Central Nervous System-Analgesics; Antipyretics
Central Nervous System-Antidepressants
Central Nervous System-Anxiolytics
= Additional active ingredients
PRESENTATION AND DOSSAGE
TABS: 20 x 25 mg.
TABS: 20 x 100 mg.
Psychiatry: Severe melancholic or depressive states, chronic refractory schizophrenia, psychosis, psychomotor excited states and confusion syndrome. General medicdbine: Severe and refractory pain, anesthesia.
This medicine is contraindicated in the following cases: Hypersensitivity to levomepromazine or any of the other ingredients, Risk of angle-closure glaucoma, Risk of urinary retention related to urethro-prostatic disorders, History of agranulocytosis, Allergy to wheat (other than celiac disease), in combination with: non-antiparkinsonian dopamine agonists (cabergoline, quinagolide) Known hypersensitivity, suspected or established subcortical brain damage.
The supervision of levomepromazine treatment should be strengthened: In epileptics because of the possibility of the epileptogenic threshold lowering. The occurrence of convulsive attacks makes it imperative to stop the treatment. In elderly patients with: An elevated sensitivity to an orthostatic hypotension, sedation and extrapyramidal effects, a chronic constipation (risk of paralytic ileus), an eventual prostatic hypertrophy; in patients – carriers of certain cardiovascular affections because of the quinidinic, tachycardiac and hypotensive effects of this class of products. in case of severe hepatic and/or renal insufficiency because of the risk of accumulation.
Hyperglycaemia: Hyperglycaemia or intolerance to glucose has been reported in patients treated with Nozinan. Patients with an established diagnosis of diabetes mellitus or with risk factors for the development of diabetes who are started on Nozinan, should get appropriate glycaemic monitoring during treatment.
At low doses
Autonomic disturbances: postural hypotension, anticholinergic effects such as dry mouth, constipation, even paralytic ileus, visual accommodation disorders, risk of urinary retention.
Neuropsychiatric disorders: sedation or drowsiness, more pronounced at the beginning of treatment, indifference, anxiety reactions, mood changes.
At higher doses
Neuropsychiatric disorders: early-onset dyskinesia (spasmodic torticollis, oculogyric crises, trismus, etc.). extrapyramidal syndrome:
akinetic symptoms with or without hypertonia, partially resolving with anticholinergic antiparkinsonian agents, hyperkinetic-hypertonic and excitatory motor activity, akathisia tardive dyskinesia, occurring particularly during long-term treatment. It may sometimes occur after the neuroleptic agent is withdrawn and resolve after rechallenge or if dosage is increased. Anticholinergic antiparkinsonians have no effect and may cause exacerbation.
Autonomic disturbances: anticholinergic effects: very rare cases of potentially fatal necrotizing enterocolitis have been reported.
Endocrine and metabolic disorders: hyperprolactinemia: amenorrhea, galactorrhea, gynecomastia, impotence, frigidity, thermoregulation disorders, weight gain, hyperglycemia, impaired glucose tolerance.
Cytochrome P450 2D6 Metabolism: Levomepromazine and its non-hydroxylated metabolites are reported to be potent inhibitors of cytochrome P450 2D6. Coadministration of levomepromazine and drugs primarily metabolised by the cytochrome P450 2D6 enzyme system may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic or adverse effects of those drugs
Drugs lowering the seizure threshold: Use of this drug in combination with seizure-inducing agents or seizure-threshold lowering drugs should be carefully considered due to the severity of the risk incurred. These drugs include in particular most antidepressants (imipramine agents, selective serotonin reuptake inhibitors), neuroleptics (phenothiazines and butyrophenones), mefloquine, chloroquine, bupropion, and tramadol.
Atropine-like drugs: It must be taken into account that atropine-like substances can have additive adverse
effects and more easily lead to urinary retention, acute attacks of glaucoma, constipation, dry mouth, etc. The various atropine-like drugs include imipramine antidepressants, most atropinelike H1-antihistamines, anticholinergic antiparkinsonians, atropine-like antispasmodics, disopyramide, phenothiazine neuroleptics, and clozapine.
Sedatives: It must be taken into account that many drugs or substances can have additive depressant effects on the central nervous system and contribute to a decrease in alertness. These drugs include morphine derivatives (analgesics, antitussives, and replacement therapies), neuroleptics, barbiturates, benzodiazepines, nonbenzodiazepine anxiolytics (such as meprobamate), hypnotics, sedative antidepressants (amitriptyline, doxepin, mianserin, mirtazapine, trimipramine), sedative H1-antihistamines, centrally-acting antihypertensives, baclofen, and thalidomide.
For use in adults only: Oral route The minimal efficient dosage should be always sought. The treatment should be started from a low dose and then gradually increasing it. The dosage is from 25 to 200 mg/day. In certain exceptional cases, the dosage can be increased to 400 mg/day maximum. The daily dose should be either taken in the evening when going to bed, or distributed into three takings during meals.
Extremely serious parkinsonian syndrome, coma. Symptomatic treatment, continuous respiratory and cardiac supervision (risk of the lengthening of QT interval), which should be continued until the recovery of the patient.
PREGNANCY & LACTATION
Pregnancy: Good mental health should preferably be maintained throughout pregnancy to avoid 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 not revealed any particular teratogenic effect with levomepromazine. Phenothiazines may occasionally cause the following signs in newborns if treatment is continued at the end of pregnancy, particularly at high doses: signs related to their atropine-like properties, exacerbated if combined with antiparkinsonian agents: tachycardia, hyperexcitability, abdominal distension, delayed meconium excretion, extrapyramidal signs: hypertonia, tremor, sedation. Consequently, use of levomepromazine can be considered at any stage of pregnancy. Monitoring of newborns should take the above-mentioned effects into account.
Lactation: As there are no data available on excretion in breast milk, breast-feeding is not recommended during treatment.
MANUFACTURER & DISTRIBUTER:
Manufacturer: Aventis Pharma
License Holder: Sanofi-Aventis Israel