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PROCHLORPERAZINE MALEATE is a brand name for Prochlorperazine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Vertigo due to Meniere's syndrome, labyrinthine and other causes, nausea and vomiting from whatever cause including that associated with migraine, schizophrenia and other psychotic disorders, short-term management of anxiety.
Verbatim from this product's MHRA label. Tap a section to expand.
To be taken orally. d. s. Treatment of nausea and vomiting: 20 mg stat. followed if necessary by 10 mg two hours later. s. increasing if necessary to 30 mg daily. Dosage may be reduced gradually to 5-10 mg daily. Adjunct in the short-term management of anxiety: 15-20 mg daily in divided doses initiaily but this may be increased if necessary to a maximum of 40 mg daily in divided doses.
Schizophrenia and other psychotic disorders:
Usual effective daily oral dosage is 75-100 mg. Amounts as small as 50 mg or 25 mg have been found to be effective. 5 mg at four to seven day intervals until a satisfactory response is obtained. An attempt should be made to reduce this dosage after some weeks at the effective dosage.
Children:
Prevention and treatment nausea and vomiting: The dosage is 25 micrograms/kg bodyweight two or three times a day. It is recommended that the 5 mg tablet should be used. Not recommended for children weighing less than 10 kgs.
Elderly:
Prochlorperazine Maleate should be used cautiously in this group of psychotic disorders. Lower initial dosage is recommended. g. orthostatic hypotension, with effects due to the primary disorder.
Cardio-respiratory:
Hypotension, usually postural, occurs commonly. The elderly are particularly susceptible. Hypotension and interference with temperature regulation are dose- related side effects and are liable to cause dangerous falls and hypo/hyperthermia in the elderly.
Cardiac arrhythmias, including auricular arrhythmia A-V block, ventricular tachycardia and fibrillation have been reported. This may be related to dosage. Pre-existing cardiac disease, old age, hypokalaemia and concurrent tricyclic antidepressants may predispose cardiac arrhythmias.
ECG changes include widened QT interval, ST depression, U-waves and T-wave changes. Respiratory depression is possible in susceptible patients.
Blood dyscrasias:
Mild leukopaenia occurs in up to 30% of patients on prolonged high dose therapy. Agranulocytosis may occur rarely. Any occurrence of unexplained infections or fever requires haematological investigation.
Extrapyramidal:
Acute dystonias or dyskinesias, usually transitory are more common in children and young adults, and usually occur within the first 4 days of treatment or after dosage increases. Akathisia occurs after large initial doses. Parkinsonism is more common in adults and the elderly.
It usually develops after weeks or months of treatment. One or more of the following may be seen: tremor, rigidity, akinesia or other features of Parkinsonism. Commonly just tremor. Symptoms remit if the drug is withdrawn and may be suppressed with anticholinergic drugs.
Tardive dyskinesia:
If this occurs it is usually, but not necessarily, after prolonged or high dosage. It can even occur after treatment has been stopped. Dosage should therefore be kept low whenever possible and in the elderly, the treatment must be frequently reviewed.
Prochlorperazine should be used with caution in patients with renal or liver dysfunction, cardiovascular disease, epilepsy, Parkinson's disease, depression, hypothyroidism, myasthenia gravis and prostrate hypertrophy. Prochlorperazine should be avoided in patients known to be hypersensitive to phenothiazines or with a history of narrow angle glaucoma.
Caution is also required in patients with severe respiratory disease, blood dyscrasias, a history of jaundice or agranulocytosis. As agranulocytosis has been reported, regular monitoring of the complete blood count is recommended. 8) and requires immediate haematological investigation.
It is imperative that treatment be discontinued in the event of unexplained fever, as this may be a sign of neuroleptic malignant syndrome (pallor, hyperthermia, autonomic dysfunction, altered consciousness, muscle rigidity). Signs of autonomic dysfunction, such as sweating and arterial instability, may precede the onset of hyperthermia and serve as early warning signs.
Although neuroleptic malignant syndrome may be idiosyncratic in origin, dehydration and organic brain disease are predisposing factors. Acute withdrawal symptoms, including nausea, vomiting and insomnia have very rarely been reported following abrupt cessation of high doses of neuroleptics.
Relapse may also occur and the emergence of extrapyramidal reactions has been reported. Therefore, gradual withdrawal is advisable. 8). g. cardiac disease; metabolic abnormalities such as hypokalaemia, hypocalcaemia or hypomagnesaemia; starvation; alcoholic abuse; concomitant therapy with other drugs known to prolong the QT interval) should be carefully monitored (biochemical status and ECG), particularly during the initial phase of treatment.
It should be used with caution in the elderly who are particularly susceptible to postural hypotension and to risk of hyper-/hypothermia during very hot or very cold weather. Lower initial dose is recommended in the elderly. There is an increased risk of drug-induced Parkinsonism in the elderly particularly after prolonged use.
Prochlorperazine belongs to Phenothiazines (antipsychotic drugs). Antipsychotic drugs may be contraindicated in comatose states, CNS depression and phaeochromocytoma. Most antipsychotics are best avoided during pregnancy, unless essential and is advisable to discontinue breast-feeding during treatment.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Prochlorperazine in United Kingdom.
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Skin and eyes:
Contact skin sensitisation is a serious but rare complication, the greatest care must be taken to avoid contact of the drug with the skin. Skin rashes, corneal and lens opacities and purplish pigmentation of the skin, cornea, conjunctiva and retina may also be seen in patients treated with the drug.
Patients on high dosage should be warned that they may develop photosensitivity in sunny weather and should avoid exposure to direct sunlight. Ocular changes and the development of metallic greyish mauve coloration of exposed skin have been noted in some individuals, mainly females, who have received chlorpromazine continuously for long periods (4-8 years) and that this could possibly happen with Prochlorperazine.
Jaundice, usually transient, occurs in a very small percentage of patients. A premonitory sign may be a sudden onset of fever after one to three weeks of treatment followed by the development of jaundice. Neuroleptic jaundice has the biochemical and other characteristics of obstructive jaundice; the frequent presence of an accompanying eosinophilia indicates the allergic nature of this phenomenon.
Treatment should be withheld on the development of jaundice. Minor side effects of neuorleptics are agitation, anticholinergic symptoms (such as, blurred vision, constipation, difficulty with micturition, dry mouth), apathy, convulsions, excitement, GI disturbances, nasal stuffiness, headache, confusion and insomnia.
Endocrine:
Hyperprolactinaemia, which may result in menstrual disturbances, galactorrhoea, gynaecomastia, amenorrhoea, impotence and weight gain. 6), Frequency: not known. Neuroleptic malignant syndrome (hyperthermia, muscular rigidity, autonomic dysfunction and altered consciousness) may occur with any neuroleptic.
Cases of venous thromboembolism, including cases of pulmonary embolism and cases of deep vein thrombosis have been reported with antipsychotic drugs- Frequency unknown.
Photosensitisation may occur with higher dosages, patients should avoid direct sunlight. Patients with rare hereditary problems of galactose / fructose intolerance, Lapp lactase deficiency or glucose/galactose malabsorbtion or sucrase- isomaltase insufficiency should not take Prochlorperazine.
Data from two large observational studies showed that elderly people with dementia who are treated with antipsychotics are at a small increased risk of death compared with those who are not treated. There are insufficient data to give a firm estimate of the precise magnitude of the risk and the cause of the increased risk is not known.
Prochlorperazine is not licensed for the treatment of dementia-related behavioural disturbances. Cases of venous thromboembolism (VTE) have been reported with antipsychotic drugs. Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with Prochlorperazine and preventive measures undertaken.