August 29, 2016
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Daypro Alta

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Daypro Alta

DAYPRO ALTA
(oxaprozin potassium) 600 mg Tablets




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 the treatment and may increase with duration of use [see WARNINGS AND PRECAUTIONS].
  • DAYPRO ALTATM is contraindicated in the setting of coronary artery bypass graft (CABG) surgery [see WARNINGS AND PRECAUTIONS].

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 [see WARNINGS AND PRECAUTIONS].

DRUG DESCRIPTION

DAYPRO ALTA (oxaprozin potassium) tablet is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs), available as tablets of 600 mg (678 mg of oxaprozin potassium equivalent to 600 mg of oxaprozin) for oral administration. The chemical name for oxaprozin potassium is 4,5-diphenyl-2-oxazolepropionic acid, potassium salt. The molecular weight is 331. Its molecular formula is C18H14NO3K, and it has the following chemical structure.

It has the following structural formula:

DAYPRO ALTA (oxaprozin potassium) Structural Formula Illustration

Oxaprozin potassium is a white to off white powder with a melting point of 215°C. It is slightly soluble in alcohol and very soluble in water. The PK in water is 9.7.

The inactive ingredients in DAYPRO ALTA include: microcrystalline cellulose, hydroxypropyl methylcellulose, pregelatinized corn starch, stearic acid, colloidal silicon dioxide, polyethylene glycol, titanium dioxide, FD&C Blue #1 Aluminum Lake, and pharmaceutical glaze. Daypro ALTA 600 mg tablets are blue, capsule-shaped, film-coated, with Searle 1391 printed on one side.

What are the possible side effects of oxaprozin (Daypro)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking oxaprozin and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
  • black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • urinating less than usual or not at all;
  • nausea, stomach pain, low fever, loss of...

Read All Potential Side Effects and See Pictures of Daypro Alta »

Last reviewed on RxList: 6/21/2016
This monograph has been modified to include the generic and brand name in many instances.

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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