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(KEY-toe-PRO-fen)
Orudis, Orudis KT, Oruvail,  APO-Keto, APO-Keto-E, APO-Keto SR, Novo-Keto, Novo-Keto-EC, Nu-Ketoprofen, Nu-Ketoprofen-E, Orafen, Orudis E, Orudis SR, PMS-Ketoprofen, PMS-Ketoprofen-E, Rhodis, Rhodis-EC, Rhodis SR, Rhovail
Class: Analgesic/NSAID

 Action Decreases inflammation, pain and fever, probably through inhibition of cyclooxygenase activity and prostaglandin synthesis.

 Indications Treatment of rheumatoid arthritis, osteoarthritis, mild to moderate pain, primary dysmenorrhea.

Sustained-release form, only: Treatment of rheumatoid arthritis and osteoarthritis. OTC Use: Temporary relief of minor aches and pains associated with common cold, headache, toothache, muscular aches, backache, minor arthritis pain, menstrual cramps, and reduction of fever. Unlabeled use(s): Treatment of juvenile rheumatoid arthritis, sunburn, migraine prophylaxis.

 Contraindications Patients in whom aspirin, iodides or any NSAID has caused allergic-type reactions.

 Route/Dosage

Rheumatoid or Osteoarthritis

ADULTS: PO 75 mg tid or 50 mg qid; do not exceed 300 mg/day. Maintenance dose: Reduce initial dosage to 75 to 150 mg/day in elderly or disabled patients or patients with renal impairment. Sustained-release capsule: 200 mg once daily can be used in patients already stabilized on that dose.

Mild to Moderate Pain, Primary Dysmenorrhea

ADULTS: PO 25 to 50 mg q 6 to 8 hr prn; do not exceed 300 mg/day.

Mild-To-Severe Renal Function Impairment

PO Maximum recommended total daily dose is 150 mg. In patients with a more severe renal impairment (GFR < 25 ml/min or end-stage renal impairment), the maximum total daily dose should not exceed 100 mg.

Hepatic Function Impairment

PO For patients with impaired liver function and serum albumin concentration < 3.5 g/dl, the maximum initial total daily dose shoudl be 100 mg.

OTC Use

ADULTS: PO 12.5 mg with a full glass of liquid q 4 to 6 hr. If pain or fever persists after 1 hour, follow with 12.5 mg. Do not exceed 25 mg in a 4- to 6-hr period or 75 mg in a 24–hour period. Use the smallest effective dose. CHILDREN: PO Do not give to those < 16 yr unless directed by a physician.

 Interactions

Anticoagulants: Increased risk of gastric erosion and bleeding. Aspirin: Additive GI toxicity. Cyclosporine: Nephrotoxicity of both agents may be increased. Lithium: Serum lithium levels may be increased. Methotrexate: Increased methotrexate levels.

 Lab Test Interferences May prolong bleeding time.

 Adverse Reactions

CV: Peripheral edema; fluid retention; CHF. CNS: Headache; dizziness; lightheadedness; drowsiness; vertigo. DERM: Rash; pruritus. EENT: Visual disturbances; stomatitis. GI: Peptic ulcer; GI bleeding; dyspepsia; nausea; diarrhea; constipation; abdominal pain; flatulence; anorexia; vomiting. GU: Menorrhagia. RESP: Bronchospasm; laryngeal edema; rhinitis; dyspnea.

 Precautions

Pregnancy: Category B. Lactation: Excreted in breast milk. Children: Safety and efficacy not established. Elderly: Increased risk of adverse reactions. GI: Bleeding, ulceration or perforation can occur at any time, with or without warning symptoms. GU: Acute renal insufficiency, interstitial nephritis, hyperkalemia, hyponatremia and renal papillary necrosis may occur. Hepatic impairment: Avoid sustained-release product. Hypersensitivity: May occur; use caution in aspirin-sensitive individuals because of possible cross-sensitivity. Renal impairment: Lower doses may be necessary.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

  • Do not crush capsules.
  • Administer with food, milk or antacids to minimize GI upset.
  • Store at room temperature in tightly closed, light-resistant container.

 Assessment/Interventions

  • Obtain patient history, including drug history and any known allergies. Note renal or hepatic impairment or sensitivity to NSAIDs.
  • Do not administer to patients in whom aspirin, iodides or other NSAIDs have induced symptoms of asthma, rhinitis, urticaria, nasal polyps, angioedema, bronchospasm and other symptoms of allergic or anaphylactoid reactions.
  • Assess carefully for hypersensitivity (fever, rash, abdominal pain, headache, nausea, vomiting, signs of liver damage) and for signs of infection (NSAIDs may mask the usual signs of infection).
  • Monitor patients on long-term therapy for signs and symptoms of ulceration and bleeding of upper and lower GI tract.
  • Monitor renal and hepatic function tests.
  • If skin rash, diarrhea, weight gain, edema, black stools, constipation, persistent headache, blurred vision, dizziness, nervousness, ringing in the ears, taste changes or changes in vision occur or are reported, discontinue use and notify physician.
OVERDOSAGE: SIGNS & SYMPTOMS
  Drowsiness, dizziness, confusion, disorientation, lethargy, numbness, vomiting, gastric irritation, nausea, abdominal pain, headache, tinnitus, convulsions, acute renal failure

 Patient/Family Education

  • Advise patient to take medication with food, milk or antacids. Capsule should be swallowed whole, not chewed or crushed.
  • Warn patient not to take aspirin or other NSAIDs.
  • Caution patient to report changes in stool (color, consistency, frequency), fluid retention and shortness of breath.
  • Instruct patient to report these symptoms to physician: skin rash, itching, visual disturbances, weight gain, edema, black stools or persistent headache.
  • Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
  • Caution patient to avoid exposure to sunlight and other sources of ultraviolet light and to use sunscreen or wear protective clothing to avoid photosensitivity reaction.
  • Instruct patient not to ingest alcohol or take otc medications without notifying physician.

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