OUR PRODUCTS
Each film coated tablet contains 30 mg Etoricoxib.
Each film coated tablet contains 60 mg Etoricoxib.
Each film coated tablet contains 90 mg Etoricoxib.
Each film coated tablet contains 120 mg Etoricoxib
- Hypersensitivity to the active substance or to any of the excipients used.
- Active peptic ulceration or active gastrointestinal bleeding.
- Patients who, after taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2) inhibitors, experience bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria, or allergic reactions .
- Pregnancy and lactation.
- Severe hepatic impairment (serum albumin <25 g/L or Child-Pugh score of 10).
- Renal creatinine clearance <30 mL/min.
- Children and adolescents under 16 years of age.
- Inflammatory bowel disease.
- Congestive heart failure (NYHA II-IV).
- Patients with hypertension whose blood pressure is persistently above 140/90 mmHg and has not been adequately controlled.
Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, administration of etoricoxib 120 mg daily was associated with an approximate 13% increase in the ratio (INR) of prothrombin time. Therefore, patients receiving oral anticoagulants should be closely monitored for their prothrombin time (INR), especially in the first few days when treatment with etoricoxib is started or the dose of etoricoxib is changed.
• Diuretics, ACE inhibitors and angiotensin II antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with impaired renal function (eg dehydrated patients or elderly patients with impaired renal function), co-administration of an ACE inhibitor or angiotensin II antagonists and agents that inhibit cyclooxygenase may lead to further deterioration. In renal function, including acute renal failure, which is usually reversible. These interactions should be considered in patients taking etoricoxib concomitantly with an ACE inhibitor or an angiotensin II antagonist. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and monitoring of renal function should be considered after initiation of concomitant therapy, and periodically thereafter.
• acetylsalicylic acid : In a study in healthy, steady-state subjects, etoricoxib 120 mg once daily had no effect on the anti-platelet activity of acetylsalicylic acid (81 mg once daily). Etoricoxib can be used concomitantly with acetylsalicylic acid in doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid). However, low-dose acetylsalicylic acid combined with etoricoxib may result in an increased rate of GI ulceration or other complications compared to using etoricoxib alone. Co-administration of etoricoxib with doses of acetylsalicylic acid higher than cardiovascular prophylactic doses or with other NSAIDs is not recommended.
• cyclosporine and tacrolimus: Although this interaction with etoricoxib has not been studied, coadministration of cyclosporine or tacrolimus with any NSAID may increase the renal effect of cyclosporine or tacrolimus. Kidney function should be monitored when etoricoxib and any of these medicines are used together.
- Etoricoxib is used in adults and adolescents 16 years of age or older to relieve symptoms of osteoarthritis (OA), rheumatoid arthritis (RA), ankylosing spondylitis, and the pain and signs of inflammation associated with acute gouty arthritis.
- Etoricoxib is indicated in adults and adolescents 16 years of age and older for the short-term treatment of moderate pain associated with dental surgery.
- Since the cardiovascular risks of etoricoxib may increase with dose and duration of exposure, the shortest possible duration and lowest effective daily dose should be used. The patient's need for symptom relief and response to treatment should be periodically reassessed, especially in patients with osteoporosis
- in the spine
The recommended dose is 30 mg once daily. In some patients with insufficient symptomatic relief, increasing the dose to 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
- Rheumatoid arthritis
The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, a dose increase of 90 mg once daily may increase efficacy. Once the patient is clinically stable, it may be appropriate to reduce the dose to 60 mg once daily. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
- Spondyloarthritis
The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, a dose increase of 90 mg once daily may increase efficacy. Once the patient is clinically stable, it may be appropriate to reduce titration to 60 mg once daily. In the absence of an increase in therapeutic benefit, other therapeutic options should be considered.
- Acute pain conditions
For acute pain conditions, etoricoxib should only be used for the period of acute symptoms.
- Acute gouty arthritis
The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, etoricoxib was administered for 8 days.
- Pain after dental surgery
The recommended dose is 90 mg once daily, for a maximum of 3 days. Some patients may require other analgesics after surgery in addition to etoricoxib during the triple therapy period.
• hepatic insufficiency
Regardless of indication, the dose of 60 mg once daily should not be exceeded in patients with mild hepatic impairment (Child-Pugh score 5-6). In patients with moderate hepatic impairment (Child-Pugh score 7-9), regardless of indication, the dose of 30 mg once daily should not be exceeded.
Clinical experience is limited especially in patients with moderate hepatic dysfunction and caution is advised. There is no clinical experience in patients with severe hepatic dysfunction (Child-Bow score of 10); Therefore, its use is not indicated in these patients.
•renal failure
No dose adjustment is required for patients with creatinine clearance ≥30 mL/min. Use of etoricoxib in patients with creatinine clearance <30 mL/min is not indicated
• children
Etoricoxib is not indicated in children and adolescents under 16 years of age
Infections and injuries: alveolar osteitis, gastroenteritis, upper respiratory tract infection, urinary tract infection.
Blood and lymphatic system disorders: anemia mainly associated with gastro-intestinal haemorrhage, leukopenia, thrombocytopenia.
Immune system disorders: hypersensitivity, angioedema, anaphylactic reactions.
Nutritional disorders: fluid retention, increased or decreased appetite, weight gain.
Nervous system disorders: dizziness, headache, dysgeusia, insomnia, numbness, drowsiness.
Eye disorders: blurred vision, conjunctivitis.
Ear disorders: tinnitus, vertigo
Heart disorders: palpitations and arrhythmias, atrial fibrillation, congestive heart failure, non-specific changes in the electrocardiogram, angina pectoris, myocardial infarction.
Vascular disorders: hypertension, transient ischemic attack, cerebrovascular accident, vasculitis.
Respiratory disorders: bronchospasm, cough, shortness of breath, and epistaxis.
Gastrointestinal disorders: Abdominal pain, constipation, flatulence, gastritis, diarrhea, indigestion, heartburn, nausea and vomiting, oesophagitis and mouth ulcers, gastro-intestinal ulcers, irritable bowel syndrome, pancreatitis
Skin and subcutaneous tissue disorders: ecchymosis, facial edema, itching, rash, Stevens-Johnson syndrome, .........
General disorders: weakness, fatigue, flu-like symptoms, chest pain.
Vivoxib 30 mg Film Coated Tablets ................... (116/2021)
Vivoxib 60 mg film-coated tablet……………………..(117/2021)
Vivoxib 90 mg Film Coated Tablets ....................( 118/2021)
Vivoxib 120 mg Film Coated Tablets ……………….(119/2021)
A carton box containing 2 blisters, each one contains 10 f.c.tablets.