Consensi

Consensi is a prescription medication used for the treatment of osteoarthritis (OA) pain and high blood pressure (known as hypertension) simultaneously.

It is a single product containing 2 medications: amlodipine and celecoxib.

Amlodipine belongs to a group of drugs called calcium channel blockers, which lower blood pressure by relaxing arteries and veins so blood can pass more easily through them. Celecoxib belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs), which work by blocking the production of proteins called prostaglandins and reducing inflammation.

This medication comes in tablet form and is taken once a day.

Common side effects of Consensi include stomach pain, heartburn, and swelling. Consensi can also cause dizziness. Do not drive or operate heavy machinery until you know how Consensi affects you.

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.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Consensi. See the “Consensi Precautions” section.

Common side effects of Consensi include the following:

• swelling of the arms, legs, hands, and feet
• headache
• joint swelling
• frequent urination
• dizziness
• stomach pain
• diarrhea
• heartburn
• flushing (hot or warm feeling in your face)
• gas
• tiredness
• extreme sleepiness

This is not a complete list of Consensi side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• anticoagulant (blood thinner) medications such as warfarin (Coumadin, Jantoven)
• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem), and fluvoxamine (Luvox)
• selective serotonin and norepinephrine reuptake inhibitors (SNRIs) such as desvenlafaxine (Pristiq), duloxetine (Cymbalta), and venlafaxine (Effexor XR)
• angiotensin-converting enzyme (ACE) blockers such as
  • benazepril (Lotensin, Lotensin HCT)
  • captopril (Capoten, Capozide)
  • enalapril (Vasotec, Vaseretic)
  • fosinopril (Monopril, Monopril HCT)
  • lisinopril (Prinivil, Prinzide, Zestril, Zestoretic)
  • moexipril (Univasc, Uniretic)
  • quinapril (Accupril, Accuretic, Quinaretic)
  • ramipril (Altace)
  • trandolapril (Mavik, Tarka)
• angiotensin receptor II blockers such as
  • azilsartan (Edarbi)
  • candesartan (Atacand)
  • irbesartan (Avapro)
  • losartan (Cozaar)
  • olmesartan (Benicar)
  • telmisartan (Micardis, Twynsta)
  • valsartan (Diovan)
• beta blockers such as
  • metoprolol (Toprol XL, Lopressor)
  • carvedilol (Coreg)
  • bisoprolol (Zebeta)
  • betaxolol (Kerlone)
  • nebivolol (Bystolic)
  • propranolol (Inderal)
• loop or thiazide diuretics such as
  • bumetanide (Bumex)
  • chlorothiazide (Diuril)
  • chlorthalidone (Thalitone)
  • ethacrynic acid (Edecrin)
  • furosemide (Lasix)
  • hydrochlorothiazide (Microzide, HCTZ)
• corticosteroids such as prednisone, prednisolone, or methylprednisolone
• medications that use the enzyme CYP2D6 such as desipramine, dextromethorphan, and atomoxetine
• medications that increase the activity of the enzyme CYP2C9 such as rifampin
• medications that decrease the activity of the enzyme CYP2C9 such as fluconazole
• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone
• digoxin
• simvastatin
• aspirin

This is not a complete list of Consensi drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Consensi 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

 Tell your healthcare provider right away if you have some or all of the following symptoms of heart attack or stroke.

• Chest pain
• Shortness of breath
• Pain in the arms, back, shoulders, neck, jaw, or upper part of the stomach
• Sudden numbness or weakness of the face, arm or leg (especially on one side of the body)
• Sudden confusion or difficulty speaking or understanding speech
• Sudden difficulty seeing in one or both eyes
• Sudden difficulty walking or a loss of balance or coordination
• Sudden severe headache

Chest pain. Tell your healthcare provider right away if you have some or all of the following symptoms of angina:

• a pressure, squeezing, burning, or tightness in the chest
• pain in the chest, breastbone area, arms, neck, shoulders, or back
• nausea
• fatigue
• shortness of breath
• light headedness
• weakness

Hypotension. Hypotension, or low blood pressure, may cause you to feel faint or dizzy. Inadequate fluid intake, excessive sweating, diarrhea, or vomiting can lead to an excessive fall in blood pressure too. Lie down if you feel faint or dizzy. Call your doctor right away.

Bleeding or ulcers of the gastrointestinal (GI) tract. Tell your healthcare provider right away if you have some or all of the following symptoms of bleeding or ulcers of GI tract.

• Burning stomach or throat pain
• Bright red blood in vomit or vomit that looks like coffee grounds
• Black or tarry stools
• Bloody stools

A decline in liver function. Tell your healthcare provider about any signs or symptoms of liver damage, which include the following:

• loss of appetite or sudden weight loss (anorexia)
• nausea or vomiting
• feeling tired
• stomach pain or tenderness
• dark urine or light colored stools
• yellowing of your skin or the whites of your eyes
• fever or rash

A decline in kidney function. Toxicity from Consensi may occur with kidney dysfunction. Your doctor may want to monitor your kidney functions with certain blood tests as well. Tell your healthcare provider right away right away if you have any of the following symptoms of kidney dysfunction:

• swelling of face, ankles, hands, or feet
• feeling tired
• paleness of skin
• decreased urination
• shortness of breath
• changes in blood pressure

Congestive heart failure (CHF). Tell your healthcare provider right away if you experience any of the following symptoms of CHF:

• sudden weight gain
• worsening shortness of breath
• increased swelling of your feet, legs, or abdomen
• needing to use more pillows to go to sleep or sleeping in a recliner
• waking from sleep to catch your breath
• a cough that does not go away
• new or increasing irregularities in your heart rate

Low red blood cell count (anemia). Tell your doctor if you have any of these symptoms of anemia during treatment with Consensi:

• feeling weak, tired, or you get tired easily
• you look pale
• you feel short of breath

Hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, which include the following:

• chest pain
• swelling of the face, eyes, lips, tongue, arms, or legs
• difficulty breathing or swallowing rash

Severe skin and mouth reactions. Tell your doctor or get medical help right away if you get any of these symptoms at anytime during your treatment:

• painful sores or ulcers on your skin, lips or in your mouth
• blisters
• peeling skin
• rash
• pustules

Consensi can cause dizziness. Do not drive or operate heavy machinery until you know how Consensi affects you.

Do not take Consensi if you:

• are allergic to Consensi or to any of its ingredients
• have had an allergic reaction to aspirin or other NSAIDs such as ibuprofen or naproxen
• have had an allergic reaction to sulfonamides such as sulfamethoxazole and trimethoprim (Bactrim, Septra) or sulfasalazine (Azulfidine)
• have recently had or will soon have heart bypass surgery

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Consensi, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Consensi, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Consensi or to any of its ingredients
• have or have had asthma
• have had an allergic reaction to aspirin or other NSAIDs such as ibuprofen or naproxen
• have kidney problems
• have liver problems
• have heart problems
• are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking Consensi during pregnancy. You should not take Consensi after 29 weeks of pregnancy.
• are breastfeeding or plan to breastfeed. Consensi can pass into your breast milk. It is not known if Consensi will harm your baby. Talk with your healthcare provider about the best way to feed your baby if you take Consensi.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Consensi is a combination product containing amlodipine and celecoxib.

Use of NSAIDs including celecoxib during the last trimester of pregnancy increases the risk of early closure of a structure in the babies heart. Therefore, Consensi you should not take Consensi after 29 weeks of pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Consensi has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Consensi, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered.

Take Consensi exactly as prescribed.

Consensi comes in tablet form and is taken once a day.

If your osteoarthritis pain stops, do not stop taking Consensi until your doctor can prescribe another medication to treat your high blood pressure.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your age

The recommended dose range of Consensi for the treatment of hypertension and osteoarthritis is 2.5 mg amlodipine per 200 mg celecoxib to 10 mg amlodipine per 200 mg celecoxib.

If you take too much Consensi, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Consensi at room temperature between 68° and 77°F (20°C to 25°C).
• Keep this and all medicines out of the reach of children.

WARNING: 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.

CONSENSI is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.

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.