Company: Lundbeck Ireland Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Aripiprazole 400mg per vial.
Description: Powder and solvent for prolonged-release suspension for injection.
Presentation: 1 vial, €322.69.
Indications: Maintenance treatment of schizophrenia in patients stabilised with oral aripiprazole.
Pharmacology: Aripiprazole’s efficacy in schizophrenia is proposed to be mediated through a combination of partial agonism at dopamine D2 and serotonin 5‑HT1A receptors and antagonism at serotonin 5‑HT2A receptors.
Dosage: Adult: Titration not required. 400mg once monthly as a single injection (no sooner than 26 days apart). Consider reducing to 300mg once monthly if not well tolerated. After the first injection, take 10mg to 20mg oral formulation for 14 consecutive days. Adjust dosage if taken with strong CYP3A4 or CYP2D6 inhibitors for more than 14 days. See SPC. Known CYP2D6 poor metabolisers: 300mg (or 200mg if taking strong CYP3A4 inhibitors). For intramuscular use only. Elderly: 65 years and older, safety and efficacy not established. Children: Under 18 years, safety and efficacy not established.
Contraindications: Hypersensitivity to the active ingredient or to any of the excipients. Pregnancy, lactation (unless benefit outweighs risk).
Special precautions: Do not use for dementia-related psychosis. Caution: Cardiovascular disease, cerebrovascular disease, predisposition for hypotension or hypertension, family history of QT prolongation, history of seizure disorder, seizure-associated conditions, risk for aspiration pneumonia. Venous thromboembolism reported with antipsychotic agents; identify risk factors before and during treatment. Hyperglycaemia reported; monitor diabetics (or patients with risk factors for diabetes) regularly for worsening of glucose control. Supervise closely for suicidal behaviour, particularly those at high risk (especially early treatment and switching of therapy). History of pathological gambling (monitor carefully). Consider dose reduction or discontinuation if signs and symptoms of tardive dyskinesia occur. Discontinue if neuroleptic malignant syndrome or unexplained high fever develops. Severe hepatic impairment (use oral formulation). Hypersensitivity reactions may occur. Driving/using machines.
Drug interactions: Avoid: CYP3A4 inducers (including rifabutin, phenobarbital, primidone) for more than 14 days. Caution: Drugs causing QT prolongation or electrolyte imbalance, alcohol or other CNS drugs. Strong CYP3A4 (including escitalopram) or CYP2D6 (including quinidine) inhibitors, certain antihypertensives, other serotonergics, agents increasing aripiprazole concentrations. See appendix I.
Adverse drug reactions: Increased weight, decreased weight, diabetes, agitation, anxiety, restlessness, insomnia, extrapyramidal disorder, akathisia, tremor, dyskinesia, sedation, somnolence, dizziness, headache, dry mouth, musculoskeletal stiffness, erectile dysfunction, injection site pain, injection site induration, fatigue, increased blood creatine phosphokinase.
Full prescribing information and references available from Lundbeck Ireland Ltd. Telephone: (01) 468 9800.
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