Šalis: Malaizija
kalba: anglų
Šaltinis: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ZUCLOPENTHIXOL ACETATE
Lundbeck Malaysia Sdn. Bhd.
ZUCLOPENTHIXOL ACETATE
1ml mL
H. LUNDBECK A/S
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Since zuclopenthixol is partly metabolised by CYP2D6 concomitant use of drugs known to inhibit this enzyme may lead to decreased clearance of zuclopenthixol. Increases in the QT interval related to antipsychotic treatment may be exacerbated by the co administration of other drugs known to significantly increase the QT interval. Co-administration of such drugs should be avoided. Relevant classes include: • class Ia and III antiarrhythmics (e.g. quinidine, amiodarone, sotalol, dofetilide) • some antipsychotics (e.g. thioridazine) • some macrolides (e.g. erythromycin) • some antihistamines (e.g. terfenadine, astemizole) • some quinolone antibiotics (e.g. gatifloxacin, moxifloxacin) The above list is not exhaustive and other individual drugs known to significantly increase QT interval (e.g. cisapride, lithium) should be avoided. Drugs known to cause electrolyte disturbances such as thiazidediuretica (hypokalemia) and drugs known to increase the plasma concentration of zuclopenthixol acetate should also be used with caution as they may increase the risk of QT prolongation and malignant arrhythmias (see section 4.4). 4.6 Fertility, pregnancy and lactation Pregnancy Zuclopenthixol acetate should not be administered during pregnancy unless the expected benefit to the patient outweighs the theoretical risk to the foetus. Neonates exposed to antipsychotics (including zuclopenthixol acetate) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, or feeding disorder. Consequently, newborns should be monitored carefully. Animal studies have shown reproductive toxicity (see section 5.3) Breast-feeding As zuclopenthixol is found in breast milk in low concentrations it is not likely to affect the infant when therapeutic doses are used. The dose ingested by the infant is less than 1% of the w Perskaitykite visą dokumentą