INDICATION AND USAGE
What is Duectra?
Duectra contains two medicines: ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and famotidine, a histamine H2-receptor blocker medicine.
Duectra is a prescription medicine used to relieve the signs and symptoms of rheumatoid arthritis and osteoarthritis, and to decrease the risk of developing ulcers of the stomach and upper intestines (upper gastrointestinal ulcers) in people taking ibuprofen for rheumatoid arthritis and osteoarthritis.
Duectra was mostly studied in people less than 65 years of age and who did not have any history of ulcers of the stomach and upper intestines.
It is not known if Duectra is safe and effective in children.
What is the most important information I should know about Duectra?
Duectra 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.
Duectra 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 Duectra exactly as prescribed, at the lowest dose possible and for the shortest time needed.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about Duectra?
Duectra 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.
Duectra 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 Duectra exactly as prescribed, at the lowest dose possible and for the shortest time needed.
Duectra can cause serious side effects. Stop taking Duectra 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 Duectra. Please talk to your doctor if you experience any symptoms that bother you or that do not go away. If you take too much Duectra, call your poison control center at 1-800-222-1222.
INDICATIONS AND USAGE
What is Duectra (ibuprofen and famotidine)?
Duectra contains two medicines: ibuprofen, a nonsteroidal anti-inflammatory drug (NSAID), and famotidine, a histamine H2-receptor blocker medicine.
Duectra 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 Duectra is safe and effective in children.
Who should not use Duectra?
Do not take Duectra:
-if you are allergic to ibuprofen, famotidine, any other histamine H2-receptor blocker, or any of the ingredients in Duectra. 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 Duectra?
Take Duectra exactly as your health care provider tells you to take it. Do not change your dose or stop Duectra without first talking to your health care provider. Swallow Duectra tablets whole with liquid. Do not split, chew, crush, or dissolve the Duectra tablet. If you forget to take a dose of Duectra, 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 Duectra tablet, because they will not work in the same way.
What are the possible side effects of Duectra?
The most common side effects of Duectra include nausea, diarrhea, constipation, upper abdominal pain, and headache.
What other medications might interact with Duectra?
Do not use Duectra 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 Duectra 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 Duectra, 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 Medical Information Department toll-free at 1-866-479-6742 or medicalinformation@horizontherapeutics.com.
The risk information provided here is not comprehensive. To learn more, talk about Duectra with your health care provider or pharmacist. Click here for the Prescribing Information and Medication Guide or call 1-866-479-6742.