Ketofan (Ketoprofen): Uses, Dosage, Side Effects, Contraindications & Safety Guide

MEDICAL INFORMATION: This is a prescription-only medication. This information is for educational purposes and does not replace professional medical advice. Use only under the supervision of a licensed physician.

KETOFAN® (Ketoprofen): Complete Guide to the Propionic Acid NSAID

Summary

KETOFAN® contains ketoprofen, a non-steroidal anti-inflammatory drug (NSAID) of the propionic acid derivatives. It provides analgesic, anti-inflammatory, and antipyretic effects by inhibiting prostaglandin synthesis. It is used for musculoskeletal pain, rheumatic conditions, trauma, and other painful or inflammatory conditions. It is marketed in Egypt under several formulations by AMRIYA and other pharmaceutical manufacturers.

Manufacturer & Licensor

• Manufacturers: AMRIYA Pharmaceutical Industries, Alexandria, Egypt; European Egyptian Pharmaceutical Industries.
• Active Ingredient Source: Ketoprofen.

Category & Active Ingredient

• Category: Non-Steroidal Anti-Inflammatory Drug (NSAID), Propionic Acid Derivative.
• Active Ingredient: Ketoprofen.

Available Forms & Strengths

• Tablets: 25 mg, 50 mg, 150 mg.
• Capsules: 50 mg, 75 mg, 100 mg SR, 200 mg SR.
• Syrup/Suspension: 12.5 mg/5 ml (120 ml bottle).
• Suppositories: 100 mg (5 suppositories per pack).
• Injectable: 100 mg/2 ml ampoules (I.M.).
• Topical Gel: 2.5% (40 g tube).

Mechanism of Action

Ketoprofen inhibits cyclooxygenase (COX-1 and COX-2) enzymes, blocking the biosynthesis of prostaglandins. This reduces inflammation, pain, and fever. It also inhibits platelet aggregation and stabilizes lysosomal membranes. The onset is rapid, with analgesic effect starting within 30–60 minutes after oral or I.M. administration.

Pharmacokinetics

• Absorption: Rapid after oral or I.M. administration; peak plasma levels in 30–60 minutes (I.M.), ~1–2 hours (oral).
• Distribution: ~99% protein bound; penetrates synovial fluid and CNS; crosses placenta and blood-brain barrier.
• Metabolism: Mainly glucuronidation in the liver.
• Excretion: Renal (mainly conjugated metabolites), t½ ~1.5–2 hours.

Indications

KETOFAN® is indicated for:

• Acute and chronic inflammatory rheumatic diseases (osteoarthritis, rheumatoid arthritis, ankylosing spondylitis).
• Low back pain and sciatica.
• Traumatic injuries (sprains, strains, contusions).
• Postoperative or post-traumatic pain.
• Soft tissue disorders: bursitis, tendinitis, painful shoulder.
• Primary dysmenorrhea.
• Dental pain, headache, and cancer pain (as part of multimodal therapy).

Dosage & Administration

• Oral (tablets/capsules): 50–200 mg daily, divided doses. Sustained-release capsules: once daily.
• I.M. injection: 100 mg once or twice daily (short-term use, ≤3 days), then switch to oral.
• Suppositories: 100 mg once or twice daily.
• Syrup: Dose adjusted by age/weight in pediatrics (not well established in all age groups).
• Topical gel: Apply thin layer to affected area 2–3 times daily.
• Maximum daily dose: 300 mg.

Contraindications

• Hypersensitivity to ketoprofen, aspirin, or other NSAIDs.
• History of peptic ulcer, GI bleeding, or perforation.
• Severe heart failure, hepatic failure, or renal impairment.
• Active bleeding disorders.
• During pregnancy (especially third trimester) and breastfeeding.
• Children with suppositories/injectables containing benzyl alcohol.
• Use in perioperative CABG surgery.

Warnings & Precautions

• Risk of GI bleeding and ulceration, higher in elderly.
• Risk of cardiovascular thrombotic events (MI, stroke).
• May mask signs of infection.
• Caution in patients with asthma, hypertension, diabetes, fluid retention, or peptic ulcer history.
• Monitor renal/hepatic function during prolonged therapy.

Adverse Effects

• GI: Nausea, vomiting, dyspepsia, gastritis, ulcer, bleeding, perforation.
• CNS: Headache, dizziness, somnolence, mood changes.
• CV: Hypertension, edema, rare MI or stroke.
• Renal: Nephritis, renal impairment, acute renal failure (rare).
• Dermatologic: Rash, urticaria, pruritus, photosensitivity.
• Hematologic: Rare anemia, thrombocytopenia, agranulocytosis.
• Local: Pain at injection site (I.M. formulation).

Drug Interactions

• Anticoagulants/antiplatelets: ↑ bleeding risk.
• Other NSAIDs or corticosteroids: ↑ GI ulceration risk.
• ACE inhibitors, diuretics, beta-blockers: ↓ antihypertensive effect; ↑ renal risk.
• Methotrexate: ↑ toxicity (esp. ≥15 mg/week).
• Lithium: ↑ plasma lithium, risk of toxicity.
• Probenecid: ↓ clearance of ketoprofen.

Use in Pregnancy & Lactation

• Contraindicated in 3rd trimester (risk of premature ductus arteriosus closure, fetal/neonatal toxicity).
• Use only if necessary during 1st/2nd trimester.
• Excreted in small amounts in breast milk – avoid use during lactation.

Use in Pediatrics

Safety not well established in young children. Avoid injectables containing benzyl alcohol in neonates/infants due to toxicity.

Use in Elderly

Greater risk of GI bleeding, renal and cardiovascular side effects. Use lowest effective dose with monitoring.

Overdose

Symptoms: Nausea, vomiting, abdominal pain, lethargy, dizziness, rarely seizures or renal failure. No specific antidote. Management: gastric lavage, activated charcoal, supportive therapy, correction of acidosis, dialysis may help in renal failure.

Storage

Store below 30°C, away from light and moisture. Keep out of reach of children.

Packaging

KETOFAN® is available in boxes containing tablets, capsules, ampoules, suppositories, suspension, or gel depending on dosage form. Each pack includes an insert leaflet with full prescribing information.

Frequently Asked Questions (FAQ)

Is Ketofan safe for long-term use?
No. Long-term NSAID use increases risk of GI bleeding, ulcers, cardiovascular events, and kidney damage.

Can Ketofan be used for fever?
Yes, it has antipyretic activity, but paracetamol or ibuprofen are generally preferred.

Is Ketofan stronger than ibuprofen?
Ketoprofen is more potent than ibuprofen, but also associated with higher GI risk.

Can I use Ketofan during pregnancy?
No, especially in the third trimester. It may cause fetal harm.

Can Ketofan be combined with paracetamol?
Yes, they act via different mechanisms and may be combined for stronger analgesia if prescribed by a doctor.

References

1. British National Formulary (BNF) – Ketoprofen.
2. DailyMed – Ketoprofen injection and oral formulations.
3. AMRIYA Pharmaceuticals official product leaflets.