DICLOFENAC- diclofenac sodium solution/ drops

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Altaire Pharmaceuticals Inc.

INN (Internationale Bezeichnung):

DICLOFENAC SODIUM

Zusammensetzung:

DICLOFENAC SODIUM 1 mg in 1 mL

Verabreichungsweg:

OPHTHALMIC

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

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 Polypropylene grey closure. The 2.5 mL is supplied in a 7.5 mL size bottle and the 5 mL is supplied in a 10 mL size bottle. Bottles of 2.5 mL Bottles of 5 mL Store at 20° to 25°C (68° to 77°F). Dispense in original, unopened container only . [LOGO] ALTAIRE PHARMACEUTICALS, INC. 311 West Lane, PO Box 849 Aquebogue, NY 11931 Altaire 2014

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

DICLOFENAC- DICLOFENAC SODIUM SOLUTION/ DROPS
ALTAIRE PHARMACEUTICALS INC.
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DICLOFENAC SODIUM OPHTHALMIC SOLUTION 0_1
DICLOFENAC SODIUM OPHTHALMIC SOLUTION, 0.1%
RX ONLY
STERILE OPHTHALMIC SOLUTION
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% (1mg/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 ophthalmic solution, 0.1% 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 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.
14
10
l2
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 incr