In the U.S.—

In Canada—

• Antianxiety agent–antidepressant
• Antipsychotic

Loxapine ( LOX-a-peen) is used to treat nervous, mental, and emotional conditions.

Loxapine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Solution (U.S. and Canada)
• Capsules (U.S.)
• Tablets (Canada)

Parenteral
• Injection (U.S. and Canada)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For loxapine, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to loxapine or amoxapine. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Loxapine has not been shown to cause birth defects or other problems in humans. However, animal studies have shown unwanted effects in the fetus.

Breast-feeding—It is not known if loxapine passes into breast milk.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of loxapine in children with use in other age groups.

Older adults—Elderly patients are usually more sensitive than younger adults to the effects of loxapine. Constipation, dizziness or fainting, drowsiness, dry mouth, trembling of the hands and fingers, and symptoms of tardive dyskinesia (such as rapid, worm-like movements of the tongue or any other uncontrolled movements of the mouth, tongue, or jaw, and/or arms and legs) are especially likely to occur in elderly patients.

Other medicines—Although certain medicines should not be used together at all, in other cases 2 different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking loxapine, it is especially important that your health care professional know if you are taking any of the following:

• Amoxapine (e.g., Asendin) or
• Methyldopa (e.g., Aldomet) or
• Metoclopramide (e.g., Reglan) or
• Metyrosine (e.g., Demser) or
• Other antipsychotics (medicine for mental illness) or
• Pemoline (e.g., Cylert) or
• Pimozide (e.g., Orap) or
• Promethazine (e.g., Phenergan) or
• Rauwolfia alkaloids (alseroxylon [e.g., Rauwiloid], deserpidine [e.g., Harmonyl], rauwolfia serpentina [e.g., Raudixin], reserpine [e.g., Serpasil]) or
• Trimeprazine (e.g., Temaril)—Taking these medicines with loxapine may increase the chance and seriousness of some side effects

• Central nervous system (CNS) depressants (medicine that causes drowsiness) or
• Tricyclic antidepressants (medicine for depression)—Taking these medicines with loxapine may increase the CNS depressant effects

• Guanadrel (e.g., Hylorel) or
• Guanethidine (e.g., Ismelin)—Loxapine may decrease the effects of these medicines

• Alcohol abuse—CNS depressant effects may be increased

• Difficult urination or
• Enlarged prostate or
• Glaucoma (or predisposition to) or
• Parkinson's disease—Loxapine may make the condition worse

• Heart or blood vessel disease—An increased risk of low blood pressure (hypotension) or changes in the rhythm of your heart may occur

• Liver disease—Higher blood levels of loxapine may occur, increasing the chance of side effects

• Seizure disorders—Loxapine may increase the risk of seizures

This medicine may be taken with food or a full glass (8 ounces) of water or milk to reduce stomach irritation.

For patients taking the oral solution:

• Measure the solution only with the dropper provided by the manufacturer. This will give a more accurate dose.

The liquid medicine must be mixed with orange juice or grapefruit juice just before you take it to make it easier to take.

Do not take more of this medicine, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of unwanted effects.

Dosing—

The dose of loxapine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of loxapine. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules or tablets or amount of solution that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking loxapine.

• For oral dosage forms (capsules, oral solution, or tablets):
  • Adults: To start, 10 milligrams taken two times a day. Your doctor may increase your dose if needed.
  • Children up to 16 years of age: The dose must be determined by the doctor.
• For injection dosage form:
  • Adults: 12.5 to 50 milligrams every four to six hours, injected into a muscle.
  • Children up to 16 years of age: The dose must be determined by the doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is within one hour of your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store the capsule or tablet form of this medicine in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the liquid form of this medicine from freezing.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

Your doctor should check your progress at regular visits, especially during the first few months of treatment with this medicine. The amount of loxapine you take may be changed often to meet the needs of your condition and to help avoid side effects.

Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to reduce gradually the amount you are taking before stopping completely. This will allow your body time to adjust and to keep your condition from becoming worse.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.

Do not take this medicine within two hours of taking antacids or medicine for diarrhea. Taking loxapine and antacids or medicine for diarrhea too close together may make this medicine less effective.

This medicine may cause some people to become drowsy or less alert than they are normally, especially as the amount of medicine is increased. Even if you take this medicine at bedtime, you may feel drowsy or less alert on arising. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert.

Although it is not a problem for most patients, dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. Getting up slowly may help. However, if the problem continues or gets worse, check with your doctor.

Loxapine may cause your skin to be more sensitive to sunlight than it is normally. Exposure to sunlight, even for brief periods of time, may cause a skin rash, itching, redness or other discoloration of the skin, or a severe sunburn. When you begin taking this medicine:

• Stay out of direct sunlight, especially between the hours of 10:00 a.m. and 3:00 p.m., if possible.
• Wear protective clothing, including a hat. Also, wear sunglasses.
• Apply a sun block product that has a skin protection factor (SPF) of at least 15. Some patients may require a product with a higher SPF number, especially if they have a fair complexion. If you have any questions about this, check with your health care professional.
• Apply a sun block lipstick that has an SPF of at least 15 to protect your lips.
• Do not use a sunlamp or tanning bed or booth.

If you have a severe reaction from the sun, check with your doctor.

Loxapine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Before having any kind of surgery, dental treatment, or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine. Taking loxapine together with medicines that are used during surgery or dental or emergency treatments may increase the CNS depressant effects.

Along with its needed effects, loxapine can sometimes cause serious side effects. Tardive dyskinesia (a movement disorder) may occur and may not go away after you stop using the medicine. Signs of tardive dyskinesia include fine, worm-like movements of the tongue, or other uncontrolled movements of the mouth, tongue, cheeks, jaw, or arms and legs. Other serious but rare side effects may also occur. These include severe muscle stiffness, fever, unusual tiredness or weakness, fast heartbeat, difficult breathing, increased sweating, loss of bladder control, and seizures (neuroleptic malignant syndrome). You and your doctor should discuss the good this medicine will do as well as the risks of taking it.

Stop taking loxapine and get emergency help immediately if any of the following side effects occur:

• Rare
  • Convulsions (seizures);  difficult or fast breathing;  fast heartbeat or irregular pulse ;  fever (high);  high or low blood pressure;  increased sweating;  loss of bladder control;  muscle stiffness (severe);  unusually pale skin;  unusual tiredness or weakness 
  
  

Check with your doctor immediately if any of the following side effects occur:

• More common
  • Lip smacking or puckering;  puffing of cheeks;  rapid or fine, worm-like movements of tongue ;  uncontrolled chewing movements;  uncontrolled movements of arms or legs 
  
  

Also, check with your doctor as soon as possible if any of the following side effects occur:

• More common (occurring with increase of dosage)
  • Difficulty in speaking or swallowing;  loss of balance control;  mask-like face;  restlessness or desire to keep moving;  shuffling walk;  slowed movements;  stiffness of arms and legs;  trembling and shaking of fingers and hands 
  
  

• Less common
  • Constipation (severe);  difficult urination ;  inability to move eyes;  muscle spasms, especially of the neck and back;  skin rash;  twisting movements of the body 
  
  

• Rare
  • Sore throat and fever;  increased blinking or spasms of eyelid;  uncontrolled twisting movements of neck, trunk, arms, or legs;  unusual bleeding or bruising;  unusual facial expressions or body positions ;  yellow eyes or skin 
  
  

• Symptoms of overdose
  • Dizziness (severe);  drowsiness (severe) ;  muscle trembling, jerking, stiffness, or uncontrolled movements (severe);  troubled breathing (severe);  unusual tiredness or weakness (severe) 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome:

• More common
  • Blurred vision;  confusion;  dizziness, lightheadedness, or fainting;  drowsiness;  dryness of mouth 
  
  

• Less common
  • Constipation (mild);  decreased sexual ability;  enlargement of breasts (males and females) ;  headache;  increased sensitivity of skin to sun;  missing menstrual periods;  nausea or vomiting;  trouble in sleeping ;  unusual secretion of milk;  weight gain 
  
  

Certain side effects of this medicine may occur after you have stopped taking it. Check with your doctor as soon as possible if you notice any of the following effects after you have stopped taking loxapine:

• Dizziness;  nausea and vomiting;  rapid or worm-like movements of the tongue;  stomach upset or pain;  trembling of fingers and hands ;  uncontrolled chewing movements 

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, loxapine is used in certain patients with the following medical condition:

• Anxiety associated with mental depression

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.