Savi Etodolac 200mg medicine helps relieve pain, anti -inflammatory (3 blisters x 10 tablets)
Dosage form Box of 3 blisters x 10 tablets
Specifications Etodolac
Ingredient
| Composition information | Content |
| Etodolac | 200mg |
Uses
indications
Savi Etodolac 200 medicine is indicated in the following cases:
For acute pain and long -term use in the treatment of the following signs and symptoms:
Pharmacy
Etodolac is a nonsteroidal anti -inflammatory drug (NSAID) with anti -inflammatory, analgesic and antipyretic activity in animal testing models. Etodolac's mechanism of action, like other NSAIDs, is not fully understood, but may be related to prostaglandin synthesis inhibitors. Etodolac is the Racemic mixture of ( -) r and (+) S - Etodolac. Like other NSAIDs, it has been shown in animals that are configured (+) s with biological activity. Both of the squads are sustainable and there is no conversion (-) r to (+) s in vivo.
Pharmacokinetics
absorption
Etodolac's body bioavailability reaches at least 80% determined from mass balancing studies. Etodolac is well absorbed. After drinking, Etodolac does not have to undergo the first significant biological transformation process. The average peak concentration in plasma (C) ranges from about 14 ± 4 to 37 ± 9mg/ml after a single dose of 200 to 600 mg and is reached in about 80 ± 30 minutes.corresponds to the dose based on AUC (the area below the concentration curve - plasma time) is linear after 600 mg doses every 12 hours. Peak concentration - Dosage is proportional for both the total number of Etodolac links and free after the 400 mg doses every 12 hours, but after a dose of 600 mg, the peak concentration reaches about 20% higher than the prediction on a lower dose. Etodolac absorption level is not affected when used after meals. However, food reduces the peak concentration of about half and increases the peak time from 1.4 to 3.8 hours.
Distribution
The average distribution volume (VD/F) of Etodolac is about 390 ml/kg. There are more than 99% Etodolac linked to plasma proteins, mainly albumin. Free component is less than 1% and independent of the total Etodolac concentration within the research dose range. It is not known whether Etodolac will be excreted in breast milk, however, based on its physical properties, the excretion of breast milk has been expected. Data from In vitro studies, using serum peak concentration at the treatment dose for people in the program, the free Etodolac part is not significantly changed by acetaminophen, ibuprofen, indomethacin, naproxen, piroxicam, chlorpropamid, glipizid, glybid, phenytoin and probenecid.
Metabolism
Etodolac is metabolized in the liver. The role, if any, of the typical cytochrom PA enzyme system in Etodolac's metabolism is currently unknown. Some metabolites of Etodolac have been determined in plasma and urine of humans. Other metabolites have not been determined. Known metabolites include 6 -, 7 - and 8 - Hydroxylation Etodolac and Etodolac Glucuronid. After a single dose of 14C - Etodolac, hydroxylation accounts for less than 10% of the total number of drugs in serum. After many doses, hydroxyl - Etodolac metabolites do not accumulate in the plasma of patients with normal renal function. The accumulation of hydroxyl - Etodolac metabolites in patients with kidney dysfunction has not been studied. Hydroxyl - Etodolac is also subject to glucuronide; Excreted through the kidneys and partly eliminated feces.
Elimination
Etodolac's average oral clearance at the standard dose standard is 49 (± 16) ml/h/kg. About 1% of the Etodolac dose is excreted in the form of unchanged urine in which 72% of the dose is excreted into the urine in the form of intact plus the metabolic substance:
Etodolac has glucuronids 13%.
Hydroxyl metabolites have been 20%.
Although the renal removal is an important sugar of the excretion of Etodolac metabolites, in general, there is no need to adjust the dose standard in patients with mild to medium to medium -sized kidney dysfunction. Etodolac's waste sale time (T1/2) is 6.4 hours (22% CV). In patients with severe kidney dysfunction or dialysis, the dose adjustments need to be adjusted. Excretion through the part accounts for 16% of the dose.
Before taking Savi Etodolac 200mg medicine helps relieve pain, anti -inflammatory (3 blisters x 10 tablets)
How to use
Take oral use.
Be careful to consider the potential and risk benefits of Etodolac and other treatment options before deciding to use Etodolac, using the lowest doses to be effective in the shortest time suitable for the treatment goals for each patient.
After observing the response to Etodolac's initial treatment, the dosage and frequency should be adjusted to suit the needs of each patient.
Adjusting the dose of Etodolac is generally unnecessary in patients with mild to moderate renal failure. Etodolac must be used cautiously in the aforementioned patients, because similar to other NSAIDs, Etodolac can reduce kidney function in some patients who have been impaired renal function.
Dosage
adults
Pain relief
Etodolac's daily recommendations for acute pain up to 1000 mg, divided by 200 - 400 mg every 6 - 8 hours.The dose of Etodolac is greater than 1000 mg/day has not been fully assessed in good control clinical trials.
osteoarthritis and rheumatoid arthritis
The recommended dose starts Etodolac for the treatment of signs and symptoms of osteoarthritis or rheumatoid arthritis: 300 mg x 2-3 times/day or 400 mg x 2 times or 500 mg x 2 times/day.
Dosage lower than 600 mg/day may sufficient for long -term treatment.
Doctors need to be aware that above 1000 mg/day has not been fully assessed in well -controlled clinical trials.
In chronic treatment conditions, an Etodolac therapy response is sometimes determined within a week of treatment, but most often after two weeks. After achieving a satisfactory response, the patient's dose should be considered and adjusted as required.
Children
Safety and effectiveness of drugs for patients under the age of 18 have not been established.
Elderly
Similar to any NSAID, be cautious when treating the elderly (from 65 years of age) and when increasing the dose.
No need to adjust the dose standard in the elderly on the basis of pharmacokinetics.
Etodolac is excreted mainly through the kidneys. Because older patients are more likely to impaired renal function, it is necessary to be careful in choosing the dose and need to monitor the kidney function when taking the drug.
In clinical studies with Etodolac, there is no overall difference in safety and effectiveness observed between elderly patients and young patients. In pharmacokinetic studies, the age of displayed has no effect on Etodolac's protein or half -life link and has no change in expected drug accumulation. Therefore, there is no need to adjust the dose in the elderly based on pharmacokinetics.
Elderly patients may be more sensitive to Prostaglandin inhibitors (Antiprostaglandin) of NSAID (on the gastrointestinal tract and kidneys) compared to young patients. In particular, the elderly or depressed patients, who are treated with NSAID, seem less tolerant ulcers or gastrointestinal bleeding than other individuals and most spontaneous reports of death events due to the digestive system are among these patients.
Etodolac is excreted mainly through the kidneys. Because older patients are more likely to reduce renal function, it is necessary to consider the selection of the dose and need to monitor the kidney function.
Note: The above dose is for reference only. Specific dosage depends on the condition and level of progression of the disease. For a suitable dose, you need to consult a doctor or medical specialist.What do
do when overdose? Gastrointestinal bleeding can occur and coma has occurred after an overdose with large amounts of ibuprofen or mefenamic acid.
High blood pressure, acute renal failure and respiratory failure may occur but very rare. Anaphylactic reaction was reported to NSAID's oral dosage and then overdose.
Patients should be taken care of symptoms and support treatment after the overdose of NSAID.
No specific antidote.
Causes vomiting and/or activated carbon (60 to 100 g in adults, 1 - 2 g/kg in children) and/or osmotic bleach can be indicated in patients with symptoms or after large doses (5-10 times the usual dose) is determined within 4 hours. Forced diuretic, alkalinizing urine, dialysis, or hemolysis is probably not helpful because Etodolac binds high protein.
What to do when you forget a dose? However, if close to the next dose, skip the forgotten dose and take the next dose at the time as planned. Note that it should not be used double the prescribed dose.
Side Effects
When using Savi Etodolac 200, you may experience unwanted effects (ADR).
In patients using Etodolac or NSAID, reports on the most common side effects occur in about 1 - 10% of patients:
Newly complained patients (with greater than or equal to 1%) are listed below by the body system. The incidence rate is determined from clinical trials related to 465 patients with osteoarthritis treated at a dose of 300 to 500 mg of Etodolac twice daily (from 600 to 1000 mg/day).
The ratio is greater than or equal to 1%
Digestive system: indigestion (10%), abdominal pain*, diarrhea*, flatulence, nausea*, constipation, gastritis, black stool, vomiting. Nervous system: weakness/nerve instability*, dizziness*, depression, stress. Skin and appendages: itching, rash. Special senses: blurred vision, tinnitus. *Patients with complaints related to drugs occur in 3% to 9% of patients treated with Etodolac. Regarding the complaint patient's drug in less than 3%, but greater than 1%, not marked*. Ratio less than 1% - Causes (adverse reactions in the experience of use after giving market drugs, unprecedented in clinical trials, are considered rare). Digestive system: thirst, dry mouth, stomach ulcers, mouth stomach, anorexia, belching, increased liver enzymes, cholecystitis, hepatitis, jaundice, duodenum, jaundice, liver failure, liver necrosis, stomach ulcer with bleeding and/or perforation, intestinal ulcers, pancreatitis. Respiratory system: Asthma, lung infiltration with eosinophilia. Special senses: Fear of light, transient visual disorders. The rate of less than 1% - unknown reasons (Medical events occur in circumstances of causal relationships with irrecongasting Etodolac. These reactions are listed as warning information to doctors). Cardiovascular system: arrhythmia, myocardial infarction, stroke. About the risk of cardiovascular thrombosis (see more caution when used). Digestive system: Esophagitis whether or not narrow or choking due to the last sphincter of the tank (cardiospasm), colitis. Respiratory system: bronchitis, shortness of breath, sore throat, rhinitis, sinusitis. Skin and appendages: hair loss, lumpy, sensitive to light, skin peeling. Special senses: conjunctivitis, deafness, mouth. additional reports on side effects of NSAID Cardiovascular system: tachycardia. Digestive system: stomach ulcers, gastritis, gastrointestinal bleeding, gastritis, vomiting. Instructions on how to handle ADR Stop taking the drug if serious side effects occur and consult and report to the treating doctor.
Warnings
Before using the drug you need to read the instructions carefully and refer to the information below.
Contraindicated
Savi Etodolac 200 medicine is contraindicated in the following cases:
Etodolac should not be used for patients with a history of asthma, urticaria or other allergic reactions after taking aspirin or other NSAIDs.
Etodolac is contraindicated to treat pain after surgery in the northern coronary artery setting (Cabg, Coronary Artery bypass Graft Surgery).
Be cautious when using
general
Etodolac is not expected to replace corticosteroid anti -inflammatory drugs or corticosteroidal treatment.
Suddenly stopping corticosteroids can lead to a worse disease. Prolonged corticosteroid treatment patients need to reduce the dose from the decision to terminate corticosteroid treatment. Etodolac's pharmacological impact in reducing fever and anti -inflammatory can obscure diagnostic signs to detect these complications under infections without infection.
impact on the liver
The basic rise of one or more liver tests may occur in 15% of NSAID patients including Etodolac. The abnormalities in this laboratory may progress, may not change or may be fleeting when continuing treatment. It is noteworthy that the high level of ALT, AST (about three or many of the upper limits of normal levels) has been reported in about 1% of patients in clinical trials with NSAID drugs. In addition, there have been reports of rare cases of severe liver reactions, including jaundice and hepatitis, liver necrosis, liver failure and some of them died.
In a patient with symptoms and/or signs that there is a liver dysfunction or in people with abnormal liver tests, it is necessary to re -evaluate the evidence of serious liver reaction development while treating Etodolac. If clinical signs and symptoms are suitable for liver disease developing or if there are systemic manifestations (for example, leukemia, rash, etc.), Etodolac should be stopped.
impact on hematology
Anemia is sometimes seen in patients who are used NSAID, including Etodolac. This may be due to water retention, blood loss that is obscured or clear from the digestive system or an incomplete effect when creating erythropoiesis. Patients with long -term treatment with NSAID, including Etodolac, should check hemoglobin or hematocrit (measurement of blood cells) to detect any signs or symptoms of anemia.
NSAIDs inhibit platelet aggregation and show signs of prolonged bleeding time in some patients. Unlike Aspirin, it affects low platelet function, shorter time and recovery.
Patients who receive Etodolac may be affected by changes in platelet function, such as people with coagulation disorders or patients who receive anticoagulant drugs, should be monitored carefully.
Patients with a history of asthma
Patients with asthma may be sensitive to aspirin. The use of aspirin in patients with asthma is sensitive to aspirin related to severe bronchospasm, can be fatal. Due to the cross -reaction, including bronchospasm, between aspirin and nonsteroidal NSAID anti -inflammatory drugs have been reported in patients sensitive to aspirin, etodolac should not be used for patients sensitive to aspirin and should be used cautiously in all patients with a history of asthma.
Laboratory tests
Due to serious digestive ulcer event and bleeding may occur without warning symptoms, doctors should monitor signs or symptoms of digestive bleeding. Patients with long -term treatment with NSAID drugs need personal data on Hematology CBC (Complete Blood Count) and a personal profile on periodic chemical examination of signs or symptoms of anemia.
It is necessary to take appropriate measures in the case of signs of anemia. If the signs and clinical symptoms are suitable for liver disease or developing kidney disease, there is a systemic manifestation (for example, leukemia, rash, ...) or if the abnormal or more abnormal liver test is severe, it is advisable to stop Etodolac.
The ability to drive and operate machinery
Experience shows that the treatment does not affect the ability to drive or use the patient's machines. However, some adverse reactions such as dizziness, rare headaches can still occur; Hence can affect the ability to drive or operate machinery.
During pregnancy
Similar to other NSAIDs, Etodolac should be avoided in the last three months of pregnancy, as it can cause early fetal artery.
The period of breastfeeding
It is not known whether Etodolac will be excreted in breast milk or not. Because there are many drugs excreted through breast milk and because of the potential serious side effects in infant breastfeeding are using Etodolac, deciding to stop breastfeeding or stopping the drug to the importance of the mother.
Drug interaction
ACE inhibitors
Reports that NSAID can reduce the hypotension effect of ACE enzyme inhibitors. This interaction should be considered in patients using NSAID simultaneously with ACE inhibitors.
antacids
Simultaneous treatment with antacids has no significant impact on Etodolac's absorption. However, antacids can reduce the peak concentration of about 15% to 20% but do not affect the peak time.
aspirin
When Etodolac is treated with aspirin, linking to Etodolac's protein is reduced, although free Etodolac clearance is not changed. The clinical significance of this interaction is not known, however, similar to other NSAIDs, Etodolac simultaneous treatment with aspirin is often not recommended due to the increased potential of side effects.
cyclosporin, digoxin, methotrexate
Etodolac, similar to other NSAIDs, through the effects on kidney prostaglandin, can cause changes in removing the above drugs leading to an increase in serum levels of cyclosporin, digoxin, methotrexate and cause increased toxicity. Kidney toxicity related to cyclosporin may also be increased.
Patients who are receiving these drugs are used for Etodolac or any other NSAIDs and especially in patients with renal function, which should be monitored the development of the specific toxicity of each drug. There have been reports on competitive NSAID inhibitors, causing methotrexate accumulation in thin slices of rabbit kidneys. This shows that there is an increase in toxicity of methotrexate. Should be cautious when NSAID is used simultaneously with methotrexat.
Diuretics
Etodolac does not have clear pharmacokinetic interactions when used with Furosemid, hydrochlorothiazid. However, clinical studies as well as observations after bringing the drug to the market have shown that Etodolac can reduce the effect of excreting sodium sodium of Furosemid and Thiazid in some patients. This reaction is thought to be due to the synthesis of kidney prostaglandin. During the same treatment process with NSAID drugs, patients need to be closely monitored by signs of renal failure, as well as to ensure the effectiveness of diuretics.
glybid
Etodolac does not have a clear pharmacokinetic interaction when used with Glybid.
lithium
NSAIDs have caused an increase in lithium concentration in plasma and reducing lithium kidney clearance. The average minimum concentration of lithium increased by 15% and the renal clearance decreased by about 20%. These effects occur due to the synthesis of kidney prostaglandin synthesis by NSAID. Therefore, when used simultaneously with NSAID, the subjects need to be carefully monitored the signs of lithium poisoning.
phenylbutazon
phenylbutazon causes increased (about 80%) of free Etodolac. Although In Vivo studies do not indicate how Etodolac clearance is changed when used with phenylbutazon, it is still recommended to not be shared.
phenytoin
Etodolac has no clear pharmacokinetic interaction when used with phenytoin.
warfarin
The digestive bleeding effects of Warfarin and NSAIDs are the bronze, so when the user is because both of these drugs will have a higher risk of gastrointestinal bleeding than the user of either of the above drugs. Short -term pharmacokinetic research has shown that simultaneous use of Warfarin and Etodolac gives the results of reducing warfarin protein bonds, but does not change the free warfarin clearance.
There is no significant difference in the pharmaceutical effect of Warfarin used single -rise compared to Warfarin used in combination with Etodolac and is measured by prothrombin time. Thus, simultaneous treatment of warfarin with Etodolac does not need to adjust the dosage of both drugs. However, it is necessary to use caution because there have been a few spontaneous reports on prolongrombin time, with or without bleeding in patients treated with Warfarin therapy used simultaneously with Etodolac.
Interactive drugs in laboratory tests
The patient's urine using Etodolac may give a false positive reaction to the urinary bilirubin test (urobilin) due to the presence of Etodolac phenolic metabolites.Dipstick diagnostic method, used to detect ketone in urine, leading to false positive results in some patients treated with Etodolac. In general, this phenomenon is not related to other clinical events.
There is no relationship of the observed dosage.
Etodolac treatment is associated with slight decline in serum uric acid levels. In clinical trials, an average decrease from 1 to 2 mg/dl was observed in patients with arthritis that received Etodolac (dose of 600 mg to 1000 mg/day) after 4 weeks of treatment. These levels are still stable until 1 year of treatment.
Storage
In the dry place, the temperature does not exceed 30 ° C. Avoid light.
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