Pronunciation:........ na-PROX-en SOH-dee-um
Drug class: Analgesic (Nonsteroidal Anti-Inflammatory Drug [NSAID]); Antipyretic
Generic available? Yes
Controlled substance? No

      Oral naproxen sodium is a nonsteroidal anti-inflammatory drug (NSAID) used to relieve fever and reduce inflammation and pain associated with arthritis and other conditions. It has anti-inflammatory, fever-reducing, and pain-relieving properties. Naproxen works by inhibiting cyclooxygenase, an enzyme responsible for making prostaglandins which are mediators of inflammation. It is recommended that this medication be taken with food to minimize stomach irritation.

FDA Approved Uses

• Treatment of primary dysmenorrhea
• Treatment of bursitis or tendonitis of the shoulder
• Treatment of acute gouty arthritis
• Treatment of juvenile arthritis
• Treatment of rheumatoid arthritis and osteoarthritis
• Treatment of ankylosing spondylitis
• Treatment of mild to moderate pain

• Allergic to aspirin, naproxen, or any other non-steroidal anti-inflammatory drug (NSAID)
• Active peptic ulcer disease
• Bleeding disorders
• Uncontrolled hypertension
• Congestive heart failure
• Past acute asthma attacks, urticaria, or rhinitis caused by aspirin or NSAIDs
• Thrombocytopenia (low platelet count)
• Ulcerative colitis
• Chrohn's disease
• Severe kidney function impairment

Adults Under 60

• For treatment of various arthritis:
  • Extended-release tablets: 750mg once a day.
  • For all other forms: 250, 375, or 500 mg taken by mouth every 12 hours.
• For treatment of burisitis, tendonitis, mild to moderate pain, and dysmenorrhea:
  • 500mg taken by mouth for the first dose, then 250mg every 6 to 8 hours as needed.
• For treatment acute gouty arthritis:
  • 750mg taken by mouth for the first dose, then 250mg every 8 hours until the attack has subsided.

Adults 60 and Over
      Reduced dosage may be necessary. Consult your physician.

Infants and Children
      For juvenile rheumatoid arthritis: 10 mg/kg per day up to 1000mg taken by mouth divided into 2 doses.

Children over 2 years:
      As an antipyretic or analgesic: 2.5-5 mg/kg taken by mouth every 8-12 hours as needed.

Maximum Dosage Recommendations

• Children: 1000 mg or 15mg/kg per day, whichever is less.
• Adults: Not to exceed 1.25 g of naproxen for relief of mild to moderate pain and dysmenorrhea.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

Common Symptoms Nausea Headache Dizziness Constipation Heartburn Drowsiness Rash or hives Mild to moderate abdominal pain or discomfort Ringing in ears Shortness of breath or troubled breathing Swollen feet, face, or legs

Less Common to Rare Symptoms Jaundice (May experience yellow eyes or skin) Itch Flatulence Peptic ulcer Blurred vision Black stools (May be a sign of GI bleed. Stop therapy and call your doctor right away) Diminished hearing Kidney function impairment Photosensitivity Severe abdominal pain Constipation Unusual bleeding or bruising Worsening of heart failure Diarrhea Mild or moderate stomach pain or discomfort

Life-threatening Symptoms

• Anaphylaxis (a severe allergic reaction)

• Convulsions
• Severe headache
• Severe nausea, vomiting, or abdominal pain
• Confusion
• Coma
• Agitation
• Possible hemorrhage from stomach or intestine
• Lethargy
• Bluish color of fingernails, lips, or skin

• Allergic to aspirin, sulindac, or any other non-steroidal anti-inflammatory drug (NSAIDs)
• Active peptic ulcer disease
• Bleeding disorders
• Uncontrolled hypertension
• Congestive heart failure
• Past acute asthma attacks, urticaria, or rhinitis caused by aspirin or NSAIDs
• Thrombocytopenia (low platelet count)
• Ulcerative colitis
• Chrohn's disease
• Impaired kidney function

Adults Under 60
      Start at 150 to 200 mg taken by mouth twice per day every 12 hours.

Note: Take with food to minimize gastrointestinal side effects. Avoid taking with aspirin unless instructed to do so by your physician. Avoid alcoholic beverages while taking this medication or any other medication.

Adults 60 and Over
      Reduced dosage may be necessary. Consult your physician.

Infants and Children
      The safety and efficacy have not been established.

Maximum Dosage Recommendations
      Adults: 400 mg per day. Dosages above 400 mg per day have not been fully studied.

Usual Duration of Use
      Response occurs within 1 week in about half of patients with osteoarthritis, ankylosing spondylitis and rheumatoid arthritis.
      Others may require longer to respond. In acute painful shoulder and acute gouty arthritis, therapy for 1 to 2 weeks is usually adequate.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

Common Symptoms Abdominal pain Diarrhea or constipation Nausea or vomiting Life-threatening Symptoms Anaphylaxis (severe allergic reactions including hives, troubled breathing, swelling of the eyelids or around the eyes) Possible Overdose Symptoms Convulsions Severe headache Severe nausea, vomiting, or abdominal pain Confusion Coma Agitation Possible hemorrhage from stomach or intestine Lethargy Bluish color of fingernails, lips, or skin

Less Common to Rare Symptoms Skin rash Headache Dizziness Jaundice (may experience yellowish eyes or skin) Weakness or fatigue Confusion Ringing in ears Sore throat Swollen feet, face or legs Black stools (May be a sign of gastrointestinal bleed. Stop therapy and call your doctor right away) Depression Blurred vision Blood in urine Frequent, painful urination Hives Itch Unusual bleeding or bruising Nose bleeds

What to Do in Case of Overdose
      Dial 911 for emergency help or call your poison control center.

• Allergic to aspirin, ibuprofen, or any other non-steroidal anti-inflammatory drug (NSAID)
• Active peptic ulcer disease
• Bleeding disorders
• Uncontrolled hypertension
• Congestive heart failure
• Past acute asthma attacks, urticaria, or rhinitis caused by aspirin or NSAIDs
• Thrombocytopenia (low platelet count)
• Ulcerative colitis
• Chrohn's disease
• Impaired kidney function

Adults Under 60

• As an antirheumatic agent: 1200-3200mg per day in 3-4 divided doses.
• For other conditions or uses: 200-400 mg taken by mouth as needed 3 or 4 times per day.

Adults 60 and Over
      Reduced dosage may be necessary. Consult your physician.

Infants and Children
For children 6 months to 12 years:

• Juvenile rheumatoid arthritis: 30-40 mg/kg per day taken by mouth in 3 or 4 divided doses; 20 mg/kg/day may be adequate for milder disease.
• Fever reduction: 5 mg/kg per dose taken by mouth as needed every 4 to 6 hours for patients with temperature 102.5 deg F (39.2 deg C)or less. 10 mg/kg per dose taken by mouth as needed every 4 to 6 hours for patients with temperature above 102.5 deg F (39.2 deg C).
• Analgesic for children 6 months to 12 years: 5-10 mg/kg taken by mouth as needed every 6 to 8 hours.

• For juvenile rheumatoid arthritis: 50mg/kg per day.
• As an antipyretic: 40 mg/kg per day.

Usual Duration of Use
      Allow 1 to 2 weeks of use to assess the drug's effectiveness for arthritis. Long term therapy may be warranted.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children
      Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

Common Symptoms

• Stomach cramps
• Dizziness
• Nausea or vomiting

• Jaundice (May experience yellow eyes or skin)
• Itch
• Flatulence
• Peptic ulcer
• Blurred vision
• Black stools (May be a sign of GI bleed. Stop therapy and call your doctor right away)
• Diminished hearing
• Kidney function impairment
• Rash
• Ringing in ears
• Severe abdominal pain
• Constipation
• Unusual bleeding or bruising
• Edema (accumulation of fluid in the body)
• Worsening of heart failure
• Diarrhea

• Anaphylaxis (severe allergic reactions including hives, troubled breathing, swelling of the eyelids or around the eyes)

• Convulsions
• Severe headache
• Severe nausea, vomiting, or abdominal pain
• Confusion
• Coma
• Agitation
• Possible hemorrhage from stomach or intestine
• Lethargy
• Bluish color of fingernails, lips, or skin

• Allergic to aspirin, indomethacin, or any other non-steroidal anti-inflammatory drug (NSAID)
• Active peptic ulcer disease
• Bleeding disorders
• Uncontrolled hypertension
• Congestive heart failure
• Past acute asthma attacks, urticaria, or rhinitis caused by aspirin or NSAIDs
• Severe depression
• Psychiatric disorders
• Parkinsonism
• Thrombocytopenia (low platelet count)
• Ulcerative colitis
• Chrohn's disease
• Impaired kidney function

Adults Under 60

• For antirheumatic uses:
  • For immediate-release form: 25-50 mg taken by mouth 2 to 4 times per day. This dose may be increased at one week intervals by 25-50 mg per day if needed.
  • For extended-release form: 75 mg taken by mouth 1 to 2 times per day.
• For acute gouty arthritis:
  • For immediate-release form: Take 100 mg by mouth for the first dose. Then take 50 mg 3 times per day until pain is relieved.
  • Use the lowest effective dose for the shortest period of time.
• For acute bursitis or tendinitis:
  • For immediate-release form: 75-150 mg taken by mouth per day in 3 to 4 divided doses for 7 to 14 days.

Adults 60 and Over
      Reduced dosage may be necessary. Consult your physician.

Infants and Children
      For antirheumatic use: Start at 1.5-2.5 mg/kg per day taken by mouth in 3 to 4 divided doses, given under the supervision of a physician experienced in the pediatric use of indomethacin.

Maximum Dosage Recommendations

• Adults: 200 mg per day.
• Children: 4mg/kg per day or 150-200 mg per day, which ever is less.

If You Miss a Dose
      This is taken as needed for the relief of pain. Do not double dose.

Storage
      Keep all medications out of the reach of children Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

Common Symptoms

• Dizziness
• Nausea
• Indigestion
• Headache
• Edema (accumulation of fluid in the body)
• Mild to moderate abdominal pain or discomfort

• Jaundice (May experience yellow eyes or skin)
• Itch
• Flatulence
• Peptic ulcer
• Blurred vision
• Black stools (May be a sign of GI bleed. Stop therapy and call your doctor right away)
• Diminished hearing
• Kidney function impairment
• Rash
• Ringing in ears
• Severe abdominal pain
• Constipation
• Unusual bleeding or bruising
• LWorsening of heart failure
• Diarrhea

• Anaphylaxis (a severe allergic reaction)

• Convulsions
• Severe headache
• Severe nausea, vomiting, or abdominal pain
• Confusion
• Coma
• Agitation
• Possible hemorrhage from stomach or intestine
• Lethargy
• Bluish color of fingernails, lips, or skin

• Allergic to aspirin, etodolac, or any other non-steroidal anti-inflammatory drug (NSAID)
• Active peptic ulcer disease
• Bleeding disorders
• Uncontrolled hypertension
• Congestive heart failure
• Past acute asthma attacks, urticaria, or rhinitis caused by aspirin or other NSAIDs
• Thrombocytopenia (low platelet count)
• Ulcerative colitis
• Chrohn's disease
• Impaired kidney function

Adults Under 60

• For osteoarthritis: Start at 300 mg 3-4 times per day.
• For acute pain: 200-400 mg of the immediate release form as needed every 6-8 hours.

Adults 60 and Over
      Reduced dosage may be necessary. Consult your physician.

Maximum Dosage Recommendations

• For adults >60kg: 1200 mg per day of the immediate release, and 1000 mg of the extended release.
• For adults <60kg: do not exceed 20mg/kg per day.

If You Miss a Dose
      Take as soon as possible. If close to the next dose, skip and take the next dose. Do not double the dose.

Storage
      Keep all medications out of the reach of children Store in a tightly closed container at room temperature in a dry, dark place. Do not store in the bathroom. Moisture can cause the drug to break down.

Possible Side Effects
      You may experience the following side effects with the use of this drug:

Common Symptoms

• Nausea
• Dizziness
• Mild to moderate abdominal discomfort or pain
• Flatulence (gas)
• Diarrhea
• Mild to moderate headache

• Skin rash
• Jaundice (May experience yellow eyes or skin)
• Itch
• Edema (accumulation of fluid in the body)
• Peptic ulcer
• Blurred vision
• Black stools (May be a sign of GI bleed. Stop therapy and call your doctor right away)
• Diminished hearing
• Kidney function impairment
• Ringing in ears
• Severe abdominal pain
• Constipation
• Unusual bleeding or bruising
• Worsening of heart failure

• Anaphylaxis (severe allergic reaction)

• Convulsions
• Severe headache
• Severe nausea, vomiting, or abdominal pain
• Confusion
• Coma
• Agitation
• Possible hemorrhage from stomach or intestine
• Lethargy
• Bluish color of fingernails, lips, or skin