Active Substance: Sodium hyaluronate , L Proline , Glycine , L Lysine monohydrochloride , L Leucine.
Overview
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This medicine contains an important and useful components, as it consists of
Sodium hyaluronate , L Proline , Glycine , L Lysine monohydrochloride , L Leucineis available in the market in concentration
Etodolac
Etodolac, a nonsteroidal anti-inflammatory drug (NSAID), requires specific precautions to ensure safe use, especially in patients with certain health conditions or special populations: - **Pregnancy and breastfeeding**: Etodolac is classified as a Category C drug in pregnancy during the first and second trimesters, meaning its use should be considered only if the potential benefits outweigh the risks. During the third trimester, it is contraindicated due to the risk of premature closure of the ductus arteriosus and other complications for the fetus. Etodolac is excreted in breast milk, so its use during breastfeeding should be avoided unless absolutely necessary. - **Cardiovascular risks**: Etodolac can increase the risk of serious cardiovascular events such as myocardial infarction, stroke, and thrombotic events, especially with prolonged use or in patients with existing cardiovascular risk factors. It should be used with caution in patients with hypertension, heart failure, or a history of cardiovascular disease. - **Gastrointestinal issues**: As with all NSAIDs, Etodolac can cause gastrointestinal irritation, bleeding, or ulceration. It should be used cautiously in individuals with a history of gastrointestinal ulcers, bleeding disorders, or inflammatory bowel disease. The risk of serious gastrointestinal adverse effects may be increased when taken in high doses or over prolonged periods. - **Renal function**: Etodolac can impair renal function, especially in patients with pre-existing kidney disease. Monitoring renal function is recommended in patients who are elderly, dehydrated, or taking other medications that affect renal function. - **Hematological and hepatic monitoring**: Etodolac may cause hematological changes, such as thrombocytopenia or leukopenia, and liver enzyme abnormalities. Regular blood tests should be considered for long-term users to monitor these effects. - **Elderly patients**: Older adults are more likely to experience adverse effects from Etodolac, including gastrointestinal bleeding, renal impairment, and cardiovascular events. Dosing adjustments or close monitoring may be required.
Etodolac is indicated for the treatment of various conditions related to inflammation and pain, primarily: - **Osteoarthritis and rheumatoid arthritis**: Etodolac is used to manage pain and inflammation in conditions such as osteoarthritis and rheumatoid arthritis. It works by inhibiting cyclooxygenase (COX), enzymes involved in the production of prostaglandins that mediate pain and inflammation. - **Acute pain management**: It is also indicated for the relief of moderate to severe pain, such as in postoperative recovery or musculoskeletal injuries. - **Other off-label uses**: Etodolac is sometimes used off-label for other inflammatory conditions, including gout attacks and ankylosing spondylitis, though it is not typically the first-line choice for these conditions.
There are several contraindications for the use of Etodolac: - **Hypersensitivity**: Patients with a known hypersensitivity to Etodolac or other NSAIDs (including aspirin) should avoid the drug due to the risk of severe allergic reactions, including anaphylaxis or severe skin reactions like Stevens-Johnson syndrome. - **Active gastrointestinal bleeding or ulceration**: Etodolac should not be used in patients with active peptic ulcers or gastrointestinal bleeding, as NSAIDs are known to increase the risk of bleeding or ulcer formation. - **Severe renal impairment**: Etodolac is contraindicated in patients with severe renal insufficiency or those at risk of acute renal failure, as the drug can exacerbate renal dysfunction. - **Severe liver disease**: Patients with severe hepatic impairment should avoid using Etodolac, as the liver metabolizes the drug, and dysfunction may result in increased drug toxicity. - **Third-trimester pregnancy**: Etodolac is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the ductus arteriosus, a serious fetal cardiovascular condition.
Common side effects of Etodolac can vary in severity: - **Gastrointestinal effects**: The most common side effects include nausea, dyspepsia, abdominal pain, and diarrhea. More serious gastrointestinal issues include peptic ulcers, gastrointestinal bleeding, and perforation, especially with long-term use. - **Cardiovascular effects**: Prolonged use of Etodolac may increase the risk of heart attack, stroke, or other cardiovascular events, especially in patients with pre-existing cardiovascular risk factors. - **Renal effects**: Etodolac can cause renal impairment, particularly in patients with pre-existing kidney disease or those who are dehydrated. Symptoms of renal dysfunction can include reduced urine output, fluid retention, or swelling. - **Hematological effects**: Rarely, Etodolac may cause blood-related side effects like thrombocytopenia (low platelet count), leukopenia (low white blood cell count), or anemia. Blood counts should be monitored during prolonged therapy. - **Central nervous system effects**: Dizziness, headache, and drowsiness are possible CNS side effects, especially during the initial stages of treatment or with higher doses. - **Allergic reactions**: Allergic reactions to Etodolac can range from mild rashes to severe anaphylaxis. Rare but serious side effects include Stevens-Johnson syndrome or toxic epidermal necrolysis.
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Etodolac is a selective COX-2 inhibitor, a subtype of cyclooxygenase enzyme responsible for the production of prostaglandins that mediate inflammation, pain, and fever. By inhibiting COX-2, Etodolac reduces the formation of these inflammatory mediators, thereby alleviating pain and inflammation. - **Pharmacodynamics**: Etodolac is primarily effective in treating conditions like osteoarthritis, rheumatoid arthritis, and acute pain because it specifically targets the inflammatory pathways while preserving the gastric mucosal protection provided by COX-1. The selective inhibition of COX-2 is considered to reduce the risk of gastrointestinal side effects that are typically associated with non-selective NSAIDs. - **Pharmacokinetics**: Etodolac is well absorbed orally, with peak plasma concentrations occurring within 1-2 hours of administration. It has a half-life of approximately 6-9 hours, allowing for twice-daily dosing. The drug is extensively metabolized in the liver and excreted mainly in the urine.
Etodolac can interact with several drugs and substances that may alter its effectiveness or safety: - **Anticoagulants**: Etodolac may enhance the effects of anticoagulants like warfarin, increasing the risk of bleeding. Regular monitoring of INR levels is recommended if Etodolac is taken with anticoagulants. - **Other NSAIDs and corticosteroids**: Concurrent use of Etodolac with other NSAIDs or corticosteroids increases the risk of gastrointestinal irritation, bleeding, and ulceration. It is advised to avoid combining NSAIDs and corticosteroids. - **Antihypertensives**: Etodolac may reduce the effectiveness of antihypertensive drugs like ACE inhibitors, angiotensin receptor blockers (ARBs), or diuretics, possibly leading to worsened blood pressure control. Close monitoring of blood pressure is advised. - **Lithium**: Etodolac can elevate lithium levels in the blood, increasing the risk of lithium toxicity. Lithium levels should be closely monitored during concomitant use with Etodolac. - **Alcohol**: Combining Etodolac with alcohol may increase the risk of gastrointestinal bleeding and stomach irritation. Patients should avoid alcohol consumption during treatment.
Pregnancy category: C; D in 3rd trimester or near delivery. Avoid in late pregnancy (may cause premature closure of ductus arteriosus)
For adults, the standard dosing regimen of Etodolac varies based on the condition being treated: - **Osteoarthritis and rheumatoid arthritis**: The usual starting dose is 400 mg to 600 mg taken once or twice daily. The dose may be adjusted up to a maximum of 1,000 mg per day in divided doses depending on the patient's response and tolerance. - **Acute pain**: For the relief of acute pain, the recommended dose is typically 400 mg to 600 mg every 6-8 hours, as needed. The maximum dose should not exceed 1,000 mg per day.
Etodolac is generally not recommended for use in children under the age of 18, as safety and efficacy in pediatric patients have not been well established. If prescribed for pediatric use, appropriate dosing would be based on body weight, but this should be done under careful medical supervision due to the increased risk of side effects in this population.
In patients with renal impairment, Etodolac should be used with caution, and dose adjustments may be necessary. Patients with mild to moderate renal dysfunction may not require a dose reduction, but careful monitoring of renal function is important. In patients with severe renal impairment (creatinine clearance <30 mL/min), Etodolac should be avoided due to the potential for toxicity and accumulation.
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