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Loxitane
Loxapine
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FDA boxed warning
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychos is 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 psychos is (see
WARNINGS).
About Loxitane
Overview
Loxitane is a prescription medicine containing loxapine. It is used to treat schizophrenia. Loxapine belongs to a group of medicines called tricyclic antipsychotics.
What it treats
Schizophrenia.
Safety information
Side effects
Frequently reported side effects include tremor, muscle stiffness, excessive saliva, reduced facial expression and a feeling of restlessness or needing to move. These often occur during the first few days of treatment. Drowsiness may occur when treatment begins or the prescribed dose is increased. Other reported effects include dizziness, dry mouth, constipation, blurred vision, nasal congestion, nausea, vomiting, sleep problems, weight changes, headache and rash. Contact a doctor promptly for new or uncontrolled movements of the tongue, face, mouth, jaw or limbs. These may be signs of tardive dyskinesia, which can persist and may be irreversible, including after treatment has stopped. Seek urgent medical attention for muscle spasms involving the neck or throat, trouble swallowing or breathing, seizures, very high fever or fainting. Neuroleptic malignant syndrome, a serious reaction, has been reported. Other serious reported effects include a fast heartbeat, high or low blood pressure, inability to pass urine, loss of bowel movement due to intestinal paralysis, liver injury and rare blood disorders involving low white blood cells or platelets. Yellowing of the skin or eyes and hepatitis have rarely been reported, although their relationship to loxapine is uncertain.
FDA boxed warning
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis
Elderly patients with dementia-related psychos is 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 psychos is (see
WARNINGS).
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Interactions
Tell your doctor if you take lorazepam. Rare reports of serious breathing suppression, greatly reduced alertness or responsiveness, and/or low blood pressure have occurred when lorazepam and loxapine were used together. Also discuss any other medicines that act on the brain or nervous system. The risks of combining these medicines with loxapine have not been systematically studied, so caution is advised.
Using Loxitane
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store below 25°C in a dry place, in the original pack, away from direct light and moisture. Do not keep it in a bathroom. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label LOXAPINE (LOXAPINE SUCCINATE) TABLET [MARLEX PHARMACEUTICALS INC] (DailyMed, retrieved 19 September 2026).
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