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Each tablet contains: Prochlorperazine Maleate 5 mg

Prochlorperazine has a wide range of activity arising from its depressant actions on the central nervous system and its alpha-adrenergic blocking and weaker anti-cholinergic activities. It is a dopamine inhibitor, it inhibits prolactin-release inhibitory factor, considered to be dopamine, thus stimulating the release of prolactin. The turnover of dopamine in the brain is also increased. Prochlorperazine possesses sedative and tranquilising properties but patients usually develop tolerance rapidly to the sedation. It has anti-emetic, anti-pruritic and weak anti-histamine properties and inhibit the heat regulating centre so that the patient tends to acquire the temperature of his surroundings. Prochlorperazine produces direct effects on the heart and blood vessels and also indirect ones through actions on CNS and autonomic reflexes. Hypotension is primarily due to inhibition of centrally mediated pressor effects but peripheral alpha-adrenergic blockage may also play a role. There is also a direct depressant action on the heart. The drug has a vasodilating action due to both its effects on the autonomic nervous system and a direct action on blood vessels.

Prochlorperazine is well absorbed from the gastrointestinal tract. From 60 to 70% of an administered dose is rapidly removed from the portal circulation by the liver and there is a very active enterohepatic circulation. Fecal excretion of prochlorperazine is significant. A reciprocal relationship exists between the amounts excreted in the faeces and the urine. After absorption, it is rapidly distributed in all body tissues. Brain concentrations are relatively low compared to those in other organs, but considerably higher than in plasma; the highest concentrations of the drug is found in the lung, followed by the liver, the adrenal gland, and the spleen.

For control of severe nausea and vomiting and treatment of non-psychotic anxiety.

It is contraindicated in greatly depressed states due to central nervous system depressants and in the presence of bone marrow depression.

It is also contraindicated in children under 2 years of age or under 9 kg in weight. It should not be used in children for conditions for which dosage has not been established.

Side effects / adverse reactions
Drowsiness, dizziness, amenorrhea, blurred vision, skin reactions and hypotension may occur.
Cholestatic jaundice has occurred. Leukopenia and agranulocytosis have also occurred.
Neuromuscular reactions characterised by motor restlessness, be of the dystonic type or may resemble parkinsonism are observed. Symptoms of motor restlessness may include agitation, jitteriness and sometimes insomnia. Symptoms of dystonia may include spasm of the neck muscles, sometimes progressing to torticollis; extensor rigidity of back muscles, sometimes progressing to opisthotonos; carpopedal spasm, trismus, swallowing difficulty, oculogyric crisis and protrusion of the tongue. Symptoms of pseudo-parkinsonism may include mask-like facies; drooling; tremors; pillrolling motion; cogwheel rigidity and shuffling gait. As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long term therapy. This condition appears in all age groups. However, the risk appears to be greater in elderly patients on high dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterised by rhythmical involuntary movements of the tongue, face, mouth or jaw. Sometimes these may be accompanied by involuntary movements of extremities.

Precautions / Warnings
The extrapyramidal symptoms which can occur secondary to prochlorperazine may be confused with the central nervous system signs of an undiagnosed primary disease responsible for the vomiting, e.g. Reye's syndrome or other encephalopathy. The use of prochlorperazine and other potential hepatotoxins should be avoided in children and adolescents whose signs and symptoms suggest Reye's syndrome.
When prochlorperazine is used with cancer chemotherapeutic drugs, vomiting as a sign of the toxicity of these agents may be obscured by the antiemetic effect of prochlorperazine. Phenothiazines can diminish the effect of oral anticoagulants.

Thiazide diuretics may accentuate the orthostatic hypotension that may occur with phenothiazines. Antihypertensive effects of guanethidine and related compounds may be counteracted when phenothiazines are used concomitantly.

Concomitant administration of propranolol with phenothiazines results in increased plasma levels of both drugs.

Patients with bone marrow depression or who have previously demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) with a phenothiazine should not receive any phenothiazine, including prochlorperazine, unless in the judgement of the physician the potential benefits of treatment outweigh the possible hazards.

Prochlorperazine may impair mental and/or physical abilities, especially during the first few days of therapy. Therefore, caution patients about activities requiring alertness (e.g. operating vehicles or machinery).

The antiemetic action of prochlorperazine may mask the signs and symptoms of overdosage of other drugs and may obscure the diagnosis and treatment of other conditions such as intestinal obstruction, brain tumor and Reye's syndrome.

Aspiration of vomitus has occurred in a few post-surgical patients who have received prochlorperazine as an antiemetic. Although no causal relationship has been established, this possibility should be borne in mind during surgical aftercare.

As with all drugs which exert an anticholinergic effect and/or cause mydriasis, prochlorperazine should be used with caution in patients with glaucoma.

Because phenothiazines may interfere with thermoregulatory mechanisms, use with caution in persons who will be exposed to extreme heat.

Phenothiazines can produce alpha-adrenergic blockade.

The presence of phenothiazines may produce false-positive phenylketonuria (PKU) test results.

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