Generic Name

Composition

Therapeutic Category

Division

Aceclofenac

Aceclofenac 100mg Tablets

NSAID

NEXUS

    BRAND COMPOSITION DESCRIPTION
    ANTIFLA

    Each film coated tablet contains:

    Aceclofenac BP                                         100mg

    ANTIFLA is a white, circular biconvex film-coated tablet with smooth finishing on both sides

    PHARMACOLOGY

    Pharmacotherapeutic Group: Non-steroidal anti-inflammatory drug, Anti-rheumatoid drug

    Pharmacodynamic properties: ANTIFLA is a non steroidal agent with marked anti inflammatory and analgesic properties. The mode of action of ANTIFLA is largely based on the inhibition of prostaglandin synthesis. ANTIFLA is a potent inhibitor of the enzyme cyclooxygenase which is involved in the production of prostaglandin.

    Pharmacokinetic properties:
    After oral administration, ANTIFLA is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3 hours following ingestion. ANTIFLA penetrates the synovial fluid where the concentrations reach approx. 57% of those in plasma. The mean plasma elimination half life is around 4 hours. ANTIFLA is highly protein bound >99%.

     INDICATIONS

    For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, lower back pain, gynecological pain, dental pain, ENT pain, post operative pain.

     DOSE

    Adults: 100mg two times a day after meal.

    Paediatric: not recommended for use in children under 18 years of age.

     

    PATIENT INFORMATION

     Administration:

    • Should be taken with or immediately after food. Do not crush or chew the tablets.

      Pregnancy:

    • Category category C for the first two quarters and D during the third quarter.

      Storage:

    • Store tablets in an airtight container in a cool dry place. Protect from sun light.

      Missed dose:

    • Take the missed dose as soon as you remember.
    • Skip the missed dose if it is almost time for your next scheduled dose.
    • Do not take extra medicine to make up the missed dose.
    CONTRAINDICATIONS

    Hypersensitivity to aspirin or NSAIDs; moderate to severe renal impairment; pregnancy (3rd trimester); history of peptic ulceration or GI bleeding.

     SPECIAL PRECAUTIONS

    Cautiously administer to patients with GI disease, ulcerative colitis, Crohn's disease, hematological abnormalities, hepatic porphyria; history of bronchial asthma; history of heart failure or hypertension; mild renal, hepatic or cardiac impairment. May impair ability to drive or operate machinery. 

    ADVERSE DRUG REACTIONS

    Serious AEs: GI bleeding; nephrotoxicity; blood dyscrasias.

    General AEs: Diarrhoea, nausea, dyspepsia, abdominal pain, dizziness, rashes; increased LFTs. 

    DRUG INTERACTIONS

    May increase plasma concentrations of lithium and digoxin. Increased nephrotoxicity when used with diuretics or ciclosporin. Monitor serum potassium when used with potassium-sparing diuretics and ACE inhibitors. May enhance activity of anticoagulants. May increase risk of methotrexate toxicity when administered within 24 hr of methotrexate administration. Increased risk of GI bleeding with other NSAIDs.

    PRESENTATION

    Each box is supplied with 20 blister packs each containing 10 tablets.