Central Nervous System-Anxiolytics
= Additional active ingredients
PRESENTATION AND DOSSAGE
CAPS: 50 X 10 mg
DROPS: 30 ml X 4%
Aggressiveness, behaviour and character disorders, obessional neurosis, character problems of epileptics, agitation.
This medicinal product must not be used in the following situations: Hypersensitivity to pericyazine or any of the other ingredients, Risk of angle-closure glaucoma, Risk of urinary retention related to urethroprostatic disorders, History of agranulocytosis, In combination with dopamine agonists excluding those used in Parkinson’s disease (cabergoline, quinagolide).
Monitoring of treatment with pericyazine must be intensified in the following cases: Epileptic patients, as periciazine may lower the seizure threshold. Treatment must be discontinued if seizures occur, Elderly patients with : o greater susceptibility to postural hypotension, sedation and extrapyramidal effects, o chronic constipation (risk of paralytic ileus), o possible prostatic hypertrophy. Patients with certain cardiovascular disease due to the quinidine-like, tachycardiainducing and hypotensive effects of this class of drugs. Patients with severe hepatic and/or renal insufficiency, due to the risk of accumulation. Cases of hyperglycemia or glucose intolerance and onset or exacerbation of diabetes have been reported in patients treated with phenothiazines. Patients treated with antipsychotics including Neuleptil require clinical monitoring and monitoring of laboratory test results as per the current recommendations. Diabetic patients or those with risk factors for diabetes should be particularly closely monitored.
Starting at low doses: Autonomic disorders: Postural hypotension, Anticholinergic effects such as dry mouth, constipation and even paralytic ileus, visual accommodation disorders, risk of urinary retention.
Neuropsychaitric disorders: Sedation or drowsiness, particularly at the start of treatment. Indifference, anxiety reactions, mood changes.
At higher doses: Neuropsychaitric disorders: Early onset dyskinesia (spasmodic torticollis, oculogyric crises, trismus, etc.). Tardive dyskinesia during long-term treatment. Anticholinergic antiparkinsonian agents have no effect or may cause exacerbation. Extrapyramidal syndrome : Akinetic symptoms with or without hyertonia, partially resolving with anticholinergic antiparkinsonian agents, Hyperkinetic-hypertonic and excitatory motor activity, akathisia Endocrine and metabolic disorders: Hyperprolactinemia : amenorrhoea, galactorrhoea, gynecomastia, impotence, frigidity. Weight gain.
Thermoregulation disorders Elevated blood glucose levels, diabetes, impaired glucose tolerance.
Dose dependent and rarely reported:
Cardiac disorders: Risk of QT interval prolongation.
Non dose-dependent and more rarely reported: Skin reactions: Allergic skin reactions, Photosensitization.
Blood disorders: Exceptionally agranulocytosis: regular complete blood counts are recommended, Leucocytopenia.
Eye disorders: Brownish deposits in the anterior segment of the eye caused by accumulation of the drug and generally without effect on vision.
Drugs affecting the central nervous system, antiallergics, surgical anesthetics, narcotic analgesics, lithium, antidepressants, phenylbutzone, thiouracil, phenothiazines, epinephrine.
For the tablets For use in adults only: The lowest effective dosage should always be used. If the patient’s clinical status permits, treatment should be instituted at low doses and then gradually increased step-wise. The daily dose should be taken in 2 or 3 divided doses. The dosage is 30 to 100 mg/day. In certain exceptional cases, dosage may be increased to 200 mg/day maximum.
For the Drops: One drop contains 1 mg of pericyazine. 1 ml of solution contains 40 drops. 2 ORAL USE. The lowest effective dosage should always be used. If the patient’s clinical status permits, treatment should be instituted at low doses and then gradually increased step-wise. The daily dose should be taken in 2 or 3 divided doses.
Adults: 30 to 100 mg/day. In certain exceptional cases, dosage may be increased to 200 mg/day. Children over 3 years of age: 0.1 to 0.5 mg/kg/day.
Extremely serious parkinsonian syndrome, coma. Symptomatic treatment, continuous respiratory and cardiac monitoring (risk of prolonged QT interval) until the patient’s condition resolves.
PREGNANCY & LACTATION
Pregnancy: Maternal psychological wellbeing should preferably be maintained throughout pregnancy in order to prevent any decompensation. If drug therapy is necessary in order to maintain such a balance, it must be initiated or continued at an effective dose throughout pregnancy. Analysis of exposed pregnancies has shown no specific teratogenic effects with pericyiazine. Phenothiazines may occasionally cause the following signs in newborns if treatment is continued during the third trimester of pregnancy (reported in the context of postmarketing surveillance):
Respiratory disorders of varying degrees, ranging from tachypnea to respiratory distress, bradycardia, and hypotonia, usually occurring during co-administration with other medicinal products such as psychotropic agents or antimuscarinic agents.
Signs related to the atropinic effects of phenothiazines such as: tachycardia, hyperexcitability, abdominal bloating, delayed meconium excretion, meconium ileus, feeding difficulties.
Neurological disorders such as extrapyramidal signs: hypertonia, tremor, somnolence, agitation. Consequently, the use of pericyiazine may be considered, regardless of the stage of pregnancy. Appropriate monitoring and treatment of newborns should take the abovementioned effects into account.
Neuleptil drops: Since Neuleptil drops contains alcohol, it is not recommended in pregnant women. Use of another pharmaceutical form not containing alcohol is recommended.
Lactation: In absence of data on excretion of the drug in breast milk, breast-feeding is not recommended during treatment.
MANUFACTURER & DISTRIBUTER:
Manufacturer: Aventis Pharma
License Holder: Sanofi-Aventis Israel