Nchi: Marekani
Lugha: Kiingereza
Chanzo: NLM (National Library of Medicine)
DICLOFENAC SODIUM (UNII: QTG126297Q) (DICLOFENAC - UNII:144O8QL0L1)
Rising Pharmaceuticals, Inc.
DICLOFENAC SODIUM
DICLOFENAC SODIUM 3.5 mg in 1 mL
OPHTHALMIC
PRESCRIPTION DRUG
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.
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
Abbreviated New Drug Application
Rising Pharmaceuticals, Inc. ---------- 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. Soma hati kamili
DICLOFENAC SODIUM - DICLOFENAC SODIUM SOLUTION/ DROPS RISING PHARMACEUTICALS, INC. ---------- 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 Soma hati kamili