Cromolyn Ophthalmic Solution ? We recommend to use www.Drugs.com Typical mistypes for Cromolyn Cromolyn Ophthalmic Solution xromolyn cromolyn ophthalmic solution, vromolyn cromolyn ophthalmic solution, fromolyn cromolyn ophthalmic solution, dromolyn cromolyn ophthalmic solution, ceomolyn cromolyn ophthalmic solution, cdomolyn cromolyn ophthalmic solution, cfomolyn cromolyn ophthalmic solution, ctomolyn cromolyn ophthalmic solution, c5omolyn cromolyn ophthalmic solution, c4omolyn cromolyn ophthalmic solution, crimolyn cromolyn ophthalmic solution, crkmolyn cromolyn ophthalmic solution, crlmolyn cromolyn ophthalmic solution, crpmolyn cromolyn ophthalmic solution, cr0molyn cromolyn ophthalmic solution, cr9molyn cromolyn ophthalmic solution, cronolyn cromolyn ophthalmic solution, crokolyn cromolyn ophthalmic solution, crojolyn cromolyn ophthalmic solution, cromilyn cromolyn ophthalmic solution, cromklyn cromolyn ophthalmic solution, cromllyn cromolyn ophthalmic solution, cromplyn cromolyn ophthalmic solution, crom0lyn cromolyn ophthalmic solution, crom9lyn cromolyn ophthalmic solution, cromokyn cromolyn ophthalmic solution, cromopyn cromolyn ophthalmic solution, cromooyn cromolyn ophthalmic solution, cromoltn cromolyn ophthalmic solution, cromolgn cromolyn ophthalmic solution, cromolhn cromolyn ophthalmic solution, cromolun cromolyn ophthalmic solution, cromol7n cromolyn ophthalmic solution, cromol6n cromolyn ophthalmic solution, cromolyb cromolyn ophthalmic solution, cromolym cromolyn ophthalmic solution, cromolyj cromolyn ophthalmic solution, cromolyh cromolyn ophthalmic solution, cromolyn xromolyn ophthalmic solution, cromolyn vromolyn ophthalmic solution, cromolyn fromolyn ophthalmic solution, cromolyn dromolyn ophthalmic solution, cromolyn ceomolyn ophthalmic solution, cromolyn cdomolyn ophthalmic solution, cromolyn cfomolyn ophthalmic solution, cromolyn ctomolyn ophthalmic solution, cromolyn c5omolyn ophthalmic solution, cromolyn c4omolyn ophthalmic solution, cromolyn crimolyn ophthalmic solution, cromolyn crkmolyn ophthalmic solution, cromolyn crlmolyn ophthalmic solution, cromolyn crpmolyn ophthalmic solution, cromolyn cr0molyn ophthalmic solution, cromolyn cr9molyn ophthalmic solution, cromolyn cronolyn ophthalmic solution, cromolyn crokolyn ophthalmic solution, cromolyn crojolyn ophthalmic solution, cromolyn cromilyn ophthalmic solution, cromolyn cromklyn ophthalmic solution, cromolyn cromllyn ophthalmic solution, cromolyn cromplyn ophthalmic solution, cromolyn crom0lyn ophthalmic solution, cromolyn crom9lyn ophthalmic solution, cromolyn cromokyn ophthalmic solution, cromolyn cromopyn ophthalmic solution, cromolyn cromooyn ophthalmic solution, cromolyn cromoltn ophthalmic solution, cromolyn cromolgn ophthalmic solution, cromolyn cromolhn ophthalmic solution, cromolyn cromolun ophthalmic solution, cromolyn cromol7n ophthalmic solution, cromolyn cromol6n ophthalmic solution, cromolyn cromolyb ophthalmic solution, cromolyn cromolym ophthalmic solution, cromolyn cromolyj ophthalmic solution, cromolyn cromolyh ophthalmic solution, cromolyn cromolyn iphthalmic solution, cromolyn cromolyn kphthalmic solution, cromolyn cromolyn lphthalmic solution, cromolyn cromolyn pphthalmic solution, cromolyn cromolyn 0phthalmic solution, cromolyn cromolyn 9phthalmic solution, cromolyn cromolyn oohthalmic solution, cromolyn cromolyn olhthalmic solution, cromolyn cromolyn o-hthalmic solution, cromolyn cromolyn o0hthalmic solution, cromolyn cromolyn opgthalmic solution, cromolyn cromolyn opbthalmic solution, cromolyn cromolyn opnthalmic solution, cromolyn cromolyn opjthalmic solution, cromolyn cromolyn oputhalmic solution, cromolyn cromolyn opythalmic solution, cromolyn cromolyn ophrhalmic solution, cromolyn cromolyn ophfhalmic solution, cromolyn cromolyn ophghalmic solution, cromolyn cromolyn ophyhalmic solution, cromolyn cromolyn oph6halmic solution, cromolyn cromolyn oph5halmic solution, cromolyn cromolyn ophtgalmic solution, cromolyn cromolyn ophtbalmic solution, cromolyn cromolyn ophtnalmic solution, cromolyn cromolyn ophtjalmic solution, cromolyn cromolyn ophtualmic solution, cromolyn cromolyn ophtyalmic solution, cromolyn cromolyn ophthzlmic solution, cromolyn cromolyn ophthslmic solution, cromolyn cromolyn ophthwlmic solution, cromolyn cromolyn ophthqlmic solution, cromolyn cromolyn ophthakmic solution, cromolyn cromolyn ophthapmic solution, cromolyn cromolyn ophthaomic solution, cromolyn cromolyn ophthalnic solution, cromolyn cromolyn ophthalkic solution, cromolyn cromolyn ophthaljic solution, cromolyn cromolyn ophthalmuc solution, cromolyn cromolyn ophthalmjc solution, cromolyn cromolyn ophthalmkc solution, cromolyn cromolyn ophthalmoc solution, cromolyn cromolyn ophthalm9c solution, cromolyn cromolyn ophthalm8c solution, cromolyn cromolyn ophthalmix solution, cromolyn cromolyn ophthalmiv solution, cromolyn cromolyn ophthalmif solution, cromolyn cromolyn ophthalmid solution, cromolyn cromolyn ophthalmic aolution, cromolyn cromolyn ophthalmic zolution, cromolyn cromolyn ophthalmic xolution, cromolyn cromolyn ophthalmic dolution, cromolyn cromolyn ophthalmic eolution, cromolyn cromolyn ophthalmic wolution, cromolyn cromolyn ophthalmic silution, cromolyn cromolyn ophthalmic sklution, cromolyn cromolyn ophthalmic sllution, cromolyn cromolyn ophthalmic splution, cromolyn cromolyn ophthalmic s0lution, cromolyn cromolyn ophthalmic s9lution, cromolyn cromolyn ophthalmic sokution, cromolyn cromolyn ophthalmic sopution, cromolyn cromolyn ophthalmic sooution, cromolyn cromolyn ophthalmic solytion, cromolyn cromolyn ophthalmic solhtion, cromolyn cromolyn ophthalmic soljtion, cromolyn cromolyn ophthalmic solition, cromolyn cromolyn ophthalmic sol8tion, cromolyn cromolyn ophthalmic sol7tion, cromolyn cromolyn ophthalmic solurion, cromolyn cromolyn ophthalmic solufion, cromolyn cromolyn ophthalmic solugion, cromolyn cromolyn ophthalmic soluyion, cromolyn cromolyn ophthalmic solu6ion, cromolyn cromolyn ophthalmic solu5ion, cromolyn cromolyn ophthalmic solutuon, cromolyn cromolyn ophthalmic solutjon, cromolyn cromolyn ophthalmic solutkon, cromolyn cromolyn ophthalmic solutoon, cromolyn cromolyn ophthalmic solut9on, cromolyn cromolyn ophthalmic solut8on, cromolyn cromolyn ophthalmic solutiin, cromolyn cromolyn ophthalmic solutikn, cromolyn cromolyn ophthalmic solutiln, cromolyn cromolyn ophthalmic solutipn, cromolyn cromolyn ophthalmic soluti0n, cromolyn cromolyn ophthalmic soluti9n, cromolyn cromolyn ophthalmic solutiob, cromolyn cromolyn ophthalmic solutiom, cromolyn cromolyn ophthalmic solutioj, cromolyn cromolyn ophthalmic solutioh, romolyn cromolyn ophthalmic solution, comolyn cromolyn ophthalmic solution, crmolyn cromolyn ophthalmic solution, croolyn cromolyn ophthalmic solution, cromlyn cromolyn ophthalmic solution, cromoyn cromolyn ophthalmic solution, cromoln cromolyn ophthalmic solution, cromoly cromolyn ophthalmic solution, cromolyn cromolyn ophthalmic solution, cromolyn cromolyn ophthalmic solution, cromolyn romolyn ophthalmic solution, cromolyn comolyn ophthalmic solution, cromolyn crmolyn ophthalmic solution, cromolyn croolyn ophthalmic solution, cromolyn cromlyn ophthalmic solution, cromolyn cromoyn ophthalmic solution, cromolyn cromoln ophthalmic solution, cromolyn cromoly ophthalmic solution, cromolyn cromolynophthalmic solution, cromolyn cromolyn phthalmic solution, cromolyn cromolyn ohthalmic solution, cromolyn cromolyn opthalmic solution, cromolyn cromolyn ophhalmic solution, cromolyn cromolyn ophtalmic solution, cromolyn cromolyn ophthlmic solution, cromolyn cromolyn ophthamic solution, cromolyn cromolyn ophthalic solution, cromolyn cromolyn ophthalmc solution, cromolyn cromolyn ophthalmi solution, cromolyn cromolyn ophthalmicsolution, cromolyn cromolyn ophthalmic olution, cromolyn cromolyn ophthalmic slution, cromolyn cromolyn ophthalmic soution, cromolyn cromolyn ophthalmic soltion, cromolyn cromolyn ophthalmic soluion, cromolyn cromolyn ophthalmic soluton, cromolyn cromolyn ophthalmic solutin, cromolyn cromolyn ophthalmic solutio, rcomolyn cromolyn ophthalmic solution, cormolyn cromolyn ophthalmic solution, crmoolyn cromolyn ophthalmic solution, croomlyn cromolyn ophthalmic solution, cromloyn cromolyn ophthalmic solution, cromoyln cromolyn ophthalmic solution, cromolny cromolyn ophthalmic solution, cromoly n cromolyn ophthalmic solution, cromolyn cromolyn ophthalmic solution, cromolyn c romolyn ophthalmic solution, cromolyn rcomolyn ophthalmic solution, cromolyn cormolyn ophthalmic solution, cromolyn crmoolyn ophthalmic solution, cromolyn croomlyn ophthalmic solution, cromolyn cromloyn ophthalmic solution, cromolyn cromoyln ophthalmic solution, cromolyn cromolny ophthalmic solution, cromolyn cromoly nophthalmic solution, cromolyn cromolyno phthalmic solution, cromolyn cromolyn pohthalmic solution, cromolyn cromolyn ohpthalmic solution, cromolyn cromolyn opthhalmic solution, cromolyn cromolyn ophhtalmic solution, cromolyn cromolyn ophtahlmic solution, cromolyn cromolyn ophthlamic solution, cromolyn cromolyn ophthamlic solution, cromolyn cromolyn ophthalimc solution, cromolyn cromolyn ophthalmci solution, cromolyn cromolyn ophthalmi csolution, cromolyn cromolyn ophthalmics olution, cromolyn cromolyn ophthalmic oslution, cromolyn cromolyn ophthalmic sloution, cromolyn cromolyn ophthalmic soultion, cromolyn cromolyn ophthalmic soltuion, cromolyn cromolyn ophthalmic soluiton, cromolyn cromolyn ophthalmic solutoin, cromolyn cromolyn ophthalmic solutino, ccromolyn cromolyn ophthalmic solution, crromolyn cromolyn ophthalmic solution, croomolyn cromolyn ophthalmic solution, crommolyn cromolyn ophthalmic solution, cromoolyn cromolyn ophthalmic solution, cromollyn cromolyn ophthalmic solution, cromolyyn cromolyn ophthalmic solution, cromolynn cromolyn ophthalmic solution, cromolyn cromolyn ophthalmic solution, cromolyn cromolyn ophthalmic solution, cromolyn ccromolyn ophthalmic solution, cromolyn crromolyn ophthalmic solution, cromolyn croomolyn ophthalmic solution, cromolyn crommolyn ophthalmic solution, cromolyn cromoolyn ophthalmic solution, cromolyn cromollyn ophthalmic solution, cromolyn cromolyyn ophthalmic solution, cromolyn cromolynn ophthalmic solution, cromolyn cromolyn ophthalmic solution, cromolyn cromolyn oophthalmic solution, cromolyn cromolyn opphthalmic solution, cromolyn cromolyn ophhthalmic solution, cromolyn cromolyn ophtthalmic solution, cromolyn cromolyn ophthhalmic solution, cromolyn cromolyn ophthaalmic solution, cromolyn cromolyn ophthallmic solution, cromolyn cromolyn ophthalmmic solution, cromolyn cromolyn ophthalmiic solution, cromolyn cromolyn ophthalmicc solution, cromolyn cromolyn ophthalmic solution, cromolyn cromolyn ophthalmic ssolution, cromolyn cromolyn ophthalmic soolution, cromolyn cromolyn ophthalmic sollution, cromolyn cromolyn ophthalmic soluution, cromolyn cromolyn ophthalmic soluttion, cromolyn cromolyn ophthalmic solutiion, cromolyn cromolyn ophthalmic solutioon, cromolyn cromolyn ophthalmic solutionn, etc.
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
