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Logo MITIL TABLETS

SCHEDULING STATUS:
S5

PROPRIETARY NAME
(and dosage form):

MITIL TABLETS

COMPOSITION:
Each tablet contains:
Prochlorperazine Maleate        5 mg

PHARMACOLOGICAL CLASSIFICATION:
A 2.6 Phenothiazines and derivatives

PHARMACOLOGICAL ACTION:
Prochlorperazine, like its related molecules chlorpromazine and trifluoperazine, is a psychotherapeutic agent believed to act at the subcortical level of the brain, principally it depresses the central nervous system. Prochlorperazine is more potent than chlorpromazine but less so than trifluoperazine. The depressant action, hypotensive effect, antimuscarinic activity, potentiation of central nervous system depressants, and antihistaminic activity of prochlorperazine are all less than the respective effects of chlorpromazine.

INDICATIONS:
Prochlorperazine tablets are used in the control of mild and moderate mental and emotional disturbances, characterised by anxiety, tension and agitation. These tablets are used in the treatment of Ménière's syndrome, labyrinthitis, vertigo and migraine. It is also particularly effective for the prevention and treatment of nausea and vomiting.

CONTRA-INDICATIONS:
Contra-indicated in patients with pre-existing central nervous system depression or coma, bone marrow suppression, or phaechromocytoma. Central nervous system depression may be enhanced by other drugs with central nervous system-depressant properties including, alcohol, general anaesthetics, hypnotics and sedatives, and opioid anaesthetics. Phenothiazines effects on the vomiting centre may mask the symptoms of overdosage of other agents, or of disorders such as gastro-intestinal obstruction. Should not be given to children weighing under 10 kg. Safely in pregnancy and lactation has not yet been established therefore prochlorperazine is best avoided.

WARNINGS:
Usage of prochlorperazine may lead to drowsiness and impaired concentration which is aggravated by the simultaneous intake of alcohol or other central nervous system depressant agents. Patients should be warned against operating vehicles or machinery, or performing potentially hazardous tasks. Severe dystonic reactions have followed the use of prochlorperazine, particularly in children and adolescents. It should therefore be used with extreme care in children. Geriatric, emaciated, or debilitated patients usually required a lower initial dose, the dosage being gradually increased as needed and tolerated.

DOSAGE AND DIRECTIONS FOR USE:
Tablets are not suitable for many paediatric patients' requirements and should not be given to children weighing less than 10 kg. Geriatric, emaciated and debilitated patients usually required a lower initial dose, the dosage being gradually increased as needed and tolerated.
PREVENTION OF NAUSEA AND VOMITING:
5 to 10 mg (1 to 2 tablets) of maleate two or three times a day.
TREATMENT OF NAUSEA AND VOMITING:
20 mg (4 tablets) of maleate given orally; further doses may be given as required.
TREATMENT OF MIGRAINE:
20 mg (4 tablets) of maleate at once followed, if required, by 10 mg (2 tablets) of maleate two hours later. In an established attack if the patient is unable to retain tablets treatment may be administered in a different form (25 mg of maleate suppository).
TREATMENT OF VERTIGO AS WELL AS THAT ASSOCIATED WITH MÉNIÈRES DISEASE:
15 to 30 mg (3 to 6 tablets) of maleate in divided doses; after several weeks the dose may gradually be reduced to 5 to 10 mg (1 to 2 tablets) of maleate daily.
TREATMENT OF PSYCHOSES:
12,5 mg (2½ tablets) of maleate twice a day for seven days adjusted gradually to 75 to 100 mg (15 to 20 tablets) of maleate daily according to the response. Some patients may be maintained on doses of 25 to 50 mg (5 to 10 tablets) of maleate daily.
TREATMENT OF NON-PSYCHOTIC ANXIETY DISORDERS:
5 to 10 mg (1 to 2 tablets) of maleate up to 3 to 4 times daily.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Dry mouth, constipation, difficulty with micturition, blurred vision, and mydriasis may occur. Also tachycardia and electrocardiographic changes may occur. Hypotension (usually postural) is common. Other side effects include delirium, agitation and, rarely, catatonic-like states, insomnia, depression, miosis, EEG changes and convulsions, nasal congestion, minor abnormalities in liver function tests, inhibition of ejaculation, impotence, and priapism. Hypersensitivity reactions include urticaria, exfoliative dermatitis, erythema multiforme, and contact sensitivity. A syndrome resembling systemic lupus erythematosus has been reported. Photosensitivity reactions, jaundice and deposition of pigment in the skin, or more frequently in the eyes, may occur.
Haematological disorders such as haemolytic anaemia, aplastic anaemia, thrombocytopenic purpura, a potentially fatal agranulocytosis (have occurred within 4 to 10 weeks of starting treatment) and mild leucopenia may occur. Extrapyramidal dysfunction can result in the following disorders: acute dystonia, a Parkinsonism-like syndrome, and akathisia; late effects include tardive dyskinesia and perioral tremor.
Endocrine and metabolic functions may be altered resulting in the following: amenorrhoea, galactorrhoea, gynaecomastia, weight gain, hyperglycaemia and altered glucose tolerance. Body temperature regulation is impaired and may result in both hypo- or hyperthermia depending on environment. Use with caution in patients with impaired liver, kidney, cardiovascular, cerebrovascular, and respiratory function and in those with closed-angle glaucoma, Parkinsonism, diabetes mellitus, hypothyroidism, myasthenia gravis, or prostatic hypertrophy.
Care is, required in epileptic patients receiving anticonvulsant therapy as phenothiazines may lower the seizure threshold. Elderly and debilitated patients may be more prone to the adverse effects of prochlorperazine.
Regular eye examinations and the monitoring of haematological parameters is advisable for patients receiving long term prochlorperazine therapy. Mild symptoms resembling the withdrawal symptoms of dependence have been seen following the abrupt withdrawal of phenothiazines from patients receiving prolonged maintenance therapy.

INTERACTIONS:
Most common interactions encountered with phenothiazines are adverse effects resulting from concomitant administration of agents with similar pharmacological action. When given with other hypotensives a severe hypotensive effect can be produced. Phenothiazines reduce the antihypertensive action of guanethidine and other adrenergic neurone blockers. May also potentiate the adverse effects of other antimuscarinics. Concomitant administration of metoclopramide may increase the risk of neuroleptic-induced extrapyramidal effects, and antiarrhythmics which prolong the QT interval may increase the likelihood of ventricular arrhythmias.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Acute hypotension, and severe extrapyramidal reactions. In severe overdosage the stomach should be emptied by aspiration and lavage. Emetics are generally of little value. Treatment should be symptomatic.

IDENTIFICATION:
White biconvex tablets engraved with mortar and pestle.

PRESENTATION:
Securitainers of 250 tablets.

STORAGE INSTRUCTIONS:
Store below 25°C. Protect from light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
J/2.6/184.

NAME AND BUSINESS ADDRESS OF APPLICANT:
Pharmacare Limited
7 Fairclough Road
PORT ELIZABETH
6001

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
12/1978

        G893
                A & S PRINTERS

Updated on this site: February 2000
Current: September 2004
Source: Community Pharmacy

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