ACULAR- 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.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ACULAR ® ophthalmic solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. ACULAR ® ophthalmic solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. ACULAR ® solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation. Teratogenic Effects.   Pregnancy Category C Ketorolac tromethamine, administered during organogenesis, was not teratogenic in rabbits and rats at oral doses of 3.6 mg/kg/day and 10 mg/kg/day, respectively. These doses are approximately 100 times and 250 times higher respectively than the maximum recommended human topical ophthalmic daily dose of 2 mg (5 mg/mL x 0.05 mL/drop, x 4 drops x 2 eyes) to affected eyes on a mg/kg basis. Additionally, when administered to rats after Day 17 of gestation at oral doses up to 1.5 mg/kg/day (approximately 40 times the typical human topical ophthalmic daily dos

Product summary:

ACULAR ® (ketorolac tromethamine ophthalmic solution) 0.5% is supplied sterile, in white opaque plastic LDPE bottles with white droppers, with gray high impact polystyrene (HIPS) caps as follows: 5 mL in 10 mL bottle             NDC 0023-2181-05 Storage: Store at 15°-25°C (59°-77°F). Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

ACULAR- KETOROLAC TROMETHAMINE SOLUTION/ DROPS
ALLERGAN, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ACULAR SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR ACULAR .
ACULAR (KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION) 0.5%
INITIAL U.S. APPROVAL: 1991
INDICATIONS AND USAGE
ACULAR ophthalmic solution is a nonsteroidal, anti-inflammatory
indicated for:
The treatment of inflammation following cataract surgery. (1)
The temporary relief of ocular itching due to seasonal allergic
conjunctivitis. (1)
DOSAGE AND ADMINISTRATION
One drop of ACULAR should be applied to the affected eye(s) four times
a 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 2 weeks of the postoperative period. (2.1)
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing 5 mg/mL ketorolac tromethamine. (3)
10 mL size bottle filled with 5 mL of solution
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 frequent adverse reactions reported by up to 40% of patients
participating in clinical trials have been transient
stinging and burning on instillation. (6.1)
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 INFORMATION.
REVISED: 12/2011
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 CONTRA