Alocril - Nedocromil Sodium solution/ Drops prescribing information
INDICATIONS AND USAGE
ALOCRIL ® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.
DOSAGE AND ADMINISTRATION
The recommended dosage is one or two drops in each eye twice a day. ALOCRIL ® ophthalmic solution should be used at regular intervals.
Treatment should be continued throughout the period of exposure (i.e., until the pollen season is over or until exposure to the offending allergen is terminated), even when symptoms are absent.
CONTRAINDICATIONS
ALOCRIL ® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.
ADVERSE REACTIONS
The most frequently reported adverse experience was headache (~40%).
Ocular burning, irritation and stinging, unpleasant taste, and nasal congestion have been reported to occur in 10 – 30% of patients. Other events occurring between 1 – 10% included asthma, conjunctivitis, eye redness, photophobia, and rhinitis.
Some of these events were similar to the underlying ocular disease being studied.
DESCRIPTION
ALOCRIL ® (nedocromil sodium ophthalmic solution) 2% is a clear, yellow, sterile solution for topical ophthalmic use.
Nedocromil sodium is represented by the following structural formula:
Chemical N ame: 4 H -Pyrano[3,2-g]quinoline-2,8-dicarboxylic acid, 9-ethyl-6,9-dihydro-4,6-dioxo-10-propyl-, disodium salt.
Each mL contains: Active: Nedocromil sodium 20 mg/mL (2%); Preservative: Benzalkonium chloride 0.01%; Inactives : Edetate disodium 0.05%, purified water, and sodium chloride 0.5%. It has a pH range of 4.0 to 5.5 and an osmolality range of 270 to 330 mOsm/kg.
CLINICAL PHARMACOLOGY
Nedocromil sodium is a mast cell stabilizer. Nedocromil sodium inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and decreased activation of eosinophils have also been demonstrated.
In vitro studies with adult human bronchoalveolar cells showed that nedocromil sodium inhibits histamine release from a population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.
Pharmacokinetics and Bioavailability
Nedocromil sodium exhibits low systemic absorption. When administered as a 2% ophthalmic solution in adult human volunteers, less than 4% of the total dose was systemically absorbed following multiple dosing. Absorption is mainly through the nasolacrimal duct rather than through the conjunctiva. It is not metabolized and is eliminated primarily unchanged in urine (70%) and feces (30%).
HOW SUPPLIED
ALOCRIL ® (nedocromil sodium ophthalmic solution) 2% is supplied sterile in opaque white LDPE plastic bottles with dropper tips and white high impact polystyrene (HIPS) caps as follows:
5 mL in 10 mL bottle NDC 0023-8842-05
Storage:
Store at 2º–25º C (36º–77º F).
Rx only
Revised: 0 6 /2018
Distributed by: Allergan USA, Inc.
Madison, NJ 07940
© 2018 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
v1.0USPI8842
Information for the Patient
ALOCRIL ®
(nedocromil sodium ophthalmic solution) 2%
sterile
It is important to use ALOCRIL ® ophthalmic solution 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 ALOCRIL ® bottle upside down. Place tip as close as possible to the lower eyelid without touching the tip to the eye, and gently squeeze out the prescribed number of drops (Figure 5).
7. Do not touch the eye or eyelid with the bottle 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 ALOCRIL ® 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 bottle cap after use. It is recommended that any remaining contents be discarded after treatment period prescribed by your physician.
3. Store at 2º–25º C (36º–77º F). Store in original carton.
4. Keep bottle 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 ALOCRIL ® ophthalmic solution.
Figure 1
Figure 2
Figure 3
Figure 4
Figure 5
Distributed by: Allergan USA, Inc.
Madison, NJ 07940
© 2018 Allergan. All rights reserved.
All trademarks are the property of their respective owners.
v1.0PPI8842
