Loxapine (Oral route)
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Loxapine is not approved for the treatment of patients with dementia-related psychosis .
Uses of This Medicine:
Loxapine is used to treat a mental condition called schizophrenia.
This medicine is available only with your doctor's prescription.
Before Using This Medicine:
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 this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of loxapine in the pediatric population. Safety and efficacy have not been established.
No information is available on the relationship of age to the effects of loxapine in geriatric patients. However, elderly patients (especially females) are more likely to have tardive dyskinesia (a movement disorder), which may require caution in patients receiving loxapine.
|All Trimesters||C||Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two 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 this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Morphine Sulfate Liposome
- Sodium Oxybate
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Betel Nut
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Other medical problems—
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Brain tumor or
- Intestinal blockage—Loxapine may interfere with the diagnosis of these conditions.
- Breast cancer, prolactin-dependent or
- Difficult urination or
- Glaucoma or
- Heart or blood vessel disease or
- Neuroleptic malignant syndrome (NMS), history of or
- Seizures, history of or
- Urinary retention—Use with caution. May make these conditions worse.
- Coma or
- Depression, severe and caused by medicines—Should not be used in patients with these conditions.
Proper Use of This Medicine:
Take this medicine only as directed by your doctor. Do not take more of it, 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 side effects.
The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine 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 using the medicine.
- For schizophrenia:
- For oral dosage form (capsules):
- Adults—At first, 20 to 50 milligrams (mg) per day, divided and given in two to four doses per day. Your doctor may increase your dose if needed. However, the dose is usually not more than 250 mg per day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (capsules):
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions While Using This Medicine:
It is very important that your doctor check your progress at regular visits, especially during the first few months of treatment with this medicine. This will allow changes in your dose and to check for unwanted effects.
Do not stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce 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 make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever or allergies; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking this medicine.
This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have any of the following symptoms while taking this medicine: lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.
Stop taking this medicine and check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).
This medicine may cause some people to become drowsy or less alert than they are normally, especially when 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 dry 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.
Side Effects of This Medicine:
- More common
- Difficulty with speaking or swallowing
- lip smacking or puckering
- loss of balance control
- mask-like face
- puffing of the cheeks
- rapid or fine, worm-like movements of the tongue
- restlessness or desire to keep moving
- shuffling walk
- slowed movements
- stiffness of the arms and legs
- trembling and shaking of the fingers and hands
- uncontrolled chewing movements
- uncontrolled movements of the arms or legs
- Less common
- Constipation (severe)
- difficult urination
- inability to move the eyes
- muscle spasms, especially of the neck and back
- skin rash
- twisting movements of the body
- Convulsions (seizures)
- difficult or fast breathing
- fast heartbeat or irregular pulse
- fever (high)
- high or low blood pressure
- increased blinking or spasms of the eyelid
- increased sweating
- loss of bladder control
- muscle stiffness (severe)
- sore throat and fever
- uncontrolled twisting movements of neck, trunk, arms, or legs
- unusual bleeding or bruising
- unusual facial expressions or body positions
- unusual tiredness or weakness
- unusually pale skin
- 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)
- More common
- Blurred vision
- dizziness, lightheadedness, or fainting
- dryness of the mouth
- Less common
- Constipation (mild)
- decreased sexual ability
- enlargement of breasts (males and females)
- increased sensitivity of the skin to sun
- missing menstrual periods
- nausea or vomiting
- trouble with sleeping
- unusual secretion of milk
- weight gain
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Get emergency help immediately if any of the following symptoms of overdose occur:
Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Last Updated: 11/4/2014