KETOROLAC TROMETHAMINE- ketorolac tromethamine solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ketorolac tromethamine (UNII: 4EVE5946BQ) (ketorolac - UNII:YZI5105V0L)

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

ketorolac tromethamine

Composition:

ketorolac tromethamine 5 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ketorolac Tromethamine Ophthalmic Solution is indicated for the temporary relief of ocular itching due to seasonal allergic conjunctivitis. Ketorolac Tromethamine Ophthalmic Solution is also indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction. Ketorolac Tromethamine Ophthalmic Solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

Product summary:

Ketorolac Tromethamine Ophthalmic Solution is supplied sterile in white LDPE plastic bottles with natural droppers and gray short skirt caps as follows: 5 mL in l0 mL bottle - NDC 35356-771-05 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

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KETOROLAC TROMETHAMINE- KETOROLAC TROMETHAMINE SOLUTION
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
----------
KETOROLAC TROMETHAMINE OPHTHALMIC SOLUTION, 0.5%
STERILE
RX ONLY
DESCRIPTION
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-1H pyrrolizine-1-carboxylic acid, compound with
2-amino-2-(hydroxymethyl)-l,3-
propanediol(1:1) and it has the following structural formula:
The molecular formula of Ketorolac Tromethamine Ophthalmic Solution is
C
H NO •C H NO .
Ketorolac Tromethamine Ophthalmic Solution is supplied as a sterile
isotonic aqueous 0.5% solution,
with a pH of 7.4.
Ketorolac Tromethamine 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 376.41.
The osmolality of Ketorolac
Ophthalmic Solution is 290 mOsml/kg.
15
13
3
4
11
3
Each mL of Ketorolac Tromethamine Ophthalmic Solution contains:
ACTIVE: ketorolac tromethamine 0.5%
PRESERVATIVE: benzalkonium chloride 0.01%
INACTIVES: edetate disodium 0.1%; octoxynol 40; sodium chloride;
hydrochloric acid and/or sodium
hydroxide may be added to adjust the pH (6.8-7.4) and purified water.
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, pros