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: Aceliofinaz 100 mg F.C. tab.
Manufacturer:
Aceliofinaz 100 mg F.C. tab. is manufactured by **AUG → People Pharma**, Egypt. [1]
Introduction:
Aceliofinaz contains **aceclofenac 100 mg**, an acetic acid–derived non-steroidal anti-inflammatory drug (NSAID) closely related to diclofenac. It provides effective relief from pain, inflammation, and fever, with a slightly improved gastrointestinal tolerability profile compared to some older NSAIDs. [2, 3]
Indications and Usage:
Aceliofinaz is indicated for the symptomatic relief of:
* **Osteoarthritis:** A degenerative joint disease causing pain and stiffness. [2]
* **Rheumatoid Arthritis:** A chronic inflammatory disorder affecting joints. [2]
* **Ankylosing Spondylitis:** A chronic inflammatory disease primarily affecting the spine. [2]
* **Acute lower back pain, cervical pain.** [2]
* **Soft tissue and post-traumatic pain:** Such as sprains and strains. [2]
* **Dental pain.** [2]
* **Dysmenorrhea.** [2]
* **Acute gout attacks.** [2]
Characteristics:
* **Dosage Form:** Film-coated tablet. [1, 2]
* **Strength:** 100 mg aceclofenac per tablet. [1, 2]
* **Drug Class:** NSAID (acetic acid derivative). [2, 3]
* **Mechanism of Action:** Aceclofenac inhibits cyclooxygenase (COX-1 and COX-2) enzymes, thereby reducing prostaglandin synthesis. This action results in its analgesic (pain-relieving), anti-inflammatory, and antipyretic (fever-reducing) effects. [2, 3]
Dosage and Administration:
Aceliofinaz 100 mg is administered orally as film-coated tablets.
* **Adults:** The usual recommended dose is 100 mg twice daily (every 12 hours). [2]
* **Administration Method:** Tablets should be swallowed whole with a sufficient amount of liquid, preferably with or after meals to reduce gastrointestinal irritation. [2]
* **Typical Course:** As prescribed by a healthcare provider; often 5–14 days depending on the condition's severity. [2]
* **Elderly:** Use the lowest effective dose for the shortest duration; monitor closely for adverse events. [2]
* **Children:** Not recommended in children due to limited data. [2]
* **Important Note:** Do not exceed the recommended daily dose of 200 mg. [2]
Contraindications:
Aceclofenac should not be used in individuals with the following conditions:
* Hypersensitivity to aceclofenac, diclofenac, other NSAIDs, or any of the excipients. [2]
* Active gastrointestinal ulceration, bleeding, or perforation, or a history of recurrent peptic ulcer/hemorrhage. [2]
* History of gastrointestinal bleeding or perforation related to previous NSAID therapy. [2]
* Severe renal or hepatic impairment. [2]
* Congestive heart failure, established ischemic heart disease, peripheral arterial disease, and/or cerebrovascular disease. [2]
* Pregnancy in the third trimester and during breastfeeding. [2]
* History of NSAID-induced asthma, urticaria, or acute rhinitis/allergic reactions. [2]
Warnings and Precautions:
* **General:** Use the lowest effective dose for the shortest duration to minimize risks. [2]
* **Gastrointestinal (GI):** NSAIDs can cause serious GI adverse events including ulcers, bleeding, and perforation, which can be fatal. This risk is higher in elderly patients or those with a history of ulcers. [2]
* **Cardiovascular (CV):** May increase the risk of serious cardiovascular thrombotic events (e.g., myocardial infarction, stroke), particularly with long-term use or high doses. [2]
* **Renal:** Monitor kidney function in dehydrated or renal-impaired patients, as NSAIDs can cause dose-dependent reduction in prostaglandin formation, leading to renal decompensation. [2]
* **Hepatic:** Monitor liver enzymes; discontinue if significant elevation or liver symptoms occur. [2]
* **Respiratory Disorders:** Use with caution in patients suffering from bronchial asthma or a history of it, as NSAIDs can precipitate bronchospasm. [2]
* **Skin Reactions:** Rare but serious skin reactions (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis) have been reported; discontinue at first sign of rash or hypersensitivity. [2]
* **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. [2]
* **Lupus Erythematosus and Mixed Connective Tissue Disease:** Increased risk of aseptic meningitis. [2]
Pharmacokinetics:
* **Absorption:** Aceclofenac is rapidly and completely absorbed after oral administration. Peak plasma concentrations are reached approximately 1.25 to 3 hours after ingestion. Food may slow the rate but not the extent of absorption. [2, 3]
* **Distribution:** It is highly protein-bound (>99.7%). Aceclofenac penetrates into the synovial fluid, where concentrations may reach approximately 57-60% of those in plasma. [2, 3]
* **Metabolism:** Aceclofenac is metabolized extensively in the liver, primarily via cytochrome P450 2C9 (CYP2C9), to its main metabolite, 4'-hydroxyaceclofenac, and other metabolites. [2, 3]
* **Elimination:** The mean plasma elimination half-life is approximately 4 to 4.3 hours. Approximately two-thirds of the administered dose is excreted in the urine, mainly as hydroxymetabolites, and one-third in the faeces. [2, 3]
Side Effects:
* **Common:** Dyspepsia, abdominal pain, nausea, diarrhea, headache, dizziness. [2]
* **Less Common / Serious:** Gastrointestinal ulceration, bleeding, or perforation; hepatic impairment; renal dysfunction; allergic reactions; cardiovascular events (e.g., myocardial infarction, stroke); and rare severe skin reactions. Other less common effects include rash, pruritus (itching), edema (swelling), hypertension, and anemia. [2]
Drug Interactions:
Aceclofenac may interact with several other medications:
* **Lithium, Digoxin, Methotrexate:** May increase serum levels of these drugs; monitor closely. [2]
* **Anticoagulants (e.g., Warfarin):** Increased risk of bleeding. [2]
* **Antiplatelet agents (e.g., Aspirin, Clopidogrel) and Selective Serotonin Reuptake Inhibitors (SSRIs):** Increased risk of gastrointestinal bleeding. [2]
* **Corticosteroids:** Increased risk of gastrointestinal ulceration or bleeding. [2]
* **Diuretics, ACE inhibitors, ARBs:** May reduce their antihypertensive effect; increased risk of renal impairment. [2]
* **Cyclosporine:** Increased risk of nephrotoxicity. [2]
* **Quinolone Antibiotics:** May precipitate convulsions. [2]
* **Potassium-sparing diuretics:** Monitor potassium levels. [2]
* **Alcohol, other NSAIDs:** Increased risk of gastrointestinal toxicity. [2]
* **Mifepristone:** NSAIDs should not be used for 8-12 days after mifepristone administration as they can reduce its effect. [2]
Patient Counseling:
* Take Aceliofinaz with food and a full glass of water to reduce gastrointestinal irritation. [2]
* Do not exceed the prescribed dose, typically two tablets (200 mg) daily. [2]
* Report any signs of gastrointestinal bleeding (e.g., black, tarry stools, severe abdominal pain), liver issues (e.g., jaundice, dark urine), or shortness of breath immediately to your doctor. [2]
* Avoid alcohol consumption while on this medication, as it may increase the risk of stomach bleeding. [2]
* Monitor blood pressure, kidney, and liver function if using long-term, as advised by your doctor. [2]
* Keep out of children’s reach; store below 30 °C in original packaging, protected from moisture. [2]
Sources:
* دواء دوت اورج - ACELIOFINAZ 100 MG 20 F.C. TAB: https://dw2.org/drug/aceliofinaz-100-mg-20-f-c-tab [1]
* emc - Aceclofenac 100 mg Film-coated Tablets - Summary of Product Characteristics (SmPC): https://www.medicines.org.uk/emc/product/2389/smpc [2]
* DrugBank Online - Aceclofenac: https://go.drugbank.com/drugs/DB06736 [3]
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