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ATOCIB 120

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ATOCIB 120

 

INFORMATION FOR MEDICAL STAFF

 

COMPOSITION:

Etoricoxib ....................................... 120 mg

Excipients q.s ................................. 1 tablet

(Lactose monohydrate, microcrystalline cellulose M101, calcium hydrogen phosphate dihydrate, PVP K30, croscarmellose sodium, magnesium stearate, aerosil, talc, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, green lake, black ferric oxide).

PHARMACEUTICAL FORM: Film coated tablet.

PHARMACODYNAMIC PROPERTIES:

ATC code: M01AH05

Atocib 120 contains the active ingredient etoricoxib that is a nonsteroidal anti-inflammatory agent and produces selective inhibition of cyclo-oxygenase-2 (COX-2), and exhibits anti-inflammatory, analgesic, and antipyretic activities. Etoricoxib does not inhibit gastric prostaglandin synthesis and has no effect on platelet function.

PHARMACOKINETIC PROPERTIES:

Orally administered etoricoxib is well absorbed. The absolute bioavailability is approximately 100%. Dosing with food had no effect on the extent of absorption of etoricoxib. Etoricoxib is approximately 92% bound to human plasma protein. Etoricoxib is extensively metabolised with <1% of a dose recovered in urine as the parent drug. The major route of metabolism to form the 6'-hydroxymethyl derivative is catalyzed by enzyme cytochrome P450 (CYP). Elimination of etoricoxib occurs almost exclusively through metabolism followed by renal excretion. Steady state concentrations of etoricoxib are reached within seven days of once daily administration of 120 mg, with an accumulation ratio of approximately 2, corresponding to a half-life of approximately 22 hours.

PRESENTATION: Box of 3 blisters x 10 film coated tablets.

THERAPEUTIC INDICATIONS:

Treatment of symptoms and signs of acute and chronic osteoarthritis (OA), rheumatoid arthritis.

Treatment of ankylosing spondylitis.

Treatment of acute gouty arthritis (acute gout)

Relief of acute and chronic pain conditions.

Treatment of primary dysmenorrhea.

DOSAGE & ADMINISTRATION:

Atocib 120 is administered orally and may be taken with or without food.

Arthritis or osteoarthritis (degenerative joint disease): 30 mg or 60 mg once daily.

Rheumatoid arthritis: 90 mg once daily.

Ankylosing spondylitis: 90 mg once daily.

Acute gouty arthritis (acute gout): 120 mg once daily.

Acute pain conditions and primary dysmenorrhea: 120 mg once daily.

Chronic pain conditions: 60 mg once daily.

The dose for acute symptoms should not exceed 120 mg daily, limited to a maximum of 8 days treatment.

As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure of the selective inhibitor of COX-2, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.

Elderly patients: No dosage adjustment is necessary. 

Patients with hepatic impairment:

- In patients with mild hepatic dysfunction (Child-Pugh score 5-6), a dose of 60 mg once daily should not be exceeded.

- In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), a dose of 30 mg once daily should not be exceeded.

- In patients with severe hepatic dysfunction (Child-Pugh score ≥ 10), the use is contra-indicated.

Patients with renal impairment: No dosage adjustment is necessary for patients with creatinine clearance ³ 30 ml/min.

The use of etoricoxib in patients with creatinine clearance < 30 ml/min is contra-indicated.

CONTRAINDICATIONS:

Hypersensitivity to any ingredients of the drug.

Active peptic ulceration or active gastro-intestinal (GI) bleeding, inflammatory bowel disease.

Patients who are allergic to aspirin or other NSAIDs.

Patients who, after taking aspirin or other NSAIDs, have experience bronchospasm, asthma, acute rhinitis, nasal polyps, Quincke's oedema, urticaria, or allergic-type reactions.

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

Severe renal dysfunction (creatinine clearance < 30 ml/min).

Congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.

Congestive heart failure (NYHA II-IV).

Children and adolescents under 16 years of age.

WARNINGS AND PRECAUTIONS:

Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal disease, such as ulceration and GI bleeding.

Patients with significant risk factors for cardiovascular events e.g. myocardial infarction, congestive heart failure, stroke, hypertension, hyperlipidaemia, diabetes mellitus, and smoking should only be treated with etoricoxib after careful consideration.

Patients with impaired renal function or cirrhosis.

The elderly.

Serious hypersensitivity reactions (such as anaphylaxis and angioedema) have been reported in patients receiving etoricoxib.

Cardiovascular thrombotic events:

Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the first weeks of treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses.

Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. To minimize the potential risk for an adverse cardiovascular event in etoricoxib-treated patients, use the lowest effective dose for the shortest duration possible.

Pregnancy and lactation:

Etoricoxib is contraindicated in pregnant women.

Using the drug in breastfeeding women depends on its clear outweight any possible benefit from breastfeeding.

Effects on works: Patients who experience dizziness, vertigo or somnolence while taking etoricoxib should refrain from driving, operating machinery, working at height, and other cases.

INTERACTIONS:

The concurrent administration of etoricoxib and warfarin was associated with an approximate 13% increase in prothrombin time International Normalised Ratio (INR).

Co-administration of etoricoxib with rifampicin produced a decrease in etoricoxib plasma concentrations.

Plasma concentrations of methotrexate, lithium, oral contraceptives containing ethinyl estradiol, conjugated estrogens are increased by given concomitantly with etoricoxib.

Etoricoxib may reduce the effect of diuretics and other antihypertensive drugs, ACE inhibitors, and angiotensin II antagonists.

The GI ulcers may occur in patients taking concomitant with aspirin.

Etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone, prednisolone, digoxin, antacids, and ketoconazole.

UNDESIRABLE EFFECTS:

Cardiovascular thrombotic events (see the Warnings and Precautions).

Very common, ADR ≥ 1/10

GI disorders: abdominal pain.

Common, 1/100 ≤ ADR < 1/10

Infections and infestations: alveolar osteitis. Metabolism and nutrition disorders: oedema/fluid retention. Nervous system disorders: dizziness, headache. Cardiac disorders: palpitations, arrhythmia. Vascular disorders: hypertension. Respiratory, thoracic and mediastinal disorders: bronchospasm. Gastrointestinal disorders: constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, dyspepsia, nausea, vomiting, oesophagitis, oral ulcer. Hepatobiliary disorders: increases in ALT, AST. Skin and subcutaneous tissue disorders: ecchymosis. General disorders and administration site conditions: asthenia, flu-like disease.

Uncommon, 1/1000 ≤ ADR <1/100

Infections and infestations: gastroenteritis, upper respiratory infection, urinary tract infection. Blood and lymphatic system disorders: anaemia (primarily associated with gastrointestinal bleeding), leukopenia, thrombocytopenia. Immune system disorders: hypersensitivity. Metabolism and nutrition disorders: appetite increase or decrease, weight gain. Psychiatric disorders: anxiety, depression, decreased mental acuity, hallucinations. Nervous system disorders: dysgeusia, insomnia, paresthaesia, somnolence. Eye disorders: blurred vision, conjunctivitis. Ear and labyrinth disorders: tinnitus, vertigo. Cardiac disorders: atrial fibrillation, tachycardia, congestive heart failure, non-specific ECG changes, angina pectoris, myocardial infarction. Vascular disorders: flushing, cerebrovascular accident, transient ischaemic attack, hypertensive crisis, vasculitis. Respiratory, thoracic and mediastinal disorders: cough, dyspnoea, epistaxis. Gastrointestinal disorders: abdominal distention, bowel movement pattern change, dry mouth, gastroduodenal ulcer, peptic ulcers including gastrointestinal perforation and bleeding, irritable bowel syndrome, pancreatitis. Skin and subcutaneous tissue disorders: facial oedema, pruritus, rash, erythema, urticaria. Musculoskeletal and connective tissue disorders: muscular cramp, musculoskeletal pain/stiffness. Renal and urinary disorders: proteinuria, increased serum creatinine, renal failure. General disorders and administration site conditions: chest pain. Investigations: increased blood nitrogen, increased creatinine phosphokinase, hyperkalaemia, increased uric acid.

Rare, 1/10 000 ≤ ADR < 1/1000

Immune system disorders: angioedema/anaphylactic/anaphylactoid reactions including shock. Psychiatric disorders: confusion, restlessness. Hepatobiliary disorders: hepatic failure, jaundice. Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, fixed drug eruption. Investigations: decreased blood sodium.

The following serious undesirable effects have been reported in association with the use of NSAIDs and cannot be ruled out for etoricoxib: nephrotoxicity including interstitial nephritis and nephrotic syndrome.

OVERDOSE:

There have been reports of acute overdosage with etoricoxib, although adverse experiences were not reported in the majority of cases. The most frequently observed adverse experiences were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, cardiorenal events).

In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the GI tract, employ clinical monitoring, and institute symptomatic treatment, if required.

Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.

Read the directions carefully before use.

For more information, please consult a physician.

This drug is for prescription only.

STORAGE CONDITIONS: Store in dry places, not exceeding 30oC, protect from light.

SHELF-LIFE: 36 months from the manufacturing date.

DATE OF REVISION OF THE TEXT: June 5, 2018.

INFORMATION FOR THE USER

 

Read all of this leaflet carefully before you start taking this medicine.

Keep out of reach of children

Immediately tell your doctor or pharmacist of undesirable effects encountered during the treatment.

The drug is for prescription only.

QUALITATIVE AND QUANTITATIVE COMPOSITION:

Etoricoxib ....................................... 120 mg

Excipients q.s ................................. 1 tablet

(Lactose monohydrate, microcrystalline cellulose M101, calcium hydrogen phosphate dihydrate, PVP K30, croscarmellose sodium, magnesium stearate, aerosil, talc, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, green lake, black ferric oxide).

PRODUCT DESCRIPTION:

A grey film coated caplet, plain on one side, a score line on the other, intact edges.

PRESENTATION: Box of 3 blisters x 10 film coated tablets.

WHAT THE DRUG IS USED FOR:

Treatment of symptoms and signs of acute and chronic osteoarthritis (OA), rheumatoid arthritis.

Treatment of ankylosing spondylitis.

Treatment of acute gouty arthritis (acute gout)

Relief of acute and chronic pain conditions.

Treatment of primary dysmenorrhea.

HOW TO TAKE THIS MEDICINE:

Atocib 120 is administered orally and may be taken with or without food.

Arthritis or osteoarthritis (degenerative joint disease): 30 mg or 60 mg once daily.

Rheumatoid arthritis: 90 mg once daily.

Ankylosing spondylitis: 90 mg once daily.

Acute gouty arthritis (acute gout): 120 mg once daily.

Acute pain conditions and primary dysmenorrhea: 120 mg once daily.

Chronic pain conditions: 60 mg once daily.

The dose for acute symptoms should not exceed 120 mg daily, limited to a maximum of 8 days treatment.

As the cardiovascular risks of etoricoxib may increase with dose and duration of exposure of the selective inhibitor of COX-2, the shortest duration possible and the lowest effective daily dose should be used. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically.

Elderly patients: No dosage adjustment is necessary. 

Patients with hepatic impairment:

- In patients with mild hepatic dysfunction (Child-Pugh score 5-6), a dose of 60 mg once daily should not be exceeded.

- In patients with moderate hepatic dysfunction (Child-Pugh score 7-9), a dose of 30 mg once daily should not be exceeded.

- In patients with severe hepatic dysfunction (Child-Pugh score ≥ 10), the use is contra-indicated.

Patients with renal impairment: No dosage adjustment is necessary for patients with creatinine clearance ≥ 30 ml/min.

The use of etoricoxib in patients with creatinine clearance < 30 ml/min is contra-indicated.

WHEN SHOULD YOU NOT TAKE THIS MEDICINE:

Hypersensitivity to any ingredients of the drug.

Active peptic ulceration or active gastro-intestinal (GI) bleeding, inflammatory bowel disease.

Patients who are allergic to aspirin or other NSAIDs.

Patients who, after taking aspirin or other NSAIDs, have experience bronchospasm, asthma, acute rhinitis, nasal polyps, Quincke's oedema, urticaria, or allergic-type reactions.

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

Severe renal dysfunction (creatinine clearance < 30 ml/min).

Congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

Patients with hypertension whose blood pressure is persistently elevated above 140/90mmHg and has not been adequately controlled.

Congestive heart failure (NYHA II-IV).

Children and adolescents under 16 years of age.

UNDESIRABLE EFFECTS:

Cardiovascular thrombotic events.

Very common, ADR ≥ 1/10

GI disorders: abdominal pain.

Common, 1/100 ≤ ADR < 1/10

Infections and infestations: alveolar osteitis. Metabolism and nutrition disorders: oedema/fluid retention. Nervous system disorders: dizziness, headache. Cardiac disorders: palpitations, arrhythmia. Vascular disorders: hypertension. Respiratory, thoracic and mediastinal disorders: bronchospasm. Gastrointestinal disorders: constipation, flatulence, gastritis, heartburn/acid reflux, diarrhea, dyspepsia, nausea, vomiting, oesophagitis, oral ulcer. Hepatobiliary disorders: increases in ALT, AST. Skin and subcutaneous tissue disorders: ecchymosis. General disorders and administration site conditions: asthenia, flu-like disease.

Uncommon, 1/1000 ≤ ADR <1/100

Infections and infestations: gastroenteritis, upper respiratory infection, urinary tract infection. Blood and lymphatic system disorders: anaemia (primarily associated with gastrointestinal bleeding), leukopenia, thrombocytopenia. Immune system disorders: hypersensitivity. Metabolism and nutrition disorders: appetite increase or decrease, weight gain. Psychiatric disorders: anxiety, depression, decreased mental acuity, hallucinations. Nervous system disorders: dysgeusia, insomnia, paresthaesia, somnolence. Eye disorders: blurred vision, conjunctivitis. Ear and labyrinth disorders: tinnitus, vertigo. Cardiac disorders: atrial fibrillation, tachycardia, congestive heart failure, non-specific ECG changes, angina pectoris, myocardial infarction. Vascular disorders: flushing, cerebrovascular accident, transient ischaemic attack, hypertensive crisis, vasculitis. Respiratory, thoracic and mediastinal disorders: cough, dyspnoea, epistaxis. Gastrointestinal disorders: abdominal distention, bowel movement pattern change, dry mouth, gastroduodenal

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