Rx Item-Acular 0.5% Drops 5ml By Allergan Pharma

Item
info.
These highlights do not include all the info.
needed to use ACULAR
?
safely and effectively. See
full prescribing info. for ACULAR
?
.
ACULAR
?
(ketorolac tromethamine ophthalmic
solution) 0.5%
Initial U.S. Approval: 1991
_________
INDICATIONS AND USAGE
________
_
ACULAR
?
ophthalmic solution is nonsteroidal,
anti
-inflammatory indicated for:
?
The treatment of inflammation following cataract
surgery.
?
The temporary relief of ocular itching due to
seasonal allergic conjunctivitis.
______
DOSAGE AND ADMINISTRATION
_____
One drop of
ACULAR
?
should be applied to the
affected eye(s) four times day for relief of ocular
itching due to seasonal allergic conjunctivitis.
For the treatment of postoperative inflammation in
patients who have undergone cataract extraction, one
drop of
ACULAR
?
should
be applied to the affected
eye four times daily beginning 24 hours after cataract
surgery and continuing through the first weeks of the
postoperative period.
_____
__
DOSAGE FORMS AND STRENGTHS
______
Ophthalmic solution containing mg/mL ketor
olac
tromethamine
.
?
10 mL size bottle filled with mL of solution
___________
CONTRAINDICATIONS
______________
Hypersensitivity to any component of this product.
____
____
WARNINGS AND PRECAUTIONS
________
?
Delayed healing
?
Cross
-sensitivity or hypersensitivity
?
Increased bleeding time due to interference with
thrombocyte aggregation
?
Corneal effects including keratitis
_____________
ADVERSE REACTIONS
____________
The most frequent adverse reactions reported b
y up to
40% of patients participating in clinical trials have been
transient stinging and burning on instillation.
To report SUSPECTED ADVERSE REACTIONS,
contact Allergan at 1
-800
-433
-8871 or FDA at 1-
800
-
FDA-
1088 or www.fda.gov/medwatch
.
See 17 for PATIENT COUNSELING info.
Revised:
06/2012

Rx Item-Acular 0.5% Drops 5ml By Allerga
NDC No. 00023-2181-05 UPC/GTIN No. 3-00232-18105-9 MPN No. 2181 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA

Allergan USA, Inc.
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KETOROLAC TROMETHAMINE OP
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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