Acepar MR®,Dawa Limited
Aclosara-MR®,Krishna Chemists Ltd
Apigesic Forte®,Cosmos Limited
Lofen MR® ,Lords Healthcare Ltd
Lysodol MR® ,Galaxy Pharmaceutical Limited
Myonac MR®,Win-pharma Ltd
RAF® ,Zest Pharma
Rilif MR® , Corona Remedies Pvt. Ltd
Siclofen-MR® , Syner-Med Pharmaceuticals (k) Ltd
Zofen CZ® , Zawadi Healthcare Ltd
Zulu MR®,Innocia Lifesciences Private Ltd
Zyrtal MR®, Saga Laboratories
MODE OF ACTION
Aceclofenac inhibits synthesis of the inflammatory cytokines, interleukin-1B, and tumor necrosis factor, and inhibits prostaglandin E2 production. It Increases glycosaminoglycans (GAG) synthesis, the principle macromolecule of the extracellular matrix, which aids in repair and regeneration of articular cartilage. Thus aceclofenac has positive effects on cartilage anabolism combined with modulating effect of matrix catabolism.
Chlorzoxazone primarily acts at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic areas involved in producing and maintaining skeletal muscle spasm of varied etiology.
Paracetamol has analgesic and antipyretic action with weak anti-inflammatory activity. These effects are related to inhibition of prostaglandin synthesis.
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, Rheumatoid arthritis, and ankylosing spondylitis.
Chlorzoxazone is indicated for the Central skeletal muscle relaxant.
Paracetamol is used as analgesic.
DOSAGE AND ADMINISTRATION:
1 tablet twice a day by mouth (oral)
This combination is Contraindicated in children
Gastrointestinal bleeding or perforation, ulcer/ hemorrhage. moderate to severe renal impairment, severe heart failure, Hypersensitivity to aceclofenac, acute rhinitis or urticaria, pregnancy
Hypersensitivity to chlorzoxazone. Porphyria, Liver disease, Lactation
Hypersensitivity to paracetamol, Moderate to severe renal impairment, GI bleeding
WARNINGS / PRECAUTIONS
The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase-2-selective inhibitors should be avoided. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms.
Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. Hepatotoxicities such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine or jaundice
Renal or Hepatic Impairment, analgesic nephropathy.
PREGNANCY AND LACTATION
Not recommended in pregnancy and lactating mothers.
Gastrointestinal disorders in particular dyspepsia, abdominal pain, nausea and diarrhea and the occasional occurrence of dizziness.
Peptic ulcers, perforation, or GI bleeding sometimes fatal, particularly in the elderly may occur.
Nausea, vomiting diarrhea, flatulence constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis
Rarely nausea, dyspepsia, allergic reaction, hepatic necrosis (high dose).
Drowsiness, dizziness, lightheadedness G.I disturbances, headache, excitement, restlessness, irritability sensitivity reactions (skin rash). Jaundice, liver damage has been reported
Reporting Adverse Effects:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, email@example.com or clicking below button:
After oral administration. Aceclofenac is rapidly and completely absorbed as an unchanged drug. Aceclofenac penetrates into the synovial fluid. Aceclofenac circulates mainly as unchanged drug. 4‘-Hydroxyaceclofenac is the main metabolite detected in plasma. Approximately two-thirds of the administered dose is excreted via the urine mainly as hydroxy metabolites.
No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.
chlorzoxazone is rapidly and completely absorbed after oral administration. It is metabolized in the liver and excreted in the urine primarily as glucuronide
Paracetamol is readily absorbed from the gastrointestinal tract. It is distributed in most body tissues. It is metabolized predominantly in the liver and excreted in urine as the glucuronide.
Clinical | Pharmacokinetic data
Pregnancy Category: Not Recommended
Routes of Administration: Oral
Bioavailability: refer to each drug
Protein Binding: refer to each individual drug
Metabolosim: Not Available
Onset of Action: Not Available
Elimination Half life: Not Available
Excretion: Not Available
Legal Status | Dosage forms & Strengths
Prescription Only Medicine (POM)
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
Tablets : aceclofenac 100mg/paracetamol 500mg/ chlorzoxazone 375mg
- PPB Drugs Retention Register
- Shaikh, K. A., and A. B. Devkhile. “Simultaneous determination of aceclofenac, paracetamol, and chlorzoxazone by RP-HPLC in pharmaceutical dosage form.” Journal of chromatographic science 46.7 (2008): 649-652.
- Drug package/product leaflets