LIOMETACEN® (Indomethacin): A Guide to the Injectable NSAID

MEDICAL INFORMATION: This is a prescription-only medication for parenteral (injectable) use. It must be administered by a healthcare professional. This information is for educational purposes and is not a substitute for professional medical advice. Do not use this product without a doctor's prescription and supervision.

LIOMETACEN® (Indomethacin): A Guide to the Injectable NSAID

Summary

LIOMETACEN® is an injectable form of Indomethacin, a potent non-steroidal anti-inflammatory drug (NSAID). It is designed for the symptomatic treatment of acute, painful episodes of inflammatory musculoskeletal diseases. Given via intramuscular (I.M.) or intravenous (I.V.) injection, LIOMETACEN® provides rapid and powerful relief from pain and inflammation when oral medications are not suitable. It is manufactured by The Nile Co. under license from the Italian company CHIESI FARMACEUTICI.

Manufacturer & Licensor

• Manufacturer: The Nile Co. for Pharmaceuticals and Chemical Industries, Egypt.
• Under License from: CHIESI FARMACEUTICI S.p.A., Parma, Italy.

Category & Active Ingredient

• Category: Non-Steroidal Anti-Inflammatory Drug (NSAID); Acetic Acid Derivative.
• Active Ingredient: Indomethacin (50 mg per vial, as Meglumine indomethacinate).

Available Forms & Strengths

LIOMETACEN® is available as a powder for solution for injection:

• Lyophilized Vials: Each pack contains 6 vials of lyophilized (freeze-dried) powder, each containing 50 mg of Indomethacin, along with 6 solvent ampoules (2 ml each) for reconstitution.

Mechanism of Action

Indomethacin, like other NSAIDs, works by inhibiting the cyclo-oxygenase (COX) enzymes (both COX-1 and COX-2). These enzymes are responsible for producing prostaglandins, which are chemical messengers that cause pain, fever, and inflammation in the body. By blocking prostaglandin synthesis, LIOMETACEN® effectively reduces these symptoms at the site of injury or disease.

Indications for LIOMETACEN®

LIOMETACEN® is indicated for the short-term, symptomatic treatment of acute painful episodes during inflammatory musculoskeletal diseases, such as:

• Acute flare-ups of rheumatoid arthritis.
• Ankylosing spondylitis.
• Acute gouty arthritis.
• Acute painful shoulder (bursitis and/or tendinitis).

Dosage and Administration

This medication must be administered by a healthcare professional.

• Recommended Dose: 1-2 ampoules (50-100 mg) per day. The maximum daily dose should not exceed 200 mg.
• Intramuscular (I.M.) Route: The powder is reconstituted with the provided solvent and injected deep into a large muscle.
• Intravenous (I.V.) Route: For IV infusion, the reconstituted product must be further diluted in 250-500 ml of saline or glucose solution and administered slowly over 30-60 minutes.
• Duration: Treatment should be for the shortest possible duration required to control symptoms.

Possible Side Effects

• Gastrointestinal: nausea, vomiting, abdominal pain, indigestion, diarrhea, peptic ulcers, GI bleeding.
• Cardiovascular: increased risk of hypertension, edema, heart attack, or stroke.
• Neurological: headache, dizziness, drowsiness, confusion (may impair ability to drive).
• Renal & Hepatic: impaired kidney or liver function.
• Allergic Reactions: skin rash, itching, asthma attacks in sensitive patients.

⚠ CRITICAL WARNINGS & Contraindications

LIOMETACEN® should NOT be used in patients with:

• A history of peptic ulcer, gastrointestinal bleeding, or perforation.
• Severe heart failure.
• Known hypersensitivity (allergy) to Indomethacin, Aspirin, or other NSAIDs (e.g., asthma, urticaria).
• Pregnancy (especially the last trimester) and lactation.
• Severe kidney or liver disease.
• Patients taking anticoagulant (blood-thinning) medications.
• Children under 14 years of age.

Precautions & Drug Interactions

• Cardiovascular Risk: NSAIDs may increase the risk of serious cardiovascular thrombotic events, such as heart attack and stroke.
• Gastrointestinal Risk: NSAIDs increase the risk of serious GI adverse events including bleeding, ulceration, and perforation.
• Neurological Effects: May cause dizziness or drowsiness; caution is advised when driving or operating machinery.
• Drug Interactions: LIOMETACEN® can interact with:
  • Other NSAIDs and Corticosteroids: Increases risk of GI bleeding.
  • Anticoagulants (e.g., Warfarin): Enhances bleeding risk.
  • Diuretics and ACE Inhibitors: May worsen kidney function and reduce blood pressure control.
  • Lithium and Methotrexate: Can increase the toxicity of these drugs.

Storage & Shelf Life

• Store below 25°C, in a dry place away from light.
• Keep out of reach of children.
• Use the reconstituted solution immediately; discard any unused portion.
• Shelf life (unopened vials): 2 years from date of manufacture.

Frequently Asked Questions (FAQ)

Why is LIOMETACEN® given as an injection instead of a tablet?
The injectable form is used for acute, severe pain where rapid effect is needed, or when oral administration is not possible.

Is this medication safe for long-term use?
No. LIOMETACEN® is intended for short-term treatment. Long-term use increases the risk of cardiovascular and gastrointestinal complications.

Can I receive this injection if I have a history of stomach problems?
Generally, no. A history of peptic ulcers or GI bleeding is a major contraindication.

References

1. U.S. National Library of Medicine (DailyMed): DailyMed - Indomethacin Injection
2. British National Formulary (BNF): NICE BNF - Indometacin
3. Product Information: Internal leaflet (The Nile Co. / CHIESI).