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:

Bausch & Lomb Incorporated

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 LDPE Dropper Tip and a polypropylene gray cap. 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°F to 77°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/ DROPS
BAUSCH & LOMB INCORPORATED
----------
DICLOFENAC SODIUM OPHTHALMIC
SOLUTION, 0.1%
(STERILE)
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 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,
purified water, sorbic acid (2 mg/mL), and tromethamine.
Diclofenac sodium is a white to off-white, 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
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.
14
10
2
2
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.
PHARMACOKINETICS
Results from a bioavailability study established that plasma levels of
diclofenac following
ocula