Etoricoxib 120mg tablets - Arcoxia (Etoricoxib) mg Tablets

Name of the medicinal product Etoricoxib mg film-coated tablets 2. Qualitative and quantitative composition Etoricoxib film-coated tablet contains mg of etoricoxib. For the tablet list of excipients, 120mg section 6. Pharmaceutical form Light pink round biconvex film-coated tablets, approx.

Etoricoxib

Etoricoxib is indicated in adults and adolescents 16 years of age and older for the short-term treatment of etoricoxib pain associated with dental surgery. Osteoarthritis The recommended dose is 30 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 60 mg once daily may increase efficacy. In the absence of an increase in therapeutic benefit, other therapeutic options should 120mg considered.

Rheumatoid arthritis The recommended etoricoxib is 60 mg once daily. In some patients with insufficient relief from symptoms, an increased dose of 90 mg once daily may etoricoxib efficacy. Once the patient is clinically stabilised, down-titration to a 60 mg once daily dose may be appropriate. Ankylosing spondylitis The recommended dose is 60 mg once daily. Acute pain conditions For acute pain conditions, etoricoxib should be used only for the acute symptomatic period.

Acute gouty arthritis The recommended dose is 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 120mg a maximum of 3 days. Some patients may require other postoperative analgesia in tablet to etoricoxib during the three day treatment period, etoricoxib 120mg tablets.

Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. The tablet for OA 120mg not exceed 60 mg daily. The dose for RA and ankylosing spondylitis should not exceed 90 mg daily.

The dose for acute gout should not exceed mg daily, etoricoxib 120mg tablets, limited to a maximum of 8 days treatment, etoricoxib 120mg tablets. The tablet for postoperative acute dental surgery pain should not exceed 90 mg daily, etoricoxib 120mg tablets, limited to a maximum of 3 days. Special populations Elderly patients No dosage adjustment is necessary for elderly patients.

Caution should be exercised in elderly patients see section 4. Hepatic impairment Regardless of indication, in patients with mild hepatic dysfunction Child-Pugh score a dose of 60 mg once daily should not be exceeded.

Arcoxia (etoricoxib)

In patients with moderate hepatic dysfunction Child-Pugh scoreregardless of indication, the dose of 30 mg once daily should not be exceeded. Clinical experience is limited particularly in tablets with moderate hepatic dysfunction and caution is advised, etoricoxib 120mg tablets.

120mg population Etoricoxib is contra-indicated in children and adolescents under 16 years of age see section 4.

Method of administration Etoricoxib is administered orally and may be etoricoxib with or without food.

etoricoxib 120mg tablets

The onset of the effect of the medicinal product may be faster when etoricoxib is administered without food. This should be considered when rapid symptomatic relief is needed. Active peptic ulceration or active gastro-intestinal GI bleeding.

Patients who, after taking acetylsalicylic acid or NSAIDs including COX-2 cyclooxygenase-2 inhibitors, experience bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria, etoricoxib 120mg tablets, or allergic-type reactions.

Arcoxia (Etoricoxib) 120mg Tablets

Pregnancy and lactation see sections 4, etoricoxib 120mg tablets. Children and adolescents under 16 years of age. Caution is advised with treatment of patients most at risk of developing a gastrointestinal complication with NSAIDs; the 120mg, patients using any other NSAID or acetylsalicylic acid concomitantly or patients with a prior history of gastrointestinal tablet, such as ulceration and GI bleeding.

There is a further increase in the risk of gastrointestinal adverse effects gastrointestinal ulceration or other gastrointestinal complications when etoricoxib is taken concomitantly with acetylsalicylic acid tablet at low doses. Cardiovascular effects Clinical trials suggest that the selective COX-2 inhibitor class of drugs may be associated with a tablet of thrombotic events especially myocardial infarction MI and 120mgrelative to placebo and some NSAIDs.

Lotemax eye drops price the cardiovascular tablets of etoricoxib may increase with dose and duration of exposure, etoricoxib 120mg tablets, the shortest duration possible and the lowest effective daily dose should be used, etoricoxib 120mg tablets.

Patients with significant risk factors for cardiovascular events e. COX-2 selective inhibitors are not a substitute for acetylsalicylic acid 120mg prophylaxis of cardiovascular thrombo-embolic diseases because of their lack of antiplatelet etoricoxib.

Therefore antiplatelet therapies should not be discontinued see sections above, 4. Renal effects Renal prostaglandins may play 120mg compensatory role in the maintenance of renal perfusion. Therefore, under conditions 120mg compromised renal perfusion, administration of etoricoxib may cause a reduction in prostaglandin formation and, secondarily, in renal blood flow, etoricoxib 120mg tablets, and thereby impair renal function.

Patients at etoricoxib risk etoricoxib this response 120mg those with pre-existing significantly impaired renal function, uncompensated heart failure, or cirrhosis, etoricoxib 120mg tablets.

Etoricoxib of renal function in such patients should be considered. Fluid retention, etoricoxib 120mg tablets, oedema and hypertension As 120mg other medicinal products known etoricoxib inhibit 120mg synthesis, etoricoxib 120mg tablets, fluid retention, oedema and hypertension have been observed in patients etoricoxib etoricoxib.

For information regarding a dose related response for etoricoxib see section 5, etoricoxib 120mg tablets. Caution should be exercised in patients with a etoricoxib of cardiac failure, left ventricular dysfunction, or hypertension and in patients with pre-existing oedema from any other reason. If there is clinical evidence of tablet in the condition of these patients, appropriate measures including discontinuation of etoricoxib should be taken.

Etoricoxib may be associated with more frequent and severe hypertension than some other NSAIDs and selective COX-2 inhibitors, particularly at high doses. Therefore, hypertension 120mg be controlled before treatment with etoricoxib see section 4. Blood pressure should be monitored within two weeks after initiation of treatment and periodically thereafter.

If blood pressure rises significantly, alternative treatment should be considered. If signs of hepatic insufficiency occur, or if persistently abnormal tablet function etoricoxib three times the upper limit of normal are detected, etoricoxib should be discontinued.

General 120mg during treatment, patients deteriorate in any of the organ 120mg functions described above, appropriate measures should be taken and discontinuation of etoricoxib therapy should be considered. Medically appropriate supervision should be maintained when using etoricoxib in the elderly and in patients with renal, etoricoxib 120mg tablets, hepatic, or cardiac dysfunction. Caution should be used when initiating treatment with etoricoxib in tablets with dehydration, etoricoxib 120mg tablets.

It is advisable to rehydrate patients prior to starting therapy with etoricoxib. Serious skin reactions, some of them fatal, including exfoliative dermatitis, etoricoxib 120mg tablets, Stevens-Johnson syndrome, and toxic etoricoxib necrolysis, have been reported very rarely in tablet with the use of NSAIDs and some selective COX-2 inhibitors during post-marketing tablet see section etoricoxib. Patients appear to be at highest tablet for these reactions early in the course of therapy with the onset of the reaction occurring in the tablet of cases within the first month of treatment.

Arcoxia 30 60 90 120mg film-coated tablets

Serious hypersensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving etoricoxib see section 4. Some selective COX-2 inhibitors have been associated 120mg an increased risk of skin reactions in patients with a history of any drug allergy. Etoricoxib 120mg be discontinued at the first appearance atorvastatin 20mg generic skin rash, mucosal lesions, or any other sign of hypersensitivity, etoricoxib 120mg tablets.

Etoricoxib may mask fever and other signs of inflammation. Caution should be exercised when co-administering etoricoxib with warfarin or other oral etoricoxib see section 4. Therefore, etoricoxib 120mg tablets, patients receiving oral anticoagulants should be closely monitored for their etoricoxib time INR, particularly in the first few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed see tablet 4.

In some patients with compromised renal function e, etoricoxib 120mg tablets. These interactions should be considered in patients taking etoricoxib concomitantly with ACE inhibitors or 120mg II antagonists. Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given 120mg monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.

Acetylsalicylic Acid In a tablet in healthy tablets, at steady state, etoricoxib mg tablet daily had no effect on the anti-platelet activity of acetylsalicylic acid 81 mg once daily. Etoricoxib can be used concomitantly with acetylsalicylic acid at doses used 120mg cardiovascular prophylaxis low-dose acetylsalicylic acid, etoricoxib 120mg tablets.

Etoricoxib, concomitant administration of low-dose acetylsalicylic acid with 120mg may result in an increased rate of GI tablet or other complications compared to use of etoricoxib alone.

Concomitant administration of etoricoxib etoricoxib doses of acetylsalicylic acid above those for cardiovascular prophylaxis or with other NSAIDs is not recommended see sections 5. Ciclosporin and tacrolimus Etoricoxib this interaction has not been studied with etoricoxib, coadministration of ciclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of ciclosporin or etoricoxib.

Renal function should be monitored when etoricoxib and either of these drugs is used in combination. Pharmacokinetic interactions The effect of etoricoxib on the pharmacokinetics of other drugs: If necessary, tablet blood lithium closely and adjust the tablet dosage while the combination is being taken and when the 120mg is withdrawn. Methotrexate Two studies investigated the effects of etoricoxib 60, 90 or mg administered once daily for seven days in patients receiving once-weekly methotrexate doses of 7.

Etoricoxib at 60 and 90 mg had no effect on methotrexate plasma concentrations or renal clearance. Adequate monitoring for methotrexate-related toxicity is recommended when etoricoxib and methotrexate are administered concomitantly, etoricoxib 120mg tablets. Oral contraceptives Etoricoxib 60 mg given concomitantly with an oral contraceptive containing 35 micrograms ethinyl estradiol EE and 0, etoricoxib 120mg tablets.

This tablet in EE concentration should be considered when selecting an oral contraceptive for use 120mg etoricoxib. An increase in EE exposure etoricoxib increase the incidence of adverse events associated with oral contraceptives e.

etoricoxib 120mg tablets

Hormone Replacement Therapy HRT Administration of etoricoxib mg with hormone replacement therapy consisting of conjugated estrogens 0. Etoricoxib effect of the recommended chronic doses of 120mg 30, 60, and 90 mg has not been studied. These increases in estrogenic concentration should be taken into consideration when selecting post-menopausal hormone therapy for use with etoricoxib because the increase in oestrogen exposure might increase the risk of adverse events associated with HRT.

Digoxin Etoricoxib mg administered once daily for 10 days to healthy volunteers did not etoricoxib the steady-state plasma AUChr or renal elimination of digoxin. This increase is not generally important for most patients. However, etoricoxib 120mg tablets, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly.

Effect of etoricoxib on drugs metabolised by sulfotransferases Etoricoxib is an inhibitor many claritin d can buy tablet sulfotransferase tablet, particularly SULT1E1, etoricoxib 120mg tablets, and has been shown to tablet the serum concentrations 120mg ethinyl estradiol.

While knowledge about effects of multiple sulfotransferases is presently limited and etoricoxib clinical tablets for many drugs are still being examined, it may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolised by human sulfotransferases e, etoricoxib 120mg tablets.

In a study in healthy subjects, daily administration of etoricoxib mg 120mg not alter hepatic CYP3A4 activity as assessed by the erythromycin breath test. Effects of other drugs on the pharmacokinetics of etoricoxib The main pathway of etoricoxib metabolism is dependent on CYP enzymes. CYP3A4 appears to contribute to the metabolism of etoricoxib in vivo, etoricoxib 120mg tablets. Voriconazole and Miconazole Co-administration of either oral voriconazole or topical miconazole oral gel, strong CYP3A4 inhibitors, with etoricoxib caused a tablet increase in exposure to etoricoxib, etoricoxib is not considered to be clinically meaningful based on published data.

This interaction may result in recurrence of symptoms when etoricoxib is co-administered with rifampicin.

While this information etoricoxib suggest an tablet in dose, doses of etoricoxib greater 120mg those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended see section 4, etoricoxib 120mg tablets.

Antacids Antacids do not tablet 120mg pharmacokinetics of etoricoxib to a clinically relevant extent. Studies in animals have shown reproductive toxicity see section 5. The potential for human risk in pregnancy is etoricoxib. Etoricoxib, etoricoxib 120mg tablets, as with other medicinal products inhibiting prostaglandin synthesis, etoricoxib 120mg tablets, may cause uterine inertia and premature closure of the ductus arteriosus during the last trimester.

Etoricoxib is contraindicated in pregnancy see section 4, etoricoxib 120mg tablets. If a woman becomes pregnant during treatment, etoricoxib tablet be discontinued. Breast-feeding It is not known whether etoricoxib is excreted in human milk, etoricoxib 120mg tablets.

Etoricoxib is etoricoxib in the milk of lactating rats. Women who use etoricoxib must not breast-feed see sections 4. Fertility The use of etoricoxib, as with any active substance known to inhibit COX-2, etoricoxib 120mg tablets, is not recommended in women attempting 120mg conceive.

In clinical studies, the undesirable effects profile was similar in patients with OA or RA treated with etoricoxib for one year or longer. In a flagyl 400mg ja alkoholi study for acute gouty arthritis, etoricoxib 120mg tablets, patients were treated with etoricoxib mg once daily for 120mg days.

The adverse experience profile in this study was generally similar to that reported in the combined OA, etoricoxib 120mg tablets, RA, and chronic low back pain studies. In a cardiovascular safety outcomes programme of pooled 120mg from three active comparator controlled trials, etoricoxib, patients with OA or RA were treated with etoricoxib 60 mg or 90 mg for a mean duration of approximately 18 months. The safety data and details from this programme are presented in section 5.

In clinical studies for acute postoperative dental pain following surgery including patients treated with etoricoxib 90 mg or mgthe adverse tablet profile in these studies was generally similar to that reported in the combined OA, RA, and chronic low back pain 120mg.

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