Loxapine
Adasuve · ATC code N05AH01
Also known as: Loxapin, Loksapin
- Key facts
- Active substance
- Loxapine
- Drug class
- Antipsychotics
- ATC code
- N05AH01
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxapine is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
Key facts
Loxapine is a dibenzoxazepine antipsychotic. Per the US prescribing information, the capsules are used to treat schizophrenia.
What it is used for
- Schizophrenia
- Not approved for dementia-related psychosis
Dosing
- Usually given in divided doses two to four times a day, adjusted to symptom severity and previous response
- Initially 10 mg twice daily; in severely disturbed patients up to a total of 50 mg daily
- Increase fairly rapidly over the first seven to ten days until symptoms are controlled; usual therapeutic and maintenance range 60 mg to 100 mg daily
- Daily doses higher than 250 mg are not recommended
- Maintenance: lowest effective dose; many patients are maintained on 20 to 60 mg daily
Contraindications
- Comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.)
- Known hypersensitivity to dibenzoxazepines
Important warnings
- Boxed warning: increased mortality in elderly patients with dementia-related psychosis
- Tardive dyskinesia, potentially irreversible
- Neuroleptic malignant syndrome
- Leukopenia, neutropenia and agranulocytosis; discontinue if the neutrophil count falls below 1000/mm³
- Lowers the seizure threshold; extreme caution with a history of convulsive disorders
- Anticholinergic action: caution in glaucoma or urinary retention
Side effects
- Extrapyramidal reactions are frequent, often in the first days: tremor, rigidity, excessive salivation, masked facies, akathisia
- Drowsiness, usually mild, at the start or when the dose is increased; dizziness, insomnia, agitation
- Anticholinergic effects: dry mouth, nasal congestion, constipation, blurred vision, urinary retention
- Serious: seizures, neuroleptic malignant syndrome, tardive dyskinesia
Interactions
- Lorazepam: respiratory depression, stupor and/or hypotension have been reported
- Other CNS-active drugs: caution
- Anticholinergic antiparkinson medication: increased anticholinergic effects
Pregnancy and breastfeeding
- Safe use in pregnancy and breastfeeding is not established; use only if the benefit justifies the risk
- Newborns exposed in the third trimester are at risk of extrapyramidal and/or withdrawal symptoms
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Turkey
- AdasuveADEKA İLAÇ SAN. VE TİC. A.Ş. · 2 register entries
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 4 more European countries
- France
- Loxapac, Loxapine Arrow
- Iceland
- Adasuve
- Liechtenstein
- Adasuve
- Norway
- Adasuve
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Sources
- U.S. Food and Drug Administration. Loxapine (Chartwell RX, LLC) – Prescribing Information, 2025-12-08. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=3e412c36-66b0-444b-833b-cea79976844e
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
- Wikidata (CC0): ATC N05AH.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.