Loxitane is an antipsychotic medication that is used to treat schizophrenia.

Loxitane may also be used for purposes not listed in this medication guide.

You should not use Loxitane if you have decreased alertness caused by taking certain medications or drinking alcohol.

Loxitane is not approved for use in older adults with dementia-related psychosis.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

You may not start feeling better right away when you start taking Loxitane. Call your doctor if your symptoms do not improve, or if they get worse while using this medicine.

Store at room temperature away from moisture, heat, and light.

You should not use Loxitane if you are allergic to Loxitane or amoxapine, or if you have decreased alertness caused by taking certain medications or drinking alcohol.

Loxitane may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• epilepsy or other seizure disorder;

• low white blood cell (WBC) counts;

• glaucoma;

• urination problems;

• blockage in your digestive tract (stomach or intestines);

• Parkinson's disease;

• heart disease; or

• breast cancer.

Tell your doctor if you are pregnant or you get pregnant. Using antipsychotic medication during the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn.

You should not breastfeed while using Loxitane.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include weak or shallow breathing, fainting, or seizure (convulsions).

Avoid driving or operating machinery until you know how Loxitane will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Loxitane can decrease perspiration and you may be more prone to heat stroke.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

High doses or long-term use of loxapine can cause a serious movement disorder that may not be reversible. The longer you use Loxitane, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Loxitane may cause serious side effects. Call your doctor at once if you have:

• uncontrolled muscle movements in your arms or legs, or your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• fast heart rate;

• a light-headed feeling, like you might pass out;

• confusion, slurred speech;

• agitation, trouble sleeping;

• seizure (convulsions);

• little or no urinating;

• severe constipation;

• low white blood cell counts--fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed; or

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects of Loxitane may include:

• dizziness, problems with balance or walking;

• swelling in your face;

• itching or rash;

• tremors, muscle twitching or stiffness;

• numbness, weakness;

• blurred vision;

• feeling restless or agitated;

• nausea, vomiting, constipation;

• dry mouth, stuffy nose; or

• insomnia.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Taking Loxitane with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect Loxitane, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.