Shrizine Injection Warnings

As this preparation contains Benzyl Alcohol, its use should be avoided in children under 2 years of age. Not to be used in neonates.
Neuroleptic Malignant Syndrome: The neuroleptic malignant syndrome appears to be an idiosyncratic reaction to neuroleptic drug therapy. Clinical features usually include hyperthermia, severe extrapyramidal symptoms including muscular rigidity, autonomic dysfunction, and altered levels of consciousness. Skeletal muscle damage may occur. The incidence of the condition has been reported to vary from 0.02 to 3.2%; the mortality rate has been substantial although it has decreased over the years with improved diagnosis and management. Factors which possibly predispose to development of neuroleptic malignant syndrome include dehydration, pre-existing organic brain disease, and AIDS; infants and young males have also been reported to be particularly susceptible.
The pathogenesis of the neuroleptic malignant syndrome is still unclear. It may be the result of central dopamine-receptor blockade although peripheral mechanisms such as sustained muscular contraction and vasomotor paralysis may be partly responsible for the hyperthermia. Symptoms develop rapidly over 24 to 72 hours and may occur days to months after initiation of neuroleptic medication or increase in dosage. There appears, however, to be no consistent correlation with dosage or duration of therapy. Symptoms may last for up to 14 days after cessation of oral neuroleptics, or for up to 4 weeks after cessation of depot preparations. Deport preparation may be associated with prolonged recovery from the syndrome if it develops, and hence a higher mortality rate.
Concomitant administrations of other drugs such as lithium carbonate or antimuscarinic agents may increase the likelihood of developing the syndrome.
On diagnosis of neuroleptic malignant syndrome neuroleptics should be immediately withdrawn and symptomatic and supportive therapy indicated. Specific pharmacological therapy is less well established and is based mainly on case reports. Dantrolene was first used because of its effectiveness in malignant hyperthermia. It has a direct action on skeletal muscle and may be particularly effective for the reversal of hyperthermia of muscle origin. In contrast, dopaminergic agonists may resolve hyperthermia of central origin, restoring dopaminergic transmission and hence alleviating extrapyramidal symptoms. The presynaptic agonists amantadine and levodopa have been used with some success, but the postsynaptic agonist bromocriptine is generally preferred. Any underlying psychosis may, however, be aggravated by dopaminergic drugs. There is as yet no consensus over the choice between bromocriptine and dantrolene as first line agent for the treatment of neuroleptic malignant syndrome. In view of their differing modes of action a combination of the two may prove to be the optimum therapy. Isolated success in the management of neuroleptic malignant syndrome has also been reported with diazepam, sodium nitroprusside, pancuronium bromide, nifedipine, and electroconvulsive therapy. A suggestion that the neuroleptic malignant syndrome is a form of acute phase reaction controllable by salicylates and paracetamol, also requires confirmation. Re-introduction of neuroleptic therapy may be possible after resolution of neuroleptic malignant syndrome but is not always successful; extreme caution is advised.
The use of fluphenazine decanoate may impair the mental and physical abilities required for driving a car or operating heavy machinery. Physicians should be alert to the possibility that severe adverse reactions may occur which require immediate medical attention. Potentiation of the effects of alcohol may occur with the use of this drug. Since there is no adequate experience in children who have received this drug, safety and efficacy in children have not been established.