ACULAR LS- ketorolac tromethamine solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)

Available from:

Allergan, Inc.

INN (International Name):

Ketorolac Tromethamine

Composition:

Ketorolac Tromethamine 4 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ACULAR LS  ophthalmic solution is indicated for the reduction of ocular pain and burning/stinging following corneal refractive surgery.  ACULAR LS ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation [see Adverse Reactions ( 6.1 )] . Risk Summary There are no adequate or well-controlled studies with ACULAR LS in pregnant women. No evidence of teratogenicity has been observed in rats or rabbits with ACULAR LS at clinically relevant doses. Risk Summary It is not known whether ketorolac when given topically is present in human milk. Because many drugs are excreted in human milk, caution should be exercised when ACULAR LS is administered to a nursing woman. Safety and effectiveness of ketorolac tromethamine in pediatric patients below the age of 3 have not been established. No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Product summary:

ACULAR LS (ketorolac tromethamine ophthalmic solution) 0.4% is supplied sterile, in white opaque plastic LDPE bottles with  white droppers, with a gray high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle             NDC 0023-9277-05 Storage: Store at 15o C to 25o C (59o F to 77o F). Protect from light. After opening, ACULAR LS can be used until the expiration date on the bottle.

Authorization status:

New Drug Application

Summary of Product characteristics

ACULAR LS- KETOROLAC TROMETHAMINE SOLUTION/ DROPS
ALLERGAN, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACULAR LS SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ACULAR LS.
ACULAR LS (KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION) 0.4%,
FOR TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
ACULAR LS ophthalmic solution is a nonsteroidal, anti-inflammatory
drug (NSAID) indicated for the
reduction of ocular pain and burning/stinging following corneal
refractive surgery. (1)
DOSAGE AND ADMINISTRATION
One drop of ACULAR LS should be applied in the operated eye 4 times
per day as needed for pain and
burning/stinging for up to 4 days following corneal refractive
surgery. (2.1)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing ketorolac tromethamine 0.4% (4 mg/mL).
(3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product. (4)
WARNINGS AND PRECAUTIONS
Delayed healing (5.1)
Cross-sensitivity or hypersensitivity (5.2)
Increased bleeding time due to interference with thrombocyte
aggregation (5.3)
Corneal effects including keratitis (5.4)
ADVERSE REACTIONS
The most common adverse reactions occurring in 1 - 5% of patients
included conjunctival hyperemia,
corneal infiltrates, headache, ocular edema and ocular pain. (6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ALLERGAN AT
1-800-678-1605 OR THE FDA
AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 3/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 RECOMMENDED DOSING
2.2 USE WITH OTHER TOPICAL OPHTHALMIC MEDICATIONS
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 DELAYED HEALING
5.2 CROSS-SENSITIVITY OR HYPERSENSITIVITY
5.3 INCREASED BLEEDING TIME
5.4 CORNEAL EFFECTS
®
5.5 RISK OF CONTAMINATION
5.6 CONTACT LENS WEAR
6 ADVERSE REACTIONS
6.1 CLINICAL TRIALS EXPERIENCE
6.2 POSTMARKETING EXPERIENCE
8 USE IN SPECIFIC PO