April 29, 2017
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Dyloject

"July 10, 2015 -- Popular painkillers like ibuprofen and naproxen have carried warnings for years about potential risks of heart attacks and strokes. This week, the FDA decided to strengthen those warnings on the medications, known as nonsteroidal"...

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Dyloject

DYLOJECT™
(diclofenac sodium) Injection

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

  • Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use [see WARNINGS AND PRECAUTIONS].
  • DYLOJECT is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Gastrointestinal Bleeding, Ulceration, and Perforation

  • NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

DYLOJECT (diclofenac sodium) Injection is a nonsteroidal anti-inflammatory drug for intravenous administration. Each mL of aqueous solution contains 37.5 mg of diclofenac sodium (34.8 mg of diclofenac).

Diclofenac sodium is a phenylacetic acid derivative that is a white to off-white, virtually odorless, crystalline powder. Diclofenac sodium is freely soluble in methanol, soluble in ethanol, and practically insoluble in chloroform and in dilute acid. Diclofenac sodium is sparingly soluble in water. Its chemical formula and name are: C14H10Cl2NO2Na [M.W. = 318.14] 2-[(2,6-dichlorophenyl) amino] benzeneacetic acid, monosodium salt.

DYLOJECT™ (diclofenac sodium) Structural Formula Illustration

DYLOJECT is a clear colorless sterile solution. The inactive ingredients of DYLOJECT include: 333 mg hydroxypropyl betadex (HPβCD), 5 mg monothioglycerol, sodium hydroxide and/or hydrochloric acid for pH adjustment, and water for injection.

Last reviewed on RxList: 5/23/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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