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ALOFEN 100

Generic Name:                    Aceclofenac

Therapeutic Category:     Non-Steroidal Anti-inflammatory Drugs (NSAID)

Pharmacological Class:   Non-selective COX inhibitor

Composition:                      Each film-coated tablet contains Aceclofenac BP 100 mg

Pregnancy Category:        C (up to second trimester) and D (in third trimester)

Presentation:                      Available in the pack size as 10 tablets X 20 blisters

Description

Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) with marked anti-inflammatory and analgesic properties. It is reported to have a higher anti-inflammatory action or at least comparable effects than conventional NSAIDs

Mechanism of Action

Aceclofenac is a NSAID that inhibits both isoforms of Cyclooxygenase enzyme, a key enzyme involved in the inflammatory cascade. COX-1 enzyme is a constitutive enzyme involved in prostacyclin production and protective functions of gastric mucosa whereas COX-2 is an inducible enzyme involved in the production of inflammatory mediators in response to inflammatory stimuli. Aceclofenac displays more selectivity towards COX-2 than COX-1, which promotes its gastric tolerance compared to other NSAIDs. Although the mode of action of aceclofenac is thought to mainly arise from the inhibition of synthesis of prostaglandins (PGE2), aceclofenac also inhibits the production of inflammatory cytokines, interleukins (IL-1β, IL-6), and tumor necrosis factors (TNF). It is also reported that aceclofenac also affects the cell adhesion molecules from neutrophils.

Indications

Pain and inflammation in

  • Rheumatoid arthritis
  • Osteoarthritis
  • Ankylosing spondylitis*

Dosage

Route of administration: Oral

Adults (>18 years): 100 mg two times a day, in the morning and in the evening.

Safety and efficacy not established below 18 years of age.

 

 

Pharmacokinetics

Absorption: Aceclofenac is rapidly and completely absorbed from the gastrointestinal tract and circulates mainly as unchanged drug following oral administration.

Protein binding: Highly protein-bound >99%

Metabolism: Hepatic

Route of elimination: Renal

Half-life: 4 hours

Adverse Effects

  • Abdominal pain
  • Constipation
  • Diarrhea
  • Nausea and vomiting
  • Skin rash

 

Contraindications

ALOFEN is contraindicated in the following populations and situations:

  • Hypersensitivity to aceclofenac or any other components of the formulation.
  • Active or history of peptic ulcer disease, hemorrhage, bleeding disorders.
  • Severe heart failure, hepatic failure and renal failure.
  • Below 18 years of age

Precautions

  • Pregnancy and breastfeeding

 Interactions

  • Alcohol: Increases the risk of GI bleeding
  • Other NSAIDs: Increases the risk of adverse effects.
  • Mifepristone: Aceclofenac may decrease the effect of Mifepristone.
  • Warfarin: Potentiate its effects
*Terminologies:

Ankylosing spondylitis: A type of arthritis that affects the spine.