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| Product NDC Code | 68788-8490 | ||||
|---|---|---|---|---|---|
| Drug Name | Cromolyn sodium |
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| Type | Generic | ||||
| Pharm Class | Decreased Histamine Release [PE], Mast Cell Stabilizer [EPC] |
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| Active Ingredients |
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| Route | OPHTHALMIC | ||||
| Dosage Form | SOLUTION/ DROPS | ||||
| RxCUI drug identifier | 831109 | ||||
| Application Number | ANDA075282 | ||||
| Labeler Name | Preferred Pharmaceuticals Inc. | ||||
| Packages |
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Adverse reactions
Information about undesirable effects, reasonably associated with use of the drug, that may occur as part of the pharmacological action of the drug or may be unpredictable in its occurrence. Adverse reactions include those that occur with the drug, and if applicable, with drugs in the same pharmacologically active and chemically related class. There is considerable variation in the listing of adverse reactions. They may be categorized by organ system, by severity of reaction, by frequency, by toxicological mechanism, or by a combination of these.ADVERSE REACTIONS The most frequently reported adverse reaction attributed to the use of cromolyn sodium ophthalmic solution, 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 attributable to the drug: Conjunctival injection; watery eyes; itchy eyes; dryness around the eye; puffy eyes; eye irritation; and styes. Immediate hypersensitivity reactions have been reported rarely and include dyspnea, edema and rash.
Clinical pharmacology
Information about the clinical pharmacology and actions of the drug in humans.CLINICAL PHARMACOLOGY 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, antihistaminic 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.
Contraindications
Information about situations in which the drug product is contraindicated or should not be used because the risk of use clearly outweighs any possible benefit, including the type and nature of reactions that have been reported.CONTRAINDICATIONS 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.
Description
General information about the drug product, including the proprietary and established name of the drug, the type of dosage form and route of administration to which the label applies, qualitative and quantitative ingredient information, the pharmacologic or therapeutic class of the drug, and the chemical name and structural formula of the drug.DESCRIPTION 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%. Inactives: edetate disodium 0.1% and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (4.0-7.0). chemicalstructure
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.DOSAGE AND ADMINISTRATION The dose is 1 or 2 drops in each eye 4 to 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 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%.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.INDICATIONS AND USAGE Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.
Spl product data elements
Usually a list of ingredients in a drug product.Cromolyn Sodium Cromolyn Sodium CROMOLYN SODIUM CROMOLYN BENZALKONIUM CHLORIDE EDETATE DISODIUM WATER HYDROCHLORIC ACID SODIUM HYDROXIDE
Carcinogenesis and mutagenesis and impairment of fertility
Information about carcinogenic, mutagenic, or fertility impairment potential revealed by studies in animals. Information from human data about such potential is part of the warnings field.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/m 2 for mice, 47.2 mg/m 2 for hamsters and 385.8 mg/m 2 for rats. These doses correspond to approximately 6.8, 1.7 and 14 times the maximum daily human dose of 28 mg/m 2 . Cromolyn sodium showed no mutagenic potential in the Ames Salmonella /microsome plate assays, mitotic gene conversion in Saccharomycas 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 2 ) in males and 100 mg/kg/day (600 mg/m 2 ) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m 2 .
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL NDC 68788-8490-1 Cromolyn Sodium Ophthalmic Solution USP 4% Rx Only STERILE 10 mL SANDOZ Relabeled By: Preferred Pharmaceuticals Inc. Cromolyn Sodium Opth Solution 4%
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.300049857-0821 Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA August 2021 Relabeled By: Preferred Pharmaceuticals Inc. Information for the Patient Cromolyn Sodium (KRO moe lin SOE dee um) Ophthalmic Solution USP, 4% Sterile It is important to use Cromolyn Sodium Ophthalmic Solution USP, 4% regularly, as directed by your physician. 1. Thoroughly wash your hands. 2. Remove safety seal (Figure 1). 3. Remove cap (Figure 2). 4. Sit or stand comfortably, with your head tilted back (Figure 3). 5. Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4). 6. Hold the Cromolyn Sodium Ophthalmic Solution USP, 4% bottle upside down. Place dropper tip as close as possible to the lower eyelid and gently squeeze out the prescribed number of drops (Figure 5). 7. Do not touch the eye or eyelid with the dropper tip. 8. Blink a few times to make sure the eye is covered with the solution. 9. Close your eye and remove any excess solution with a clean tissue. 10. Repeat process in the other eye. SPECIAL TIPS 1. Avoid placing Cromolyn Sodium Ophthalmic Solution USP, 4% directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of the eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5. 2. To avoid contamination of the solution, do not touch dropper tip to the eye, fingers, or any other surface. Replace cap after use. It is recommended that any remaining contents be discarded after the treatment period prescribed by your physician. 3. Store between 15°-30°C (59°-86°F). Protect from light - store in original carton. 4. Keep tightly closed and out of the reach of children. 5. Do not use with any other ocular medication unless directed by your physician. Do not wear contact lenses during treatment with Cromolyn Sodium Ophthalmic Solution USP, 4%. Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540 Printed in USA August 2021 300049857-0821 Relabeled By: Preferred Pharmaceuticals Inc. image
Cromolyn Sodium: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Information for the Patient 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%.
Nursing mothers
Information about excretion of the drug in human milk and effects on the nursing infant, including pertinent adverse effects observed in animal offspring.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.
Pediatric use
Information about any limitations on any pediatric indications, needs for specific monitoring, hazards associated with use of the drug in any subsets of the pediatric population (such as neonates, infants, children, or adolescents), differences between pediatric and adult responses to the drug, and other information related to the safe and effective pediatric use of the drug.Pediatric Use Safety and effectiveness in children below the age of 4 years have not been established.
Pregnancy
Information about effects the drug may have on pregnant women or on a fetus. This field may be ommitted if the drug is not absorbed systemically and the drug is not known to have a potential for indirect harm to the fetus. It may contain information about the established pregnancy category classification for the drug. (That information is nominally listed in the teratogenic_effects field, but may be listed here instead.)Pregnancy
Teratogenic effects
Pregnancy category A: Adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in the first trimester of pregnancy, and there is no evidence of a risk in later trimesters. Pregnancy category B: Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women. Pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus, there are no adequate and well-controlled studies in humans, and the benefits from the use of the drug in pregnant women may be acceptable despite its potential risks. Pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks (for example, if the drug is needed in a life-threatening situation or serious disease for which safer drugs cannot be used or are ineffective). Pregnancy category X: Studies in animals or humans have demonstrated fetal abnormalities or there is positive evidence of fetal risk based on adverse reaction reports from investigational or marketing experience, or both, and the risk of the use of the drug in a pregnant woman clearly outweighs any possible benefit (for example, safer drugs or other forms of therapy are available).Teratogenic Effects Pregnancy Category B. Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m 2 ) and 164 mg/kg (984 mg/m 2 ), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m 2 ) produced no evidence of fetal malformation. These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m 2 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.
How supplied
Information about the available dosage forms to which the labeling applies, and for which the manufacturer or distributor is responsible. This field ordinarily includes the strength of the dosage form (in metric units), the units in which the dosage form is available for prescribing, appropriate information to facilitate identification of the dosage forms (such as shape, color, coating, scoring, and National Drug Code), and special handling and storage condition information.HOW SUPPLIED Cromolyn Sodium Ophthalmic Solution USP, 4% is supplied in a white, opaque, plastic ophthalmic dispenser in the following size: 10 mL NDC 68788-8490-1 Storage: Store between 15° - 30°C (59°- 86°F). Protect from light-store in original carton. Keep tightly closed and out of the reach of children. Rx Only
General precautions
Information about any special care to be exercised for safe and effective use of the drug.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 ).
Precautions
Information about any special care to be exercised for safe and effective use of the drug.PRECAUTIONS 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 ). Information for the Patient 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%. 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/m 2 for mice, 47.2 mg/m 2 for hamsters and 385.8 mg/m 2 for rats. These doses correspond to approximately 6.8, 1.7 and 14 times the maximum daily human dose of 28 mg/m 2 . Cromolyn sodium showed no mutagenic potential in the Ames Salmonella /microsome plate assays, mitotic gene conversion in Saccharomycas 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 2 ) in males and 100 mg/kg/day (600 mg/m 2 ) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m 2 . Pregnancy Teratogenic Effects Pregnancy Category B. Reproduction studies with cromolyn sodium administered subcutaneously to pregnant mice and rats at maximum daily doses of 540 mg/kg (1620 mg/m 2 ) and 164 mg/kg (984 mg/m 2 ), respectively, and intravenously to rabbits at a maximum daily dose of 485 mg/kg (5820 mg/m 2 ) produced no evidence of fetal malformation. These doses represent approximately 57, 35, and 205 times the maximum daily human dose, respectively, on a mg/m 2 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 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. Pediatric Use Safety and effectiveness in children below the age of 4 years have not been established.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API