Loxapine

Older adults with dementia (loss of memory and brain function) may have an increased chance of death if treated with antipsychotic medications such as loxapine.

Loxapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior problems in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking loxapine.

Loxapine is used to treat the symptoms of schizophrenia (a mental illness that affects how a person thinks, feels and behaves). Loxapine is in a group of medications called antipsychotics. It works by decreasing abnormal excitement in the brain.

Loxapine comes as a capsule to take by mouth. Take two to four times a day. Try to take loxapine at around the same times every day.

Take loxapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor will probably start you on a low dose of loxapine and increase your dose during the first 7 to 10 days of your treatment until your symptoms are controlled. Once your symptoms have been controlled for some time, your doctor may decrease your dose. Be sure to tell your doctor how you are feeling during your treatment with loxapine.

Loxapine may control your symptoms but will not cure your condition. It may take several weeks or longer for you to feel the full benefit of loxapine. Continue to take loxapine even if you feel well. Do not stop taking loxapine without talking to your doctor.

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

Before taking loxapine,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking loxapine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had seizures, difficulty urinating, glaucoma (condition in which increased pressure in the eye can lead to gradual loss of vision), trouble keeping your balance, breast cancer, or heart disease. Also tell your doctor if you have ever had to stop taking any medication for mental illness due to severe side effects.
• tell your doctor if you are pregnant, if you plan to become pregnant, or are breast-feeding. If you become pregnant while taking loxapine, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking loxapine.
• you should know that this medication may make you drowsy and may affect your thinking and movements. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcohol during your treatment with loxapine. Alcohol can make the side effects of loxapine worse.
• you should know that loxapine may cause dizziness, fainting, and lightheadedness, especially when you get up from a lying position. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.

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

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Loxapine may cause side effects. Tell your doctor if any of these symptoms or those in the SPECIAL PRECAUTIONS section are severe or do not go away:

• feeling unsteady, or having trouble keeping your balance
• faintness
• weakness
• difficulty falling asleep or staying asleep
• blurred vision
• dry mouth
• increased saliva
• nausea, vomiting, constipation
• difficulty urinating
• excessive thirst
• weight gain or loss
• agitation
• slurred speech
• headache
• unusual, slowed, or uncontrollable movements of any part of the body
• restlessness
• numbness, burning, or tingling of the hands or feet
• breast milk production
• breast enlargement
• missed menstrual periods
• decreased sexual ability in men

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately:

• fever, stiff muscles; sweating; confusion; sweating; or fast, pounding, or irregular heartbeat
• rash, itching
• falling down
• neck cramps
• tightness in the throat, difficulty breathing or swallowing
• tongue that sticks out of the mouth, fine, worm-like tongue movements
• uncontrollable, rhythmic face, mouth, or jaw movements
• seizures
• changes in vision, especially in low light

Loxapine may cause other side effects. Tell your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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).

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• sleepiness
• loss of consciousness
• slowed breathing
• slowed heartbeat
• unusual, slowed, or uncontrollable movements of any part of the body
• seizures

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.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Loxitane^®¶

• Oxilapine