Loxitane

Loxitane is used for:

Treating schizophrenia. It may also be used for other conditions as determined by your doctor.

Loxitane is a tricyclic antipsychotic. Exactly how Loxitane works is unknown.

Do NOT use Loxitane if:

• you are allergic to any ingredient in Loxitane or to other similar medicines
• you have severe central nervous system depression (eg, severe drowsiness), are in a coma, or have been sedated
• you are taking sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Loxitane :

Some medical conditions may interact with Loxitane . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of other mental problems, heart problems, glaucoma, difficulty urinating or risk factors for difficult urination, Parkinson disease, breast cancer, liver problems, brain growths or cancer, a stomach blockage, or seizures
• if you are very ill or weakened
• if you are dependent on alcohol or drink large amounts of alcohol regularly

Some MEDICINES MAY INTERACT with Loxitane . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), narcotics (eg, codeine), or sodium oxybate ( GHB) because the risk of side effects, such as severe drowsiness, may be increased
• Anticholinergics (eg, trihexyphenidyl) because side effects of Loxitane may be increased
• Benzodiazepines (eg, lorazepam) because side effects may be increased by Loxitane

This may not be a complete list of all interactions that may occur. Ask your health care provider if Loxitane may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Loxitane :

Use Loxitane as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Loxitane may be taken with or without food.
• Using Loxitane at the same times each day will help you to remember to take it.
• Use Loxitane regularly to receive the most benefit from it.
• Continue to use Loxitane even if you feel well. Do not miss any doses.
• If you miss a dose of Loxitane , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Loxitane .

Important safety information:

• Loxitane may cause drowsiness, dizziness, or blurred vision. Alcohol, hot weather, exercise, and fever can increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Also, sit or lie down at the first sign of dizziness, lightheadedness, or weakness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Loxitane . Using Loxitane alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
• Avoid drinking alcohol or taking other medications that cause drowsiness (eg, sedatives, tranquilizers) while taking Loxitane . Loxitane will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
• Do not become overheated in hot weather or during exercise or other activities because heatstroke may occur.
• Neuroleptic malignant syndrome (NMS) is a potentially deadly syndrome associated with Loxitane . Symptoms include: Increased body heat; muscle rigidness; altered mental abilities, including lack of response to your surroundings; irregular pulse and blood pressure; increased heart rate; sweating; irregular heart rhythm. Contact your doctor at once if any of these symptoms occur.
• Involuntary and uncontrollable movements may develop in patients taking Loxitane . Occurrence is highest among the elderly, especially women. The risk of developing these involuntary muscle movements and the likelihood they will become permanent are increased with long-term use and with high doses. However, it is possible to develop these symptoms after short-term treatment at low doses. Contact your health care provider at once if any of the following occur: Involuntary movements of the tongue, face, mouth, or jaw (eg, protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements), sometimes accompanied by involuntary movements of the arms and legs.
• Use Loxitane with caution in the ELDERLY because they may be more sensitive to its effects, especially involuntary muscle movements.
• Loxitane is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Loxitane during pregnancy. It is unknown if Loxitane is excreted in breast milk. If you are or will be breast-feeding while you are using Loxitane , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Loxitane :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Blurred vision; constipation; dizziness; drowsiness; dry mouth; headache; nausea; stuffy nose; trouble sleeping; vomiting; weight gain or loss.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); agitation; altered mental abilities, including lack of response to your surroundings; chills or persistent sore throat; confusion; dark urine; decreased urination; fainting or faintness; fast or irregular heartbeat; hyperactivity; increased saliva production; increased thirst; involuntary, uncontrolled muscle movements; menstrual changes; mental or mood changes; muscle twitching; numbness or tingling of the skin; restlessness; seizures; shortness of breath; severe constipation; slurred speech; staggering or shuffling gait; stiff or rigid muscles; sweating; tremor; unexplained fever; vision changes; yellowing of the eyes or skin.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased urination; difficulty breathing; involuntary, uncontrolled muscle movements; loss of consciousness; seizures; severe or persistent dizziness.

Store Loxitane at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Loxitane out of the reach of children and away from pets.

General information:

• If you have any questions about Loxitane , please talk with your doctor, pharmacist, or other health care provider.
• Loxitane is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Loxitane . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.