Amlodipine/Celecoxib - Oral

Pronunciation: am-LOE-di-peen/SEL-e-KOX-ib

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Warning

Nonsteroidal anti-inflammatory drugs (including celecoxib) may rarely increase the risk for a heart attack or stroke. This effect can happen at any time while taking this drug but is more likely if you take it for a long time. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes). Do not take this drug right before or after heart bypass surgery (CABG).

Also, this drug may rarely cause serious (rarely fatal) bleeding from the stomach or intestines. This effect can occur without warning symptoms at any time while taking this drug. Older adults may be at higher risk for this effect.

Stop taking amlodipine/celecoxib and get medical help right away if you notice any of these rare but serious side effects: stomach/abdominal pain that doesn't go away, black/tarry stools, vomit that looks like coffee grounds, chest/jaw/left arm pain, shortness of breath, unusual sweating, confusion, weakness on one side of the body, trouble speaking, sudden vision changes.

Talk to your doctor or pharmacist about the benefits and risks of taking this drug.

Uses

This product contains 2 medications: amlodipine and celecoxib. This combination medication is used to treat people who have both high blood pressure and arthritis. Amlodipine belongs to a class of drugs known as calcium channel blockers. It works by relaxing blood vessels so blood can flow more easily. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID), specifically a COX-2 inhibitor. It is used to reduce pain, swelling, and joint stiffness from arthritis.

How To Use

Read the Medication Guide provided by your pharmacist before you start using amlodipine and celecoxib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor, usually once daily. Take this medication with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking this medication. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid.

The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose or use this drug more often or for longer than prescribed. For ongoing conditions such as arthritis, keep taking this medication as directed. Discuss the risks and benefits with your doctor or pharmacist.

It may take up to two weeks of taking this drug regularly before you get the full benefit.

Side Effects

See also Warning section.

Stomach upset, diarrhea, dizziness, gas, or swelling ankles/feet may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

The celecoxib in this product may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

  • severe headache
  • pain/swelling/warmth in the groin/calf
  • signs of kidney problems (such as change in the amount of urine)
  • difficult/painful swallowing
  • symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

Although this medication is effective in preventing chest pain (angina), some people who already have severe heart disease may rarely develop worsening chest pain or a heart attack after starting this medication or increasing the dose. Get medical help right away if you experience:

  • worsening chest pain
  • symptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating)

This drug may rarely cause serious (possibly fatal) liver disease. Get medical help right away if you have any symptoms of liver damage, including:

  • nausea/vomiting that doesn't stop
  • loss of appetite
  • stomach/abdominal pain
  • yellowing eyes/skin
  • dark urine

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • fever
  • swollen lymph nodes
  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Warning section.

Before taking this product, tell your doctor or pharmacist if you are allergic to amlodipine or celecoxib; or to aspirin, other NSAIDs (such as ibuprofen), other COX-2 inhibitors; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • asthma
  • aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs)
  • blood disorders (such as anemia, bleeding/clotting problems)
  • growths in the nose (nasal polyps)
  • heart disease (such as angina, previous heart attack, aortic stenosis)
  • high blood pressure
  • liver disease
  • stomach/intestinal/esophagus problems (such as bleeding, heartburn, ulcers)
  • stroke
  • swelling (edema, fluid retention)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Kidney problems can sometimes occur with the use of NSAID medications, including celecoxib. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.

This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Limit alcohol and stop smoking. Ask your doctor or pharmacist about how much alcohol you may safely drink.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially dizziness, stomach bleeding, and kidney problems.

Caution is advised when using this drug for children with a certain type of arthritis (systemic onset juvenile rheumatoid arthritis) because they may be at increased risk for a very serious bleeding/clotting problem (disseminated intravascular coagulation). Get medical help right away if your child develops sudden bleeding/bruising, or if they develop bluish skin on the fingers/toes.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

This medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • aliskiren
  • ACE inhibitors (such as captopril, lisinopril)
  • angiotensin II receptor blockers (such as valsartan, losartan)
  • cidofovir
  • lithium
  • "water pills" (diuretics such as furosemide)

This medication may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (including aspirin, NSAIDs such as naproxen, ibuprofen, ketorolac). These drugs are similar to celecoxib and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Some products have ingredients that could raise your blood pressure. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include severe stomach pain, slow/shallow breathing, severe headache, or loss of consciousness.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, complete blood count, liver and kidney function) may be done while you are using this medication. Keep all medical and lab appointments.

Lifestyle changes that may help this medication work better include exercising, stopping smoking, and eating a low-cholesterol/low-fat diet. Weight loss if needed and strengthening/conditioning exercises may help improve your flexibility and joint function. Consult your doctor for more details.

Check your blood pressure and pulse (heart rate) regularly while taking this medication. Learn how to check your own blood pressure and pulse at home, and share the results with your doctor.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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