Generic Name

Composition

Therapeutic Category

Division

Prochlorparazine Maleate

Prochlorparazine Maleate 5mg Tablets

Anti-emetic

NEXUS

    BRAND COMPOSITION DESCRIPTION
     PARAZINE

    Each uncoated tablet contains:

    Prochlorperazine maleate IP                5mg
     PARAZINE is a light blue, circular tablet with break-line on one side.
    PHARMACOLOGY

    Pharmacotherapeutic Group: Antiemetic and antipsychotics

    Pharmacodynamic properties: 

    Prochlorperazine blocks both postsynaptic dopamine receptors as well as the medullary chemoreceptor trigger zone. It depresses hypothalamic and hypophyseal hormone release and posssesses α-adrenergic and anticholinergic inhibitory activity.

    Pharmacokinetic properties:

    Absorption: Well absorbed from the GI tract but is subject to considerable first pass metabolism from the gut wall. Bioavailability: 12.5%, onset: 30-40 min

    Distribution: Extensively bound to plasma proteins, widely distributed in the body (it crosses the blood brain barrier) and its metabolites cross the placental barrier and are excreted in milk.

    Metabolism: Extensively metabolised in the liver and forms N-desmethylprochlorperazine (active), excreted in the urine and bile.

    Excretion: Plasma half-life is reported to be only a few hours but elimination of the metabolites may be very prolonged.

     INDICATIONS

    Nausea and vomiting associated with radiotherapy and chemotherapy, pre and post operation, vertigo, schizophrenia, mania 

    DOSE

    Adult: 5-10 mg twice or three times a day.

    Pediatric:

    Less than 2 years old: not recommended

    Greater than 2 years old: 2.5-5 mg every 8-12 hr

    PATIENT INFORMATION

     Administration:

    • May be taken with or without food

    Food Interaction:

    Alcohol may increase the effects of prochlorperazine.

    Pregnancy:   Category C

    Nursing Mothers

    Prochlorperazine maleate can pass into breast milk and may harm a nursing baby. Do not breastfeed while using prochlorperazine.

    Storage: Store tablets at room temperature

    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

    Children less than 2 years, lactation, hypersensitivity to phenothiazines, coma, severe CNS depression

    SPECIAL PRECAUTIONS

    Extrapyramidal syndrome, hypotension, epilepsy, impaired hepatic, renal, cardiovascular, cerebrovascular or respiratory function, glaucoma. May impair ability to drive or perform tasks requiring mental alertness or physical coordination. History of jaundice, parkinsonism, diabetes mellitus, hypothyroidism, myasthenia gravis, paralytic ileus, prostatic hyperplasia or urinary retention. Regular eye examinations are recommended in patients on long-term treatment

     ADVERSE DRUG REACTIONS

    Severe AEs: Bone-marrow suppression, cardiac arrhythmias or aspiration.

    Common AEs: Jaundice, cardiac arrhythmias, orthostatic hypotension, leucopenia, thrombocytopenia, dry mouth, blurring of vision, glaucoma, urinary retention, constipation, galactorrhoea, gynaecomastia, amenorrhoea

     DRUG INTERACTIONS

    Potentiation of other CNS depressants including alcohol, sedatives, hypnotics, barbiturates, opioids, antihistamines and general anaesthetics.

    PRESENTATION

    Each box is supplied with 20 strips of 10 tabs packed in blisters