Buy ARCOXIA® 60 mg Film-Coated Tablets, 28 Tablets
Brand: Pliva Hrvatska d.o.o.
Drug form: Coated tablets
Manufacturers: ROVI PHARMA INDUSTRIAL SERVICES, S.A. (Spain)
Active substance: Etoricoxib
Expiration date: 3 years
ARCOXIA (Etoricoxib)
One film-coated tablet contains:
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Active ingredient: etoricoxib 60.0 mg
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Excipients:
- Calcium hydrogen phosphate 60.0 mg
- Microcrystalline cellulose 74.0 mg
- Croscarmellose sodium 4.0 mg
- Magnesium stearate 2.0 mg
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Film coating: Opadry II Green 39K11520 8.0 mg, which includes:
- Lactose monohydrate 35.0% (w/w)
- Hypromellose 33.0% (w/w)
- Titanium dioxide 16.6% (w/w)
- Triacetin 8.0% (w/w)
- Aluminium lake based on indigo carmine dye (E132) 5.4% (w/w)
- Iron oxide yellow dye (E172) 1.9% (w/w)
- Carnauba wax 0.02 mg
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Nonsteroidal Anti-Inflammatory Drugs (NSAIDs)
- Treatment of chronic lower back pain.
- Symptomatic therapy of osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, pain, and inflammation associated with acute gouty arthritis.
- Short-term treatment of moderate acute pain following dental surgery.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the overall risks for the individual patient (see sections "Contraindications" and "Special Warnings and Precautions for Use").
- Hypersensitivity to any component of the medication.
- Active peptic ulcer disease or gastrointestinal bleeding.
- Complete or partial combination of bronchial asthma, acute rhinitis, recurrent nasal polyposis, and intolerance to acetylsalicylic acid or other NSAIDs (including a history of these conditions).
- Pregnancy and lactation.
- Severe liver impairment (serum albumin < 25 g/L).
- Severe renal insufficiency (creatinine clearance < 30 mL/min).
- Age under 16 years.
- Inflammatory bowel diseases.
- Chronic heart failure (NYHA functional class II-IV).
- Uncontrolled hypertension with persistently elevated blood pressure readings > 140/90 mm Hg.
- Confirmed ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
- Confirmed hyperkalemia.
- Progressive kidney diseases.
Oral Administration: Take with or without food, with a small amount of water.
General Guidelines: ARCOXIA® should be used at the lowest effective dose for the shortest possible duration.
Osteoarthritis
- Recommended dose: 30 mg or 60 mg once daily.
Rheumatoid Arthritis
- Recommended dose: 60 mg once daily. For some patients, if symptom relief is insufficient, the dose can be increased to 90 mg once daily. Once clinical stabilization is achieved, it is advisable to titrate the dose down to 60 mg once daily. If there is no increase in therapeutic effect, other treatment options should be considered.
Ankylosing Spondylitis
- Recommended dose: 60 mg once daily. For some patients, if symptom relief is insufficient, the dose can be increased to 90 mg once daily. Once clinical stabilization is achieved, it is advisable to titrate the dose down to 60 mg once daily. If there is no increase in therapeutic effect, other treatment options should be considered.
Chronic Lower Back Pain
- Recommended dose: 60 mg once daily. Treatment duration should not exceed 12 weeks.
Conditions Associated with Acute Pain
- For conditions with acute pain, etoricoxib should be used only during the acute symptomatic period.
Acute Gouty Arthritis
- Recommended dose: 120 mg once daily. The duration of treatment at a dose of 120 mg should not exceed 8 days.
Acute Pain Following Dental Surgery
- Recommended dose: 90 mg once daily. For the treatment of acute pain after dental surgery, ARCOXIA® should be used only during the acute symptomatic period, with a maximum duration of 3 days.
Maximum Daily Doses:
- Osteoarthritis: 60 mg
- Rheumatoid Arthritis: 90 mg
- Ankylosing Spondylitis: 90 mg
- Chronic Lower Back Pain: 60 mg (maximum 12 weeks)
- Acute Gouty Arthritis: 120 mg (maximum 8 days)
- Post-dental Surgery Pain: 90 mg (maximum 3 days)
Special Considerations:
- Elderly Patients: No dose adjustment is necessary. However, caution is advised (see "Special Warnings and Precautions for Use").
- Hepatic Impairment: For mild hepatic impairment (Child-Pugh score 5-6), do not exceed 60 mg once daily. For moderate hepatic impairment (Child-Pugh score 7-9), do not exceed 30 mg once daily. Etoricoxib is contraindicated in patients with severe hepatic impairment (Child-Pugh score ≥10).
- Renal Impairment: No dose adjustment is necessary for patients with a creatinine clearance ≥30 mL/min. Etoricoxib is contraindicated in patients with a creatinine clearance <30 mL/min.
- Pediatric Patients: Etoricoxib is contraindicated for children and adolescents under 16 years of age.
Note: The risk of cardiovascular complications may increase with dose and duration of therapy. Therefore, the shortest possible course and the lowest effective daily dose should be used. Periodic assessment of the patient's need for symptom relief and response to therapy is required (see "Special Warnings and Precautions for Use").
Summary of the Safety Profile
The safety of etoricoxib was evaluated in clinical studies involving 9,295 subjects, including 6,757 patients with osteoarthritis (OA), rheumatoid arthritis (RA), chronic low back pain, and ankylosing spondylitis. Approximately 600 patients with OA or RA were treated for one year or longer.
In clinical studies, the adverse effect profile was similar for patients with OA or RA treated with etoricoxib for one year or longer. In a clinical study of acute gouty arthritis, patients received 120 mg of etoricoxib once daily for eight days. The adverse effect profile in this study was generally similar to the combined OA, RA, and chronic low back pain studies.
The cardiovascular safety assessment program, summarizing data from three active-controlled studies, involved 17,412 patients with OA or RA receiving etoricoxib (60 mg or 90 mg) for an average duration of 18 months.
In clinical studies of acute postoperative pain associated with dental surgery, where 614 patients received etoricoxib (90 mg or 120 mg), the adverse effect profile was generally similar to the combined OA, RA, and chronic low back pain studies.
List of Adverse Reactions
The following adverse reactions were reported more frequently with etoricoxib than with placebo in clinical studies involving patients with OA, RA, chronic low back pain, or ankylosing spondylitis treated with etoricoxib at doses of 30 mg, 60 mg, or 90 mg for up to 12 weeks, in the MEDAL program studies lasting up to 3.5 years, in short-term studies of acute pain lasting up to 7 days, and during post-marketing use.
System/Organ Class Adverse Reaction Frequency Category Infections and Infestations Alveolar osteitis Common Gastroenteritis, upper respiratory tract infection, urinary tract infection Uncommon Blood and Lymphatic System Disorders Anemia (mainly due to gastrointestinal bleeding), leukopenia, thrombocytopenia Uncommon Immune System Disorders Hypersensitivity reactions Uncommon Angioedema/anaphylactic/anaphylactoid reactions, including shock Rare Metabolism and Nutrition Disorders Edema/fluid retention Common Decreased or increased appetite, weight gain Uncommon Psychiatric Disorders Anxiety, depression, concentration disorders, hallucinations Uncommon Confusion, restlessness Rare Nervous System Disorders Dizziness, headache Common Taste alteration, insomnia, paresthesia/hypoesthesia, drowsiness Uncommon Eye Disorders Blurred vision, conjunctivitis Uncommon Ear and Labyrinth Disorders Tinnitus, vertigo Uncommon Cardiac Disorders Palpitations, arrhythmia Common Atrial fibrillation, tachycardia, chronic heart failure, non-specific ECG changes, angina, myocardial infarction Uncommon Vascular Disorders Hypertension Common Flushing, cerebrovascular accident, transient ischemic attack, hypertensive crisis, vasculitis Uncommon Respiratory, Thoracic, and Mediastinal Disorders Bronchospasm Common Cough, dyspnea, epistaxis Uncommon Gastrointestinal Disorders Abdominal pain Very common Constipation, flatulence, gastritis, heartburn/gastroesophageal reflux, diarrhea, dyspepsia/epigastric discomfort, nausea, vomiting, esophagitis, mouth ulceration Common Abdominal bloating, altered bowel habits, dry mouth, gastroduodenal ulcer, gastric ulcer including gastrointestinal perforation and bleeding, irritable bowel syndrome, pancreatitis Uncommon Hepatobiliary Disorders Elevated ALT, elevated AST Common Hepatitis Rare Liver failure, jaundice Rare Skin and Subcutaneous Tissue Disorders Ecchymosis Common Facial swelling, pruritus, rash, erythema, urticaria Uncommon Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption Rare Musculoskeletal and Connective Tissue Disorders Muscle cramps/spasms, musculoskeletal pain/stiffness Uncommon Renal and Urinary Disorders Proteinuria, increased serum creatinine, decompensated renal failure/renal insufficiency Uncommon General Disorders and Administration Site Conditions Asthenia/weakness, flu-like syndrome Common Chest pain Uncommon Investigations Elevated blood urea nitrogen, elevated creatine phosphokinase, hyperkalemia, elevated uric acid Uncommon Decreased blood sodium Rare - Frequency categories: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000).
- These adverse reactions were reported during post-marketing surveillance, with frequency estimates based on clinical study data.
Note: Serious adverse reactions reported with NSAIDs, which cannot be excluded for etoricoxib, include nephrotoxicity, interstitial nephritis, and nephrotic syndrome.