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

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

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

Loxapine 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 loxapine. Call your doctor if your symptoms do not improve, or if they get worse while using loxapine.

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

Usual Adult Dose for Schizophrenia:

Initial Dose: 10 mg orally twice a day
-Initial doses of up to 50 mg a day may be needed in severely disturbed patients
Titrate rapidly over the first 7 to 10 days until symptoms are effectively controlled
Maintenance Dose: 60 mg to 100 mg daily in divided doses, 2 to 4 times a day
Maximum dose: 250 mg/day

Comments:
-Daily dosage should be adjusted to the individual patient's needs based on severity of symptoms and previous antipsychotic drug response.
-Usual therapeutic and maintenance range is 60 to 100 mg daily; however, some patients may respond to lower, and others higher, doses.
-For maintenance therapy, 20 to 60 mg has been satisfactory for a majority of patients.

Use: For the treatment of schizophrenia

Usual Adult Dose for Agitated State:

10 mg by oral inhalation once within a 24-hour period

Comments:
-To mitigate the risk of bronchospasm, all patients must undergo screening and examination prior to administration.
-This drug must be administered by a healthcare professional only in an enrolled healthcare facility.

Use: For the acute treatment of agitation associated with schizophrenia or bipolar I disorder

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

Loxapine 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 loxapine.

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).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unless your doctor tells you otherwise, continue your normal diet.

Avoid driving or operating machinery until you know how loxapine 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. Loxapine 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 loxapine, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

Loxapine 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 loxapine 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 loxapine 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 loxapine, 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.

Keep all appointments with your doctor.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.