REMSIMA SC 120 mg/ ml Price

Overview

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This medicine contains an important and useful components, as it consists of
Infliximabis available in the market in concentration

Name

Aceclofenac

Precaution

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) that is primarily used to relieve pain and inflammation in conditions like osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. While it is effective for managing these conditions, several precautions should be taken into consideration before starting therapy with aceclofenac: - **Gastrointestinal (GI) risk**: Like other NSAIDs, aceclofenac can cause gastrointestinal irritation, ulcers, and bleeding. The risk is heightened in individuals with a history of peptic ulcers, gastrointestinal bleeding, or those who consume alcohol regularly. Co-administration with proton pump inhibitors (PPIs) or misoprostol may be recommended to mitigate these risks, especially in long-term use. - **Cardiovascular (CV) risk**: Chronic use of NSAIDs, including aceclofenac, has been associated with an increased risk of cardiovascular events, such as heart attack and stroke. This risk may be more pronounced in individuals with pre-existing cardiovascular conditions, hypertension, or those taking other medications affecting the cardiovascular system. Close monitoring of blood pressure and heart health is necessary. - **Renal impairment**: Aceclofenac is excreted via the kidneys, and it can lead to fluid retention or kidney dysfunction, particularly in individuals with pre-existing renal disease. Renal function should be monitored during therapy, especially in elderly patients or those with risk factors for renal impairment. - **Hepatic impairment**: Caution is advised when using aceclofenac in patients with liver disorders. Liver function tests should be performed before and periodically during therapy to detect any potential hepatotoxicity, which, although rare, can occur. - **Pregnancy and breastfeeding**: Aceclofenac is contraindicated during the third trimester of pregnancy due to its potential to cause premature closure of the ductus arteriosus in the fetus. It should be used with caution in the first and second trimesters only if the potential benefit justifies the potential risk. It is also not recommended during breastfeeding, as the drug can be excreted in breast milk. - **Asthma and allergic reactions**: Aceclofenac can exacerbate asthma or cause allergic reactions in sensitive individuals, particularly in those with a history of hypersensitivity to NSAIDs or aspirin. Patients with asthma or allergies should be monitored for any signs of exacerbation during treatment.

Indication

Aceclofenac is primarily indicated for the relief of pain and inflammation associated with the following conditions: - **Osteoarthritis**: A degenerative joint disease characterized by the breakdown of cartilage in the joints. Aceclofenac can help reduce the pain and inflammation associated with this condition, improving mobility and quality of life. - **Rheumatoid arthritis**: An autoimmune disorder that causes chronic inflammation in the joints, leading to pain, swelling, and eventually joint damage. Aceclofenac can help manage the pain and inflammation in rheumatoid arthritis, aiding in symptom relief. - **Ankylosing spondylitis**: A chronic inflammatory disease affecting the spine and large joints, aceclofenac is used to manage pain, stiffness, and inflammation in patients with this condition. - **Other musculoskeletal pain**: Aceclofenac is also used for the treatment of other musculoskeletal pain conditions, including back pain, soft tissue injuries, and conditions causing inflammation and pain in muscles and ligaments. Off-label, aceclofenac may sometimes be used for acute pain management (such as after surgery or injury), but its primary role is in managing chronic inflammatory conditions. It should be noted that aceclofenac is not used as a first-line treatment for conditions like gout or acute inflammatory conditions where other NSAIDs may be preferred.

Contra indication

There are several contraindications to aceclofenac use due to the risk of serious adverse effects: - **Hypersensitivity**: Aceclofenac should not be used in patients who have a known hypersensitivity to the drug or other NSAIDs, including aspirin, as these individuals may experience severe allergic reactions such as anaphylaxis or angioedema. - **Active gastrointestinal bleeding or ulcers**: Patients with active or a history of gastrointestinal bleeding, peptic ulcers, or gastrointestinal perforation should avoid using aceclofenac, as NSAIDs can worsen these conditions by inhibiting the production of prostaglandins that protect the gastric mucosa. - **Severe renal or hepatic impairment**: Aceclofenac is contraindicated in patients with severe renal or liver dysfunction, as the drug is metabolized in the liver and excreted through the kidneys. It can exacerbate renal or hepatic problems, leading to further complications. - **Heart failure or significant cardiovascular disease**: Due to the increased risk of fluid retention and exacerbation of heart failure, aceclofenac should be avoided in patients with significant cardiovascular conditions, such as severe heart failure or coronary artery disease. - **Pregnancy (third trimester)**: Aceclofenac is contraindicated in the third trimester of pregnancy due to the risk of premature closure of the ductus arteriosus, which can lead to fetal complications. It should be used with caution in the first and second trimesters only when the benefits outweigh the potential risks. - **Asthma, rhinitis, or urticaria induced by NSAIDs**: Patients who have a history of NSAID-induced asthma, rhinitis, or urticaria should not take aceclofenac, as it can trigger exacerbations of these conditions.

Side Effect

Like all NSAIDs, aceclofenac can cause a variety of side effects, ranging from mild to severe. The side effects are typically dose-dependent and can vary from patient to patient: - **Common side effects**: - **Gastrointestinal issues**: These include nausea, dyspepsia, abdominal pain, and flatulence. Gastrointestinal upset is one of the most common side effects, especially during the initial stages of treatment. - **Headache and dizziness**: Some patients may experience headache or dizziness, particularly during the first few days of therapy. - **Rash or itching**: Mild skin reactions, such as rash or pruritus, can occur but are usually not serious. - **Serious side effects**: - **Gastrointestinal bleeding or ulceration**: Prolonged use of aceclofenac can lead to bleeding, perforation, or ulcers in the gastrointestinal tract. These are serious conditions that require immediate medical attention. - **Renal impairment**: Aceclofenac can affect kidney function, especially in patients with pre-existing kidney issues. Symptoms of renal dysfunction include fluid retention, decreased urine output, and swelling. - **Cardiovascular events**: Prolonged use of NSAIDs can increase the risk of cardiovascular events such as heart attack or stroke, particularly in individuals with pre-existing heart conditions. - **Management**: To minimize gastrointestinal side effects, aceclofenac should be taken with food. Patients should be regularly monitored for signs of bleeding or ulcers, especially if using aceclofenac long-term. If serious side effects occur, therapy should be discontinued, and the patient should seek medical attention.

Pregnancy Category ID

0

Mode of Action

Aceclofenac exerts its therapeutic effects through inhibition of the **cyclooxygenase (COX)** enzymes, primarily **COX-2**, which are responsible for the production of prostaglandins involved in inflammation and pain. By inhibiting COX-2, aceclofenac reduces the synthesis of prostaglandins, leading to decreased inflammation, pain, and fever. - **Pharmacodynamics**: Aceclofenac’s anti-inflammatory, analgesic, and antipyretic properties make it effective for managing conditions associated with inflammation and pain, such as arthritis. Unlike non-selective NSAIDs, which inhibit both COX-1 and COX-2, aceclofenac primarily targets COX-2, which is primarily involved in inflammatory processes. This selective inhibition helps reduce the gastrointestinal side effects commonly seen with non-selective NSAIDs. - **Pharmacokinetics**: Aceclofenac is rapidly absorbed after oral administration and is extensively metabolized in the liver, producing active metabolites. It has a half-life of about 4 hours, which necessitates twice-daily dosing for effective symptom control. Aceclofenac is primarily excreted in the urine.

Interaction

Aceclofenac can interact with various medications, and these interactions may influence the drug’s effectiveness or lead to adverse effects: - **Anticoagulants (warfarin)**: The concomitant use of aceclofenac with anticoagulants increases the risk of bleeding, as both aceclofenac and anticoagulants affect platelet aggregation. If combined, the patient should be closely monitored for signs of bleeding, and dose adjustments may be necessary. - **Other NSAIDs or corticosteroids**: Using aceclofenac in combination with other NSAIDs or corticosteroids can significantly increase the risk of gastrointestinal bleeding and ulcer formation. Co-administration is generally avoided. - **Antihypertensives (ACE inhibitors, diuretics)**: NSAIDs like aceclofenac can reduce the effectiveness of antihypertensive medications, particularly ACE inhibitors and diuretics, by causing fluid retention and decreasing renal blood flow. Blood pressure should be carefully monitored when using these combinations. - **Lithium**: Aceclofenac can increase plasma lithium levels, potentially leading to lithium toxicity. Regular monitoring of lithium levels is recommended when both drugs are used together. - **Methotrexate**: The co-administration of aceclofenac and methotrexate may increase the toxicity of methotrexate by inhibiting its renal clearance, leading to elevated methotrexate levels. Caution is advised when these medications are used together. - **Alcohol**: Drinking alcohol while taking aceclofenac increases the risk of gastrointestinal bleeding and ulceration. Patients should be advised to limit alcohol consumption during treatment.

Pregnancy Category Note

Information not available

Adult Dose

The usual adult dose of aceclofenac for conditions like osteoarthritis or rheumatoid arthritis is **100 mg** taken once or twice daily, depending on the severity of symptoms. For acute pain, the dose can be increased to 200 mg daily, but it is generally recommended to start with the lower dose to minimize side effects. - **Titration**: The dose can be adjusted based on the patient's response and tolerance to the drug, with a maximum daily dose of **200 mg**.

Child Dose

Aceclofenac is not recommended for use in children under the age of 18 due to insufficient safety and efficacy data. In pediatric populations, alternative therapies should be considered for pain and inflammation management.

Renal Dose

In patients with renal impairment, aceclofenac should be used with caution. For those with mild to moderate renal dysfunction, dose adjustments may be necessary, and renal function should be closely monitored. Aceclofenac is contraindicated in severe renal impairment (creatinine clearance <30 mL/min).

Administration

Information not available