| Indications |
| NAPRELAN® Tablets are indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, tendinitis, bursitis, and acute gout. It is also indicated in the relief of mild to moderate pain and the treatment of primary dysmenorrhea. |
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| Important Safety Information |
NAPRELAN® belongs to a class of medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:
• different types of arthritis
• menstrual cramps and other types of short-term pain
All NSAIDs, including NAPRELAN®, have the same cardiovascular warning: They may increase the chance of heart attack or stroke that can lead to death. This chance increases with longer use of NSAID medicines and in people who have heart disease.
NAPRELAN® should never be used right before or after a heart surgery called a coronary artery bypass graft (CABG).
NAPRELAN® can cause ulcers and bleeding in the stomach and intestines at any time during treatment. This can happen without warning symptoms and may cause death. Patients taking aspirin and the elderly are at an increased risk.
Serious skin reactions, or allergic reactions, sometimes fatal, can occur without warning and have been reported with NAPRELAN® use. Do not take NAPRELAN® if you are allergic to naproxen, or have had an asthma attack, hives, or other allergic reactions when taking aspirin or another NSAID medicine.
Get emergency help right away if you have shortness of breath or trouble breathing, chest pain, weakness in one part or side of your body, slurred speech, swelling of the face or throat.
Before using NAPRELAN®, talk to your health care professional about all of your medical conditions and the medications you take, and if you are pregnant, planning to become pregnant, or breast-feeding. NAPRELAN® should not be taken in late pregnancy.
NAPRELAN® should be used exactly as prescribed at the lowest dose possible and for the shortest time needed.
The most frequent side effects that have been reported with NAPRELAN® are headache, heartburn, and flu syndrome. Other side effects that may occur include back pain, other types of pain, infection, nausea, diarrhea, constipation, abdominal pain, sore throat, runny nose, sinusitis, urinary tract infection, skin rash, skin eruptions, black and blue marks, drowsiness, excess fluid in the tissues, trouble breathing, and ringing in the ears.
For more information about NAPRELAN® and other NSAIDs, please see the Medication Guide.
These are not all the side effects with NSAID medicines, including NAPRELAN®. Talk to your healthcare provider or pharmacist for more information about NSAID medicines, including NAPRELAN®.
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. |
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| Click here for full Prescribing Information |
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Reference: 1. US Department of Health and Human Services. FDA approved drug products: NAPRELAN.
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.DrugDetails. Accessed October 3, 2011.
References: 1. NAPRELAN® [package insert]. 2009. 2. Gaston G. A double-blind, randomized, parallel-group study of the pharmacokinetics and onset of action of Naprelan in patients following oral surgery. Am J Orthop. 1996;25(suppl 9):37-41. 3. Lane NE, Schnitzer TJ. Osteoarthritis. In: Goldman L, Ausiello D, eds. Cecil Medicine. 23rd ed. Philadelphia, PA: Elsevier; 2008:1993-1997.
NAPRELAN is a registered trademark of Alkermes Pharma Ireland Limited. (APIL).
IPDAS is a registered trademark of Alkermes Pharma Ireland Limited. (APIL). US Patent No.: US 5637320 |
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