Rx Item-Alocril 2% Drops 5ml By Allergan Pharma

Clinical Information
Gen. Code and Des.
23551 nedocromil sodium OPHTHALMIC DROPS 2 %
GCN and Des.
33160 nedocromil sodium OPHTHALMIC DROPS 2 %
Strength
2%
Dose Form
DROPS
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
48103200 MAST-CELL STABILIZERS
52020000 ANTIALLERGIC AGENTS
Active Ingredients
3748 nedocromil sodium 69049747
Inactive Ingredients
3141 benzalkonium chloride 8001545
3785 edetic acid 60004





ALOCRIL- nedocromil sodium solution/ drops
Allergan, Inc.
sterile
DESCRIPTION
ALOCRIL (nedocromil sodium ophthalmic solution) 2% is clear, yellow, sterile solution for topical ophthalmic use.
Chemical Name:
4H -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 pH range of 4.0 to 5.5 and an osmolality range of 270 to 330 mOsm/kg.
CLINICAL PHARMACOLOGY
Nedocromil sodium is 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 population of mast cells having been defined as belonging to the mucosal sub type and inhibits beta-glucuronidase release from macrophages.
INDICATIONS AND USAGE
ALOCRIL ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis.
CONTRAINDICATIONS
ALOCRIL ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.
PRECAUTIONS
info. for Patients
Patients should be advised to follow the patient instructions listed on the info. for Patients sheet.
Users of contact lenses should refrain from wearing lenses while exhibiting the signs and symptoms of allergic conjunctivitis.
DOSAGE AND ADMINISTRATION
The recommended dosage is one or two drops in each eye twice 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.

Rx Item-Alocril 2% Drops 5ml By Allergan
RX139634 139634 NDC No.00023-8842-05 0023-8842-05 00023884205 0023884205 UPC/GTIN No. 3-00238-84205-3 300238-842053 300238842053 MPN No. 884205

Alocril 2% Drops 5ml By Allerg
RX139634 139634 NDC No.00023-8842-05 0023-8842-05 00023884205 0023884205 UPC/GTIN No. 3-00238-84205-3 300238-842053 300238842053 MPN No. 884205

NEDOCROMIL SODIUM OPHTHAL
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