Comprehensive Guide to Ketoprofen: Uses, Dosage, Side Effects, and More

What is Ketoprofen?

Overview of Ketoprofen

Generic Name: Ketoprofen

Brand Name: Orudis, Oruvail, generics

Drug Group: Nonsteroidal anti-inflammatory drug (NSAID)

Commonly Used For

• Relieve rheumatoid arthritis pain.
• Manage osteoarthritis symptoms.
• Treat mild to moderate acute pain.

Key Characteristics

Form: Oral capsules (50 mg, 75 mg), extended-release tablets (100 mg, 200 mg), topical gel (2%), or injectable solution (50 mg/2 mL) (detailed in Dosage section).

Mechanism: Inhibits COX-1 and COX-2, reducing prostaglandin-mediated inflammation and pain.

Approval: FDA-approved (1986 for Orudis) and EMA-approved for pain and inflammation.

Indications and Uses of Ketoprofen

Ketoprofen is indicated for a variety of inflammatory and pain-related conditions, leveraging its anti-inflammatory and analgesic properties:

Rheumatoid Arthritis: Alleviates joint pain, stiffness, and swelling, per rheumatology guidelines, supported by clinical trials showing improved joint mobility within 2 weeks.

Osteoarthritis: Manages chronic joint pain and cartilage degradation, recommended in orthopedic protocols with evidence of reduced synovial inflammation.

Acute Pain: Treats mild to moderate pain from dental procedures, musculoskeletal injuries, or postoperative recovery, with pain management data.

Ankylosing Spondylitis: Investigated off-label to reduce spinal stiffness and inflammation, with rheumatologic evidence.

Dysmenorrhea: Managed off-label to relieve menstrual pain and cramping, with gynecology studies.

Tendonitis/Bursitis: Explored off-label for inflammation of tendons and bursae, with sports medicine research.

Gout Attacks: Used off-label to control acute gouty arthritis pain, with rheumatology data.

Migraine: Initiated off-label to reduce migraine-associated inflammation, with neurology evidence.

Post-Traumatic Pain: Applied off-label post-injury to manage swelling and pain, with emergency medicine studies.

Chronic Back Pain: Investigated off-label for lumbar disc disease, with orthopedic research.

Dosage of Ketoprofen

Dosage for Adults

Rheumatoid Arthritis or Osteoarthritis:

Oral (Immediate-Release): 50–100 mg every 6–8 hours, maximum 300 mg/day.

Oral (Extended-Release): 100–200 mg once daily.

Acute Pain:

Oral: 25–50 mg every 6–8 hours as needed, maximum 300 mg/day.

Injectable: 50–100 mg every 6 hours, maximum 200 mg/day for short-term use.

Topical (Gel): Apply 2–4 g to affected area 2–4 times daily, not exceeding 15 g/day per joint.

Dosage for Children (≥2 years)

Juvenile Rheumatoid Arthritis (Off-Label):

Oral: 0.5–1 mg/kg every 6–8 hours, maximum 5 mg/kg/day, under pediatric rheumatology supervision.

Dosage for Pregnant Women

Pregnancy Category C: Avoid in the third trimester due to closure of ductus arteriosus risk; consult an obstetrician, with fetal monitoring.

Dosage Adjustments

Renal Impairment:

Mild (CrCl 60–89 mL/min): No adjustment; monitor closely.

Moderate (CrCl 30–59 mL/min): Reduce dose by 50%; avoid if severe (CrCl <30 mL/min).

Hepatic Impairment: Mild to moderate (Child-Pugh A or B): Reduce dose by 50%; severe (Child-Pugh C): Avoid.

Concomitant Medications: Adjust if combined with anticoagulants (e.g., warfarin) or other NSAIDs; monitor for bleeding.

Elderly: Start with 50 mg every 6–8 hours; monitor for renal and GI effects.

Duration: Limit to the shortest duration necessary; avoid exceeding 10 days without review.

Additional Considerations

• Take this active ingredient with food or milk to reduce gastric irritation.
• Apply topical gel to clean, dry skin, avoiding broken skin or eyes.
• Use the lowest effective dose for the shortest time to minimize risks.

How to Use Ketoprofen

Administration:

Oral: Swallow capsules or tablets whole with a full glass of water, with or after food.

Topical: Apply a thin layer of gel to the affected area, rubbing gently until absorbed.

Injectable: Administer intramuscularly or intravenously by a healthcare professional.

Timing: Take or apply at regular intervals (e.g., every 6–8 hours), avoiding late-night doses to reduce GI risk.

Monitoring: Watch for stomach pain, black stools, or signs of renal dysfunction (e.g., reduced urine output); report changes immediately.

Additional Tips:

• Store at 20–25°C (68–77°F), protecting from moisture and light.
• Keep out of reach of children; dispose of unused topical gel properly.
• Avoid alcohol to reduce GI bleeding risk; use with antacids if approved by a provider.
• Schedule regular blood tests (e.g., creatinine, hemoglobin) every 1–2 weeks during prolonged use.
• Educate patients on recognizing allergic reactions (e.g., rash, swelling) and seeking prompt care.

Contraindications for Ketoprofen

Hypersensitivity: Patients with a known allergy to Ketoprofen, other NSAIDs, or aspirin.

Severe Renal Impairment: Contraindicated in CrCl <30 mL/min due to toxicity risk.

Severe Hepatic Impairment: Avoid in Child-Pugh Class C due to metabolism concerns.

Active Gastrointestinal Bleeding: Contraindicated in active peptic ulcer or GI hemorrhage.

Late Pregnancy: Avoid in the third trimester due to fetal cardiovascular risks.

Severe Heart Failure: Contraindicated in NYHA Class IV due to fluid retention risk.

History of Asthma with NSAID Sensitivity: Avoid due to potential bronchospasm.

Coronary Artery Bypass Graft (CABG) Surgery: Contraindicated perioperatively due to increased cardiovascular events.

Warnings & Precautions for Ketoprofen

General Warnings

Gastrointestinal Bleeding: Risk of ulcers or perforation; monitor for abdominal pain or melena.

Cardiovascular Risk: Increased risk of heart attack or stroke with long-term use; assess cardiac history.

Renal Toxicity: Risk of acute kidney injury or hyperkalemia; check renal function regularly.

Hepatic Effects: Risk of liver enzyme elevation; monitor LFTs in chronic use.

Hypertension: Risk of blood pressure elevation; monitor BP weekly.

Additional Warnings

Anaphylactic Reactions: Rare risk with prior NSAID sensitivity; discontinue if severe.

Skin Reactions: Risk of Stevens-Johnson syndrome or toxic epidermal necrolysis; stop if rash appears.

Fluid Retention: Risk in heart failure or hypertension patients; monitor weight.

Bone Marrow Suppression: Rare anemia or leukopenia; check CBC if symptoms arise.

Hypersensitivity Reactions: Rare angioedema or bronchospasm; seek immediate care.

Use in Specific Populations

Pregnancy: Category C; avoid in third trimester; monitor fetal outcomes.

Breastfeeding: Use caution; monitor infant for effects.

Elderly: Higher GI and renal risk; start with lowest dose.

Children: Safe for off-label use with pediatric oversight.

Renal/Hepatic Impairment: Adjust or avoid based on severity.

Additional Precautions

• Inform your doctor about heart disease, liver issues, or GI history before starting this medication.
• Avoid prolonged sun exposure if using topical forms to prevent photosensitivity.
• Use with proton pump inhibitors if at high GI risk.

Overdose and Management of Ketoprofen

Overdose Symptoms

Nausea, vomiting, or abdominal pain.

Severe cases: Gastrointestinal bleeding, renal failure, or respiratory depression.

Drowsiness, dizziness, or tinnitus as early signs.

Coma or cardiovascular collapse with extremely high doses.

Immediate Actions

Contact the Medical Team: Seek immediate medical help.

Supportive Care: Administer activated charcoal if recent ingestion, monitor vital signs, and provide IV fluids.

Specific Treatment: No specific antidote; use proton pump inhibitors for GI bleeding or dialysis for renal failure.

Monitor: Check renal function, liver enzymes, and coagulation parameters for 24–48 hours.

Patient Education: Advise against exceeding prescribed doses and to store safely.

Additional Notes

• Overdose risk is higher in renal impairment; store securely and limit access.
• Report persistent symptoms (e.g., severe stomach pain, blood in stool) promptly.

Side Effects of Ketoprofen

Common Side Effects

• Stomach Pain (10–15%, managed with food)
• Nausea (5–10%, reduced with antacids)
• Dizziness (5–8%, decreases with rest)
• Rash (3–7%, relieved with discontinuation)
• Edema (2–5%, monitored with weight checks)

These effects may subside with adaptation.

Serious Side Effects

Additional Notes

Regular monitoring with renal function tests (e.g., creatinine) and LFTs every 1–2 weeks is advised during prolonged use.

Patients with a history of ulcers should use with gastroprotective agents (e.g., omeprazole).

Report any unusual symptoms (e.g., swelling, shortness of breath) immediately to a healthcare provider.

Long-term use (>4 weeks) requires cardiovascular risk assessment and blood pressure monitoring.

Drug Interactions with Ketoprofen

This active ingredient may interact with:

• Anticoagulants: Increases bleeding risk (e.g., warfarin); monitor INR.
• Antiplatelets: Enhances bleeding (e.g., aspirin); avoid combination.
• ACE Inhibitors: Reduces efficacy and increases renal risk; monitor BP.
• Diuretics: Decreases natriuretic effect; monitor fluid status.
• Methotrexate: Increases toxicity; adjust dose.

Action: Provide your healthcare provider with a complete list of medications.

Patient Education or Lifestyle

Pharmacokinetics of Ketoprofen

Absorption: Oral, peak at 0.5–2 hours; bioavailability ~90%.

Distribution: Volume of distribution ~0.1–0.2 L/kg; 99% protein-bound.

Metabolism: Hepatic via glucuronidation to inactive metabolites.

Excretion: Primarily renal (70–90% as glucuronide); half-life 2–4 hours.

Half-Life: 2–4 hours, extended in renal impairment.

Pharmacodynamics of Ketoprofen

This drug exerts its effects by:

Inhibiting COX-1 and COX-2, reducing prostaglandin synthesis in inflamed tissues.

Alleviating pain and inflammation in arthritis and acute injuries.

Exhibiting dose-dependent risks of GI ulceration and renal damage.

Storage

Temperature: Store at 20–25°C (68–77°F); protect from moisture and light.

Protection: Keep in original container, away from heat and humidity.

Safety: Store in a secure location out of reach of children and pets due to toxicity risk.

Disposal: Dispose of unused tablets, gel, or injections per local regulations or consult a pharmacist.

Frequently Asked Questions (FAQs)

Q: What does Ketoprofen treat?
A: This medication treats arthritis and acute pain.

Q: Can this active ingredient cause stomach pain?
A: Yes, stomach pain is common; take with food.

Q: Is Ketoprofen safe for children?
A: Yes, off-label with supervision.

Q: How is this drug taken?
A: Orally, topically, or via injection, as directed.

Q: How long is Ketoprofen treatment?
A: Typically 5–10 days, or as prescribed.

Q: Can I use Ketoprofen if pregnant?
A: Yes, with caution; avoid in late pregnancy.

Regulatory Information

This medication is approved by:

U.S. Food and Drug Administration (FDA): Approved in 1986 (Orudis) for pain and inflammation.

European Medicines Agency (EMA): Approved for rheumatoid arthritis, osteoarthritis, and acute pain.

Other Agencies: Approved globally for NSAID therapy; consult local guidelines.

References

1. U.S. Food and Drug Administration (FDA). (2023). Orudis (Ketoprofen) Prescribing Information.
   • Official FDA documentation detailing the drug’s approved uses, dosage, and safety.
2. European Medicines Agency (EMA). (2023). Ketoprofen Summary of Product Characteristics.
   • EMA’s comprehensive information on the medication’s indications and precautions in Europe.
3. National Institutes of Health (NIH). (2023). Ketoprofen: MedlinePlus Drug Information.
   • NIH resource providing detailed information on the drug’s uses, side effects, and precautions.
4. World Health Organization (WHO). (2023). WHO Model List of Essential Medicines: Ketoprofen.
   • WHO’s consideration of Ketoprofen for pain management.
5. Arthritis & Rheumatology. (2022). Ketoprofen in Rheumatoid Arthritis.
   • Peer-reviewed article on Ketoprofen efficacy (note: access may require a subscription).