VOLTAREN- diclofenac sodium solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

Diclofenac Sodium (UNII: QTG126297Q) (Diclofenac - UNII:144O8QL0L1)

Dostupné s:

Novartis Pharmaceutical Corporation

INN (Mezinárodní Name):

Diclofenac Sodium

Složení:

Diclofenac Sodium 1 mg in 1 mL

Podání:

OPHTHALMIC

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

Voltaren 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. Voltaren Ophthalmic is contraindicated in patients who are hypersensitive to any component of the medication.

Přehled produktů:

Voltaren Ophthalmic 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 5 mL fill is supplied in a 10 mL size bottle. Bottles of 5 mL NDC 0078-0478-61 Store at 15°C to 25°C (59° to 77°F). Dispense in original, unopened container only. Alcon® Made in Canada Manufactured for: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134 USA © 2012 Novartis  AAA2684-0112

Stav Autorizace:

New Drug Application

Charakteristika produktu

VOLTAREN - DICLOFENAC SODIUM SOLUTION
NOVARTIS PHARMACEUTICAL CORPORATION
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VOLTAREN OPHTHAMIC
(DICLOFENAC SODIUM OPHTHALMIC SOLUTION) 0.1%
STERILE OPHTHALMIC SOLUTION
RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION SECTION
Voltaren Ophthalmic (diclofenac sodium ophthalmic solution) 0.1%
solution 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:
Voltaren 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. Voltaren
Ophthalmic 0.1% is an iso osmotic solution with an osmolality of about
300 mOsmol/1000 g, buffered
at approximately pH 7.2. Voltaren Ophthalmic solution has a faint
characteristic odor of castor oil.
®
14
10
2
2
CLINICAL PHARMACOLOGY SECTION
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.
PHARMACOKINETICS
Results from a