Loxitane IM

Loxapine is a prescription medication used to treat acute agitation adults with schizophrenia or bipolar disorder. Loxapine is a type of medication known as a typical antipsychotic. Loxapine blocks the effects of a chemical in your brain, which leads to mental and physical relaxation.

Loxapine comes in the form of a capsule to be taken 2 to 4 times a day, with or without food.

Loxapine is taken by oral (by mouth) inhalation, usually once a day.

Common side effects of loxapine capsules include drowsiness, restlessness, tremors, and unusual, slowed, or uncontrollable movements.

Common side effects of loxapine inhalation include bad taste in the mouth, sleepiness, and sore throat.

Do not drive or operate heavy machinery until you know how loxapine affects you.

Oral/Inhalational:

Loxapine is a prescription medication is used to treat acute agitation in adults with schizophrenia or bipolar disorder.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Oral:

Common side effects include:

• drowsiness
• dizziness
• faintness
• weakness
• headache
• unusual, slowed, or uncontrollable movements of any part of the body
• restlessness
• numbness, burning, or tingling of the hands or feet

Inhalational:

The most common side effects include:

• bad, bitter, or metallic taste in your mouth (dysgeusia)
• sleepiness (especially when used with other drugs that cause sleepiness)
• sore throat

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of loxapine. For more information ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Loxapine and other medicines may affect each other causing side effects. Loxapine may affect the way other medicines work, and other medicines may affect the way loxapine works.

Especially tell your healthcare provider if you take:

• alcohol
• opioid analgesics
• benzodiazepines
• tricyclic antidepressants
• general anesthetics
• phenothiazines
• sedative/hypnotics
• muscle relaxants
• illicit CNS depressants

Ask your healthcare provider or pharmacist for a list of these medicines if you are not sure.

Know the medicines you take. Keep a list of them to show to your healthcare provider and pharmacist when you get a new medicine.

Oral/Inhalational:

Loxapine may cause serious side effects, including:

• Tardive dyskinesia (TD). TD is one of a group of side effects that includes restlessness, sudden and painful muscle stiffness, and tremors and slowing down of all body muscles. These side effects may develop over months, years, and even after a decade of use of loxapine.
• Increased risk of death in elderly patients with dementia-related psychosis.
  • Medicines like loxapine can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia).
  • Loxapine is not approved for the treatment of patients with dementia-related psychosis.
• Neuroleptic malignant syndrome (NMS), a rare but serious condition that may cause death. Symptoms of NMS may include:
  • high fever
  • stiff muscles
  • confusion
  • sweating
  • changes in pulse, heart rate, and blood pressure 　

Tell your healthcare provider right away if you have any of these symptoms of NMS after taking loxapine.

• low blood pressure (hypotension), lightheadedness, or fainting
• seizures (convulsions)
• severe sleepiness and difficulty with potentially dangerous activities such as driving
• worsening of glaucoma
• difficulty urinating
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how loxapine affects you.
• Do not drink alcohol while taking loxapine. It can increase your chances of getting serious side effects.
• Do not take loxapine if you are allergic to it, medications similar to loxapine, or to any of the inactive ingredients.

Inhalational:

Loxapine is available only through a Risk Evaluation and Mitigation (REMS) Program. The healthcare facility must be enrolled in this program before you can be given loxapine.

Loxapine may cause serious side effects, including:

• Narrowing of the airways (bronchospasm) that can cause you to have problems breathing or to stop breathing.
  • People who have asthma or other airway or lung problems, such as chronic obstructive pulmonary disease (COPD), have a higher risk of bronchospasm when taking loxapine. Symptoms of bronchospasm may include:
    • wheezing
    • coughing
    • chest tightness
    • shortness of breath　

Tell your healthcare provider right away if you have any of these symptoms of bronchospasm after taking loxapine.

Your healthcare provider should check you for breathing problems before and after you take loxapine.

Do not take loxapine if you:

• have or have had asthma, chronic obstructive pulmonary disease (COPD), or other airway or lung problems that can cause bronchospasm
• are having problems with wheezing, coughing, chest tightness, or shortness of breath
• are taking medicines to treat asthma or COPD
• have taken loxapine before and had bronchospasm
• are allergic to loxapine or amoxapine 　

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of loxapine there are no specific foods that you must exclude from your diet when receiving loxapine.
 

Before you take loxapine, tell your healthcare provider if you:

• have high or low blood pressure
• have or have had heart problems or stroke
• have or have had seizures (convulsions)
• have glaucoma
• have breast cancer
• have heart disease
• drink alcohol or use street drugs
• are scheduled to undergo any medical, including dental, procedures or surgery
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if loxapine will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if loxapine passes into your breast milk. You and your healthcare provider should decide if you will take loxapine if you are breastfeeding.

Tell your doctor about all medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if loxapine will harm your unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if loxapine passes into your breast milk. You and your healthcare provider should decide if you will take loxapine if you are breastfeeding.

Oral:

Loxapine comes in the form of a capsule to be taken 2 to 4 times a day, with or without food.

Inhalational

• Loxapine must be administered only by a healthcare professional.
• Your healthcare provider will show you how to take loxapine right before you take it.
• Take loxapine exactly as your healthcare provider shows you to take it.
• Do not drive, operate heavy machinery, or do other dangerous activities until you know how loxapine affects you.
• Do not drink alcohol while taking loxapine. It can increase your chances of getting serious side effects.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• how you respond to this medication
• other medications you are taking
• previous history of response to antipsychotic drugs

The recommended dose of loxapine for acute agitation is 10 mg administered by oral inhalation.

The recommended dose range of loxapine capsules is 60 mg-100 mg/day.

If you take too much this medication, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store loxapine capsules at 20°-25°C (68°-77°F).
• Keep this and all medicines out of the reach of children.

WARNING: BRONCHOSPASM and INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Bronchospasm

Loxapine can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest. Administer loxapine only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation). Prior to administering loxapine, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs. Monitor for signs and symptoms of bronchospasm following treatment with loxapine.

Because of the risk of bronchospasm, loxapine is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS).

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.