KETOROLAC TROMETHAMINE solution

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

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

Saadav alates:

Physicians Total Care, Inc.

INN (Rahvusvaheline Nimetus):

KETOROLAC TROMETHAMINE

Koostis:

KETOROLAC TROMETHAMINE 5 mg in 1 mL

Manustamisviis:

OPHTHALMIC

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

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.

Toote kokkuvõte:

Ketorolac tromethamine ophthalmic solution is supplied sterile in white opaque LDPE dropper bottles with white opaque plug and sealed with gray pantone opaque pilfer-proof caps as follows: 5 mL in 5 mL bottle NDC 54868-6195-0 10 mL in 10 mL bottle   NDC 54868-6195-1 Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° and 30°C (59° and 86°F) [see USP Controlled Room Temperature] with protection from light. Distributed by: Caraco Pharmaceutical Laboratories, Ltd. 1150 Elijah McCoy Drive, Detroit, MI 48202 Manufactured at: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. ISS. 09/2009 PJPI0270 Distributed by: Physicians Total Care, Inc. Tulsa, OK      74146

Volitamisolek:

Abbreviated New Drug Application

Toote omadused

KETOROLAC TROMETHAMINE - KETOROLAC TROMETHAMINE SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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)-1,3-propanediol (1:1) and
it has the following structure:
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 tromethamine ophthalmic solution is 290
mOsmol/kg.
Each mL of ketorolac tromethamine ophthalmic solution contains:
ACTIVE: ketorolac tromethamine USP
0.5%. PRESERVATIVE: benzalkonium chloride solution (50%) USP-NF 0.02%.
INACTIVES: edetate
disodium USP 0.1%; octoxynol 40; water for injection USP; sodium
chloride USP; hydrochloric acid
NF and/or sodium hydroxide NF to adjust the 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