Vertisum

Vertisum

prochlorperazine

Manufacturer:

Kusum

Distributor:

JDS
Concise Prescribing Info
Contents
Prochlorperazine maleate
Indications/Uses
Vertigo due to Meniere's syndrome, labyrinthitis; nausea & vomiting including that associated w/ migraine. Schizophrenia (chronic stage), acute mania & as an adjunct to short-term anxiety management.
Dosage/Direction for Use
Adult Nausea & vomiting Treatment: Immediately give 20 mg, followed by 10 mg if necessary 2 hr later. Prevention: 5-10 mg bd or tds. Vertigo & Meniere's syndrome 5 mg tds. May be increased to 30 mg daily. Gradually reduce dose to 5-10 mg daily after several wk. Adjunct in short-term anxiety management Initially, 15-20 mg daily in divided doses. Max: 40 mg daily in divided doses. Schizophrenia & other psychotic disorder Usual effective dose: 75-100 mg daily. Patient's response may vary. Recommended schedule: Initially 12.5 mg bd for 7 days, subsequently increased to 12.5 mg at 4-7 days interval until satisfactory response is obtained. Attempt to reduce the dose after some wk to total daily dose of 50 mg or lower at 25 mg may be effective. Childn Treatment & prevention of nausea & vomiting 0.25 mg/kg bd or tds. Elderly Lower dose is recommended.
Contraindications
Special Precautions
Hypersensitivity to phenothiazines. Not for treatment of dementia-related behavioural disturbances. Avoid in patients w/ Parkinson's disease, hypothyroidism, cardiac failure, phaeochromocytoma, myasthenia gravis, prostate hypertrophy, history of narrow angle glaucoma or agranulocytosis (regular monitoring of the complete blood count). Closely monitor patients w/ epilepsy or history of seizures. Discontinue use in the event of unexplained fever, which may be a sign of neuroleptic malignant syndrome. Gradual w/drawal is advisable as acute w/drawal symptoms including nausea, vomiting & insomnia, relapse & extrapyramidal reactions may occur. Response may be delayed in schizophrenia. May potentiate QT interval prolongation, which increases potentially fatal risk of onset for serious ventricular arrythmias of torsades de pointes type; exacerbated QT prolongation in the presence of bradycardia, hypokalaemia & congenital or acquired QT prolongation; perform medical & lab evaluations (eg, biochemical status & ECG) prior to initiation of treatment, if clinical situation permits, to rule out possible risk factors (eg, cardiac disease, family history of QT prolongation; metabolic abnormalities eg, hypokalaemia, hypocalcaemia or hypomagnesemia; starvation; alcohol abuse; concomitant therapy w/ other drugs known to prolong QT interval). Avoid concomitant treatment w/ other neuroleptics. 3-fold increased risk of cerebrovascular events; patients w/ stroke risk factors. Do not use alone where depression is predominant. Avoid exposure to direct sunlight & skin contact of the drug. Avoid in patients w/ liver or renal dysfunction. Pregnancy (3rd trimester) & lactation (suspend breastfeeding during treatment). Lethargy or paradoxical hyperexcitability, tremor & low apgar score may possibly occur in neonates; risk of AR including extrapyramidal &/or w/drawal symptoms w/ varying severity & duration in neonates exposed during the 3rd trimester of pregnancy. Elderly, especially in very hot & cold weather (for risk of hyper- or hypothermia); of whom are susceptible to postural hypotension; increased risk of drug-induced Parkinsonism after prolonged use in the elderly. Not recommended for childn <1 yr or weighing <10 kg; associated w/ dystonic reactions after cumulative 0.5 mg/kg dosage.
Adverse Reactions
Acute dystonia or dyskinesia, akathisia, Parkinsonism, tremor. Angioedema, urticaria; mild leukopenia; hyperprolactinaemia (may result in galactorrhea, gynaecomastia, amenorrhoea); impotence; tardive dyskinesia, insomnia & agitation; ocular changes, development of metallic greyish-mauve color of exposed skin (mainly in females previously treated continuously w/ chlorpromazine for 4-8 yr); ECG changes including QT prolongation, ST depression, & U- & T-wave changes, cardiac arrhythmias including ventricular & atrial arrhythmias, AV block, ventricular tachycardia which may result in ventricular fibrillation or cardiac arrest; postural hypotension, venous thromboembolism including cases of pulmonary embolism & DVT; dry mouth; resp depression, nasal stuffiness; jaundice; contact skin sensitisation, skin rashes of various kinds, photosensitivity (w/ high dosage); neuroleptic malignant syndrome, glucose intolerance, hyperglycaemia. Potentially, sudden death of cardiac or unexplained origin.
Drug Interactions
Do not use concomitantly w/ adrenaline during overdosage. CNS depressant actions may be intensified w/ alcohol, barbiturates & other sedatives; resp depression may occur. Antipsychotic effect, mild anticholinergic effect may be enhanced w/ anticholinergic agents possibly leading to constipation, heat stroke. Interfered absorption w/ antacids, anti-Parkinson drugs & lithium. Antagonized antiparkinsonian action of dopaminergics. High doses reduce response to hypoglycaemic agent. Exaggerated hypotensive effects of α-adrenoreceptor blockers. May oppose actions of amfetamine, l-dopa, clonidine, guanethidine & adrenaline. Transient metabolic encephalopathy (loss of consciousness for 48-72 hr) in co-administration w/ desferrioxamine. Increased risk of arrhythmias in concomitant use w/ QT prolonging drugs (including certain antiarrhythmics, antidepressants, other antipsychotics) & electrolyte-imbalance causing drugs. Increased risk of agranulocytosis in concurrent use w/ myelosuppressive potential drugs eg, carbamazepine or certain antibiotics & cytotoxics. Potential neurotoxicity in concurrent use w/ lithium.
MIMS Class
Antipsychotics / Antiemetics / Antivertigo Drugs
ATC Classification
N05AB04 - prochlorperazine ; Belongs to the class of phenothiazine antipsychotics with piperazine structure.
Presentation/Packing
Form
Vertisum tab 5 mg
Packing/Price
20 × 10's
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