Consists of etoricoxib, thiocolchicoside
Dosage of Etoricoxib (Ezact MR) in details
Arthritis, Osteoarthritis: The recommended dose is 30 mg or 60 mg once daily.
Rheumatoid Arthritis: The recommended dose is 90 mg once daily.
Ankylosing Spondylitis: The recommended dose is 90 mg once daily.
Acute Pain: For acute pain conditions, the recommended dose is 90 mg or 120 mg once daily. ETORICOXIB (Etoricoxib (Ezact MR)) should be used only for the acute symptomatic period, limited to a maximum of 8 days treatment.
Acute Gouty Arthritis: The recommended dose is 120 mg once daily.
Primary Dysmenorrhea: The recommended dose is 120 mg once daily.
Post-Operative Dental Pain: The recommended dose is 90 mg once daily.
Post-Operative Gynecological Pain: The recommended dose is 90 mg once daily. The initial dose should be administered shortly before surgery. The dose can be increased to a maximum 120 mg once daily.
Doses greater than those recommended for each indication have either not demonstrated additional efficacy or have not been studied. Therefore: The dose for OA should not exceed 60 mg daily; the dose for RA should not exceed 90 mg daily; the dose for ankylosing spondyilitis should not exceed 90 mg daily; the dose for acute gout should not exceed 120 mg daily; the dose for acute pain and primary dysmenorrhea should not exceed 120 mg daily; the dose for post-operative acute dental surgery pain should not exceed 90 mg daily; the dose for post-operative acute gynecological surgery pain should not exceed 120 mg daily.
As the cardiovascular risks of selective COX-2 inhibitors 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.
Elderly, Gender, Race: No dosage adjustment in ETORICOXIB (Etoricoxib (Ezact MR)) is necessary for the elderly or based on gender or race.
Hepatic Insufficiency: In patients with mild hepatic insufficiency (Child-Pugh score 5-6), a dose of 60 mg once daily should not be exceeded. In patients with moderate hepatic insufficiency (Child-Pugh score 7-9), the dose should be reduced; a dose of 60 mg every other day should not be exceeded, administration of 30 mg once daily can also be considered. There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency (Child-Pugh score >9).
Renal Insufficiency: In patients with advanced renal disease (creatinine clearance <30 mL/min), treatment with ETORICOXIB (Etoricoxib (Ezact MR)) is not recommended. No dosage adjustment is necessary for patients with lesser degrees of renal insufficiency (creatinine clearance ≥30 mL/min).
Administration: ETORICOXIB (Etoricoxib (Ezact MR)) is administered orally. ETORICOXIB (Etoricoxib (Ezact MR)) may be taken with or without food. ETORICOXIB (Etoricoxib (Ezact MR)) should be administered for the shortest duration possible and the lowest effective daily dose should be used.
Etoricoxib (Ezact MR) interactions
In patients stabilized on chronic warfarin therapy, administration of etoricoxib 120 mg daily was associated with an approximate 13% increase in the prothrombin time International Normalized Ratio (INR). Therefore, patients receiving warfarin and etoricoxib should have their prothrombin time INR closely monitored, particularly in the 1st few days when therapy with etoricoxib is initiated or the dose of etoricoxib is changed. NSAIDs may reduce the effect of diuretics and other antihypertensive drugs. In some patients with compromised renal function (eg, dehydrated patients or elderly patients with compromised renal function), the co-administration of an ACE inhibitor and agents that inhibit cyclooxygenase may result in further deterioration of renal function, which is usually reversible. These interactions should be given consideration in patients taking etoricoxib concomitantly with ACE inhibitors.
Etoricoxib can be used concomitantly with aspirin at doses used for cardiovascular prophylaxis (low-dose aspirin). However, concomitant administration of low-dose aspirin with etoricoxib may result in an increased rate of GI ulceration or other complications compared to use of etoricoxib alone. Concomitant administration of etoricoxib with doses of aspirin above those for cardiovascular prophylaxis or with other NSAIDs is not recommended.
Co-administration of cyclosporin or tacrolimus with any NSAID may increase the nephrotoxic effect of cyclosporin or tacrolimus. Renal function should be monitored when etoricoxib and either of these drugs is used in combination.
NSAIDs decrease lithium renal excretion and therefore increase lithium plasma levels. If necessary, monitor blood lithium closely and adjust the lithium dosage while the combination is being taken and when the NSAID is withdrawn.
Adequate monitoring for methotrexate-related toxicity is recommended when etoricoxib and methotrexate are administered concomitantly.
Administration of etoricoxib 120 mg with an oral contraceptive containing 35 mcg ethinyl estradiol (EE) and 0.5-1 mg norethindrone for 21 days, either concomitantly or separated by 12 hrs, increased the steady-state AUC0-24hr of EE by 50-60%; however, norethindrone concentrations generally did not increase to a clinically relevant degree. This increase in EE concentration should be considered when selecting an oral contraceptive for use with etoricoxib. An increase in EE exposure can increase the incidence of adverse events associated with oral contraceptives (eg, venous thromboembolic events in women at risk).
Etoricoxib 120 mg administered once daily for 10 days to healthy volunteers did not alter the steady-state plasma AUC0-24hr or renal elimination of digoxin. There was an increase in digoxin Cmax (approximately 33%). This increase is not generally important for most patients. However, patients at high risk of digoxin toxicity should be monitored for this when etoricoxib and digoxin are administered concomitantly.
Etoricoxib is an inhibitor of human sulfotransferase activity, particularly SULT1E1 and has been shown to increase the serum concentrations of ethinyl estradiol. It may be prudent to exercise care when administering etoricoxib concurrently with other drugs primarily metabolized by human sulfotransferases (eg, oral salbutamol and minoxidil).
Co-administration of etoricoxib with rifampicin, a potent inducer of CYP enzymes, produced a 65% decrease in etoricoxib plasma concentrations. This interaction may result in recurrence of symptoms when etoricoxib is co-administered with rifampicin. While this information may suggest an increase in dose, doses of etoricoxib greater than those listed for each indication have not been studied in combination with rifampicin and are therefore not recommended.
In drug interaction studies, etoricoxib did not have clinically important effects on the pharmacokinetics of prednisone/prednisolone. Ketoconazole, a potent inhibitor of CYP3A4, did not have any clinically important effect on the single-dose pharmacokinetics of 60-mg etoricoxib (43% increase in AUC). Antacids do not affect the pharmacokinetics of etoricoxib to a clinically relevant extent.
Dosage of Thiocolchicoside (Ezact MR) in details
Oral
Muscle spasms
Adult: Initially, 16 mg daily.
Intramuscular
Muscle spasms
Adult: Up to 8 mg daily.
Thiocolchicoside (Ezact MR) interactions
LEXOTAN undergoes hepatic microsomal oxidation via the cytochrome P450 liver enzymes.
Therefore, caution should be taken in patients taking medicines that inhibit the P450 liver enzymes (e.g. azole antifungals, macrolide antibiotics, HIV protease inhibitors, calcium channel blocking agents).
LEXOTAN undergoes oxidative metabolism and, consequently, may interact with disulfiram or cimetidine resulting in increased plasma levels of LEXOTAN. Patients should be observed closely for evidence of enhanced benzodiazepine response during concomitant treatment with either disulfiram or cimetidine; some patients may require a reduction in benzodiazepine dosage.
The benzodiazepines, including LEXOTAN, produce additive CNS depressant effects when coadministered with other medications which themselves produce CNS depression e.g. barbiturates, alcohol, sedatives, antidepressants, hypnotics, anxiolytics, phenothiazines and other antipsychotics,
skeletal muscle relaxants, antihistamines, narcotic analgesics and anaesthetics.
Alcohol should be avoided in patients receiving LEXOTAN.
In the case of narcotic analgesics enhancement of euphoria may also occur, leading to an increase in psychic drug dependence.
The anticholinergic effects of atropine and similar medicines, antihistamines and antidepressants may be potentiated.
Interactions have been reported between some benzodiazepines and anticonvulsants, with changes in the serum concentration of the benzodiazepine or anticonvulsant. It is recommended that patients be observed for altered responses when benzodiazepines and anticonvulsants are prescribed together and that serum level monitoring of the anticonvulsant be performed more frequently.
Interference with Clinical, Laboratory or Other Tests:
Minor EEG changes, usually low voltage fast activity, of no known clinical significance, has been
reported with benzodiazepine administration.
References
- FDA/SPL Indexing Data. "WRX4NFY03R: The UNique Ingredient Identifier (UNII) is an alphanumeric substance identifier from the joint FDA/USP Substance Registration System (SRS).". https://www.fda.gov/ForIndustry/Data... (accessed September 17, 2018).
- MeSH. "Cyclooxygenase 2 Inhibitors". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Ezact MR are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Ezact MR. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
3 consumers reported frequency of use
How frequently do I need to take Ezact MR?It was reported by ndrugs.com website users that Ezact MR should ideally be taken Once in a day as the most common frequency of the Ezact MR. You should you adhere strictly to the instructions and guidelines provided by your doctor on how frequently this Ezact MR should be taken. Get another patient's view on how frequent the capsule should be used by clicking here.
| Users | % | ||
|---|---|---|---|
| Once in a day | 2 | 66.7% | |
| 3 times in a day | 1 | 33.3% | |
1 consumer reported doses
What doses of Ezact MR drug you have used?The drug can be in various doses. Most anti-diabetic, anti-hypertensive drugs, pain killers, or antibiotics are in different low and high doses and prescribed by the doctors depending on the severity and demand of the condition suffered by the patient. In our reports, ndrugs.com website users used these doses of Ezact MR drug in following percentages. Very few drugs come in a fixed dose or a single dose. Common conditions, like fever, have almost the same doses, e.g., [acetaminophen, 500mg] of drug used by the patient, even though it is available in various doses.
| Users | % | ||
|---|---|---|---|
| 11-50mg | 1 | 100.0% | |
Consumer reviews
There are no reviews yet. Be the first to write one! |
Information checked by Dr. Sachin Kumar, MD Pharmacology
