Etoxib

Etoxib

etoricoxib

Manufacturer:

Krka

Distributor:

Hind Wing
/
Four Star
Full Prescribing Info
Contents
Etoricoxib.
Description
Each film-coated tablet contains 30 mg, 60 mg, 90 mg or 120 mg etoricoxib.
Excipients/Inactive Ingredients: Tablet core: microcrystalline cellulose, calcium hydrogen phosphate, croscarmellose sodium, sodium stearyl fumarate, colloidal anhydrous silica.
Film coating: polyvinyl alcohol, titanium dioxide (E171), macrogol 3000, talc.
60 mg: ferric oxide yellow E172.
90 mg & 120 mg: ferric oxide red E172.
Action
Etoxib contains the active substance etoricoxib. Etoxib is one of a group of medicines called selective COX-2 inhibitors. These belong to a family of medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
Indications/Uses
Etoxib helps to reduce the pain and swelling (inflammation) in the joints and muscles of people 16 years of age and older with osteoarthritis, rheumatoid arthritis, ankylosing spondylitis and gout.
Etoxib is also used for the short term treatment of moderate pain after dental surgery in people 16 years of age and older.
Osteoarthritis: Osteoarthritis is a disease of the joints. It results from the gradual breakdown of cartilage that cushions the ends of the bones. This causes swelling (inflammation), pain, tenderness, stiffness and disability.
Rheumatoid arthritis: Rheumatoid arthritis is a long term inflammatory disease of the joints. It causes pain, stiffness, swelling, and increasing loss of movement in the joints it affects. It may also cause inflammation in other areas of the body.
Gout: Gout is a disease of sudden, recurring attacks of very painful inflammation and redness in the joints. It is caused by deposits of mineral crystals in the joint.
Ankylosing spondylitis: Ankylosing spondylitis is an inflammatory disease of the spine and large joints.
Dosage/Direction for Use
Always take this medicine exactly as advised by the doctor. The patient should check with the doctor or pharmacist if not sure.
Do not take more than the recommended dose for the condition. The doctor will want to discuss the treatment from time to time. Etoxib should be used at the lowest effective dose for the shortest possible time. This is because the risk of heart attacks and strokes might increase after prolonged treatment, especially with high doses.
There are different strengths available for this medicinal product and depending on the disease the doctor will prescribe the tablet strength that is appropriate.
The recommended dose is: Osteoarthritis: The recommended dose is 30 mg once a day, increase to a maximum of 60 mg once a day if needed.
Rheumatoid arthritis: The recommended dose is 60 mg etoricoxib once a day. The dose can be increased to a maximum of 90 mg once a day if needed.
Ankylosing spondylitis: The recommended dose is 60 mg etoricoxib once a day. The dose can be increased to a maximum of 90 mg once a day if needed.
Treatment of acute pain: Etoricoxib should be used only for the acute painful period.
Gout: The recommended dose is 120 mg once a day which should only be used for the acute painful period, limited to a maximum of 8 days treatment.
Postoperative dental surgery pain: The recommended dose is 90 mg once daily, limited to a maximum of 3 days treatment.
People with liver problems: If the patient has mild liver disease, the patient should not take more than 60 mg a day.
If the patient has moderate liver disease, the patient should not take more than 30 mg a day.
Use in children and adolescents: Etoxib tablets should not be taken by children or adolescents under 16 years of age.
Elderly: No dose adjustment is necessary for elderly patients. As with other medicines, caution should be exercised in elderly patients.
Method of administration: Etoxib is for oral use. Take the tablets once a day. Etoxib can be taken with or without food.
If the patient forgets to take Etoxib: It is important to take Etoxib as the doctor has prescribed. If a dose is missed, just resume the usual schedule the following day.
Do not take a double dose to make up for the forgotten tablet. If there are any further questions on the use of this medicine, ask the doctor or pharmacist.
Overdosage
The patient should never take more tablets than the doctor recommends. If the patient does take too many Etoxib tablets, he/she should seek medical attention immediately.
Contraindications
Etoxib is contraindicated: in patients with severe heart failure; for the treatment of peri-operative pain in the setting of coronary artery bypass graft surgery.
Do not take Etoxib: if allergic to etoricoxib or any of the other ingredients of this medicine (listed in Description); if allergic to non-steroidal anti-inflammatory drugs (NSAIDs), including acetylsalicylic acid and COX-2 inhibitors (see Side Effects); if there is a current stomach ulcer or bleeding in the stomach or intestines; if there is serious liver disease; if there is serious kidney disease; if pregnant or could be pregnant or breast-feeding (see Use in Pregnancy & Lactation); if under 16 years of age; if there is inflammatory bowel disease, such as Crohn's Disease, Ulcerative Colitis, or Colitis; if there is high blood pressure that has not been controlled by treatment (check with the doctor or nurse if not sure whether the blood pressure is adequately controlled); if the doctor has diagnosed heart problems including heart failure (moderate or severe types), angina (chest pain); if there had been a heart attack, bypass surgery, peripheral arterial disease (poor circulation in legs or feet due to narrow or blocked arteries); if there had been any kind of stroke (including mini-stroke, transient ischaemic attack or TIA).
Etoricoxib may slightly increase the risk of heart attack and stroke and this is why it should not be used in those who have already had heart problems or stroke.
If any of these are relevant, do not take the tablets until the doctor has been consulted.
Special Precautions
Talk to the doctor or pharmacist before taking Etoxib if: A history of stomach bleeding or ulcers is present.
Dehydrated, for example by a prolonged bout of vomiting or diarrhoea.
Swelling due to fluid retention is present.
A history of heart failure, or any other form of heart disease, is present.
A history of high blood pressure is present. Etoxib can increase blood pressure in some people, especially in high doses, and the doctor will want to check the blood pressure from time to time.
Any history of liver or kidney disease is present.
Being treated for an infection. Etoxib can mask or hide a fever, which is a sign of infection.
Diabetes, high cholesterol is present, or a smoker. These can increase the risk of heart disease.
A woman trying to become pregnant.
Over 65 years of age.
If not sure if any of the previously mentioned applies, talk to the doctor before taking Etoxib to see if this medicine is suitable.
Etoxib increases risk of cardiovascular adverse effects.
Etoxib works equally well in older and younger adult patients.
In rare cases, Etoxib has been associated with severe liver injury.
Cardiovascular Risk: NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk.
Gastrointestinal Risk: NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events.
Renal Effects: Long-term administration of NSAIDs has resulted in renal papillary necrosis and other renal injury. Renal toxicity has also been seen in patients in whom renal prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients, administration of a NSAID may cause a dose-dependent reduction in prostaglandin formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. Patients at greatest risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and ACE inhibitors, and the elderly. Discontinuation of NSAID therapy is usually followed by recovery to the pretreatment state.
Advanced Renal Disease: No information is available from controlled clinical studies regarding the use of Etoxib in patients with advanced renal disease. Therefore, treatment with Etoxib is not recommended in these patients with advanced renal disease. If therapy must be initiated, close monitoring of the patient's renal function is advisable.
Driving and using machines: Dizziness and sleepiness have been reported in some patients taking Etoxib.
Do not drive if experiencing dizziness or sleepiness.
Do not use any tools or machines if experiencing dizziness or sleepiness.
Use in Elderly: If over 65 years of age, the doctor will want to appropriately keep a check. No dosage adjustment is necessary for patients over 65 years of age.
Use in Children: Do not give this medicine to children and adolescents under 16 years of age.
Use In Pregnancy & Lactation
Pregnancy: Etoxib tablets must not be taken during pregnancy. If the patient is pregnant or thinks she could be pregnant, or if she is planning to become pregnant, the tablets must not be taken. If the patient becomes pregnant, she must stop taking the tablets and consult the doctor. Consult the doctor if unsure or need more advice.
Breast-feeding: It is not known if Etoxib is excreted in human milk. If breast-feeding, or planning to breast-feed, consult the doctor before taking Etoxib. If using Etoxib, do not breast-feed.
Fertility: Etoxib is not recommended in women attempting to become pregnant.
Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the patient develops any of these signs he/she should stop Etoxib and talk to the doctor immediately (see Contraindications, Precautions, Use in Pregnancy & Lactation, Interactions): shortness of breath, chest pains, or ankle swelling appear or if they get worse; yellowing of the skin and eyes (jaundice) - these are signs of liver problems; severe or continual stomach pain or the stools become black; an allergic reaction - which can include skin problems such as ulcers or blistering, or swelling of the face, lips, tongue, or throat which may cause difficulty in breathing.
Other side effects that may occur during treatment with Etoxib: Very Common (affects more than 1 in 10 people): stomach pain.
Common (affects 1 to 10 users in 100): dry socket (inflammation and pain after a tooth extraction); swelling of the legs and/or feet due to fluid retention (oedema); dizziness, headache; palpitations (fast or irregular heartbeat), irregular heart rhythm (arrhythmia); increased blood pressure; wheezing or shortness of breath (bronchospasms); constipation, wind (excessive gas), gastritis (inflammation of the lining of the stomach), heartburn, diarrhoea, indigestion (dyspepsia)/stomach discomfort, nausea, being sick (vomiting), inflammation of the oesophagus, mouth ulcers; changes in blood tests related to the liver; bruising; weakness and fatigue, flu-like illness.
Uncommon (affects 1 to 10 users in 1,000): gastroenteritis (inflammation of the gastrointestinal tract that involves both the stomach and small intestine/stomach flu), upper respiratory infection, urinary tract infection; changes in laboratory values (decreased number of red blood cells, decreased number of white blood cells, platelets decreased); hypersensitivity (an allergic reaction including hives which may be serious enough to require immediate medical attention); appetite increases or decreases, weight gain; anxiety, depression, decreases in mental sharpness, seeing, feeling or hearing things that are not there (hallucinations); taste alteration, inability to sleep, numbness or tingling, sleepiness; blurred vision, eye irritation and redness; ringing in the ears, vertigo (sensation of spinning while remaining still); abnormal heart rhythm (atrial fibrillation), fast heart rate, heart failure, feeling of tightness, pressure or heaviness in the chest (angina pectoris), heart attack; flushing, stroke, mini-stroke (transient ischaemic attack), severe increase in blood pressure, inflammation of the blood vessels; cough, breathlessness, nose bleed; stomach or bowel bloating, changes in bowel habits, dry mouth, stomach ulcer, inflammation of the stomach lining that can become serious and may lead to bleeding, irritable bowel syndrome, inflammation of the pancreas; swelling of the face, skin rash or itchy skin, redness of the skin; muscle cramp/spasm, muscle pain/stiffness; high levels of potassium in the blood, changes in blood or urine tests relating to the kidney, serious kidney problems; chest pain.
Rare (affects 1 to 10 users in 10,000): angioedema (an allergic reaction with swelling of the face, lips, tongue and/or throat which may cause difficulty in breathing or swallowing, which may be serious enough to require immediate medical attention)/anaphylactic/anaphylactoid reactions including shock (a serious allergic reaction that requires immediate medical attention); confusion, restlessness; liver problems (hepatitis); low blood levels of sodium; liver failure, yellowing of the skin and/or eyes (jaundice); severe skin reactions.
If getting any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph.
Drug Interactions
Other medicines and Etoxib: Tell the doctor or pharmacist if taking, have recently taken or might take any other medicines.
In particular if taking any of the following medicines, the doctor may want to monitor to check that the medicines are working properly, once taking Etoxib is started: medicines that thin the blood (anticoagulants), such as warfarin; rifampicin (an antibiotic); methotrexate (a drug used for suppressing the immune system, and often used in rheumatoid arthritis); ciclosporin or tacrolimus (drugs used for suppressing the immune system); lithium (a medicine used to treat some types of depression); medicines used to help control high blood pressure and heart failure called ACE inhibitors and angiotensin receptor blockers, examples include enalapril and ramipril, and losartan and valsartan; diuretics (water tablets); digoxin (a medicine for heart failure and irregular heart rhythm); minoxidil (a drug used to treat high blood pressure); salbutamol tablets or oral solution (a medicine for asthma); birth-control pills (the combination may increase the risk of side effects); hormone replacement therapy (the combination may increase the risk of side effects); acetylsalicylic acid, the risk of stomach ulcers is greater if Etoxib is taken with acetylsalicylic acid.
Acetylsalicylic acid for prevention of heart attacks or stroke: Etoxib can be taken with low-dose acetylsalicylic acid. If the patient is currently taking low dose acetylsalicylic acid to prevent heart attacks or stroke, the patient should not stop taking acetylsalicylic acid until he/she talks to the doctor.
Acetylsalicylic acid and other non-steroidal anti-inflammatory drugs (NSAIDs): do not take high dose acetylsalicylic acid or other anti-inflammatory medicines while taking Etoxib.
Etoxib with food and drink: The onset of the effect of Etoxib may be faster when taken without food.
Caution For Usage
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.
Storage
Store below 25°C.
ATC Classification
M01AH05 - etoricoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products, coxibs.
Presentation/Packing
FC tab 30 mg (white or almost white, round, slightly biconvex, with beveled edges) x 30's. 60 mg (slightly brownish yellow, round, biconvex, with beveled edges, engraved with mark "60" on one side) x 30's. 90 mg (pink, round, biconvex, with beveled edges, engraved with mark "90" on one side) x 30's. 120 mg (brownish red, round, slightly biconvex, with beveled edges, scored on one side) x 30's.
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