Aceclocopa 100 mg 20 F.C.

 

**Important Disclaimer:** This summary is for educational and informational purposes only and should not, under any circumstances, replace direct consultation with a qualified physician or pharmacist. Always refer to the product's internal leaflet or consult a healthcare professional before use.

**Drug Name:** Aceclocopa 100 mg 20 F.C. tab.

**Manufacturer:**

Aceclocopa 100 mg 20 F.C. tab. is manufactured by **Copad Pharma**.

**Introduction:**

Aceclocopa 100 mg 20 F.C. tab. contains Aceclofenac, which is a non-steroidal anti-inflammatory drug (NSAID). It is primarily used for its analgesic (pain-relieving) and anti-inflammatory properties. This medication helps to reduce pain, swelling, and inflammation associated with various musculoskeletal and joint conditions.

**Indications and Usage:**

Aceclofenac is indicated for the treatment of various painful and inflammatory conditions, including:

* **Osteoarthritis:** A degenerative joint disease causing pain and stiffness.

* **Rheumatoid Arthritis:** A chronic inflammatory disorder affecting joints.

* **Ankylosing Spondylitis:** A chronic inflammatory disease primarily affecting the spine.

* **Other painful conditions:** Such as dental pain, post-operative pain, and soft tissue rheumatic disorders.

**Characteristics:**

Aceclofenac is an NSAID that works by inhibiting the activity of cyclooxygenase (COX) enzymes, specifically COX-2, which are involved in the synthesis of prostaglandins. Prostaglandins are chemicals in the body that contribute to pain, inflammation, and fever. By reducing prostaglandin production, Aceclofenac helps to alleviate these symptoms. It is known for its good tolerability profile compared to some other NSAIDs.

**Dosage and Administration:**

Aceclocopa 100 mg is administered orally as film-coated tablets.

* **Form:** Film-coated tablets, 100 mg.

* **Recommended Use:** The usual recommended dose for adults is 100 mg twice daily (one tablet in the morning and one in the evening).

* **Administration Method:** Tablets should be swallowed whole with a sufficient amount of liquid, preferably with or after food to minimize gastrointestinal discomfort.

* **Frequency:** Doses should be taken at regular intervals, as prescribed by the physician.

* **Important Note:** Do not exceed the recommended daily dose of 200 mg. The duration of treatment should be as short as possible and based on the patient's clinical response.

**Contraindications:**

Aceclofenac should not be used in individuals with the following conditions:

* Hypersensitivity to Aceclofenac or any other NSAID (e.g., aspirin, ibuprofen) or to any of the excipients.

* Patients who have experienced asthma, urticaria, or acute rhinitis after taking aspirin or other NSAIDs.

* Active or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).

* History of gastrointestinal bleeding or perforation related to previous NSAID therapy.

* Severe heart failure, severe hepatic impairment, or severe renal impairment.

* Third trimester of pregnancy.

* Established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease.

**Warnings and Precautions:**

* **Gastrointestinal Effects:** NSAIDs can cause serious gastrointestinal adverse events including bleeding, ulceration, and perforation, which can be fatal. These events can occur at any time during treatment without warning symptoms. Caution is advised in patients with a history of GI disease.

* **Cardiovascular Risk:** NSAIDs, including Aceclofenac, may be associated with a small increased risk of serious cardiovascular thrombotic events (e.g., myocardial infarction, stroke), particularly at high doses and with long-term use.

* **Renal Effects:** Caution is advised in patients with impaired renal function, as NSAIDs can cause dose-dependent reduction in prostaglandin formation, leading to renal decompensation.

* **Hepatic Effects:** Liver function should be monitored, especially in patients with pre-existing hepatic impairment.

* **Fluid Retention and Edema:** Caution is advised in patients with a history of hypertension and/or mild to moderate congestive heart failure, as fluid retention and edema have been reported.

* **Respiratory Disorders:** Use with caution in patients suffering from bronchial asthma or a history of it, as NSAIDs can precipitate bronchospasm.

* **Skin Reactions:** Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported. Discontinue at the first appearance of skin rash or any other sign of hypersensitivity.

* **Elderly Patients:** Elderly patients are at increased risk of adverse reactions, especially gastrointestinal bleeding and perforation.

* **Lupus Erythematosus and Mixed Connective Tissue Disease:** Increased risk of aseptic meningitis.

**Nutrient Absorption and Metabolism (Pharmacokinetics):**

* **Absorption:** Aceclofenac is rapidly and completely absorbed after oral administration. Peak plasma concentrations are reached approximately 1.25 to 3 hours after ingestion.

* **Distribution:** It is highly protein-bound (>99.7%). Aceclofenac penetrates into the synovial fluid, where concentrations may reach approximately 60% of those in plasma.

* **Metabolism:** Aceclofenac is metabolized extensively in the liver, primarily by cytochrome P450 2C9 (CYP2C9), to its main metabolite, 4'-hydroxyaceclofenac, and other metabolites.

* **Elimination:** The mean plasma elimination half-life is approximately 4 hours. Approximately two-thirds of the administered dose is excreted in the urine, mainly as hydroxylated metabolites, and one-third in the faeces.

**Side Effects:**

Common side effects associated with Aceclofenac include:

* Gastrointestinal disturbances: Dyspepsia, abdominal pain, nausea, diarrhea.

* Dizziness.

* Elevated liver enzymes (transaminases).

Less common or serious side effects can include:

* Gastrointestinal ulceration, bleeding, or perforation.

* Headache.

* Rash, pruritus (itching).

* Edema (swelling).

* Hypertension (high blood pressure).

* Renal impairment.

* Anemia.

* Hypersensitivity reactions (e.g., anaphylaxis, angioedema).

* Cardiac events (e.g., myocardial infarction, stroke) - rare but serious.

**Drug Interactions:**

Aceclofenac may interact with several other medications:

* **Lithium and Digoxin:** May increase plasma levels of these drugs.

* **Diuretics and Antihypertensives (e.g., ACE inhibitors, Angiotensin II antagonists, Beta-blockers):** NSAIDs can reduce the effect of these drugs.

* **Anticoagulants (e.g., Warfarin):** Increased risk of bleeding.

* **Antiplatelet agents (e.g., Aspirin, Clopidogrel) and Selective Serotonin Reuptake Inhibitors (SSRIs):** Increased risk of gastrointestinal bleeding.

* **Corticosteroids:** Increased risk of gastrointestinal ulceration or bleeding.

* **Other NSAIDs (including COX-2 inhibitors):** Concomitant use should be avoided due to increased risk of adverse effects.

* **Methotrexate:** NSAIDs can increase plasma levels of methotrexate, leading to increased toxicity.

* **Cyclosporine and Tacrolimus:** Increased risk of nephrotoxicity.

* **Mifepristone:** NSAIDs should not be used for 8-12 days after mifepristone administration as they can reduce its effect.

* **Quinolone Antibiotics:** Increased risk of convulsions.

**Patient Counseling:**

* Take Aceclocopa exactly as prescribed by your doctor, preferably with or after food.

* Do not exceed the recommended dose or duration of treatment.

* Report any signs of gastrointestinal bleeding (e.g., black, tarry stools, vomiting blood) or severe stomach pain immediately to your doctor.

* Be aware of potential cardiovascular risks, especially if you have pre-existing heart conditions.

* Inform your doctor about all other medications, supplements, and herbal products you are taking to avoid potential drug interactions.

* Do not take other NSAIDs or aspirin concurrently without consulting your doctor.

* If you experience any skin rash, swelling, difficulty breathing, or other signs of an allergic reaction, stop taking the medication and seek immediate medical attention.

* Avoid alcohol consumption while on this medication, as it may increase the risk of gastrointestinal side effects.

* Store the medication according to the instructions on the packaging, typically below 30°C and protected from moisture.

**Sources:**

* [Link to a reliable pharmaceutical database for Aceclofenac, e.g., Drugs.com, RxList, or a national drug regulatory agency]

* [Link to a reputable medical information site, e.g., WebMD, Mayo Clinic, for Aceclofenac]

* [Link to Copad Pharma's official website or product page for Aceclocopa, if available]