DICLOFENAC- 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:

Akorn

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, 0.1% 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, 0.1% is contraindicated in patients who are hypersensitive to any component of the medication.

Product summary:

Diclofenac Sodium Ophthalmic Solution, 0.1% (1 mg/mL) Solution is supplied in a low density polyethylene (LDPE) white bottle with a LDPE Dropper Tip and Polypropylene grey closure. The 2.5 mL fill is supplied in a 10 mL size bottle. The 5.0 mL fill is also supplied in a 10.0 mL size bottle. Bottles of 2.5 mL      NDC 17478-892-25 Bottles of 5 mL         NDC 17478-892-10 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing and light. Dispense in original, unopened container only. Akorn Manufactured by: Akorn Inc. Lake Forest, IL 60045 DC00N           Rev. 06/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DICLOFENAC- DICLOFENAC SODIUM SOLUTION/ DROPS
AKORN
----------
DICLOFENAC SODIUM
OPHTHALMIC SOLUTION, 0.1%
Rx Only
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: boric acid, edetate disodium (1 mg/mL), polyoxyl
35 castor oil,
water for injection, sorbic acid (2 mg/mL), tromethamine.
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 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,
14
10
2
2
increased vascular permeability, leukocytosis, and increased
intraocular pressure.
PHARMACOKINETICS
Results from a bioavailability study established that plasma levels of
diclofenac following
ocular instillatio