What is Consensi and how is it used?
Consensi is a prescription medicine used in adults who need treatment:
- with amlodipine for high blood pressure (hypertension), to lower blood pressure, and
- with celecoxib for the management of the signs and symptoms of osteoarthritis.
It is not known if Consensi is safe and effective in children.
What are the possible side effects of Consensi?
Consensi can cause serious side effects, including:
- liver problems, including liver failure
- worsening chest pain (angina) or heart attack, particularly in people with severe obstructive coronary artery disease
- heart failure
- swelling of your arms, legs, hands and feet (peripheral edema) is common with Consensi but can sometimes be serious.
- kidney problems, including kidney failure
- increased potassium levels (hyperkalemia)
- life-threatening allergic reactions
- life-threatening skin reactions
- low red blood cells (anemia)
Your healthcare provider will monitor your blood pressure and do blood tests to check you for side effects during treatment with Consensi.
Consensi may cause fertility problems in females that is reversible when treatment with Consensi is stopped. Talk to your healthcare provider if this is a concern for you.
The most common side effects of Consensi include:
- swelling of the arms, legs, hands, and feet
- joint swelling
- stomach pain
- frequent urination
- hot or warm feeling in your face (flushing)
- extreme sleepiness
Get emergency help right away if you get any of the following symptoms:
- shortness of breath or trouble breathing
- chest pain
- weakness in one part or side of your body
- slurred speech
- swelling of the face or throat
Stop taking Consensi and call your healthcare provider right away if you get any of the following symptoms:
- more tired or weaker than usual
- indigestion or stomach pain
- flu-like symptoms
- vomit blood
- there is blood in your bowel movement or it is black and sticky like tar
- unusual weight gain
- your skin or eyes look yellow
- skin rash or blisters with fever
- swelling of the arms, legs, hands and feet
These are not all the possible side effects of Consensi.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
RISK OF SERIOUS CARDIOVASCULAR and GASTROINTESTINAL EVENTS
Cardiovascular Thrombotic Events
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular (CV) thrombotic events, including myocardial infarction (MI), and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use [see WARNINGS AND PRECAUTIONS].
- Consensi 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].
Consensi (amlodipine and celecoxib) tablet is an NSAID and long-acting calcium channel blocker for oral administration. Each tablet contains amlodipine besylate and celecoxib 3.47 mg/200 mg, 6.93 mg/200 mg, and 13.87 mg/200 mg and is equivalent to 2.5 mg/200 mg, 5 mg/200 mg, and 10 mg/200 mg amlodipine/celecoxib respectively.
Celecoxib is chemically designated as 4-[5-(4-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl] benzenesulfonamide and is a diaryl-substituted pyrazole. The empirical formula is C17H14F3N3O2S, and the molecular weight is 381.38; the chemical structure is as follows:
Celecoxib is a white to off-white powder with a pKa of 11.1 (sulfonamide moiety). Celecoxib is hydrophobic (log P is 3.5) and is practically insoluble in aqueous media at physiological pH range.
Amlodipine besylate is chemically designated as 3-Ethyl-5-methyl (±)-2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4dihydro-6-methyl-3,5-pyridinedicarboxylate, monobenzenesulphonate. The molecular formula is C20H25CIN2O5•C6H6O3S, and the molecular weight is 567.1; the chemical structure is as follows:
Amlodipine besylate is a white crystalline powder. It is slightly soluble in water and sparingly soluble in ethanol.
The inactive ingredients in Consensi include: mannitol DC 200, croscarmellose sodium, povidone K-30, sodium lauryl sulfate, magnesium stearate, and colloidal silicon dioxide.