MEXICAM 15 MG/3 ML (MELOXICAM) – SOLUTION FOR IM INJECTION – AMPOULES

Active Ingredient: Meloxicam 15 mg per 3 mL ampoule
Concentration: 5 mg/mL
Pharmaceutical Form: Solution for injection
Route of Administration: Intramuscular (IM) injection only
Pack Size: 3 mL × 6 ampoules
Therapeutic Class: Non-Steroidal Anti-Inflammatory Drug (NSAID) – Anti-inflammatory and Analgesic.

Product Overview

Mexicam 15 mg/3 mL contains meloxicam, a non-steroidal anti-inflammatory medication used for the short-term symptomatic relief of pain and inflammation associated with certain musculoskeletal and inflammatory joint conditions.

Meloxicam belongs to the oxicam group of NSAIDs and works by inhibiting cyclooxygenase (COX) enzymes, particularly COX-2, thereby reducing the production of prostaglandins involved in inflammation and pain.

The intramuscular formulation provides an alternative route of administration when oral or rectal treatment is unsuitable or cannot be used.

Its therapeutic effects include:

• Relieving joint and musculoskeletal pain.
• Reducing inflammation and swelling.
• Improving mobility and physical comfort.
• Relieving stiffness associated with inflammatory joint conditions.

Important: This injectable formulation is intended for short-term treatment. It does not cure arthritis or modify the underlying progression of chronic joint diseases.

Indications and Uses

Mexicam injection may be prescribed for the short-term symptomatic relief of pain and inflammation associated with:

• Osteoarthritis (OA): Helps relieve painful flare-ups associated with degenerative joint disease.
• Rheumatoid Arthritis (RA): Helps reduce joint pain, swelling, and stiffness associated with chronic inflammatory arthritis.
• Ankylosing Spondylitis: Helps relieve inflammatory back pain and stiffness affecting the spine and other joints.
• Acute Musculoskeletal Pain: May provide relief from inflammatory pain affecting muscles, joints, and surrounding tissues when meloxicam treatment is clinically appropriate.

The injectable formulation is particularly useful when oral or rectal administration is unsuitable.

Important: Treatment should be limited to the shortest necessary period, with a transition to oral treatment when clinically appropriate.

Mechanism of Action

Meloxicam inhibits cyclooxygenase enzymes (COX-1 and COX-2), with preferential inhibition of COX-2 at therapeutic concentrations.

These enzymes are responsible for producing prostaglandins, which contribute to inflammation, pain, and fever.

Its therapeutic actions include:

• Reducing prostaglandin production.
• Decreasing inflammatory responses.
• Relieving joint pain and tenderness.
• Reducing swelling and stiffness.
• Improving mobility and physical comfort.

Following intramuscular administration, meloxicam is absorbed into the systemic circulation and produces its anti-inflammatory and analgesic effects throughout the body.

Dosage and Administration

Route of Administration: Deep intramuscular injection only.

Usual Adult Dosage:

• Adults: 15 mg once daily by intramuscular injection.
• Elderly patients and patients at increased risk of adverse reactions: A lower dose of 7.5 mg once daily may be appropriate.
• Maximum daily dose: 15 mg from all meloxicam formulations combined.

Treatment Duration:

• Injectable treatment is generally recommended for initiation of therapy.
• Treatment is normally limited to a single injection.
• In exceptional circumstances, administration may continue for a maximum of 2–3 days.
• Switch to oral treatment as soon as clinically appropriate.

Administration Instructions:

• The injection must be administered by a qualified healthcare professional.
• Administer by deep intramuscular injection, preferably into the upper outer quadrant of the gluteal muscle.
• Do not administer intravenously.
• Do not inject subcutaneously.
• Do not mix with other medications in the same syringe.
• Avoid repeated injections at the same site.

Each Mexicam ampoule contains 15 mg in 3 mL (5 mg/mL). Therefore:

• 3 mL = 15 mg.
• 1.5 mL = 7.5 mg.

Do not confuse this presentation with other meloxicam injections containing 15 mg in 1.5 mL (10 mg/mL). Always calculate the administered volume according to the actual concentration.

Possible Side Effects

Common side effects may include:

• Nausea and vomiting.
• Abdominal pain.
• Indigestion (dyspepsia).
• Diarrhea or constipation.
• Headache.
• Dizziness.
• Fluid retention and swelling (edema).
• Injection-site pain, redness, or irritation.

Less common but potentially serious adverse reactions include:

• Gastrointestinal ulcers and bleeding.
• Kidney impairment or acute kidney injury.
• Increased blood pressure.
• Worsening of heart failure.
• Cardiovascular thrombotic events, including heart attack and stroke.
• Liver function abnormalities.
• Allergic reactions, including anaphylaxis.
• Severe skin reactions.

Seek immediate medical attention if black stools, vomiting blood, chest pain, difficulty breathing, or severe allergic reactions occur.

Contraindications and Precautions

Contraindications:

• Known hypersensitivity to meloxicam or any product component.
• History of asthma, urticaria, or allergic reactions following aspirin or other NSAIDs.
• Active gastrointestinal bleeding or peptic ulcer disease.
• History of gastrointestinal bleeding or perforation associated with previous NSAID treatment.
• Severe liver impairment.
• Severe renal failure in patients not undergoing dialysis.
• Severe uncontrolled heart failure.
• Third trimester of pregnancy.
• Patients with bleeding disorders or those receiving anticoagulant treatment, according to the applicable injectable product information.

Precautions:

• Patients with cardiovascular disease or hypertension should be monitored carefully.
• Use cautiously in patients with kidney or liver impairment.
• Elderly patients have an increased risk of gastrointestinal and renal complications.
• Patients with dehydration should be assessed before treatment because of the increased risk of kidney injury.
• Patients with inflammatory bowel disease, including Crohn's disease or ulcerative colitis, require particular caution.
• Monitor renal function and blood pressure when clinically indicated.
• Avoid prolonged treatment without medical supervision.
• Use during pregnancy requires medical assessment; NSAIDs should generally be avoided from 20 weeks onward unless specifically advised and are contraindicated in the third trimester.
• Breastfeeding patients should consult their healthcare professional before use.

Important Drug and Lifestyle Interactions

• Other NSAIDs: Avoid combining with ibuprofen, diclofenac, naproxen, or other NSAIDs because of increased gastrointestinal and renal risks.
• Aspirin: May increase the risk of gastrointestinal bleeding.
• Anticoagulants: Warfarin and other blood thinners may increase bleeding risk.
• Corticosteroids: Prednisolone and similar medications may increase the risk of gastrointestinal ulcers and bleeding.
• ACE inhibitors and ARBs: May increase the risk of kidney impairment and reduce blood pressure-lowering effectiveness.
• Diuretics: May increase the risk of kidney problems and electrolyte disturbances.
• Lithium: Meloxicam may increase lithium blood concentrations and toxicity risk.
• Methotrexate: May increase methotrexate exposure and toxicity.
• Cyclosporine: May increase the risk of kidney toxicity.

Inform your healthcare professional about all medications and supplements you are taking.

Storage Conditions

• Store according to the manufacturer's recommended temperature.
• Protect from excessive heat and direct sunlight.
• Keep ampoules in their original packaging.
• Protect from damage and contamination.
• Use immediately after opening the ampoule.
• Keep out of reach of children.
• Do not use after the expiry date or if the solution shows visible particles or discoloration.

Patient Counseling Points

• Mexicam injection must be administered by a qualified healthcare professional.
• The injection is intended for intramuscular administration only.
• Do not administer intravenously.
• Do not exceed 15 mg of meloxicam daily from all formulations combined.
• Avoid combining Mexicam with other NSAIDs unless specifically instructed by your physician.
• Inform your doctor about any history of stomach ulcers, kidney disease, cardiovascular disease, or bleeding disorders.
• Report severe injection-site reactions or signs of allergic reactions.
• Injectable treatment should generally be limited to a short period.
• Switch to oral treatment when appropriate and prescribed by your doctor.

References

1. South African Health Products Regulatory Authority (SAHPRA): Mobic 15 mg/1.5 mL Injection – Professional Information. View professional prescribing information.
2. South African Health Products Regulatory Authority (SAHPRA): Mobic Injection – Patient Information Leaflet. View patient leaflet.
3. European Summary of Product Characteristics: Melox 10 mg/mL Solution for Injection – Dosage, Administration, and Contraindications. View product information.
4. U.S. National Library of Medicine (DailyMed): Meloxicam – NSAID Safety Warnings, Contraindications, and Drug Interactions. View prescribing information.
5. Eurofarma: Meloxicam Injectable Solution – Product Information and Therapeutic Indications. View manufacturer information.

Patient Disclaimer: This information is intended for educational purposes only and should not replace professional medical advice, diagnosis, or treatment. Always consult a qualified healthcare professional before using this medication. The appropriate dosage and treatment duration depend on the patient's medical condition, age, and individual risk factors. Intramuscular administration must be performed by a qualified healthcare professional. Prolonged use of NSAIDs requires appropriate medical supervision due to potential gastrointestinal, cardiovascular, and renal complications.