Active Substance: Oestrogens (conjugated).
Overview
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This medicine contains an important and useful components, as it consists of
Oestrogens (conjugated)is available in the market in concentration
Aceclofenac
- **Gastrointestinal Risk**: Aceclofenac, like other non-steroidal anti-inflammatory drugs (NSAIDs), can cause gastrointestinal issues such as ulcers, bleeding, or perforation, particularly with long-term use. Patients with a history of peptic ulcers or gastrointestinal bleeding should be closely monitored. - **Cardiovascular Risk**: Prolonged use of aceclofenac has been associated with an increased risk of cardiovascular events such as heart attack, stroke, and hypertension, especially in high doses or in patients with existing cardiovascular conditions. - **Renal Impairment**: Aceclofenac may cause renal dysfunction, particularly in patients with pre-existing kidney disease. It should be used with caution in individuals with renal impairment, and renal function should be monitored regularly. - **Liver Dysfunction**: Liver function should be monitored during aceclofenac treatment, especially if the patient has a history of liver disease. Elevated liver enzymes or hepatotoxicity can occur. - **Pregnancy and Breastfeeding**: Aceclofenac is contraindicated in pregnancy, particularly during the third trimester, due to the risk of fetal harm. Its safety during breastfeeding has not been established, and it should be avoided unless absolutely necessary. - **Asthma and Allergies**: Aceclofenac should be used with caution in patients with asthma, rhinitis, or other allergic conditions, as NSAIDs may exacerbate these conditions. - **Elderly Population**: Older adults are more prone to the side effects of aceclofenac, such as gastrointestinal bleeding and renal toxicity. Doses should be carefully adjusted, and close monitoring is recommended. - **Discontinuation for Side Effects**: If signs of gastrointestinal bleeding (e.g., black stools, abdominal pain), severe allergic reactions (e.g., rash, difficulty breathing), or signs of liver or kidney dysfunction (e.g., jaundice, dark urine) occur, discontinuation of the drug should be considered.
- **Pain Relief**: Aceclofenac is indicated for the relief of acute and chronic pain conditions, such as osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. - **Musculoskeletal Disorders**: It is used to alleviate pain, swelling, and stiffness in conditions like sprains, strains, and other soft tissue injuries. - **Inflammatory Conditions**: Aceclofenac is effective in managing inflammation and pain in various inflammatory conditions, including arthritis and spondylitis. - **Dysmenorrhea**: Aceclofenac may also be used to relieve pain associated with dysmenorrhea (painful menstruation). - **Postoperative Pain**: It is occasionally used to manage pain following surgery, particularly in orthopedic or dental procedures. - **Off-Label Uses**: In some cases, aceclofenac may be prescribed off-label for the treatment of conditions such as tendinitis or bursitis, based on clinical judgment.
- **Hypersensitivity to Aceclofenac or NSAIDs**: Aceclofenac is contraindicated in patients with a known hypersensitivity to the drug or any NSAIDs, including those who have had an allergic reaction to aspirin or other anti-inflammatory agents. - **Gastrointestinal Disorders**: It is contraindicated in patients with active gastrointestinal bleeding, peptic ulcer disease, or a history of recurrent gastrointestinal ulcers, as it may worsen these conditions. - **Severe Renal Impairment**: Aceclofenac is contraindicated in patients with severe renal impairment (e.g., creatinine clearance less than 30 mL/min), as the drug may further damage kidney function. - **Severe Hepatic Impairment**: It should not be used in patients with severe liver disease or active liver failure due to the risk of liver toxicity. - **Pregnancy**: Aceclofenac is contraindicated in pregnancy, especially in the third trimester, as it can cause fetal harm, including premature closure of the ductus arteriosus. - **Breastfeeding**: While the drug is not well studied in breastfeeding women, it is typically avoided due to the lack of safety data. - **Asthma or Allergic Rhinitis**: Aceclofenac should be avoided in patients with asthma or allergic rhinitis due to the potential for exacerbating these conditions. - **Perioperative Pain in CABG Surgery**: Aceclofenac should not be used for pain management after coronary artery bypass graft surgery due to an increased risk of cardiovascular events.
- **Common Side Effects**: - Gastrointestinal symptoms, including nausea, vomiting, dyspepsia (indigestion), abdominal pain, bloating, and flatulence. - Headache and dizziness. - Skin rash or pruritus (itching). - **Serious Side Effects**: - **Gastrointestinal Bleeding or Ulcers**: Aceclofenac can cause gastrointestinal bleeding, ulceration, or perforation, especially with long-term use. - **Cardiovascular Risk**: Long-term use of aceclofenac can increase the risk of cardiovascular events like heart attack and stroke. - **Renal Toxicity**: Aceclofenac can lead to kidney dysfunction, including acute renal failure or interstitial nephritis, particularly in patients with pre-existing renal conditions. - **Liver Damage**: Elevated liver enzymes or hepatotoxicity may occur, requiring regular liver function monitoring. - **Allergic Reactions**: Rare but severe allergic reactions, including anaphylaxis, may occur. - **Blood Disorders**: Blood-related side effects such as thrombocytopenia, anemia, or leukopenia may rarely occur. - **Long-term Use**: Prolonged use of aceclofenac increases the risk of adverse effects, particularly gastrointestinal and renal complications.
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- **COX Inhibition**: Aceclofenac works by inhibiting the cyclooxygenase (COX) enzymes, COX-1 and COX-2, which are involved in the production of prostaglandins—chemicals that mediate inflammation, pain, and fever. - **Anti-inflammatory and Analgesic Effect**: By inhibiting COX-2, aceclofenac reduces the production of inflammatory prostaglandins, leading to decreased inflammation and pain. - **Antipyretic Effect**: Aceclofenac can reduce fever by inhibiting the production of prostaglandins in the hypothalamus, which regulates body temperature. - **Localized Effect**: While aceclofenac is a systemic drug, its effect on inflammation is mainly seen in the tissues where it is needed, such as the joints or muscles. - **Reduced Side Effects**: While aceclofenac is a potent NSAID, it is often considered to have a slightly more favorable gastrointestinal safety profile compared to other NSAIDs, although gastrointestinal risks remain significant with long-term use.
- **Anticoagulants and Antiplatelet Agents**: Concomitant use of aceclofenac with blood thinners, such as warfarin or aspirin, may increase the risk of bleeding. Close monitoring of coagulation parameters is recommended. - **Other NSAIDs**: Combining aceclofenac with other NSAIDs or corticosteroids can increase the risk of gastrointestinal ulceration, bleeding, and renal toxicity. Dual therapy with NSAIDs should be avoided unless advised by a healthcare provider. - **Antihypertensive Drugs**: NSAIDs like aceclofenac may reduce the effectiveness of antihypertensive medications, such as ACE inhibitors, diuretics, and angiotensin receptor blockers. Blood pressure should be closely monitored during concurrent use. - **Lithium**: Aceclofenac may increase the serum concentration of lithium, potentially leading to lithium toxicity. Regular monitoring of lithium levels is essential. - **Diuretics**: The use of diuretics with aceclofenac may increase the risk of renal impairment, especially in patients with pre-existing kidney conditions. - **Methotrexate**: Combining aceclofenac with methotrexate may increase the toxicity of methotrexate, particularly at higher doses. Close monitoring is advised when these drugs are used together. - **Cyclosporine**: Co-administration of aceclofenac with cyclosporine may increase the risk of kidney damage. Renal function should be carefully monitored in such cases. - **Digoxin**: NSAIDs may increase digoxin levels, leading to an increased risk of digoxin toxicity. Digoxin levels should be monitored when used together.
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- **Osteoarthritis and Rheumatoid Arthritis**: The usual starting dose is 100 mg twice daily (morning and evening), with or without food. - **Acute Pain**: For acute conditions like soft tissue injuries or postoperative pain, the recommended dose is typically 100 mg twice a day. - **Ankylosing Spondylitis**: The standard dose is 100 mg twice daily. - **Dysmenorrhea**: Aceclofenac may be used at a dose of 100 mg twice daily to alleviate menstrual pain. - **Maximum Dose**: The maximum recommended dose is 200 mg per day, divided into two doses. - **Administration**: Aceclofenac should be taken orally with food or milk to minimize gastrointestinal irritation. - **Renal and Hepatic Adjustment**: Dose adjustments may be necessary for patients with renal or hepatic impairment, and it should be used with caution in these patients.
- **Not Recommended for Children**: Aceclofenac is generally not recommended for use in children under 18 years due to limited safety data. - **Special Cases**: If prescribed to children, the dose will be determined based on the child’s age, weight, and condition, with careful consideration given to potential risks and side effects.
- **Mild to Moderate Renal Impairment**: In patients with mild to moderate renal impairment (creatinine clearance between 30-50 mL/min), the usual dose of aceclofenac may be used, but close monitoring is recommended. - **Severe Renal Impairment**: Aceclofenac is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), as the drug may exacerbate renal dysfunction. - **Dialysis**: Due to the potential for accumulation in patients with renal dysfunction, dialysis patients should avoid aceclofenac, or its use should be closely monitored.
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