Product description

Naprosyn (Naproxen)

Naprosyn is indicated for the treatment of rheumatoid arthritis, osteoarthritis, juvenile arthritis, ankylosing spondylitis, tendonitis and bursitis, and acute gout. It is also indicated in the relief of mild to moderate pain, and for the treatment of primary dysmenorrhea. Naprosyn Suspension is recommended for juvenile rheumatoid arthritis in order to obtain the maximum dosage flexibility based on the patient's weight.

Naprosyn comes as a regular tablet, an extended-release tablet, and a liquid to take by mouth. It usually is taken twice a day for arthritis, every 8 hours for gout, and once a day (extended-release tablets) or every 6-8 hours (regular tablets) as needed for pain. Naprosyn may cause an upset stomach. Take Naprosyn with food or milk.

Naproxen belongs to a class of drugs called non-steroidal anti-inflammatory drugs (NSAIDs). Other members of this class include ibuprofen (Motrin), indomethacin (Indocin), nabumetone (Relafen) and several others. These drugs are used for the management of mild to moderate pain, fever, and inflammation. They work by reducing the levels of prostaglandins, chemicals that are responsible for pain, fever and inflammation. Naproxen blocks the enzyme that makes prostaglandins (cyclooxygenase ), resulting in lower concentrations of prostaglandins. As a consequence, inflammation, pain and fever are reduced. Naproxen was approved by the FDA in December, 1991.

If you are taking Naprosyn on a regular schedule, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose. If you are taking Naprosyn as needed, take the missed dose if it is needed, then wait the recommended or prescribed amount of time before taking another dose.

Store Naprosyn suspension at room temperature; avoid excessive heat, above 40 degrees C (104 degrees F). Dispense in light-resistant container. Store Naprosyn tablets at room temperature and in well-closed containers; dispense in light-resistant container.

Safety information

Before taking this medication, tell your doctor if you have an allergy to aspirin or any other NSAIDs, have an ulcer or bleeding in your stomach, drink more than three alcoholic beverages a day, have liver disease, Have kidney disease, have a coagulation (bleeding) disorder, have congestive heart failure, have fluid retention, have heart disease, or have high blood pressure. You may not be able to take Naprosyn or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above. Naprosyn is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Naprosyn should not be taken late in pregnancy (the third trimester) because a similar drug is known to affect the baby's heart. Do not take Naprosyn without first talking to your doctor if you are pregnant. Naprosyn passes into breast milk and may affect a nursing infant. Do not take this medicine without first talking to your doctor if you are breast-feeding a baby.

Side effects

Contact your doctor if you experience blood in vomit or bloody, black, or tarry stools. These symptoms could indicate damage to the stomach or intestines, which could be dangerous. If you experience any of the following serious side effects, stop taking Naprosyn and seek medical treatment or contact your doctor immediately: an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); muscle cramps, numbness, or tingling; ulcers (open sores) in the mouth; rapid weight gain (fluid retention); seizures; decreased hearing or ringing in the ears; yellowing of your skin or eyes (jaundice); or abdominal cramping, heartburn, or indigestion. Other, less serious side effects may be more likely to occur. Continue to take Naprosyn and talk to your doctor if you experience dizziness or headache; nausea, diarrhea, or constipation; depression; fatigue or weakness; dry mouth; or irregular menstrual periods. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

• Contact your doctor if you experience blood in vomit or bloody, black, or tarry stools. These symptoms could indicate damage to the stomach or intestines, which could be dangerous.
• If you experience any of the following serious side effects, stop taking naproxen and seek medical treatment or contact your doctor immediately:
  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • muscle cramps, numbness, or tingling;
  • ulcers (open sores) in the mouth;
  • rapid weight gain (fluid retention);
  • seizures;
  • decreased hearing or ringing in the ears;
  • yellowing of your skin or eyes (jaundice); or
  • abdominal cramping, heartburn, or indigestion.
• Other, less serious side effects may be more likely to occur. Continue to take naproxen and talk to your doctor if you experience
  • dizziness or headache;
  • nausea, diarrhea, or constipation;
  • depression;
  • fatigue or weakness;
  • dry mouth; or
  • irregular menstrual periods.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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