Pronunciation:........ fen-oh-PROH-fen
.......... KAL-see-um
Drug class: Analgesic (Nonsteroidal Anti-Inflammatory Drug [NSAID])
Generic available? Yes
Controlled substance? No

      Oral fenoprofen calcium is a nonsteroidal anti-inflammatory agent (NSAID) used for the relief of mild to moderate pain in addition to the treatment of rheumatoid arthritis and osteoarthritis. It has anti-inflammatory and pain-relieving properties. Fenoprofen 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 osteoarthritis and rheumatoid arthritis.
• Used to relieve mild to moderate pain.

• Allergic to aspirin, fenoprofen, 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

• For mild to moderate pain: 200 mg taken by mouth every 4 to 6 hours as needed for pain.
• For rheumatoid arthritis and osteoarthritis: 300 to 600 mg taken by mouth 3 or 4 times per day.

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

Infants and Children
      The safety and efficacy have not been established in pediatric patients.

Maximum Dosage Recommendations

Adults: 3200 mg 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 Diarrhea Lethargy Nausea or vomiting Headache Constipation Dyspepsia (upset stomach) Dizziness

Less Common to Rare Symptoms Peptic ulcer Blurred vision Dizziness Skin rash Rapid heartbeat Weakness or fatigue Diminished hearing Itching Jaundice (shows up as yellowish eyes or skin) Black stools (this is a sign of GI bleeding. Stop therapy and call your doctor right away) Ringing in ears Swollen feet, face or legs Nose bleeds Unusual bleeding or bruising Kidney function impairment

Life-threatening Symptoms

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, ketoprofen, 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

• For rheumatoid arthritis and osteoarthritis:
  • Immediate or delayed-release forms: 50-75 mg taken by mouth as needed 3 or 4 times per day.
  • Extended-release form: 150-200 mg once per day.
• For pain and dysmenorrhea:
  • Immediate-release form: 25-50 mg as needed every 6-8 hours.
  • Do not use the extended-release forms.

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. Use smaller doses in debilitated patients.

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

Maximum Dosage Recommendations
      Adults: 300 mg of the immediate-release form or 200 mg of the extended-release form per day.

Usual Duration of Use
      Allow 1 to 2 weeks of use to assess the drug's effectiveness for treatment of chronic condition. 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 Indigestion Nausea Constipation Mild to moderate abdominal discomfort Dizziness Flatulence (gas) Edema (accumulation of fluid in the body) Irritability or nervousness Mild to moderate headache Life-threatening Symptoms Anaphylaxis (a severe allergic reaction) 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 Jaundice (May experience yellow eyes or skin) Itch 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 Unusual bleeding or bruising Worsening of heart failure Diarrhea

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

• Allergic to aspirin, mefenamic acid, 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
      Start at 500 mg taken by mouth, then 250 mg every 6 hours as needed for the relief of pain, not to exceed 7 days of use.
      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.

Maximum Dosage Recommendations

• Children less than 14 years: The safety and efficacy have not been established.
• Adults and adolescents above 14 years: 1250 mg .

If You Miss a Dose
      This is taken on as needed basis. 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

• Diarrhea
• Dizziness
• Headache
• Nausea
• Skin rash

• Stomach cramps
• Jaundice (May experience yellow eyes or skin)
• Itch
• 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
• Unusual bleeding or bruising
• Edema (accumulation of fluid in the body)
• Worsening of heart failure

• 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, diclofenac, 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, NSAIDs, or iodides
• Thrombocytopenia (low platelet count)
• Ulcerative colitis
• Chrohn's disease
• Impaired kidney function
• Prophyria

Adults Under 60

• For delayed-release tablets:
  • For rheumatoid arthritis: 150-200 mg per day taken by mouth in 3-4 divided doses.
  • For osteoarthritis: 100-150 mg per day taken by mouth in 2-3 divided doses. For ankylosing spondylitis: 100-125 mg per day taken by mouth in 4 or 5 divided doses.
• For extended-release tablets:
  • For antirheumatic use: 75-100 mg per day once daily or 75mg taken by mouth twice daily.

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

Maximum Dosage Recommendations
Adults:

• 200 mg per day for menstrual symptoms,
• 225 mg per day for rheumatoid arthritis,
• 150 mg per day for osteoarthritis.

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

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

• Skin rash
• 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
• Ringing in ears
• Severe abdominal pain
• Constipation
• Unusual bleeding or bruising
• Worsening 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