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Etoricoxib oral

Updated 2 Feb 2023 | NSAIDs

Presentation

Oral formulations of etoricoxib.

Drugs List

  • ARCOXIA 120mg tablets
  • ARCOXIA 30mg tablets
  • ARCOXIA 60mg tablets
  • ARCOXIA 90mg tablets
  • etoricoxib 120mg tablets
  • etoricoxib 30mg tablets
  • etoricoxib 60mg tablets
  • etoricoxib 90mg tablets
  • Therapeutic Indications

    Uses

    Ankylosing spondylitis
    Gouty arthritis
    Relief of acute pain associated with dental surgery
    Symptomatic relief in the treatment of osteoarthritis
    Symptomatic relief in the treatment of rheumatoid arthritis

    Dosage

    Adults

    Osteoarthritis
    The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 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, an increased dose of 90 mg once daily may increase efficacy.
    Once the patient is clinically stabilised, down titration to a 60 mg once daily dose may be appropriate

    Acute gouty arthritis
    The recommended dose is 120 mg once daily for a maximum of 8 days.
    Etoricoxib 120 mg should be used only for the acute symptomatic period.

    Ankylosing spondylitis
    The recommended dose is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may increase efficacy.
    Once the patient is clinically stabilised, down titration to a 60 mg once daily dose may be appropriate

    Postoperative dental surgery pain
    The recommended dose is 90 mg once daily, limited to a maximum of 3 days.
    Etoricoxib 90 mg should be used only for the acute symptomatic period.

    Elderly

    (See Dosage; Adult).

    Adolescents

    Adolescents 16 to 18 years
    (See Dosage; Adult).

    Patients with Hepatic Impairment

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

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

    Additional Dosage Information

    Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore, the dose for each indication is the maximum recommended dose.

    The cardiovascular risks may increase with dose and duration of exposure, therefore the shortest duration possible and the lowest effective daily dose should be used.

    Contraindications

    Children under 16 years
    Females attempting to conceive
    Breastfeeding
    Cerebrovascular disorder
    Galactosaemia
    Gastrointestinal haemorrhage
    Inflammatory bowel disease
    Ischaemic heart disease
    Peptic ulcer
    Peripheral arterial circulatory disorder
    Pregnancy
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe congestive cardiac failure
    Severe hepatic impairment - Child-Pugh score greater than or equal to 10
    Uncontrolled hypertension

    Precautions and Warnings

    Allergic disposition
    Elderly
    Females of childbearing potential
    Oedema
    Risk factors for cardiovascular disorder
    Asthma
    Cardiac impairment
    Connective tissue disorder
    Dehydration
    Glucose-galactose malabsorption syndrome
    Hepatic cirrhosis
    Hepatic impairment
    History of cardiac failure
    History of gastrointestinal bleeding
    History of gastrointestinal perforation
    History of gastrointestinal ulceration
    Lactose intolerance
    Left ventricular dysfunction
    Renal impairment

    Do not use as a substitute for acetylsalicylic acid for CV prophylaxis
    May mask fever
    May mask signs of inflammation
    Advise ability to drive/operate machinery may be affected by side effects
    Consider the need for combination therapy with gastroprotective agents
    Correct severe dehydration before commencing therapy
    Ensure hypertension is controlled prior to treatment
    Contains lactose
    Monitor blood pressure regularly
    Monitor hypertensive patients for 2 weeks after start of treatment
    Monitor patients for signs of adverse cardiovascular effects
    Monitor renal function in patients with hepatic cirrhosis
    Monitor renal function in patients with uncompensated cardiac failure
    Patients on prolonged therapy should be regularly reviewed
    Consider discontinuing therapy if significant cardiac failure develops
    Advise patient to seek advice at first indications of pregnancy
    Discontinue if ALT level exceed 3 times the upper limit of normal & persist
    Discontinue if AST level exceed 3 times the upper limit of normal & persist
    Discontinue if drug-related rash or other hypersensitivity reactions occur
    Discontinue if renal function deteriorates
    Discontinue if significant/persistent hepatic function abnormalities occur
    Maintain treatment at the lowest effective dose
    Female: Ensure adequate contraception during treatment

    The onset of effect may be greater when etoricoxib is given without food and this should considered when rapid symptomatic relief is required.

    COX-2 selective inhibitors are not a substitute for aspirin for cardiovascular prophylaxis because of their lack of effect on platelets. Because etoricoxib, a member of this class, does not inhibit platelet aggregation, antiplatelet therapies should not be discontinued and if indicated, should be considered in patients at risk for or with a history of cardiovascular or other thrombotic events.

    Any degree of worsening of asthma may be related to the ingestion of NSAIDs, either prescribed or purchased over the counter.

    On the basis of the available clinical evidence the CSM has issued the following advice:
    Recommendations are that NSAIDs associated with a low risk e.g. Ibuprofen are generally preferred, to start at the lowest recommended dose, not to use more than one oral NSAID at a time, and to remember that all NSAIDs (including selective inhibitors of cyclo-oxygenase-2) are contraindicated in patients with active peptic ulceration. The combination of a NSAID and low-dose aspirin can increase the risk of gastro-intestinal side-effects; this combination should be used only if absolutely necessary and the patient should be monitored closely.

    Pregnancy and Lactation

    Pregnancy

    Etoricoxib is contraindicated in pregnancy.

    The use of etoricoxib is not recommended in women attempting to conceive.

    Insufficient clinical data on exposed pregnancies is available for etoricoxib. Studies in animals have shown reproductive toxicity. The potential for human risk in pregnancy is unknown. Etoricoxib, as with other drugs inhibiting prostaglandin synthesis, may cause uterine inertia, miscarriage, congenital defects, premature closure of the ductus arteriosus leading to pulmonary hypertension and oligohydramnios during the last trimester. If a woman becomes pregnant during treatment, etoricoxib should be discontinued.

    When an NSAID is considered essential in the first and second trimester, a more established drug such as ibuprofen may be considered. Schaefer (2007) concludes that inadvertent use during the first trimester does not require termination of pregnancy or invasive diagnostic procedures. Detailed foetal ultrasound may be considered.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Lactation

    Etoricoxib is contraindicated in breastfeeding.

    It is not known whether etoricoxib is excreted in human milk, but other cox-2 inhibitors such as celecoxib are excreted into breast milk. Etoricoxib is excreted in the milk of lactating rats. Because of the lack of data regarding its use during lactation, and the potential for serious adverse effects in the newborn, etoricoxib should not be used during breastfeeding.

    When an NSAID is considered necessary during breastfeeding ibuprofen or flurbiprofen would be the drugs of choice.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

    Side Effects

    Abdominal distension
    Abdominal pain
    Acid regurgitation
    Altered bowel habit
    Alveolar osteitis
    Anaemia
    Anaphylactic reaction
    Anaphylactoid reaction
    Angina pectoris
    Angioedema
    Anxiety
    Arrhythmias
    Asthenia
    Atrial fibrillation
    Blurred vision
    Bronchospasm
    Cerebrovascular accident
    Chest pain
    Confusion
    Congestive cardiac failure
    Conjunctivitis
    Constipation
    Cough
    Creatine phosphokinase increased
    Decrease in mental acuity
    Decreased serum sodium
    Depression
    Diarrhoea
    Disturbances of appetite
    Dizziness
    Dry mouth
    Dysgeusia
    Dyspepsia
    Dyspnoea
    Ecchymosis
    ECG changes
    Epigastric discomfort
    Epistaxis
    Erythema
    Facial oedema
    Fatigue
    Fixed drug eruption
    Flatulence
    Flushing
    Gastritis
    Gastro-enteritis
    Gastro-intestinal perforation
    Gastrointestinal bleeding
    Hallucinations
    Headache
    Heartburn
    Hepatic failure
    Hepatitis
    Hypaesthesia
    Hyperkalaemia
    Hypersensitivity reactions
    Hypertension
    Hypertensive crisis
    Hyperuricaemia
    Increase in blood urea nitrogen
    Increase in serum ALT/AST
    Influenza-like symptoms
    Insomnia
    Irritable bowel syndrome(IBS)
    Jaundice
    Leukopenia
    Mouth ulcers
    Muscle cramps
    Muscle spasm
    Musculoskeletal pain
    Myocardial infarction
    Nausea
    Oedema
    Oesophagitis
    Palpitations
    Pancreatitis
    Paraesthesia
    Peptic ulceration
    Proteinuria
    Pruritus
    Rash
    Renal failure
    Renal impairment
    Restlessness
    Serum creatinine increased
    Somnolence
    Stevens-Johnson syndrome
    Tachycardia
    Thrombocytopenia
    Tinnitus
    Toxic epidermal necrolysis
    Transient ischaemic attack
    Upper respiratory tract infection
    Urinary tract infections
    Urticaria
    Vasculitis
    Vertigo
    Vomiting
    Weight gain

    Overdosage

    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

    Further Information

    Last Full Review Date: May 2013

    Reference Sources

    British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

    BNF for Children (2012-2013) Pharmaceutical Press, London.

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    Summary of Product Characteristics: Arcoxia 30 60 90 & 120mg Film-coated Tablets. Grunenthal Ltd. Revised July 2016.

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