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CROMOLYN SODIUM solution/ drops


  1. Cromolyn Sodium Ophthalmic Solution, Usp 4% (sterile)
  2. Description
  3. Clinical Pharmacology
  4. Indications And Usage
  5. Contraindications
  6. Precautions
  7. Adverse Reactions
  8. Dosage And Administration
  9. How Supplied
  10. Principal Display Panel Cromolyn Carton Label -10ml
  11. Description
  12. Clinical Pharmacology
  13. Indications And Usage
  14. Contraindications
  15. Precautions
  16. Principal Display Panel
  17. Cromolyn Sodium Ophthalmic Solution Usp, 4%
  18. Description:
  19. Clinical Pharmacology:
  20. Indications And Usage:
  21. Contraindications:
  22. Precautions:
  23. Adverse Reactions:
  24. Dosage And Administration:
  25. How Supplied:
  26. Patient Instructions
  27. Package/label Display Panel
  28. Cromolyn Sodiumophthalmic Solution Usp, 4%sterile
  29. Cromolyn Sodium Ophthalmic Solution, Usp 4%(sterile)
  30. Cromolyn Sodium
  31. Cromolyn Sodiumophthalmic Solution Usp, 4%sterile
  32. Description
  33. Clinical Pharmacology
  34. Indications And Usage
  35. Contraindications
  36. Precautions
  37. Adverse Reactions
  38. Dosage And Administration
  39. How Supplied
  40. Cromolyn Sodium

Cromolyn Sodium Ophthalmic Solution, Usp 4% (sterile)  

Rx only

Description 

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:

cromolyn sodium (structural formula)

C23H14Na2O11 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, USP. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (4.0 - 7.0). Preservative: 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 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 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, and 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/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 AmesSalmonella/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 mg/kg/day (600 mg/m2) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m2.

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/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 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.

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.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

FOR OPHTHALMIC USE ONLY

How Supplied 

Product: 50090-3125

NDC: 50090-3125-0 10 mL in a BOTTLE, DROPPER / 1 in a CARTON

PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Information for the Patient

Cromolyn Sodium 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.

Patient Instructions

SPECIAL TIPS

1. Avoid placing Cromolyn Sodium Ophthalmic Solution, USP 4% 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 -25 C (59 -77 F). Protect from light store in original carton. Keep tightly closed. Replace cap immediately after use.

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%.

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

Bausch & Lomb Incorporated

9087004 (Folded)
9087104 (Flat)

Principal Display Panel Cromolyn Carton Label -10ml 

pdp

CROMOLYN SODIUM
cromolyn sodium solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68071-3231(NDC:24208-961)
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:68071-3231-1 10 mL in 1 BOX; Type 0: Not a Combination Product 06/12/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074443 01/30/1995
Labeler - NuCare Pharmaceuticals, Inc. (010632300)
Establishment
Name Address ID/FEI Business Operations
NuCare Pharmaceuticals, Inc. 010632300 relabel(68071-3231)

Revised: 6/2017 NuCare Pharmaceuticals, Inc.

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

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).

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.

Indications And Usage  

Cromolyn Sodium Ophthalmic Solution USP, 4% is indicated in the treatment of vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

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.

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 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%.

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/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 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/m2) in males and 100 mg/kg/day (600 mg/m2) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m2.

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/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 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.

Principal Display Panel  

NDC 71205-230-10

Cromolyn

Sodium

Ophthalmic

Solution USP

4%

Rx Only

STERILE

10 mL

71205-230-10
CROMOLYN SODIUM
cromolyn sodium solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71205-230(NDC:61314-237)
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:71205-230-10 10 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/01/2019
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075282 06/29/1999
Labeler - Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079196022 RELABEL(71205-230)

Revised: 10/2019 Proficient Rx LP

Cromolyn Sodium Ophthalmic Solution Usp, 4%  

Rx only

Description: 

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:

cromolyn sodium (structural formula)

C23H14Na2O11 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 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 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, and 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/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 mg/kg/day (600 mg/m2) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m2.

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/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 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: 

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 63187-473-10)

DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT.

Storage:

Store between 15 -25 C (59 -77 F). Protect from light store in original carton. Keep tightly closed. Replace cap immediately after use.

KEEP OUT OF REACH OF CHILDREN.

Revised October 2014

Bausch & Lomb Incorporated
Tampa, Florida 33637
Bausch & Lomb Incorporated

9087001 (Folded)
9087101 (Flat)

Repackaged by:

Proficient Rx LP

Thousand Oaks, CA 91320

Patient Instructions 

PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Information for the Patient

Cromolyn Sodium Ophthalmic Solution USP, 4% (STERILE)

It is important to use Cromolyn sodium ophthalmic solutionUSP, 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.

Patient Instructions

SPECIAL TIPS

1. Avoid placing Cromolyn sodium ophthalmic solution USP, 4% 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 -25 C (59 -77 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 Cromolyn sodium ophthalmic solution USP, 4%.

Bausch & Lomb Incorporated
Tampa, Florida 33637

Bausch & Lomb Incorporated.

9087001 (Folded)
9087101 (Flat)

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Package/label Display Panel  

63187-473-10
CROMOLYN SODIUM
cromolyn sodium solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63187-473(NDC:24208-961)
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:63187-473-10 1 in 1 CARTON 02/02/2015
1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074443 05/26/1998
Labeler - Proficient Rx LP (079196022)
Establishment
Name Address ID/FEI Business Operations
Proficient Rx LP 079502574 RELABEL(63187-473)

Revised: 1/2019 Proficient Rx LP

Cromolyn Sodiumophthalmic Solution Usp, 4%sterile  

Rx only

Cromolyn Sodium Ophthalmic Solution, Usp 4%(sterile)  

Rx only

Cromolyn Sodium 

Label Image
CROMOLYN SODIUM
cromolyn sodium solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3125(NDC:24208-961)
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-3125-0 1 in 1 CARTON 08/22/2017
1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074443 01/30/1995
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-3125)

Revised: 5/2018 A-S Medication Solutions

Cromolyn Sodiumophthalmic Solution Usp, 4%sterile  

Rx only

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:

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%); Inactives: Edetate disodium 0.1% and Water for Injection. It has a pH of 4.0 to 7.0; Preservative: 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 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 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 Patient's 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, and 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/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 mg/kg/day (600 mg/m2) in females. These doses are approximately 37 and 21 times the maximum daily human dose, respectively, based on mg/m2.

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/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 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 children below the age of 4 years have not been established.

Adverse Reactions  

The most frequently reported adverse reaction attributed to the use of cromolyn sodium, 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 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 Sodium Chloride Ophthalmic Solution.

How Supplied  

Cromolyn Sodium Ophthalmic Solution USP 4% is supplied as 10 mL of solution in an opaque polyethylene bottle with a controlled dropper tip. NDC 17478-291-11

Storage: Store at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature].

Protect from light-store in original carton.

Keep tightly closed.

Keep out of reach of children.

Akorn
Manufactured By:
AKORN, INC.
Lake Forest, IL 60045

CR00N Rev. 06/16

PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENTS

Information for the Patient

Cromolyn Sodium Ophthalmic Solution USP, 4% Sterile

It is important to use Cromolyn Sodium Ophthalmic Solution regularly, as directed by your physician.

  1. Thoroughly wash your hands.
  2. Remove safety seal (Figure 1). Figure 1
  3. Remove cap (Figure 2). Figure 2
  4. Sit or stand comfortably, with your head tilted back (Figure 3). Figure 3
  5. Open eyes, look up, and draw the lower lid of your eye down gently with your index finger (Figure 4). Figure 4
  6. Hold the Cromolyn Sodium Ophthalmic Solution 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). 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 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 at 20 to 25 C (68 to 77 F) [see USP Controlled Room Temperature]. 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.

Akorn
Manufactured By:
AKORN, INC.
Lake Forest, IL 60045
Rev. 06/16

Principal Display Panel Text for Container Label:

NDC 17478-291-11

Cromolyn

Sodium

Ophthalmic

Solution, USP

4%

Rx only Sterile 10 mL

FOR OPHTHALMIC USE ONLY

Principal Display Panel Text for Container Label

Principal Display Panel Text for Carton Label:

NDC 17478-291-11

Cromolyn

Sodium

Ophthalmic

Solution, USP

4%

FOR OPHTHALMIC USE ONLY

Sterile

10 mL

Rx only Akorn Logo

Principal Display Panel Text for Carton Label
CROMOLYN SODIUM
cromolyn sodium solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:17478-291
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Cromolyn Sodium (UNII: Q2WXR1I0PK) (Cromolyn - UNII:Y0TK0FS77W) Cromolyn Sodium 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:17478-291-11 1 in 1 CARTON 04/29/1998
1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074706 04/29/1998
Labeler - Akorn, Inc. (062649876)
Establishment
Name Address ID/FEI Business Operations
Akorn, Inc. 603980319 MANUFACTURE(17478-291) , REPACK(17478-291) , ANALYSIS(17478-291) , LABEL(17478-291) , PACK(17478-291) , RELABEL(17478-291) , STERILIZE(17478-291)

Revised: 11/2017 Akorn, Inc.

Cromolyn Sodium 

Label Image
CROMOLYN SODIUM
cromolyn sodium solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:50090-3042(NDC:17478-291)
Route of Administration OPHTHALMIC
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CROMOLYN SODIUM (UNII: Q2WXR1I0PK) (CROMOLYN - UNII:Y0TK0FS77W) CROMOLYN SODIUM 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50090-3042-0 1 in 1 CARTON 06/07/2017
1 10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074706 04/29/1998
Labeler - A-S Medication Solutions (830016429)
Establishment
Name Address ID/FEI Business Operations
A-S Medication Solutions 830016429 RELABEL(50090-3042)

Revised: 5/2018 A-S Medication Solutions



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