Generic Name

Composition

Therapeutic Category

Division

Pregabalin

Pregabalin 50mg Capsules

Pregabalin 75mg Capsules

Anti-convulsant

NEXUS

    BRAND COMPOSITION DESCRIPTION

    PRE- Z 50

    Each capsule contains:

    Pregabalin IP                       50 mg

    PRE-Z 50 contains white crystalline powder filled in a size '2' hard gelatin capsule with yellow cap and yellow body.

    PRE- Z 75

    Each capsule contains:

    Pregabalin IP                       75mg

    PRE-Z 75 contains white crystalline powder filled in a size '2' hard gelatin capsule with yellow cap and yellow body.
    PHARMACOLOGY

     

    Pharmacotherapeutic Group: Anti-convulsant

    Pharmacodynamic Properties: Pregabalin is an anticonvulsant drug which binds to the α2δ (alpha2 delta) subunit of the voltage-dependent calcium channel in the central nervous system. This reduces calcium influx into the nerve terminals. Pregabalin also decreases the release of neurotransmitters such as glutamate, noradrenaline and substance P, possibly accounting for its actions in vivo to reduce neuronal excitability and seizures Pregabalin increases neuronal GABA levels by producing a dose-dependent increase in glutamic acid decarboxylase activity.

     Pharmacokinetic Properties:

    Absorption: Rapidly absorbed after oral doses. Peak plasma concentrations are achieved within 1.5 hours. Bioavailability: >90%

    Distribution:Not bound to plasma proteins.

    Metabolism:Negligible metabolism.

    Elimination:About 98% excreted unchanged in urine. Elimination half life: about 6.3 hours.

     INDICATIONS

    Diabetic peripheral neuropathy, postherpetic neuralgia, adjunct in partial seizures, fibromyalgia, anxiety, neuropathic pain associated with spinal cord injury, trigeminal neuralgia

     

    DOSE

     

    PATIENT INFORMATION

    Administration:

    • PREZ may be taken with or without food.

      Pregnancy:

    • Category C

      Nursing Mother:

    • It is not known whether FUZON is excreted in breast.

      Storage:

    • Store capsules at 15-30 °C

      Missed dose:

    • 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.

    Diabetic peripheral neuropathy: Adult: 50 mg tid or 75 mg bid. Max. dose: 100mg tid.

    Postherpetic neuralgia: Adult: 75-150 mg bid. May increase up to 600 mg/day in patients with ongoing pain and can tolerate 300 mg/day.

    Adjunct in partial seizures: Adult: 150-600 mg/day. Should be given in 2-3 divided doses. Max dose: 600 mg/day

    Fibromyalgia: Adult: Initiate at 75 mg bid. May increase to 225 mg bid for patients who do not experience sufficient benefit with 300 mg/day.

    Anxiety: Adult: Initiate at 150 mg daily. May increase at weekly intervals in steps of 150 mg. Max dose: 600 mg daily.

    Neuropathic pain with spinal cord injury: 75mg bid.

    CONTRAINDICATIONS

    Hypersensitivity

     SPECIAL PRECAUTIONS

    Discontinue treatment if patients develop severe angioedema. Withdraw treatment gradually over at least 1 week. May cause peripheral edema. Regular vision check is recommended. May decrease platelet count and prolong PR interval.

    ADVERSE DRUG REACTIONS

    Dizziness, drowsiness, visual disturbance (including blurred vision, diplopia), rash, muscle cramp, myalgia, arthralgia.

     DRUG INTERACTIONS

    Concurrent use with oxycodone, lorazepam and ethanol may increase the CNS effects.

     PRESENTATION

    Each box is supplied with 10 strips of 10 caps packed in blisters.