LATUDA Film-coated tablet (2020)
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Περιεχόμενα
Name of the medicinal product
Latuda 18.5 mg film-coated tablets.
Qualitative and quantitative composition
Each film-coated tablet contains lurasidone hydrochloride equivalent to18.6 mg lurasidone. For the full list of excipients, see section 6.1.
Pharmaceutical form
Film-coated tablet (tablet). White to off-white, film-coated round tablets of 6 mm debossed with LA.
Therapeutic indications
Latuda is indicated for the treatment of schizophrenia in adults and adolescent aged 13 years and over.
Posology and method of administration
Posology Adult Population The recommended starting dose is 37 mg of lurasidone once daily. No initial dose titration is required. It is effective in a dose range of 37 to 148 mg once daily. Dose increase ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Concomitant administration of strong CYP3A4 inhibitors (e.g. boceprevir, clarithromycin, cobicistat, indinavir, ...
Special warnings and precautions for use
During antipsychotic treatment, improvement in the patients clinical condition may take a few days to some weeks. Patients should be closely monitored during this period. Suicidality The occurrence of ...
Interaction with other medicinal products and other forms of interaction
Pharmacodynamic interactions Given the primary central nervous system effects of lurasidone, lurasidone should be used with caution in combination with other centrally acting medicinal products and alcohol. ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of lurasidone in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal/foetal ...
Effects on ability to drive and use machines
Lurasidone has minor influence on the ability to drive and use machines. Patients should be cautioned about operating hazardous machines, including motor vehicles and cycles, until they are reasonably ...
Undesirable effects
Summary of the safety profile The safety of lurasidone has been evaluated at doses of 18.5-148 mg in clinical studies in patients with schizophrenia treated for up to 52 weeks and in the post-marketing ...
Overdose
Management of overdose There is no specific antidote to lurasidone, therefore, appropriate supportive measures should be instituted, and close medical supervision and monitoring should continue until the ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psycholeptics, antipsychotics ATC code: N05AE05 Mechanism of action Lurasidone is a selective blocking agent of dopamine and monoamine effects. Lurasidone binds strongly to dopaminergic ...
Pharmacokinetic properties
Absorption Lurasidone reaches peak serum concentrations in approximately 1-3 hours. In a food effect study, lurasidone mean C<sub>max</sub> and AUC increased approximately by 2-3-times and 1.5-2-times, ...
Preclinical safety data
Nonclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, and carcinogenic potential. Major findings in repeat-dose ...
List of excipients
Core: Mannitol (E421) Starch, pregelatinised Croscarmellose sodium (E468) Hypromellose 2910 (E464) Magnesium stearate (E470b) Tablet coating: Hypromellose 2910 (E464) Titanium dioxide (E171) Macrogol 8000 ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 5 years.
Special precautions for storage
Store in the original package in order to protect from light.
Nature and contents of container
Cartons contain 14 1, 28 1, 30 1, 56 1, 60 1, 90 1 or 98 1 tablets in aluminium/aluminium perforated unit dose blisters. Not all pack sizes may be marketed.
Special precautions for disposal and other handling
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Aziende Chimiche Riunite Angelini Francesco – A.C.R.A.F. S.p.A., Viale Amelia 70, 00181, Rome Italy
Marketing authorization number(s)
EU/1/14/913/001-007
Date of first authorization / renewal of the authorization
Date of first authorisation: 21 March 2014 Date of latest renewal: 14 November 2018
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