Justeen Pharmaceauticals Limited

Acenol 200

Justeen

Acenol 200

ACENOL 200

Aceclofenac Sustained Release Tablets

  • NAME OF THE MEDICINAL PRODUCT

    ACENOL 200

  • QUALITATIVE AND QUANTITATIVE COMPOSITION

    Each uncoated tablet contains:
    Aceclofenac BP : 200 mg
    Excipients : Q.S.
    Colour : Erythromycine, Sunset Yellow FCF, Brilliant Blue FCF

  • PHARMACEUTICAL FORM

    Tablet. For oral administration.

  • CLlNICAL PARTICULARS

    Therapeutic indications
    Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

    Also Indicated for:

    • Serve pain & inflammation
    • Steoarthritis
    • Arthritis
    • Rheumatoid Arthritis
    • Menstrual Cramps
    • Backache

  • Posology and method of administration

    Aceclofenac tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. Aceclofenac should be taken preferably with or after food. Adults The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

  • Contraindications

    Hypersensitivity to any of the constituents, Severe hepatic and cardiac failure, Moderate to severe renal failure, During the last trimester of pregnancy, Active or previous peptic ulcer.

  • Special warnings and precautions for use

    Individuals receiving long-term treatment should be regularly monitored for renal function tests, liver function tests and blood counts. Respiratory disorders: Caution is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. Cardiovascular, Renal and Hepatic Impairment: Effects on renal function are usually reversible on withdrawal of Aceclofenac.

  • Interaction with other medicinal products and other forms of interaction

    Lithium, Diuretics, Anticoagulants, Antidiabetic agents, Mifepristone, Ciclosporin, Quinolone antimicrobials, Anti-hypertensives, Corticosteroids, Tacrolimus. Anti-platelet agents. Zidovudine.

  • Pregnancy and lactation

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

  • Undesirable effects

    Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur. Nausea, vomiting, diarrhoea, 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 relieves pain and inflammation through a variety of mechanisms and in addition exerts stimulatory effects on cartilage matrix synthesis.
      • Pharmacokinetic properties
    • 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 25 litres. 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.

  • PHARMACEUTICAL PARTICULARS

    Special precaution for storage:
    Do not store above 30?C.
    Keep out of reach of children.