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:

STAT Rx USA LLC

INN (International Name):

KETOROLAC TROMETHAMINE

Composition:

KETOROLAC TROMETHAMINE 5 mg in 1 mL

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 ® ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

Product summary:

ACULAR ® (ketorolac tromethamine ophthalmic solution) is supplied sterile in opaque white LDPE plastic bottles with white droppers with gray high impact polystyrene (HIPS) caps as follows: Store at 15°C - 25°C (59°F- 77°F) with protection from light. Rx Only Revised: 05/2011 © 2011 Allergan, Inc. Irvine, CA 92612, U.S.A. ACULAR ® is manufactured and distributed by Allergan, Inc. under license from its developer, Roche Palo Alto LLC, Palo Alto, CA, U.S.A. ® marks owned by Allergan, Inc. Made in the U.S.A. 71590US13C Relabeling and Repackaging by : STAT Rx USA LLC Gainesville, GA  30501

Authorization status:

New Drug Application

Summary of Product characteristics

ACULAR - KETOROLAC TROMETHAMINE SOLUTION/ DROPS
STAT RX USA LLC
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ACULAR
(KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION) 0.5%
S TERILE
DESCRIPTION
ACULAR (ketorolac tromethamine ophthalmic solution) is a member of the
pyrrolo-pyrrole group of
nonsteroidal anti-inflammatory drugs (NSAIDs) for ophthalmic use. Its
chemical name is (±)-5-Benzoyl-
2,3-dihydro-1_H_-pyrrolizine-1-carboxylic acid, compound with
2-amino-2-(hydroxymethyl)-1,3-
propanediol (1:1) and it has the following structure:
ACULAR ophthalmic solution is supplied as a sterile isotonic aqueous
0.5% solution, with a pH of
7.4. ACULAR ophthalmic solution is a racemic mixture of R-(+) and
S-(-)- ketorolac tromethamine.
Ketorolac tromethamine may exist in three crystal forms. All forms are
equally soluble in water. The
pKa of ketorolac is 3.5. This white to off-white crystalline substance
discolors on prolonged exposure
to light. The molecular weight of ketorolac tromethamine is 376.40.
The osmolality of ACULAR
ophthalmic solution is 290 mOsml/kg.
Each mL of ACULAR ophthalmic solution contains: ACTIVE: ketorolac
tromethamine 0.5%.
PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: edetate disodium
0.1%; octoxynol 40; purified
water; sodium chloride; and hydrochloric acid and/or sodium hydroxide
to adjust pH.
CLINICAL PHARMACOLOGY
Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug which,
when administered
systemically, has demonstrated analgesic, anti-inflammatory, and
anti-pyretic activity. The mechanism of
its action is thought to be due to its ability to inhibit
prostaglandin biosynthesis. Ketorolac tromethamine
given systemically does not cause pupil constriction.
Prostaglandins have been shown in many animal models to be mediators
of certain kinds of intraocular
inflammation. In studies performed in animal eyes, prostaglandins have
been shown to produce
disruption of the blood-aqueous humor barrier, vasodilation, increased
vascular permeability,
leukocytosis, and increased intraocular pressure. Prostaglandins also
appear to play