Dyloject (diclofenac sodium) Injection

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company:

Approval Status:

Approved December 2014

Specific Treatments:

mild, moderate or severe pain

Therapeutic Areas

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General Information

Dyloject (diclofenac sodium) Injection is a non-steroidal anti-inflammatory drug.

Dyloject is specifically indicated for the management of mild to moderate pain and management of moderate to severe pain alone or in combination with opioid analgesics. 

Dyloject is supplied as a solution for intravenous administration. The recommended dose of Dyloject is 37.5 mg administered by intravenous bolus injection over 15 seconds every 6 hours as needed, not to exceed 150 mg/day. 

 

Clinical Results

FDA Approval

The FDA approval of Dyloject was based on two double-blind, placebo and active-controlled, multiple-dose clinical trials in patients with postoperative pain. In both trials, intravenous morphine was permitted as rescue medication for pain management. 

Study One

In a controlled, multiple-dose study of adult patients with postoperative pain who had undergone elective abdominal or pelvic surgery, 245 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every 6 hours starting within 6 hours after surgery and for up to 5 days. The study population consisted of patients with a mean age of 43 years (range 18 to 65 years) and a minimum pain intensity of 50 mm on a 100-mm visual analog scale (VAS) at baseline. The mean baseline pain intensity on the VAS was 68 mm (range 50 to 100 mm). Approximately 63% of subjects in the Dyloject 37.5 mg group and 92% of subjects in the placebo group took rescue medication within the first 48 hours of the treatment phase. Efficacy was demonstrated by a reduction in pain intensity as measured by the sum of the pain intensity differences over 0 to 48 hours in patients receiving Dyloject as compared to placebo.

Study Two

In a controlled, multiple-dose study of adult patients with postoperative pain who had undergone elective orthopedic surgery, 277 patients were treated with Dyloject, a positive NSAID control (ketorolac tromethamine), or placebo administered every 6 hours starting within 6 hours postsurgery and for up to 5 days. The study population consisted of patients with a mean age of 55 years (range 19 to 84 years) and a minimum pain intensity of 50 mm on a 100-mm VAS at baseline. The mean baseline pain intensity on the VAS was 69 mm (range 50 to 100 mm). Approximately 74% of subjects in the Dyloject group and 92% of subjects in the placebo group took rescue medication within the first 48 hours of the treatment phase. Efficacy was demonstrated by a reduction in pain intensity as measured by the sum of the pain intensity differences over 0- to 48 hours in patients receiving Dyloject as compared to placebo.

 

Side Effects

Adverse effects associated with the use of Dyloject may include, but are not limited to, the following:

  • nausea
  • constipation
  • headache
  • infusion site pain
  • dizziness
  • flatulence
  • vomiting
  • insomnia

Non-steroidal anti-inflammatory drugs (NSAIDs) may increase the risk of serious cardiovascular (CV) thrombotic events, myocardial infarction, and stroke. NSAIDs increase the risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestine.

Mechanism of Action

Dyloject (diclofenac sodium) Injection is a non-steroidal anti-inflammatory drug. It exhibits anti-inflammatory analgesic and antipyretic activities in animal models. The mechanism of action of Dyloject, like that of other NSAIDs, is not completely understood but may involve inhibition of the cyclooxygenase (COX-1 and COX-2) pathways. Dyloject’s mechanism may also be related to inhibition of prostaglandin synthetase. 

Additional Information

For additional information regarding Dyloject or pain management, please visit http://www.hospira.com