Justeen Pharmaceauticals Limited

ACENOL PLUS 3

Aceclofenac, Paracetamol and Serratiopeptidase Tablets

• NAME OF THE MEDICINAL PRODUCT

  Acenol Plus 3:

• QUALITATIVE AND QUANTITATIVE COMPOSITION

  Each film coated tablet contains:
  Aceclofenac BP :100 mg
  Paracetamol SP : 325 mg
  Serratiopeptidase :15 mg
  Excipients : Q.S.
  Colour : Brilliant Blue and Tartrazine
  

• PHARMACEUTICAL DOSAGE FORM

  Tablet.
  For oral administration.

• CLlNICAL PARTICULARS

  Therapeutic indications

  Joint pains, dental pain, post operative pain, pelvic inflammatory disease. Posology and method of administration Two tablets in a day.

  Contraindications

  ACENOLOL PLUS 3 should not be administered to patients hypersensitive to Aceclofenac or Paracetamol and other NSAlDs or having GI bleeding or renal impairment.

  Special warnings and precautions for use

  Pregnancy and lactation The drug is not recommended to pregnant or breast feeding women.

  Undesirable effects

  The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastro-intestinal disorders and occasional occurrence of dizziness.

  Undesirable effects associated with NSAlDs in general:

  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 and Crohn' s disease have been reported following administration.

• Overdose

  Management consists of supportive and symptomatic measures.

• PHARMACOLOGICAL PROPERTIES

  Pharmacodynamic properties

  Aceclofenac:
  Aceclofenac relieves pain and inflammation through a variety of mechanisms and in addition exerts stimulatory effects on cartilage matrix synthesis.

  Paracetamol:
  Analgesic -Paracetamol may act predominantly by inhibiting prostaglandin synthesis in the central nervous system (CNS) and to a lesser extent, through a peripheral action by blocking pain-impulse generation.

  Antipyretic:
  It produces antipyresis by acting centrally on the hypothalamic heat-regulation centre to produce peripheral vasodilation resulting in increased blood flow through the skin, sweating and heat loss. The central action probably involves inhibition of prostaglandin synthesis in the hypothalamus.

  Serratiopeptidase:
  It binds to alpha-2-macroglobulin in the blood in the ratio of I: I. which helps to mask its antigenicity but retain its enzymatic activity. Levels of Serratiopeptidase are slowly transferred to the exudate at the site of inflammation and gradually the blood level decline. By hydrolysing bradykinin, histamine and serotonin, it indirectly reduces dilatation of blood capillaries and controls permeability. Serratiopeptidase blocks plasmin inhibitors thus helping the fibrinolytic activity of plasmin. Degradation of' extra-fibrin' to small fragment prevents clogging of microcapillaries, helps clearance of exudates, reduces swelling and improves microcirculation.

  Pharmacokinetic properties

  Aceclofenac:
  Aceclofenac is well absorbed from gastrointestinal tract and peak plasma concentrations (Cmax) are reached 1-3 hours after an oral dose. The drug is more than 99% bound to plasma proteins and the volume of distribution (Vd) is approximately 2S liters. The drug is eliminated primarily through renal excretion with 70-80 of administered dose found in urine as glucoronides and rest being excreted in faeces. The plasma elimination half life of Aceclofenac is approximately 4 hours.

  Paracetamol:
  Paracetamol is readily absorbed from the gastro intestinal tract after oral administration. Paracetamol is distributed into most body tissues. It crosses the placenta and is present in breast milk. Paracetamol is metabolised predominantly in the liver and excreted in the urine mainly as the glucuronide and sulphate conjugates. Less than 5% is excreted as unchanged paracetamol.

  Serratiopeptidase:
  On oral administration, Serratiopeptidase is absorbed in GI tract and distributed throughout the body tissues unchanged via systemic circulation. The concentration in the lymph was found two times higher than in blood. Serratiopeptidase levels in inflammatory exudates rises gradually with decline in blood levels indicating that Serratiopeptidase is quite rapidly transferred to the site of inflammation.

• PHARMACEUTICAL PARTICULARS

  Special precaution for storage Keep in a cool, dry, dark place.