Generic Name

Composition

Therapeutic Category

Division

Indomethacin

Indomethacin 25mg Capsules

NSAID

NEXUS

    BRAND COMPOSITION DESCRIPTION
    INTIME

    Each capsule contains:

    Indomethacin IP                              25mg
     INTIME is a size '2' plain hard gelatin capsule with yellow body and yellow cap.
    PHARMACOLOGY

    Pharmacotherapeutic Group: Non-steroidal anti-inflammatory drugs

    Pharmacodynamic properties: Indomethacin, an indole acetic acid derivative has anti-inflammatory, analgesic and antipyretic actions. It reversibly inhibits cyclooxygenase-1 and -2 (COX-1 and -2) enzymes, thus resulting in reduced synthesis of prostaglandin precursors.

    Pharmacokinetic properties:

    Absorption: Readily absorbed from the GI tract. Absorption may be slowed by food. Bioavailability: 100%. Time to peak plasma concentration: Approximately 2 hr.Onset: Approximately 30 min. Duration: 4-6 hr.

    Distribution: Distributed into synovial fluid, CNS and placenta; enters breast milk (small amounts). Plasma protein binding: 99%.

    Metabolism: Undergoes hepatic metabolism to its glucuronide conjugate.

    Excretion: Via urine as glucuronide conjugates (60%); faeces as metabolites (33%). Terminal half-life: 2.6-11.2 hr.

     INDICATIONS

    Pain and inflammation associated with musculoskeletal and joint disorders, ankylosing spondylitis, rheumatoid arthritis, osteoarthritis, gouty arthritis, bursitis, and tendinitis

    DOSE

    Adult: 25mg twice a day or three times daily, increased if necessary by 25-50mg at weekly intervals to 150-200mg.

    PATIENT INFORMATION

     Administration:

    • Should be taken with food.

    Food Interaction: 

    • May increase the risk of stomach bleeding with alcohol.

    PregnancyCategory B (>48 hours) or Category D (after 34 weeks gestation or close to delivery)

    Nursing Mothers:

    Indomethacin can pass into breast milk and may harm a nursing baby. Do not breast-feed while using indomethacin.

    Storage:  Store capsules below 30°C protected from 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

    Known hypersensitivity to indomethacin, aspirin or other NSAIDs.

     SPECIAL PRECAUTIONS

    Patients with cardiovascular diseases or risk factors for cardiovascular disease, fluid retention, history of GI disease like bleeding disorders, ulcers, history of mental depression or other psychiatric disorder, epilepsy.

     ADVERSE DRUG REACTIONS

    GI disturbances like nausea, vomiting, dyspepsia, indigestion, heartburn, epigastric pain, headache, apparent swelling of the temporal vessels, transient renal insufficiency, tinnitus, ataxia, tremor, dizziness, insomnia, vertigo, confusion, psychiatric disturbances 

     DRUG INTERACTIONS

    May increase plasma levels of methotrexate. Increased risk of GI bleeding with warfarin. May reduce hypotensive effects of hydralazine, furosemide, β-blockers (e.g. atenolol, propranolol) or thiazide diuretics. Increased risk of hyperkalaemia with K-sparing diuretics, ACE inhibitors, K supplements

    PRESENTATION

    Each blister is supplied with 10 capsules of INTIME.