Consensi

Generic name:amlodipine and celecoxib
Dosage form: Tablets
Drug classes:Cox-2 inhibitors, Miscellaneous antihypertensive combinations
Approval date: May 31, 2018
Company: Kitov Pharma Ltd.

Treatment for: Hypertension and Osteoarthritis Pain

FDA Approves Consensi

The U.S. Food and Drug Administration (FDA) has approved Consensi (amlodipine besylate and celecoxib), an antihypertensive calcium channel blocker and a non-steroidal anti-inflammatory drug (NSAID) combination for the treatment of hypertension and osteoarthritis pain.

Patient Information

Read this Patient Information carefully before you start treatment. This information does not take the place of talking with your doctor about your medical condition or your treatment.

Warnings

Consensi contains celecoxib, a nonsteroidal anti-inflammatory drug (NSAID), and amlodipine, a calcium channel blocker (CCB). NSAIDs can cause serious side effects, including:

• Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase:
  • with increasing doses of NSAIDs
  • with longer use of NSAIDs

  Do not take Consensi right before or after a heart surgery called a “coronary artery bypass graft” (CABG).

  Avoid taking Consensi after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack.

• Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach, and intestines:
  • anytime during use
  • without warning symptoms
  • that may cause death
  The risk of getting an ulcer or bleeding increases with:
  • past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • taking medicines called “corticosteroids”, “anticoagulants”, “selective serotonin reuptake inhibitors (SSRIs)”, or “serotonin norepinephrine reuptake inhibit