DICLOFENAC SODIUM solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sandoz 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 solution 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 solution is contraindicated in patients who are hypersensitive to any component of the medication.

Product summary:

Diclofenac sodium ophthalmic solution, 0.1% (1 mg/mL) Sterile Solution is supplied in a low density polyethylene (LDPE) white bottle with a natural LDPE dropper tip and a gray polypropylene closure in the following sizes: 2.5 mL fill in 4 mL container    NDC 61314-014-25 5 mL fill in 8 mL container       NDC 61314-014-05 STORAGE CONDITIONS Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Protect from light. Dispense in original, unopened container only.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOFENAC SODIUM- DICLOFENAC SODIUM SOLUTION
SANDOZ INC
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DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1%
STERILE OPHTHALMIC SOLUTION
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Diclofenac sodium ophthalmic solution, 0.1% is a sterile, topical,
nonsteroidal, 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
Cl
NO Na. The structural formula of diclofenac sodium is:
Diclofenac sodium ophthalmic solution, 0.1% 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 solution, 0.1% is an
iso-osmotic solution
14
10
2
2
weight is 318.14. Diclofenac sodium ophthalmic solution, 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, 0.1% 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 inc