ANTICOX II 15 mg / 3 ml solution for injection
Composition
Active ingredient:
Meloxicam – 15 mg per 3 ml ampoule
Description
ANTICOX II is a non-steroidal anti-inflammatory drug (NSAID) presented as a solution for intramuscular injection. It contains meloxicam, which provides analgesic, antipyretic, and anti-inflammatory effects. The injectable form is used when oral administration is not feasible and is indicated for the short-term treatment of acute rheumatoid arthritis and ankylosing spondylitis.
Indications for Use
Short-term symptomatic treatment of acute rheumatoid arthritis
Treatment of ankylosing spondylitis
Only for adult use when oral administration is not possible
Dosage and Method of Administration
Standard dose: 1 ampoule (15 mg) once daily
Do not exceed 15 mg/day
Treatment is generally limited to a single injection, with a maximum of 2–3 days in exceptional cases
Administer by deep intramuscular injection into the upper outer quadrant of the buttock
Always aspirate before injection to avoid intravascular administration
Switch to oral treatment as soon as possible
Special populations:
Elderly or high-risk patients: Start with 7.5 mg (half ampoule)
End-stage renal failure on dialysis: Do not exceed 7.5 mg/day
Contraindicated in children under 18, patients with severe hepatic or renal impairment
Contraindications
Hypersensitivity to meloxicam or excipients
History of NSAID-induced asthma, urticaria, angioedema
Active or recurrent peptic ulcer or GI bleeding
Severe hepatic or renal insufficiency
GI or cerebrovascular bleeding
Heart failure
Children and adolescents under 18
Pregnancy (third trimester) and breastfeeding
Perioperative pain management in CABG surgery
Bleeding disorders or concurrent anticoagulant therapy (IM contraindication)
Precautions
Use lowest effective dose for shortest possible duration
Avoid combination with other NSAIDs
Increased risk of GI bleeding, ulceration, perforation (especially in elderly)
Monitor renal and liver function in at-risk patients
NSAIDs may cause fluid retention, hypertension, worsening of heart failure
Risk of serious skin reactions (Stevens-Johnson, Lyell’s syndrome)
Use with caution in patients with GI, cardiovascular, renal, or hepatic risk factors
May reduce female fertility during use
Side Effects
Very common: GI symptoms – nausea, vomiting, dyspepsia, abdominal pain, diarrhea
Common: Headache, injection site pain, edema
Uncommon: Anemia, dizziness, pruritus, increased liver enzymes, hypertension
Rare: Gastric ulcers, GI bleeding, asthma, visual disorders, mood changes
Very rare: Agranulocytosis, hepatitis, Stevens-Johnson syndrome, renal failure
Unknown: Infertility, photosensitivity, pancreatitis
Pregnancy and Breastfeeding
Contraindicated in the 3rd trimester of pregnancy
Not recommended during breastfeeding
May impair female fertility
Storage Conditions
Store below 30°C
Keep in the original carton to protect from light
Use only clear, particle-free solution
For single use only; discard opened ampoules
Packaging
Carton box with 3 or 6 transparent glass ampoules of 3 ml each, with a package insert.