Loxapine (LOX-a-peen)

Treats acute agitation in adult patients with schizophrenia or bipolar disorder.

Brand Name(s):

Adasuve

When This Medicine Should Not Be Used:

How to Use This Medicine:

Powder

• A doctor or other trained health professional will give you this medicine in a hospital. You will breathe it in through the mouth and into the lungs.
• Your doctor will check you for breathing problems before you receive the medicine and for at least an hour afterwards.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine if you are also using medicines to treat asthma or COPD.
• Some medicines can affect how loxapine works. Tell your doctor if you are using any of the following:
  • Benzodiazepine medicines
  • Medicine to treat depression or mental health problems (including TCAs)
  • Medicine to treat Parkinson disease
  • Phenothiazine medicine
• Do not drink alcohol while you are using this medicine.
• Tell your doctor if you use anything else that makes you sleepy. Some examples are allergy medicine, narcotic pain medicine, and alcohol.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects to newborn babies if used during the later part of pregnancy.
• Tell your doctor if you are breastfeeding, or if you have kidney disease, glaucoma, trouble urinating, heart or blood vessel disease (including heart failure, heart rhythm problems), high or low blood pressure, or a history of heart attack, stroke, seizures, or alcohol or drug abuse or dependence. This medicine should not be used to treat dementia in elderly adults because of an increased risk for stroke and other side effects.
• This medicine may cause the following problems:
  • Serious lung or breathing problems
  • Neuroleptic malignant syndrome (nerve and muscle problem)
• This medicine may make you dizzy or drowsy, or may cause trouble with thinking or controlling body movements, which may lead to falls, fractures or other injuries. Do not drive or do anything that could be dangerous until you know how this medicine affects you. You may also feel lightheaded when getting up suddenly from a lying or sitting position, so stand up slowly.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Decrease in how much or how often you urinate
• Fever, sweating, confusion, uneven heartbeat, muscle stiffness
• Lightheadedness, dizziness, fainting
• Seizures
• Trouble breathing, chest pain, coughing
• Twitching or muscle movements you cannot control, problems with balance or walking

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Sleepiness or tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

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