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Frequently Asked Questions

What should I use DUEXIS for?

DUEXIS is used to:

  • Relieve the signs and symptoms of osteoarthritis and rheumatoid arthritis
  • Decrease the risk of developing ulcers in the stomach and upper intestines (upper gastrointestinal ulcers) in patients who are taking ibuprofen for osteoarthritis or rheumatoid arthritis. DUEXIS was studied mostly in people younger than 65 years and in people who did not have a prior history of ulcers of the stomach and upper intestines

DUEXIS is a prescription 2-in-1 combination tablet that contains 2 medicines, ibuprofen and famotidine.

  1. Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID)
  2. Famotidine is a histamine 2 (H2)-receptor antagonist, a medicine that may help reduce stomach acid

What is the most important information I should know about DUEXIS?

DUEXIS contains ibuprofen (an NSAID) and famotidine. NSAID-containing medicines, such as DUEXIS, increase the chance of a heart attack or stroke that can lead to death. This risk may occur early in treatment. This chance increases:

  • With increasing doses and with longer use of medicine containing NSAIDs
  • In people who have heart disease

NSAID-containing medicines, such as DUEXIS, should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).

NSAID-containing medicines, such as DUEXIS, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

  • Can happen without warning symptoms
  • May cause death

The chance of a person getting an ulcer or bleeding with NSAIDs increases with:

  • Past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs
  • Taking medicines called steroid hormones (corticosteroids), blood thinners (anticoagulants, including aspirin), serotonin reuptake inhibitors (SSRIs) and serotonin norepinephrine reuptake inhibitors (SNRIs)
  • Longer use of NSAIDs
  • Increasing doses of NSAIDs
  • Smoking
  • Drinking alcohol
  • Older age
  • Advanced liver disease
  • Bleeding problems
  • Having poor health

NSAID-containing medicines, such as DUEXIS, should only be used:

  • Exactly as prescribed
  • At the lowest dose possible for your treatment
  • For the shortest time needed

How can I get DUEXIS?

DUEXIS is available by prescription only. Ask your health care provider if DUEXIS may be right for you.

Who should not take DUEXIS?

You should not take DUEXIS:

  • If you had an asthma attack, hives or other allergic reaction after taking aspirin or other NSAID medicines
  • If you are in the late stages of pregnancy (after 29 weeks of pregnancy)
  • If you know you are allergic to ibuprofen or famotidine or any ingredients of the drug product or to other H2-receptor antagonists
  • Right before or after a heart surgery called a "coronary artery bypass graft (CABG)"

What should I tell my health care provider before starting DUEXIS?

Before you take DUEXIS, you should tell your health care provider if you:

  • Have asthma
  • Have high blood pressure (hypertension)
  • Have heart problems
  • Have a history of stomach ulcers
  • Have or had bleeding problems
  • Take or plan to take low-dose aspirin
  • Have liver or kidney problems
  • Have ulcerative colitis or Crohn's disease (inflammatory bowel disease or IBD)
  • Have any other medical conditions
  • Are pregnant or plan to become pregnant. DUEXIS should not be used by pregnant women late in their pregnancy. See Medication Guide
  • Are breastfeeding or plan to breastfeed. DUEXIS can pass into your milk and may harm your baby. You should not breastfeed while taking DUEXIS. Talk to your health care provider about the best way to feed your baby if you take DUEXIS

Can I take DUEXIS if I am taking other medicines?

You should tell your health care provider about all the medicines you take, including prescription and nonprescription medicines, vitamins and herbal supplements. Since DUEXIS contains ibuprofen, talk to your health care provider before taking any other NSAID-containing products. NSAIDs may be present in over-the-counter medications for treatment of colds, fever or insomnia; refer to the label of over-the-counter medications you are taking or ask your pharmacist.

Using DUEXIS with other medicines can cause serious side effects. DUEXIS may affect the way other medicines work, and other medicines may affect how DUEXIS works. Especially tell your doctor if you take:

  • Aspirin
  • Warfarin (Coumadin®)

Where can I get more information about DUEXIS?

Ask your health care provider about DUEXIS; only your health care provider can offer information that is specific to your own health history.

What is an NSAID?

Nonsteroidal anti-inflammatory drugs are used to treat pain and redness, swelling and heat (inflammation) from medical conditions, including different types of arthritis (e.g., osteoarthritis and rheumatoid arthritis).

What is famotidine?

Famotidine is an H2-receptor antagonist, a medicine that may help reduce stomach acid.

How should I take DUEXIS?

  • Take DUEXIS exactly as your health care provider tells you to take it
  • Your health care provider will tell you how many DUEXIS tablets to take and when to take them
  • Do not change your dose or stop taking DUEXIS without first talking to your health care provider
  • Swallow DUEXIS tablets whole. Do not split, chew, crush, or dissolve the tablets

What do I do if I think I have taken too much DUEXIS?

If you take too much DUEXIS, call your poison control center at 1-800-222-1222.

What if I forget to take a dose of DUEXIS?

If you forget to take a dose of DUEXIS, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at 1 time to make up for a missed dose.

How should I store my DUEXIS?

  • Store DUEXIS at 59°F to 86°F (15°C to 30°C)
  • Keep DUEXIS in the original container and keep the bottle tightly closed
  • Keep DUEXIS dry

 

IMPORTANT SAFETY INFORMATION

 

What is the most important information I should know about DUEXIS?

  • DUEXIS can cause an increased risk of a heart attack or stroke that can lead to death. This risk may occur early in treatment and may increase with longer use and with increasing doses of medicine containing NSAIDs.
  • DUEXIS can cause an increased risk of bleeding, ulcers, and tears (perforation) of the esophagus, stomach and intestines. These events can occur at any time during use, without warning symptoms and may cause death. Elderly patients and patients with a history of ulcer disease or stomach or intestine bleeding are at greater risk for getting an ulcer or bleeding.
  • You should take DUEXIS exactly as prescribed, at the lowest dose possible and for the shortest time needed.

DUEXIS can cause serious side effects. Stop taking DUEXIS and call your doctor or go to your emergency department right away if you get:

  • Difficulty breathing, swelling of the face or throat. These could be signs of a serious allergic reaction.
  • Chest pain, shortness of breath, weakness in one part or side of your body, or slurring of speech. These could be signs of a serious blood clotting event.
  • Upper stomach pain, upset stomach, black, tarry stools, or vomiting of blood. These could be signs of an esophagus, stomach, or intestinal ulcer, bleed, or tear. Note: if you are also taking low-dose aspirin, you are at increased risk for esophagus, stomach, or intestinal bleeding.
  • Nausea, more tired or weaker than usual, itching, yellowing of the skin or eyes, right upper abdomen tenderness, and “flu-like” symptoms. These could be signs of a liver problem.
  • Shortness of breath, unexplained weight gain, or swelling of the arms, legs, hands or feet. These could be signs of a serious heart problem.
  • Any type of rash. This could be a sign of a serious skin reaction.

These are not all of the possible side effects of DUEXIS. Please talk to your doctor if you experience any symptoms that bother you or that do not go away. If you take too much DUEXIS, call your poison control center at 1-800-222-1222.

 

INDICATIONS AND USAGE

What is DUEXIS® (ibuprofen and famotidine)?

DUEXIS contains two medicines: ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and famotidine, a histamine H2-receptor blocker medicine.

DUEXIS is a prescription medicine used to:

  • relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis.
  • decrease the risk of developing ulcers of the stomach and upper intestines (upper gastrointestinal ulcers) in people taking ibuprofen for rheumatoid arthritis and osteoarthritis.

It is not known if DUEXIS is safe and effective in children.

 

Who should not use DUEXIS?

Do not take DUEXIS:

-if you are allergic to ibuprofen, famotidine, any other histamine H2-receptor blocker, or any of the ingredients in DUEXIS. See the Medication Guide for a complete list of ingredients.

- if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs.

- right before or after heart bypass surgery called coronary artery bypass graft.

 

How should I take DUEXIS?

Take DUEXIS exactly as your health care provider tells you to take it. Do not change your dose or stop DUEXIS without first talking to your health care provider. Swallow DUEXIS tablets whole with liquid. Do not split, chew, crush, or dissolve the DUEXIS tablet. If you forget to take a dose of DUEXIS, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take the next dose on time. Do not take 2 doses at one time to make up for a missed dose. You should not take an ibuprofen tablet and famotidine tablet together instead of taking a DUEXIS tablet, because they will not work in the same way.

 

What are the possible side effects of DUEXIS?

The most common side effects of DUEXIS include nausea, diarrhea, constipation, upper abdominal pain, and headache.

 

What other medications might interact with DUEXIS?

Do not use DUEXIS while taking other NSAIDs unless your health care provider says it is OK. NSAIDs may be present in over-the-counter medications for treatment of colds, fever, or insomnia; refer to the label of over-the-counter medications you are taking or ask your pharmacist. Do not use DUEXIS and low-dose aspirin until you talk to your health care provider. Tell your health care provider about all of the medicines you take as some medicines can react with NSAIDs and cause serious side effects.

 

What should I tell my health care provider?

Before starting DUEXIS, tell your health care provider if you have a history of ulcer disease or esophagus, stomach, or intestine bleeding, liver or kidney problems, high blood pressure, heart problems, bleeding problems, asthma, or are pregnant, trying to become pregnant, or breast feeding. Also tell your health care provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins, or herbal supplements. Do not start taking new medicines without talking to your health care provider first.

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088. You may also contact the Horizon Pharma Medical Information Department toll-free at 1-866-479-6742 or medicalinformation@horizonpharma.com.

 

The risk information provided here is not comprehensive. To learn more, talk about DUEXIS with your health care provider or pharmacist. Click here for the Prescribing Information and Medication Guide or call 1-866-479-6742.