Loxapine

Loxapine is a medication used to treat schizophrenia.

Loxapine may also be used for other reasons not mentioned in this medication guide.

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

You may not feel better immediately 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.

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.

You should not use loxapine if you are allergic to loxapine or amoxapine, or if you have decreased alertness from certain medications or 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 another 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 become 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.

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.

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 patientsTitrate rapidly over the first 7 to 10 days until symptoms are effectively controlledMaintenance Dose: 60 mg to 100 mg daily in divided doses, 2 to 4 times a dayMaximum dose: 250 mg/dayComments:-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 periodComments:-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

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

Taking loxapine with other medications that can make you sleepy or slow your breathing may lead to serious or life-threatening side effects. Consult your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medications for anxiety or seizures.

Other medications may interact with loxapine, including both prescription and over-the-counter drugs, vitamins, and herbal products. Inform your doctor about all the medicines you are currently taking and any that you begin or stop using.