DICLOFENAC SODIUM solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)

Available from:

H.J. Harkins Company, Inc.

INN (International Name):

DICLOFENAC SODIUM

Composition:

DICLOFENAC SODIUM 1 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Diclofenac Sodium Ophthalmic is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction and for the temporary relief of pain and photophobia in patients undergoing corneal refractive surgery. Diclofenac Sodium Ophthalmic is contraindicated in patients who are hypersensitive to any component of the medication.

Product summary:

Diclofenac Sodium Ophthalmic 0.1% (1 mg/mL) Sterile Solution is supplied in a low-density polyethylene (LDPE) white bottle with a LDPE Dropper Tip. The 2.5 mL fill and the 5 mL fill are supplied in a 7.5 mL size bottle. 2.5 mL NDC 24208-457-25    5 mL NDC 24208-457-05 Store at 20°C to 25°C (68° to 77°F). Protect from light. Dispense in original, unopened container only. Rx Only Revised September 2007

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOFENAC SODIUM - DICLOFENAC SODIUM SOLUTION/ DROPS
H.J. HARKINS COMPANY, INC.
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DICLOFENAC SODIUM OPHTHALMIC
SOLUTION, 0.1% (STERILE)
DESCRIPTION:
Diclofenac Sodium Ophthalmic Solution 0.1% is a sterile, topical,
non-steroidal, anti-inflammatory
product for ophthalmic use. Diclofenac Sodium is designated chemically
as 2-[(2,6-
dichlorophenyl)amino] benzeneacetic acid, monosodium salt, with an
empirical formula of
C
H CI NO Na. The structural formula of diclofenac sodium is:
Diclofenac Sodium Ophthalmic is available as a sterile solution, which
contains diclofenac sodium
0.1% (1 mg/mL).
_Inactive Ingredients: _polyoxyl 35 castor oil, Boric acid,
tromethamine, sorbic acid (2 mg/mL), edetate
disodium (1 mg/mL), and purified water.
Diclofenac Sodium is a faintly yellow-white to light-beige, slightly
hygroscopic crystalline powder. It
is freely soluble in methanol, sparingly soluble in water, very
slightly soluble in acetonitrile, and
insoluble in chloroform and in 0.1N hydrochloric acid. Its molecular
weight is 318.14. Diclofenac
Sodium Ophthalmic 0.1% is an iso-osmotic solution with an osmolality
of about 300 mOsmol/1000 g,
buffered at approximately pH 7.2. Diclofenac Sodium Ophthalmic
solution has a faint characteristic
odor of castor oil.
CLINICAL PHARMACOLOGY:
PHARMACODYNAMICS
Diclofenac Sodium is one of a series of phenylacetic acids that has
demonstrated anti-inflammatory and
analgesic properties in pharmacological studies. It is thought to
inhibit the enzyme cyclooxygenase,
which is essential in the biosynthesis of prostaglandins.
ANIMAL STUDIES
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.
14
10
2
2
PHARMACOKINETICS
Results from a bioavailability study established that plasma levels of
diclofenac following ocul