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| Trade names | Hifenac, Clanza CR, Preservex, others[1] |
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| Routes of administration | By mouth,topical |
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| ECHA InfoCard | 100.169.686 |
| Chemical and physical data | |
| Formula | C16H13Cl2NO4 |
| Molar mass | 354.18 g·mol−1 |
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Aceclofenac is anonsteroidal anti-inflammatory drug (NSAID) analog ofdiclofenac. It is used for the relief of pain and inflammation inrheumatoid arthritis,osteoarthritis andankylosing spondylitis.
It was patented in 1983 and approved for medical use in 1992.[4]
Aceclofenac should not be given to people withporphyria or breast-feeding mothers, and is not recommended for children. It should be avoided near term in a pregnant woman because of the risk of having a premature closure of ductus arteriosus leading tofetal hydrops in the neonate.
Aceclofenac (C16H13Cl2NO4), chemically [(2-{2, 6-dichlorophenyl) amino} phenylacetooxyacetic acid], is a crystalline powder with a molecular weight of 354.19. It is practically insoluble in water with good permeability. It is metabolized in human hepatocytes and human microsomes to form [2-(2',6'-dichloro-4'-hydroxy- phenylamino) phenyl] acetoxyacetic acid as the major metabolite, which is then further conjugated. According to the Biopharmaceutical Classification System (BCS) drug substances are classified to four classes upon their solubility and permeability. Aceclofenac falls under the BCS Class II, poorly soluble and highly permeable drug.[5]
Aceclofenac works by inhibiting the action of cyclooxygenase (COX) that is involved in the production of prostaglandins (PG) which is accountable for pain, swelling, inflammation and fever. The incidence of gastric ulcerogenicity of aceclofenac has been reported to be significantly lower than that of the other frequently prescribed NSAIDs, for instance, 2-fold less than naproxen, 4-fold less thandiclofenac, and 7-fold less thanindomethacin.[5]
Aceclofenac is available inHungary as aprescription only medicine. The cost of the drug is low, around US$0.14 per 100 mg tablet (as of 2019[update]). InUAE, the cost of the drug is about US$0.61 per 100 mg tablet (as of 2025[update]).
Aceclofenac is available in Europe,CIS countries, Asia and the Middle East. Known trades names include: Acecgen (Generics UK), Aflamin, Airtal/Biofenac (Gedeon Richter Plc.), AklofEP (ExtractumPharma), Flemac (Aramis Pharma), Hifenac-P (Intas Pharmaceuticals, India) and Aceflam (Julphar, UAE).
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| acetic acid derivatives and related substances | |
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| propionic acid derivatives (profens) |
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| n-arylanthranilic acids (fenamates) | |
| COX-2 inhibitors (coxibs) | |
| other | |
| NSAID combinations | |
Key:underline indicates initially developed first-in-class compound of specific group;#WHO-Essential Medicines;†withdrawn drugs;‡veterinary use. | |
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