Aceclofenac / Paracetamol /Chlorzoxazone

BRANDS AVAILABLE:

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

COMPOSITION:

Aceclofenac 100mg

Paracetamol 500mg

Chlorzoxazone 375mg

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.

INDICATIONS

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:

Adults

1 tablet twice a day by mouth (oral)

Children

This combination is Contraindicated in children

CONTRAINDICATIONS

ACECLOFENAC

Gastrointestinal bleeding or perforation, ulcer/ hemorrhage. moderate to severe renal impairment, severe heart failure, Hypersensitivity to aceclofenac, acute rhinitis or urticaria, pregnancy

CHLORZOXAZONE

Hypersensitivity to chlorzoxazone. Porphyria, Liver disease, Lactation

PARACETAMOL

Hypersensitivity to paracetamol, Moderate to severe renal impairment, GI bleeding

WARNINGS / PRECAUTIONS

ACECLOFENAC

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.

CHLORZOXAZONE

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

PARACETAMOL

Renal or Hepatic Impairment, analgesic nephropathy.

PREGNANCY AND LACTATION

Not recommended in pregnancy and lactating mothers.

ADVERSE REACTIONS

ACECLOFENAC

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

PARACETAMOL

Rarely nausea, dyspepsia, allergic reaction, hepatic necrosis (high dose).

CHLORZOXAZONE

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, pv@pharmacyboardkenya.org or clicking below button:

PHARMACOKINETICS

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

chlorzoxazone is rapidly and completely absorbed after oral administration. It is metabolized in the liver and excreted in the urine primarily as glucuronide

PARACETAMOL

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 Category:
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

Drug Indentifiers:

Refer to:

  • aceclofenac
  • paracetamol
  • chlorzoxazone


Drug Images

References/ Citation:




What was the patient being treated for
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