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Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Celecoxib is indicated-

• For the relief of the signs and symptoms of osteoarthritis.
• For the relief of the signs and symptoms of rheumatoid arthritis.
• For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.

Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.

Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-

• General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
• Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
• Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
• Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
• Male reproductive system: Prostatic disorder.
• Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
• Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
• Heart rate and rhythm: Palpitation, tachycardia.
• Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
• Liver and biliary system: Peptic function abnormal, increased AST and ALT.
• Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
• Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
• Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
• Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
• Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
• Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
• Application site disorders: Cellulitis, contact dermatitis, skin nodule.
• Special senses: Taste perversion.
• Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.

Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.

Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.

Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.

Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.

Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.

Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.

Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.

Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Celecoxib is indicated-

• For the relief of the signs and symptoms of osteoarthritis.
• For the relief of the signs and symptoms of rheumatoid arthritis.
• For the regression and prevention of colorectal adenomatous polyps in patients with familial adenomatous polyposis (FAP).

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor, non-steroidal anti-inflammatory drug (NSAID). It exhibits anti-inflammatory, analgesic and antipyretic properties. The mechanism of action of Celecoxib is believed to be due to the inhibition of prostaglandin synthesis, via the inhibition of cyclooxygenase-2 (COX-2) enzyme. At therapeutic concentration, Celecoxib does not inhibit cyclooxygenase-1 (COX-1) isoenzyme.

Osteoarthritis: The recommended oral dose is 200 mg per day administered as a single dose or as 100 mg twice daily.

Rheumatoid arthritis: The recommended oral dose is 100 to 200 mg twice daily.

Familial adenomatous polyposis (FAP): Usual medical care for FAP patients should be continued while on Celecoxib. To reduce the number of adenomatous colorectal polyps in patients with FAP, the recommended oral dose is 400 mg (2x200 mg capsules) twice daily to be taken with food.

Adverse events occurring in ≥2% of patients at recommended doses - Abdominal pain 4.1%, diarrhoea 5.6%, dyspepsia 8.8%, flatulence 2.2%, nausea 3.5%, back pain 2.8%, peripheral oedema 2.1%, accidental injury 2.9%, dizziness 2.0%, headache 15.8%, insomnia 2.3%, pharyngitis 2.3%, rhinitis 2.0%, sinusitis 5.0%, upper respiratory tract infections 8.1%, rash 2.2%. The following adverse events occurred in 0.1-1.9% of patients-

• General: Allergy aggravated, allergic reaction, asthenia, chest pain, oedema generalised, face oedema, fatigue, fever, hot flushes, influenza like symptoms, pain, peripheral pain.
• Gastrointestinal: Constipation, diverticulitis, dysphagia, oesophagitis, gastritis, gastroenteritis, gastro-oesophageal reflux disease, haemorrhoids, hiatal hernia, melaena, dry mouth, stomatitis, tenesmus, tooth disorder, vomiting.
• Cardiovascular: Aggravated hypertension, angina pectoris, coronary artery disease, myocardial infarction.
• Nervous system: Leg cramps, hypertonia, hypoesthesia, migraine, neuralgia, neuropathy, paresthesia, vertigo. Female reproductive system : Breast fibroadenosis, breast neoplasm, breast pain, dysmenorrhoea, menstrual disorder, menorrhagia, vaginitis.
• Male reproductive system: Prostatic disorder.
• Resistance mechanism disorders: Herpes simplex, herpes zoster, bacterial infection, fungal infection, infection of soft tissue, viral infection, moniliasis, moniliasis genital, otitis media.
• Hearing and vestibular: Deafness, ear abnormality, earache, tinnitus.
• Heart rate and rhythm: Palpitation, tachycardia.
• Respiratory: Bronchitis, bronchospasm, bronchospasm aggravated, coughing, dyspnoea, laryngitis, pneumonia.
• Liver and biliary system: Peptic function abnormal, increased AST and ALT.
• Musculoskeletal: Arthralgia, arthrosis, accidental fracture, myalgia, neck stiffness, synovitis, tendinitis.
• Urinary system: Albuminuria, cystitis, dysuria, haematuria, micturition frequency, renal calculus, urinary incontinence, urinary tract infection.
• Metabolic and nutritional: Blood urea nitrogen (BUN), CPK, creatinine, alkaline phosphatase, are increased. Hypercholesterolaemia, hyperglycaemia, hypokalaemia. Bodyweight is also increased.
• Psychiatric: Anorexia, anxiety, increased appetite, depression, nervousness, somnolence.
• Haemic: Anaemia, ecchymosis, epistaxis, thrombocythaemia.
• Skin and appendages: Alopecia, dermatitis, photosensitivity reaction, pruritus, rash erythematous, rash maculopapular, skin disorder, dry skin, increased sweating, urticaria.
• Application site disorders: Cellulitis, contact dermatitis, skin nodule.
• Special senses: Taste perversion.
• Vision: Blurred vision, cataract, conjunctivitis, eye pain, glaucoma.

Celecoxib is contraindicated in patients with known hypersensitivity to Celecoxib. It should not be given to patients who have demonstrated allergic type reactions to Sulphonamides (Celecoxib contains a sulphonamide side chain). Celecoxib should not be given to patients who have demonstrated asthma, urticaria or allergic type reactions after taking Aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic like reactions to NSAIDs have been reported in such patients.

Celecoxib, at doses up to 200 mg bid, can be administered without regard to timing of meal. Higher doses (400 mg bid) should be administered with food.

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given into consideration in patients taking Celecoxib concomitantly with ACE inhibitors.

Frusemide: NSAIDs can reduce the natriuretic effect of Frusemide and thiazides in some patients.

Aspirin: Celecoxib can be used with low dose Aspirin. However, concomitant administration of Aspirin with Celecoxib may result in an increased rate of gastrointestinal ulceration or similar complications, compared to the use of Celecoxib alone.

Fluconazole: Concomitant administration of Fluconazole at 200 mg qid resulted in a two fold increase in Celecoxib plasma concentration. Celecoxib should be introduced at the lowest recommended dose in patients receiving Fluconazole.

Lithium: Patients on Lithium treatment should be closely monitored when Celecoxib is introduced or withdrawn.

Warfarin: Caution should be used when administering Celecoxib with Warfarin since these patients are at increased risk of bleeding complications.

Co-administration of Celecoxib with aluminium and magnesium-containing antacid should be avoided, because they may reduce the amount of Celecoxib that the body absorbs.

Celecoxib should be used during pregnancy only if the potential benefit justifies the potential risk to fetus. But in late pregnancy Celecoxib should be avoided because it may cause premature closure of ductus arteriosus. It is not known whether Celecoxib is excreted in human milk. Because many drugs are excreted in human milk and because of potential for serious adverse reactions in nursing infants from Celecoxib, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Geriatric: Dose adjustment in the elderly is not generally necessary. However, for patients of less than 50 kg in body weight, initiate therapy at the lowest recommended dose.

Paediatric: The safety and efficacy of Celecoxib is not established in pediatric patients.

Hepatic insufficiency: Celecoxib capsules should be introduced at a reduced dose in patients with moderate hepatic impairment. The use of Celecoxib in patients with severe hepatic impairment is not recommended.

Patients should be managed by symptomatic and supportive care following an NSAID overdose. There are no specific antidotes. No information is available regarding the removal of Celecoxib by hemodialysis but based on its high degree of plasma protein binding (>97%) dialysis is unlikely to be useful in overdose. Emesis and/or activated charcoal and/or osmotic cathartic may be indicated in patients seen within 4 hours of ingestion with symptoms or following a large overdose. Forced diuresis, alkalinization of urine, hemodialysis or hemoperfusion may not be useful due to high protein binding.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

For the short-term treatment of postoperative pain in adults. The decision to prescribe a selective cyclooxygenase-2 (COX-2) inhibitor should be based on an assessment of the individual patient's overall risks

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Parecoxib is a prodrug of valdecoxib. Valdecoxib is a selective COX-2 inhibitor within the clinical dose range. Cyclooxygenase is responsible for generation of prostaglandins. Two isoforms, COX-1 and COX-2, have been identified. COX-2 is the isoform of the enzyme that has been shown to be induced by pro-inflammatory stimuli and has been postulated to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. COX-2 is also involved in ovulation, implantation and closure of the ductus arteriosus, regulation of renal function, and central nervous system functions (fever induction, pain perception and cognitive function). It may also play a role in ulcer healing. COX-2 has been identified in tissue around gastric ulcers in man but its relevance to ulcer healing has not been established.

The difference in antiplatelet activity between some COX-1 inhibiting NSAIDs and COX-2 selective inhibitors may be of clinical significance in patients at risk of thrombo-embolic reactions. COX-2 selective inhibitors reduce the formation of systemic (and therefore possibly endothelial) prostacyclin without affecting platelet thromboxane. The clinical relevance of these observations has not been established.

Adult: The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by 20 mg or 40 mg as required, not to exceed 80 mg/day. As the cardiovascular risk of COX-2 specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. There is limited clinical experience with Parecoxib treatment beyond three days.

Elderly: No dose adjustment is generally necessary in elderly patients (≥65 years). However, for elderly patients weighing less than 50 kg, treatment should be initiated with half the usual recommended dose of Parecoxib and reduce the maximum daily dose to 40 mg.

Children: The safety and efficacy of parecoxib in children under 18 years old have not been established. No data are available. Therefore, parecoxib is not recommended in these patients.

The IV bolus injection may be given rapidly and directly into a vein or into an existing IV line. The IM injection should be given slowly and deeply into the muscle. For instructions on reconstitution of the medicinal product before administration. Precipitation may occur when Parecoxib is combined in solution with other medicinal products and therefore Parecoxib must not be mixed with any other medicinal product, either during reconstitution or injection. In those patients where the same IV line is to be used to inject another medicinal product, the line must be adequately flushed prior to and after Parecoxib injection with a solution of known compatibility.

Commonside effects are-

• Change in your blood pressure (up or down)
• You may get back pain
• Ankles, legs and feet may swell (fluid retention)
• You may feel numb- your skin may lose sensitivity to pain and touch
• You may get vomiting, stomach ache, indigestion, constipation, bloating and wind
• Tests may show abnormal kidney function
• You may feel agitated or find it hard to sleep
• Dizziness
• There is a risk of anaemia- changes in red blood cells after an operation that may cause fatigue and breathlessness
• You may get a sore throat or difficulty breathing (shortness of breath)
• Your skin may be itchy
• You may pass less urine than usual.
• Dry socket (inflammation and pain after a tooth extraction)
• Increased sweating
• Low levels of potassium in blood test results.

Hypersensitivity to the active substance or to any of the excipients.

Parecoxib has been studied in dental, orthopaedic, gynaecologic (principally hysterectomy) and coronary artery bypass graft surgery. There is limited experience in other types of surgery, for example gastrointestinal or urological surgery. Modes of administration other than IV or IM (e.g. intra-articular, intrathecal) have not been studied and should not be used. Because of the possibility for increaed adverse reactions at higher doses of parecoxib, other COX-2 inhibitors and NSAIDs, patients treated with parecoxib should be reviewed following dose increase and, in the absence of an increase in efficacy, other therapeutic options should be considered. There is limited clinical experience with Parecoxib treatment beyond three days. If, during treatment, patients deteriorate in any of the organ system functions described below, appropriate measures should be taken and discontinuation of parecoxib therapy should be considered.

Parecoxib is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin, it may cause premature closure of the ductus arteriosus or uterine inertia. NSAID use during the second or third trimester of pregnancy may cause foetal renal dysfunction which may result in reduction of amniotic fluid volume or oligohydramnios in severe cases. Such effects may occur shortly after treatment initiation and are usually reversible. Pregnant women on NSAIDs should be closely monitored for amniotic fluid volume. Parecoxib is contraindicated in the third trimester of pregnancy.

Administration of a single dose of parecoxib to lactating women following caesarean section resulted in the transfer of a relatively small amount of parecoxib and its active metabolite valdecoxib into human milk, and this resulted in a low relative dose for the infant (approximately 1% of the weight-adjusted maternal dose). Parecoxib must not be administered to women who breast-feed.

Reporting of overdose with parecoxib has been associated with adverse reactions which have also been described with recommended doses of parecoxib. In case of overdose, patients should be managed by symptomatic and supportive care. Valdecoxib is not removed by haemodialysis. Diuresis or alkalisation of urine may not be useful due to high protein binding of valdecoxib.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Etoricoxib is indicated for the symptomatic relief of-

• Osteoarthritis (OA)
• Rheumatoid arthritis (RA)
• Ankylosing spondylitis, and
• The pain and signs of inflammation associated with acute gouty arthritis.
• For the short-term treatment of moderate pain associated with dental surgery.

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Etoricoxib is a potent, orally active cyclooxygenase-2 (COX-2) specific inhibitor within, and significantly above, the clinical dose range. Two isoforms of cyclooxygenase have been identified: cyclooxygenase-1 (COX-1) and cyclooxygenase-2 (COX-2). COX-1 is responsible for prostaglandin-mediated normal physiologic functions such as gastric cytoprotection and platelet aggregation. Inhibition of COX-1 by nonselective NSAIDs has been associated with gastric damage and inhibition of platelet aggregation. COX-2 has been shown to be primarily responsible for the synthesis of prostanoid mediators of pain, inflammation, and fever. Selective inhibition of COX-2 by etoricoxib (within the clinical dose range) decreases these clinical signs and symptoms with decreased potential for Gl toxicity and effects on platelet aggregation. Etoricoxib produced dose-dependent inhibition of COX-2 without inhibition of COX-1 at doses up to 150 mg daily. Etoricoxib did not inhibit gastric prostaglandin synthesis.

Adult and adolescent over 16 years:

• 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.
• Rheumatoid arthritis: The recommended dose is 90 mg once daily.
• Ankylosing spondylitis: The recommended dose is 90 mg once daily.
• Acute gouty arthritis: The recommended dose is 120 mg once daily. In clinical trials for acute gouty arthritis, Etoricoxib was given for 8 days.
• Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days.

Some patients may require additional postoperative analgesia. As the cardiovascular risks of Etoricoxib may increase with dose and duration of exposure, 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, especially in patients with osteoarthritis.

Side-effects may include palpitation, fatigue, influenza-like symptoms, ecchymosis; less commonly dry mouth, taste disturbance, mouth ulcer, appetite and weight change, atrial fibrillation, transient ischaemic attack, chest pain, flushing, cough, dyspnoea, epistaxis, anxiety, mental acuity impaired, paraesthesia, electrolyte disturbance, myalgia and arthralgia; very rarely confusion and hallucinations.

With medicine:

• Oral anticoagulants: In subjects stabilized on chronic warfarin therapy, the administration of Etoricoxib was associated with an increase in prothrombin time.
• Diuretics, ACE inhibitors and Angiotensin II Antagonists: NSAIDs may reduce the effect of diuretics and other antihypertensive drugs.
• Acetylsalicylic Acid: Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used for cardiovascular prophylaxis (low-dose acetylsalicylic acid).
• Ciclosporin and tacrolimus: Although this interaction has not been studied with Etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or tacrolimus.
• Lithium: NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels.

With food & others: Take without regards to meals.

The use of Etoricoxib, as with any drug substance known to inhibit COX-2, is not recommended in women attempting to conceive. It is not known whether Etoricoxib is excreted in human milk. Etoricoxib is excreted in the milk of lactating rats. Women who use Etoricoxib must not breastfeed.

Administration of single doses of Etoricoxib up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. In the event of overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the Gl tract, employ clinical monitoring, and institute supportive therapy, if required.

Store at a temperature of below 30°C, protect from light & moisture. Keep out of reach of children.

Angiotensin-ll receptor blocker

Losartan Potassium is the first non-peptide orally active angiotensin II receptor blocker. It binds to the AT1 receptor found in many tissues (e.g. vascular smooth muscle, adrenal gland, kidneys and the heart) and reduces several important biological actions including vasoconstriction and the release of aldosterone responsible for hypertension.

The usual starting and maintenance dose is 50 mg once daily for most patients. If the antihypertensive effect using 50 mg once daily is inadequate, 25 mg twice daily is recommended prior to increasing the dose. For patients with intravascular volume-depletion (e.g., those treated with high-dose diuretics), a starting dose of 25 mg once daily should be considered. Losartan Potassium can be administered once or twice daily. The total daily dose ranges from 25 mg to 100 mg.

The side effects with the use of Losartan Potassium are mild and transient in nature. The most common side effects are dizziness, diarrhea, nasal congestion, cough, upper respiratory infection. Other side effects are fatigue, oedema, abdominal pain, chest pain, nausea, headache & pharyngitis.

Losartan Potassium is contraindicated in pregnant women and in patients who are hypersensitive to any component of this product. Losartan Potassium should not be administered with Aliskiren in patients with diabetes.

Use of Losartan Potassium during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. Plasma concentration of Losartan Potassium is significantly increased in cirrhotic patients. Changes in renal function including renal failure have been reported in renal impaired patient.

Rifampicin and fluconazole reduce levels of active metabolite of Losartan Potassium. Concomitant use of Losartan Potassium and hydrochlorothiazide may lead to potentiation of the antihypertensive effects. Concomitant use of potassium-sparing diuretics (eg, spironolactone, triamterene, amiloride), potassium supplements or salt substitutes containing potassium may lead to increases in serum potassium. The antihypertensive effect of losartan may be attenuated by the non-steroidal anti-inflammatory drug indomethacin. The use of ACE-inhibitor, angiotensin receptor antagonist, an anti-inflammatory drug and a thiazide diuretic at the same time increases the risk of renal impairment.

Pregnancy Category D. The risk to the fetus increases if Losartan Potassium is administered during the second or third trimesters of pregnancy. It is not known whether Losartan Potassium is excreted in human milk, as many drugs are excreted in human milk and because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

keep in a dry place away from light and heat. Keep out of the reach of children.

Specific mineral preparations

Marine fish collagen is a complex structural protein that helps maintain the strength and flexibility of skin, ligaments, joints, bones, muscles, tendons, blood vessels, gums, eyes, nails and hair. It has very specific amino acid compositions with a high concentration of glycine, hydroxyproline and proline. When it is ingested, hydroxyproline peptides are not completely digested to free amino acids and can be detected in the blood. These hydroxyproline peptides stimulate cells in the skin, joints and bones and lead to collagen synthesis through cell activation and growth.

1-2 capsules daily preferably with meal. Or, as directed by the registered physician.

This capsule is generally well tolerated. No significant side effects have been observed in therapeutic dosage.

It is contraindicated in patients with hypersensitivity to any component of this capsule.

Keep out of reach of children. Keep away from direct sunlight. Store below 30°C in a dry place.