KETOROLAC TROMETHAMINE (Page 2 of 2)

ADVERSE REACTIONS

The most frequent adverse events reported with the use of ketorolac ophthalmic solution have been transient stinging and burning on instillation. These events were reported by up to 40% of patients participating in clinical trials.

Other adverse events occurring approximately 1% — 10% of the time during treatment with ketorolac ophthalmic solution including allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, superficial keratitis, and superficial ocular infections.

Other adverse events reported rarely with the use of ketorolac tromethamine ophthalmic solutions included corneal infiltrates, corneal ulcer, eye dryness, headaches, and visual disturbance (blurry vision).

Clinical Practice: The following events have been identified during postmarketing use of ketorolac tromethamine ophthalmic solution 0.5% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical ketorolac tromethamine ophthalmic solution 0.5%, or a combination of these factors, including corneal erosion, corneal perforation, corneal thinning and epithelial breakdown (see PRECAUTIONS, General).

DOSAGE AND ADMINISTRATION

The recommended dose of Ketorolac Tromethamine Ophthalmic Solution is one drop (0.25 mg) 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 Ketorolac Tromethamine Ophthalmic Solution should be applied to the affected eye(s) four times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

Ketorolac Tromethamine Ophthalmic Solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.

HOW SUPPLIED

Ketorolac Tromethamine Ophthalmic Solution is supplied sterile in white LDPE plastic bottles with natural droppers and gray short skirt caps as follows:

3 mL in 10 mL bottle — NDC 17478-209-19

5 mL in l0 mL bottle — NDC 17478-209-10

10 mL in 10 mL bottle — NDC 17478-209-11

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Protect from light. Retain in carton until time of use.

Rx only

Manufactured by: Akorn, Inc.
Lake Forest, IL 60045

KR00N Rev.07/09

KETOROLAC TROM OS 0.5% 3mL LABEL

Label Image 2
(click image for full-size original)

KETOROLAC TROM OS 0.5% 5mL LABEL

Label Image 1
(click image for full-size original)
KETOROLAC TROMETHAMINE
ketorolac tromethamine solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:16590-376(NDC:17478-209)
Route of Administration OPHTHALMIC DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOROLAC TROMETHAMINE (KETOROLAC) KETOROLAC TROMETHAMINE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZALKONIUM CHLORIDE
EDETATE DISODIUM
OCTOXYNOL-40
SODIUM CHLORIDE
HYDROCHLORIC ACID
SODIUM HYDROXIDE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:16590-376-03 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
1 3 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (16590-376-03)
2 NDC:16590-376-05 1 BOTTLE, DROPPER (BOTTLE) in 1 CARTON contains a BOTTLE, DROPPER
2 5 mL in 1 BOTTLE, DROPPER This package is contained within the CARTON (16590-376-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA078434 11/05/2009
Labeler — STAT RX USA LLC (786036330)
Establishment
Name Address ID/FEI Operations
STAT RX USA LLC 786036330 relabel, repack

Revised: 11/2011 STAT RX USA LLC

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