This compound
(naproxen sodium) is a member of the non-steroidal anti-inflammatory drug (NSAIDs)
family. NSAIDs reduce inflammation (swelling), pain, and temperature. They are also prescribed for relief of the
inflammation, swelling, stiffness, and joint pain associated with rheumatoid arthritis and osteoarthritis
(the most common form of arthritis), and for spinal arthritis, tendonitis, bursitis,
acute gout, and other conditions. Naproxen and naproxen sodium are available in prescription strength; naproxen
sodium is also available in nonprescription strength.
The Food and Drug Administration in 1994 announced approval of
naproxen sodium, a prescription arthritis drug, for marketing as a nonprescription pain reliever. Naproxen
sodium is the second nonsteroidal analgesic product to win FDA approval for nonprescription pain relief. The
first was ibuprofen, which has been on the market since 1984. Naproxen has been sold as a prescription drug
under the trade name Naprosyn since 1976 and naproxen sodium under the trade name Anaprox since 1980. "Naproxen's
long record of use clearly indicated that the drug could be sold over the counter, provided the manufacturer
modified its dosage and labeling," said FDA Commissioner David A. Kessler, M.D. "We have made
sure that the necessary safeguards are included in the nonprescription version of the product." In its
over-the-counter version, naproxen sodium can be used to alleviate minor pain associated with headache, the
common cold, toothache, muscle ache, backache, arthritis and menstrual cramps, and to reduce fever.
How should you take this medication?
Take Aleve with a full
glass of water. Do not take Aleve for more than 10 days for pain or 3 days for
fever. Contact your doctor if pain or fever persists or gets worse, if the painful area becomes red or swollen,
or if you develop more than a mild digestive upset. Naproxen Sodium OTC (Aleve) 200 mg every 8 - 12 hours.
Dose not to exceed 600 mg in a 24 hour period. Generally effective in 1 hour after taken.
Take naproxen with food, milk, or an antacid to lessen
stomach upset. Watch for bloody, black, or tarry stools or blood in your vomit. These symptoms could indicate
damage to your gastrointestinal tract. Watch for bloody, black, or tarry stools or blood in your vomit. These
symptoms could indicate damage to your gastrointestinal tract. Do not crush or chew any extended-release forms
of naproxen. Swallow them whole. They are specially formulated to release slowly in your body. Ask your
pharmacist if you do not know if you have an extended-release formulation. If you drink more than
three alcoholic beverages a day, naproxen may increase the risk of stomach bleeding.
Your doctor may ask you to take Anaprox with food or an
antacid to avoid stomach upset. Take this medication exactly as prescribed by your doctor. If you are using Anaprox for
arthritis, it should be taken regularly.
If you
experience any of the following serious side effects, stop taking naproxen and seek medical treatment or call
your doctor immediately:
* an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or
hives);
* muscle cramps, numbness, or tingling;
* ulcers (open sores) in the mouth;
* rapid weight gain (fluid retention);
* seizures;
* black, bloody, or tarry stools;
* blood in your urine or vomit;
* decreased hearing or ringing in the ears;
* yellowing of your skin or eyes (jaundice); or
* abdominal cramping, heartburn, or indigestion.
Remember
that peptic ulcers and bleeding can occur without warning. This drug
should be used with caution if you have kidney or liver disease. It can cause liver inflammation in some people.
Pain reliever that has mind or emotion altering properties when
consumed in large doses.
Do not take aspirin or any other anti-inflammatory
medications while taking Anaprox, unless your doctor tells you to do so. Anaprox
and Naprelan contain sodium. If you are on a low sodium diet, discuss this with your doctor.
Use with caution if you have heart disease or high blood
pressure. This drug can increase water retention. It also may cause vision problems. If you experience any
changes in your vision, inform your doctor.
This drug makes some people drowsy or less alert. Avoid driving,
operating dangerous machinery, or participating in any hazardous activity that requires full mental alertness
if you find that the drug has this effect on you.
If you
miss a dose ... Anaprox: Take the forgotten dose as soon as you remember. If it is almost time for your next
dose, skip the one you missed and go back to your regular schedule. Never take 2 doses at the same time. Naprelan:
Take the forgotten dose only if you remember within 2 hours after the appointed time. Otherwise, skip the dose
and go back to your regular schedule.
Storage instructions: Store at room temperature in a
tightly closed container.