Xylac (Loxapine Succinate)

Loxapine is not approved for use in psychotic conditions related to dementia. Loxapine may increase the risk of death in older adults with dementia-related conditions.

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

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

Loxapine is not approved for use in psychotic conditions related to dementia. Loxapine may increase the risk of death in older adults with dementia-related conditions.

Long-term use of loxapine can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take loxapine, the more likely you are to develop this movement disorder. The risk of this side effect is higher in women and older adults.

To make sure loxapine is safe for you, tell your doctor if you have:

• epilepsy or other seizure disorder;
• a history of low white blood cell (WBC) counts;
• glaucoma;
• urination problems;
• Parkinson's disease;
• heart disease; or
• a history of breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking loxapine, do not stop taking it without your doctor's advice.

It is not known whether loxapine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Loxapine is not approved for use in psychotic conditions related to dementia. Loxapine may increase the risk of death in older adults with dementia-related conditions.

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

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

Loxapine is not approved for use in psychotic conditions related to dementia. Loxapine may increase the risk of death in older adults with dementia-related conditions.

Long-term use of loxapine can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take loxapine, the more likely you are to develop this movement disorder. The risk of this side effect is higher in women and older adults.

To make sure loxapine is safe for you, tell your doctor if you have:

• epilepsy or other seizure disorder;
• a history of low white blood cell (WBC) counts;
• glaucoma;
• urination problems;
• Parkinson's disease;
• heart disease; or
• a history of breast cancer.

Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking loxapine, do not stop taking it without your doctor's advice.

It is not known whether loxapine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

Stop using loxapine and call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• confusion, slurred speech;
• seizure (convulsions);
• sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough;
• little or no urinating;
• severe constipation; 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 may include:

• dizziness or drowsiness;
• problems with balance or walking;
• blurred vision;
• feeling restless or agitated;
• constipation;
• dry mouth, stuffy nose; or
• sleep problems (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.

Loxapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Avoid drinking alcohol. You should not take loxapine if you are under the effects of alcohol.

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 this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking loxapine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with loxapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take loxapine with a full glass of water.

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.

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

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.