Duexis (ibuprofen and famotidine)

WARNING

RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS

Cardiovascular Thrombotic Events

• Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
• Duexis 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.

Duexis may cause serious side effects including:

• sneezing,
• runny or stuffy nose,
• wheezing,
• trouble breathing,
• swelling in your face or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• chest pain spreading to your jaw or shoulder,
• sudden numbness or weakness on one side of the body,
• slurred speech,
• leg swelling,
• shortness of breath,
• changes in your vision,
• first sign of any skin rash (no matter how mild),
• headache,
• neck stiffness,
• increased sensitivity to light,
• nausea,
• vomiting,
• confusion,
• drowsiness,
• severe headache,
• blurred vision,
• pounding in your neck or ears,
• little or no urination,
• swelling,
• rapid weight gain,
• loss of appetite,
• stomach pain (upper right side),
• tiredness,
• itching,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• pale skin,
• unusual tiredness,
• lightheadedness,
• cold hands and feet,
• bloody or tarry stools, and
• coughing up blood or vomit that looks like coffee grounds

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Duexis include:

• nausea,
• stomach pain,
• diarrhea,
• constipation, and
• headache

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Duexis. For more information, ask your doctor or pharmacist.

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

• Carefully consider the potential benefits and risks of Duexis and other treatment options before deciding to use Duexis. Use ibuprofen at the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.
• The recommended daily dose of Duexis (ibuprofen and famotidine) 800 mg/26.6 mg is a single tablet administered orally three times per day.
• Duexis tablets should be swallowed whole, and should not be cut to supply a lower dose. Do not chew, divide, or crush tablets.
• Patients should be instructed that if a dose is missed, it should be taken as soon possible. However, if the next scheduled dose is due, the patient should not take the missed dose, and should be instructed to take the next dose on time. Patients should be instructed not to take 2 doses at one time to make up for a missed dose.
• Do not substitute Duexis with the single-ingredient products of ibuprofen and famotidine.

See Table 3 for clinically significant drug interactions with ibuprofen.

Table 3: Clinically Significant Drug Interactions with Ibuprofen and Famotidine

• Use of NSAIDs, including Duexis, during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus.
• Avoid use of NSAIDs, including Duexis, in pregnant women starting at 30 weeks of gestation (third trimester).
• There are no adequate and well-controlled studies of Duexis in pregnant women.
• No studies have been conducted with the use of Duexis in lactating women.
• Limited data from published literature report famotidine is present in human milk in low amounts.
• Published literature also reports the presence of ibuprofen in human milk in low amounts. No information is available on the effects of famotidine or ibuprofen on milk production or on a breastfed infant.