ALOCRIL- nedocromil sodium solution/ drops

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

NEDOCROMIL SODIUM (UNII: ET8IF4KS1T) (NEDOCROMIL - UNII:0B535E0BN0)

から入手可能:

Allergan, Inc.

投与経路:

OPHTHALMIC

処方タイプ:

PRESCRIPTION DRUG

適応症:

ALOCRIL ® ophthalmic solution is indicated for the treatment of itching associated with allergic conjunctivitis. ALOCRIL ® ophthalmic solution is contraindicated in those patients who have shown hypersensitivity to nedocromil sodium or to any of the other ingredients.

製品概要:

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 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

認証ステータス:

New Drug Application

製品の特徴

ALOCRIL- NEDOCROMIL SODIUM SOLUTION/ DROPS
ALLERGAN, INC.
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ALOCRIL (NEDOCROMIL SODIUM OPHTHALMIC SOLUTION) 2%
STERILE
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 NAME: 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%).
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
INFORMATION FOR PATIENTS
Patients should be advised to follow the