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Product Specialties - Psychotropic
Pipotiazine Palmitate
PIPORTIL L4®
Formulation:
Each 1mL contains:
Pipotiazine palmitate……………………….. 25 mg
Indications:
Chronic psychoses, especially: schizophrenia, of whatever clinical type, chronic hallucinatory psychosis, chronic, interpretative and passionate delusions.
In child psychiatry: infantile psychoses, prepsychotic conditions, evolutive disharmony and psychosis of the latency period;
Proposed in the aggressive manifestations of oligophrenic patients, psycholigically unbalanced patients and alcohilics.
Properties and Fate of the Drug:
Prolonged action neuroleptic. The active principle of PIPORTIL L4 is "bioformed" pipotiazine, which is slowly and progressively released by the hydrolysis of the ester from the point of injection.
PIPORTIL L4 is eliminated as "bioformed" pipotiazine predominantly in the feces by means of biliary excretion and in the urine.
Caution:
Food, Drugs, Devices and Cosmetics Act prohibits dispensing without prescription.
Side-Effects:
Neurological-sedation or drowsiness, dyskinesia, early dyskenesia (spasmodic torticollis, oculogyric crisis, trismus), receding with the administration of an antiparkinsonism drug; extrapyramidal syndrome, partially receding with antiparkinsonism drug; extrapyramidal syndrome, partially receding with antiparkinsonism treatment; tardive dyskinesia which as with all neuroleptics, maybe observed during prolonged treatment for which antiparkinsonism treatment has no effect and could aggravate the condition.
Orthostatic hypotension, anticholinergic effects, such dryness of the mouth, constipation, accommodation disorders of urine retention may occasionally observed.
Warnings:
In cases of hyperthermia, it is essential to suspend PIPORTIL L4 treatment as this sign can be indicative of the development of the malignant syndrome (paleness, hyperthemia, autonomic disorders) which has been described with neuroleptics.
Contraindications:
History of toxic agranulocytosis, porphyria, closed-angle galucoma, rish of urine retention liked to urethro-prostatic disorders.
Precautions:
A wash-out period of one week should be considered in patients who have been receiving long term, high dose oral neurleptic therapy, prior to initiating treatment with depot neuroleptics. Avoid alcohol.
Epileptic patients should be monitored because of possible reduction in the epileptic threshold.
Care is also required in: elderly patients, because of their higher sensitivity to sedation and hypotension; in serious cardiovascular disease because of haemodynamic modifications, especially hypotension; in renal and/or hepatic failure because of risk of overdose.
Drivers and machine operators should be warned of the risk of drowsiness, particularly at the start of the treatment.
Pregnancy and Nursing:
Although administration to animals caused no fetal malformations, the safety of such treatment during pregnancy and while nursing has not been established. PIPORTIL L4 should be used during pregnancy and breastfeeding only after having determined the expected advantages in comparison with the possible therapeutic effects.
Drug Interactions:
The hypotensive effects of most antihypertensives, and the effects of central nervous system depressants, such as hypnotics, tranquilizers, anesthetics and analgesics may be potentiated by the neuroleptic drugs.
Dosage & Administration:
In adults: the average dose for injection is in the region of 50mg. However, it can range, according to the severity of the psychotic disorder and the therapeutic effect, from 24 to 200mg (1 to 8 mL)
In elderly subjects, epileptics, encephalopathic subjects, alcoholics and psychologically unbalanced patients, the injection dose will be low to start (about 25mg), then if necessary, increased.
In the child: according to age, the initial dose ranges from 12.5 to 50mg; maximum dose being from 25 to 100mg.
The time interval between PIPORTIL L4 injections is on average, 4 weeks.
PIPORTIL L4 is administered by deep intramuscular injection.
Availability:
Box of 3 ampoules of 1 mL
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