Loxapine Succinate
FULL PRESCRIBING INFORMATION: CONTENTS*
- BOXED WARNING
- LOXAPINE SUCCINATE DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS & USAGE
- LOXAPINE SUCCINATE CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- INFORMATION FOR PATIENTS
- DRUG INTERACTIONS
- PREGNANCY
- NURSING MOTHERS
- PEDIATRIC USE
- LOXAPINE SUCCINATE ADVERSE REACTIONS
- OVERDOSAGE
- DOSAGE & ADMINISTRATION
- HOW SUPPLIED
- STORAGE AND HANDLING
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
FULL PRESCRIBING INFORMATION
BOXED WARNING
Increased Mortality in Elderly Patients with Dementia-Related PsychosisElderly 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 (seeWARNINGS).
LOXAPINE SUCCINATE DESCRIPTION
CLINICAL PHARMACOLOGY
PharmacodynamicsAbsorption, Distribution, Metabolism, and Excretion
INDICATIONS & USAGE
LOXAPINE SUCCINATE CONTRAINDICATIONS
WARNINGS
Increased Mortality in Elderly Patients with Dementia-Related PsychosisElderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Loxapine is not approved for the treatment of patients with dementia-related psychosis (seeBOXED WARNING).
Tardive Dyskinesia
ADVERSE REACTIONSInformation for Patients
Neuroleptic Malignant Syndrome (NMS)
PRECAUTIONS
Leukopenia, Neutropenia and AgranulocytosisGeneral
INFORMATION FOR PATIENTS
DRUG INTERACTIONS
PREGNANCY
NURSING MOTHERS
PEDIATRIC USE
LOXAPINE SUCCINATE ADVERSE REACTIONS
CNS Effects:WARNINGSDystonia - Class effect:
Cardiovascular Effects:
Hematologic:
Skin:
Anticholinergic Effects:
Gastrointestinal:
Other Adverse Reactions:
OVERDOSAGE
EPINEPHRINE SHOULD NOT BE USED SINCE ITS USE IN A PATIENT WITH PARTIAL ADRENERGIC BLOCKADE MAY FURTHER LOWER THE BLOOD PRESSURE.
DOSAGE & ADMINISTRATION
Oral Administration
Maintenance Therapy
HOW SUPPLIED
STORAGE AND HANDLING
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION
Loxapine SuccinateLoxapine Succinate CAPSULE
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PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
