Medicinal Products

ARCOXIA 60 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Etoricoxib
laboratory: Msd BV

Coated tablet
Box of 28
All forms

Indication

Symptomatic treatment of osteoarthritis.

The decision to prescribe a COX-2 selective inhibitor should be based on the assessment of all risks specific to each patient (see sections Contraindications and Warnings and Precautions for Use ).

Dosage ARCOXIA 60 mg Film-coated tablet Box of 28

ARCOXIA is administered orally and can be taken with or without food. When prompt relief is needed, it should be noted that the effectiveness of the drug is earlier if etoricoxib is administered without food.

Due to the possible increased cardiovascular risks of etoricoxib with the dose and duration of treatment, this drug should be prescribed at the lowest effective daily dose for the shortest possible time. The need for symptomatic treatment and its therapeutic efficacy for the patient should be re-evaluated periodically, particularly in patients with osteoarthritis (see sections Contraindications, Warnings and Precautions, Adverse Reactions and Pharmacodynamic Properties ).

The recommended dose is 30 mg once a day. In some patients, when symptom relief is insufficient, increasing the dose to 60 mg once daily may improve efficacy. In the absence of improvement in therapeutic benefit, other treatments should be considered.

Doses above those recommended have not been shown to be of additional efficacy or have been studied. Therefore, in osteoarthritis, the dose of 60 mg once a day will not be exceeded.

Elderly

No dosage adjustment is necessary in the elderly. As with other drugs, caution is required in elderly patients (see Warnings and Precautions ).

Hepatic insufficiency

In patients with mild hepatic impairment (Child-Pugh score of 5 to 6), the 60 mg once daily dose will not be exceeded. In patients with moderate hepatic impairment (Child-Pugh score of 7 to 9), the 60 mg dose every other day will not be exceeded; administration of 30 mg once daily may also be considered.

Clinical experience is particularly limited in patients with moderate hepatic impairment and caution is advised. There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score ≥ 10); therefore, the use of this drug is contraindicated in these patients (see sections Contraindications, Warnings and Precautions for Use, and Pharmacokinetic Properties ).

Renal failure

No dose adjustment is required in patients with creatinine clearance
≥ 30 ml / min (see section Pharmacokinetic properties ). The use of etoricoxib is contraindicated in patients with creatinine clearance <30 ml / min (see sections Contraindications and Warnings and Precautions ).

Pediatrics

Etoricoxib is contraindicated in children and adolescents under 16 years of age (see section 4.3 ).

Against indications

· Hypersensitivity to the active substance or to any of the excipients (see section Composition ).

· Progressive peptic ulcer or gastrointestinal bleeding (GI).

· History of bronchospasm, acute rhinitis, nasal polyps, angioedema, urticaria or allergic-type reactions triggered by taking acetylsalicylic acid or taking NSAIDs including COX inhibitors. 2 (cyclooxygenase-2).

· Pregnancy and lactation (see sections Pregnancy and lactation and Preclinical safety data ).

· Severe hepatic insufficiency (serum albumin <25 g / l or Child-Pugh score ≥ 10).

· Estimated creatinine clearance <30 ml / min.

· Children and adolescents under 16 years old.

· Inflammatory bowel disease.

· Congestive heart failure (NYHA II-IV).

· Hypertension not adequately controlled and whose values ​​are persistently greater than 140/90 mm Hg.

· Known ischemic heart disease, peripheral arterial disease and / or history of cerebrovascular accident (including transient ischemic attack).

Arcoxia side effects

In clinical trials, the safety of etoricoxib was evaluated in 7, 152 subjects, including 4, 614 patients with osteoarthritis, rheumatoid arthritis (RA), chronic low back pain, or ankylosing spondylitis (approximately 600 patients with rheumatoid arthritis). osteoarthritis or RA were treated for a year or more).

In a program evaluating cardiovascular safety from the pooled results of three controlled versus active comparator studies, 17, 412 patients with osteoarthritis or RA were treated with etoricoxib (60 or 90 mg) for an average of approximately 18 hours. month. The safety data and the details of this program are presented in section Pharmacodynamic properties .

The following adverse events have been reported with a greater incidence than placebo in clinical studies, in patients with osteoarthritis, RA, chronic low back pain or ankylosing spondylitis treated with etoricoxib 30 mg, 60 mg or 90 mg for a period of up to 12 weeks or in studies of the MEDAL Program as well as since the placing on the market of the drug:

Very common (≥ 1/10), Common (≥ 1/100 to <1/10), Uncommon (≥ 1/1000 to ≤ 1/100), Rare (≥ 1/10 000 to ≤ 1/1000) ), Very rare (≤ 1/10 000), not known (can not be estimated based on available data).

Infections and infestations:

Uncommon: gastroenteritis, upper respiratory tract infection, urinary tract infection.

Hematological and lymphatic system disorders:

Uncommon: anemia (mainly related to gastrointestinal bleeding), leukopenia, thrombocytopenia.

Immune system disorders:

Very rare: hypersensitivity reactions including angioedema, anaphylactic / anaphylactoid reactions including shock.

Metabolism and nutrition disorders:

Common: edema / fluid retention.

Uncommon: increased or decreased appetite, weight gain.

Psychiatric disorders:

Uncommon: anxiety, depression, decreased intellectual acuity.

Very rare: confusion, hallucinations.

Not known: agitation.

Nervous system disorders:

Common: dizziness, headache

Uncommon: dysgeusia, insomnia, paresthesia / hypoaesthesia, drowsiness.

Eye disorders:

Uncommon: blurred vision, conjunctivitis.

Affections of the ear and labyrinth:

Uncommon: tinnitus, vertigo.

Heart conditions:

Frequent: palpitations.

Uncommon: atrial fibrillation, congestive heart failure, nonspecific ECG changes, angina, myocardial infarction.

Not known: tachycardia, arrhythmia.

Vascular disorders:

Frequent: high blood pressure.

Uncommon: flushing, stroke, transient ischemic attack.

Very rare: hypertensive pressure.

Respiratory, thoracic and mediastinal disorders:

Uncommon: cough, dyspnea, epistaxis.

Very rare: bronchospasm.

Gastrointestinal disorders:

Common: Gastrointestinal disorders (eg, abdominal pain, flatulence, epigastric burns), diarrhea, dyspepsia, epigastric discomfort, nausea.

Uncommon: abdominal bloating, acid reflux, change in peristalsis, constipation, dry mouth, peptic ulcer, irritable bowel syndrome, esophagitis, oral ulceration, vomiting, gastritis.

Very rare: gastric ulcers sometimes complicated by gastrointestinal perforation and haemorrhage (mainly in the elderly).

Not known: pancreatitis

Hepatobiliary disorders:

Frequent: elevation of ALAT, elevation of ASAT.

Very rare: hepatitis.

Not known: jaundice

Skin and subcutaneous tissue disorders:

Frequent: bruises.

Uncommon: facial edema, pruritus, skin rash.

Rare: erythema.

Very rare: urticaria, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome).

Musculoskeletal and connective tissue disorders:

Uncommon: muscle cramps / spasm, musculoskeletal pain / stiffness.

Renal and urinary disorders:

Uncommon: proteinuria, elevated serum creatinine.

Very rare: renal impairment, including renal impairment (see Warnings and Precautions ) section.

General disorders and administration site defects:

Frequent: asthenia / fatigue, flu-like syndrome

Uncommon: chest pain.

Investigations:

Uncommon: elevation of blood urea, elevation of creatine phosphokinase, hyperkalemia, elevation of uric acid.

Rare: decreased serum sodium.

The following serious adverse reactions have been reported in association with the use of NSAIDs and can not be excluded for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome, hepatotoxicity including hepatic impairment.

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