RXULTI Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Περιεχόμενα
Name of the medicinal product
RXULTI 0.25 mg film-coated tablets. RXULTI 0.5 mg film-coated tablets. RXULTI 1 mg film-coated tablets. RXULTI 2 mg film-coated tablets. RXULTI 3 mg film-coated tablets. RXULTI 4 mg film-coated tablets. ...
Qualitative and quantitative composition
RXULTI 0.25 mg film-coated tablets: Each film-coated tablet contains 0.25 mg brexpiprazole. Excipient with known effect: Each film-coated tablet contains 48.2 mg lactose (as monohydrate). RXULTI 0.5 mg ...
Pharmaceutical form
Film-coated tablet. RXULTI 0.25 mg film-coated tablets: Light brown, round, 6 mm in diameter, shallow convex and bevel-edged, debossed with BRX and 0.25 on one side. RXULTI 0.5 mg film-coated tablets: ...
Therapeutic indications
RXULTI is indicated for the treatment of schizophrenia in adult patients.
Posology and method of administration
Posology The recommended starting dose for brexpiprazole is 1 mg once daily on days 1 to 4. The recommended target dose range is 2 mg to 4 mg once daily. Based on the patients clinical response and tolerability ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Special warnings and precautions for use
During antipsychotic treatment, improvement in the patients clinical condition may take several days to some weeks. Patients should be closely monitored throughout this period. Suicidal ideation and behaviour ...
Interaction with other medicinal products and other forms of interaction
Brexpiprazole is predominantly metabolised by CYP3A4 and CYP2D6. Potential for other medicinal products to affect brexpiprazole CYP3A4 inhibitors Co-administration of ketoconazole (200 mg twice daily for ...
Fertility, pregnancy and lactation
Pregnancy There are no or limited amount of data from the use of brexpiprazole in pregnant women. Studies in animals have shown reproductive toxicity (see section 5.3). Brexpiprazole is not recommended ...
Effects on ability to drive and use machines
Brexpiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system effects, such as sedation and dizziness that are common adverse drug reactions (see ...
Undesirable effects
Summary of the safety profile The most frequently observed adverse drug reactions (ADRs) were akathisia (5.6%) and weight gain (3.9%). Tabulated list of adverse reactions The incidences of the ADRs associated ...
Overdose
Gastric lavage and treatment with an emetic may be useful immediately after overdose. An electrocardiogram should be obtained in case of overdose and if QT interval prolongation is present, cardiac monitoring ...
Pharmacodynamic properties
Pharmacotherapeutic group: Psycholeptics, other antipsychotics ATC code: N05AX16 Mechanism of action Brexpiprazole is an atypical antipsychotic agent. The pharmacology of brexpiprazole is believed to be ...
Pharmacokinetic properties
Absorption Brexpiprazole is absorbed after administration of the tablet, with peak plasma concentrations occurring within 4.0 hours after single dose administrations; the absolute oral bioavailability ...
Preclinical safety data
Effects observed in repeated-dose toxicity studies in rats and monkeys were mainly related to the exaggerated pharmacological activity of brexpiprazole. No safety margins based on AUC<sub>0-24h</sub> at ...
List of excipients
Tablet core: Lactose monohydrate Maize starch Microcrystalline cellulose Low-substituted hydroxypropylcellulose Hydroxypropylcellulose Magnesium stearate Purified water Tablet coat: Hypromellose Talc ...
Incompatibilities
Not applicable.
Shelf life
Shelf life: 3 years.
Special precautions for storage
This medicinal product does not require any special storage conditions.
Nature and contents of container
RXULTI 0.25 mg, 0.5 mg, 2 mg, 3 mg and 4 mg film-coated tablets: 28 film-coated tablets in Aluminium/PVC blisters. RXULTI 1 mg film-coated tablets: 10 or 28 film-coated tablets in Aluminium/PVC blisters. ...
Special precautions for disposal and other handling
This medicinal product may pose a risk to the environment (see section 5.3). Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Marketing authorization holder
Otsuka Pharmaceutical Netherlands B.V., Herikerbergweg 292, 1101 CT, Amsterdam, Netherlands
Marketing authorization number(s)
RXULTI 0.25 mg film-coated tablets: EU/1/18/1294/001 (28 film-coated tablets) RXULTI 0.5 mg film-coated tablets: EU/1/18/1294/002 (28 film-coated tablets) RXULTI 1 mg film-coated tablets: EU/1/18/1294/003 ...
Date of first authorization / renewal of the authorization
Date of first authorisation: 26 July 2018
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