wrestle Crolom Generic Name: cromolyn sodium Dosage Form: ophthalmic solution Overview Side Effects Dosage Professional Pregnancy More Breastfeeding Warnings User Reviews Support Group Q & A Crolom cromolyn sodium ophthalmic solution USP, 4% STERILE OPHTHALMIC SOLUTION Rx only Slideshow Red, Irritated, Watering Eyes? Chances Are You ve Got Pink Eye DESCRIPTION: Crolom (cromolyn sodium ophthalmic solution USP, 4%) is a clear, colorless, sterile solution for topical ophthalmic use. Cromolyn sodium is represented by the following structural formula: C 23 H 14 Na 2 O 11 Mol. Wt. 512.34 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%); INACTIVES: Edetate Disodium 0.1% and Purified Water. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 - 7.0). PRESERVATIVE ADDED: Benzalkonium Chloride 0.01%. 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 nonsensitized 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 USAGE: Cromolyn sodium ophthalmic solution is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis. CONTRAINDICATIONS: Cromolyn sodium ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to cromolyn sodium or to any of the other ingredients. PRECAUTIONS: General: Patients may experience a transient stinging or burning sensation following application of cromolyn sodium ophthalmic solution. The recommended frequency of administration should not be exceeded ( see DOSAGE AND ADMINISTRATION ). 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. 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 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 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 is administered to a nursing woman. Pediatric Use: Safety and effectiveness in pediatric patients below the age of 4 years have not been established. Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients. 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 attributed 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. DOSAGE AND ADMINISTRATION: 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 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. FOR OPHTHALMIC USE ONLY HOW SUPPLIED: Crolom (cromolyn sodium ophthalmic solution USP, 4%) is supplied in a plastic bottle individually cartoned with a controlled drop tip in the following sizes: 10 mL bottle (NDC 24208-300-10) - AB30709 DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. Storage: Store between 15 -30 C (59 -86 F). Protect from light store in original carton. Keep tightly closed. Replace cap immediately after use. KEEP OUT OF REACH OF CHILDREN. Rx only Bausch & Lomb Incorporated Tampa, Florida 33637 Bausch & Lomb Incorporated XO50206 (Folded) XM10005 (Flat) R.1/04-83 Patient Instructions PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS Information for the Patient Crolom (cromolyn sodium ophthalmic solution USP, 4%) Sterile It is important to use Crolom 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 Crolom 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 Crolom solution directly on the cornea (the area just over the pupil), because it is especially sensitive. You will find the administration of eye drops more comfortable if you place the drops just inside the lower eyelid as shown in Figure 5 on the previous page. 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. Keep tightly closed. Replace cap immediately after use. 4. Keep 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 Crolom . Bausch & Lomb Incorporated Tampa, Florida 33637 Bausch & Lomb Incorporated XO50206 (Folded) XM10005 (Flat) R.1/04-83 Principal Display Panel NDC 24208-300-10 Bausch & Lomb Crolom Cromolyn Sodium Ophthalmic Solution USP, 4% [icon- eye] STERILE Rx only 10 mL Crolom cromolyn sodium solution/ drops Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:24208-300 Route of Administration OPHTHALMIC DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CROMOLYN SODIUM (CROMOLYN) CROMOLYN SODIUM 40 mg in 1 mL Inactive Ingredients Ingredient Name Strength BENZALKONIUM CHLORIDE EDETATE DISODIUM HYDROCHLORIC ACID WATER SODIUM HYDROXIDE Packaging # Item Code Package Description 1 NDC:24208-300-10 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON 1 10 mL in 1 BOTTLE, DROPPER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074443 01/30/1995 Labeler - Bausch & Lomb Incorporated (196603781) Establishment Name Address ID/FEI Operations Bausch & Lomb Incorporated 807927397 MANUFACTURE Revised: 03/2011 Bausch & Lomb Incorporated Next Pregnancy Warnings Print this page Add to My Med List More about Crolom (cromolyn ophthalmic) Side Effects During Pregnancy or Breastfeeding Dosage Information Support Group 0 Reviews Add your own review/rating Drug class: ophthalmic antihistamines and decongestants Consumer resources Crolom (Advanced Reading) Professional resources Cromolyn Sodium eent (AHFS Monograph) Related treatment guides Conjunctivitis, Allergic Keratitis Keratoconjunctivitis} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Ophthalmic antihistamines and decongestants Related Drugs ophthalmic antihistamines and decongestants azelastine ophthalmic , Pataday , Patanol , phenylephrine ophthalmic , olopatadine ophthalmic , Zaditor Conjunctivitis, Allergic prednisone , prednisolone ophthalmic , azelastine ophthalmic , Deltasone , Zaditor , cromolyn ophthalmic , doxylamine , More... Keratoconjunctivitis diclofenac ophthalmic , Maxitrol , cromolyn ophthalmic , Blephamide , Alomide , Pred-G , More... Keratitis prednisone , triamcinolone , prednisolone ophthalmic , dexamethasone , Decadron , Lotemax , Deltasone , More... Crolom Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } prior to
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