Consumer medicine information

1. Why am I using ARCOXIA?

ARCOXIA contains the active ingredient etoricoxib. ARCOXIA is used to relieve pain and inflammation in osteoarthritis, gout, menstrual cramps or period pain and minor dental procedures.
For more information, see Section 1. Why am I using ARCOXIA? in the full CMI.

2. What should I know before I use ARCOXIA?

Do not use if you have ever had an allergic reaction to etoricoxib or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use ARCOXIA? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ARCOXIA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ARCOXIA?

• Take ARCOXIA as directed by your doctor

• Swallow ARCOXIA tablets with a glass of water

5. What should I know while using ARCOXIA?

6. Are there any side effects?

Common side effects may include indigestion, dizziness, stomach pain, diarrhoea, headache, fatigue, rash, high/ increased blood pressure, signs of an infection, swelling of the legs, ankles or feet. Serious side effects may include signs of an allergic reaction (such as fever, skin rash, swelling of the face), signs of bleeding stomach ulcers (such as vomiting blood, bleeding from the back passage, bloody diarrhoea, etc.), shortness of breath and chest pains.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of Medicine

Etoricoxib.

2 Qualitative and Quantitative Composition

Etoricoxib is a white to off-white powder. Etoricoxib is freely soluble in methanol, tetrahydrofuran, dimethyl sulfoxide, methyl ethyl ketone, dimethyl formamide, and chloroform. Etoricoxib is soluble in isopropyl acetate, ethanol and toluene, sparingly soluble in 2-propanol, and practically insoluble in water.
Each tablet of Arcoxia for oral administration contains either 30, 60, 90 or 120 mg of etoricoxib.
Excipients with known effect. Lactose monohydrate.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Arcoxia (etoricoxib) 30 mg is a blue-green, apple-shaped, biconvex film coated tablet debossed "101" on one side and "ACX 30" on the other side.
Arcoxia (etoricoxib) 60 mg is a dark green, apple-shaped, biconvex film coated tablet engraved "200" on one side and "ARCOXIA 60" on the other side.
Arcoxia (etoricoxib) 90 mg is a white, apple-shaped, biconvex film coated tablet debossed "202" on one side and "ARCOXIA 90" on the other side.
Arcoxia (etoricoxib) 120 mg is a pale green, apple-shaped, biconvex film coated tablet engraved "204" on one side and "ARCOXIA 120" on the other side.

4 Clinical Particulars

4.9 Overdose

For information on the management of overdose, contact the Poison Information Centre on 131126 (Australia).
In clinical studies, administration of Arcoxia at single doses up to 500 mg and multiple doses up to 150 mg/day for 21 days did not result in significant toxicity. There have been reports of acute overdosage with etoricoxib, although adverse events were not reported in the majority of cases. The most frequently observed adverse events were consistent with the safety profile for etoricoxib (e.g. gastrointestinal events, renovascular events).
In the event of overdose, it is reasonable to employ the usual supportive measures, e.g. employ clinical monitoring and institute supportive therapy, if required.
Etoricoxib is not dialysable by haemodialysis; it is not known whether etoricoxib is dialysable by peritoneal dialysis.

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Etoricoxib was not genotoxic in assays for gene mutations (in vitro bacterial and human lymphoblast [TK locus] cell assays), chromosomal damage (CHO cells in vitro, rat bone marrow in vivo) and other genotoxic effects (alkaline elution assay of DNA damage in vitro and in vivo, DNA adduct formation in vitro).
Carcinogenicity. When etoricoxib at doses ≥ 30 mg/kg/day (> 6 times the daily human dose [90 mg]) was administered orally for up to 2 years in rats, liver adenomas were observed in the males and females and thyroid follicular cell adenomas were observed in the males, as well. At the lower dose tested in this species (10 mg/kg/day), hepatic cell and thyroid follicular cell hypertrophy were observed in both sexes, and were associated with systemic exposure (AUC_0-24hr) lower than that expected in humans at the maximum recommended dose of 120 mg.
Etoricoxib was not carcinogenic in mice given oral doses up to 400 mg/kg/day for males and up to 600 mg/kg/day for females for two years. Systemic exposure (AUC_0-24hr) at these dose levels was similar to that in humans at the maximum recommended dose of 120 mg.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Arcoxia tablets contain etoricoxib, which is described chemically as 5-chloro-6'-methyl-3-[4-(methylsulfonyl) phenyl]-2,3'-bipyridine. The empirical formula is C₁₈H₁₅ClN₂O₂S. The molecular weight is 358.84.
Chemical structure. The structural formula is:
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSETORIC.gif CAS number. The CAS Registry Number is 202409-33-4.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/ARCOXIST.gif