DICLOFENAC SODIUM solution/ drops

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

Rising Pharmaceuticals, Inc.

INN (nume internaţional):

DICLOFENAC SODIUM

Compoziție:

DICLOFENAC SODIUM 3.5 mg in 1 mL

Calea de administrare:

OPHTHALMIC

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

Diclofenac sodium ophthalmic solution, 0.1% (1 mg/mL) Sterile Solution is supplied in a Low Density Polyethylene (LDPE) squeeze bottle with a LDPE dropper and a High Density Polyethylene (HDPE) closure in the following sizes: Bottles of 2.5 mL      NDC 16571-101-25 Bottles of 5 mL         NDC 16571-101-50 Store at 20°-25°C (68° to 77°F); [See USP Controlled Room Temperature] Protect from light. Dispense in original container. Do not use if seal on the bottle is broken. Rx only Manufactured in India for: Rising Pharmaceuticals, Inc.  Allendale, NJ 07401 Distributed by: Pack Pharmaceuticals, LLC Allendale, NJ 07401

Statutul autorizaţiei:

Abbreviated New Drug Application

Prospect

Rising Pharmaceuticals, Inc.
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Revised: 8/2018
Document Id: 2a9f815d-e845-40d2-a82e-590b923b97cf
34391-3
Set id: ae8b7410-d377-4793-9bb7-889c7afc3a9a
Version: 7
Effective Time: 20180814
Rising Pharmaceuticals, Inc.

Caracteristicilor produsului

DICLOFENAC SODIUM - DICLOFENAC SODIUM SOLUTION/ DROPS
RISING PHARMACEUTICALS, INC.
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DICLOFENAC SODIUM OPHTHALMIC SOLUTION 0.1%
DICLOFENAC SODIUM OPHTHALMIC SOLUTION 0.1%
STERILE
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% (1mg/mL).
_Inactive Ingredients: _polyoxyl 35 castor oil, Boric acid,
tromethamine, sorbic acid (2 mg/mL), edetate
disodium (1 mg/mL), and purified water for injection.
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 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
14
10
l2
2
disruption of the blood-aqueous humor barrier, vasodilation, increased
vascular permeability,
leukocytosis, and increased intraocular pressure.
PHARMACOKINETICS
Results from a bioavaila