Loxapine (Oral)

Loxapine is used to treat a condition called schizophrenia. This medicine should not be used to treat behavioral problems in older adult patients who have dementia.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to ensure this medicine is working properly. Blood tests may be needed 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 help prevent your condition from worsening.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). Using alcohol or other CNS-affecting medicines with loxapine may worsen side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble sleeping. Some examples of medicines that affect the CNS are antihistamines or medicines for allergies or colds, sedatives, tranquilizers, sleeping medicines, medicines for depression, medicines for anxiety, prescription pain medicines or narcotics, medicines for attention deficit and hyperactivity disorder, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.

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.

Check with your doctor right away if you have any of the following symptoms while using this medicine: convulsions (seizures), difficulty 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 blurred vision, dizziness, drowsiness, trouble thinking, trouble controlling body movements, or vision problems, which may lead to falls, fractures, or other injuries. Make sure you know how you react to this medicine before you drive, use machines, or do other tasks that require you to be alert, coordinated, or able to think or see well.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If the problem continues or gets worse, check with your doctor.

Loxapine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If possible, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you develop a fever, chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Check with your doctor immediately if blurred vision, difficulty reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye 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 diseases, including tooth decay, gum disease, and fungal infections.

This medicine may increase prolactin blood levels if used for a long time. Check with your doctor if you have breast swelling or soreness, unusual breast milk production, absent, missed, or irregular menstrual periods, stopping of menstrual bleeding, loss of sexual ability, desire, drive, or performance, decreased interest in sexual intercourse, or an inability to have or keep an erection.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you need to think about the risks of taking it compared to the benefits it may provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional about any other allergies you have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how loxapine affects children. Its safety and effectiveness have not been established in the pediatric population.

Geriatric

There is no information on how loxapine affects older adults. However, elderly patients (especially females) are more likely to develop tardive dyskinesia (a movement disorder), which may require caution when prescribing loxapine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In some cases, two different medicines may be used together even if an interaction may happen. If you are taking this medicine, it is very important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are significant but may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to prescribe this medicine or may adjust your other medicines.

• Bromopride
• Metoclopramide
• Potassium Citrate

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both medicines.

• Acepromazine
• Alfentanil
• Alprazolam
• Amantadine
• Amifampridine
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amobarbital
• Amoxapine
• Anileridine
• Aripiprazole
• Asenapine
• Baclofen
• Belladonna
• Belladonna Alkaloids
• Benperidol
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Bupropion
• Buspirone
• Butabarbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carbamazepine
• Carbinoxamine
• Carisoprodol
• Carphenazine
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Chlorpromazine
• Chlorzoxazone
• Clobazam
• Clomipramine
• Clonazepam
• Clorazepate
• Clozapine
• Codeine
• Cyclobenzaprine
• Daridorexant
• Desipramine
• Dexmedetomidine
• Diacetylmorphine
• Diazepam
• Dibenzepin
• Dichloralphenazone
• Difenoxin
• Dihydrocodeine
• Diphenhydramine
• Diphenoxylate
• Donepezil
• Doxepin
• Doxylamine
• Droperidol
• Enflurane
• Epinephrine
• Esketamine
• Estazolam
• Eszopiclone
• Ethchlorvynol
• Ethopropazine
• Ethylmorphine
• Fentanyl
• Flibanserin
• Fluphenazine
• Flurazepam
• Fluspirilene
• Fospropofol
• Gabapentin
• Gabapentin Enacarbil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Halazepam
• Haloperidol
• Halothane
• Hexobarbital
• Hydrocodone
• Hydromorphone
• Hydroxyzine
• Imipramine
• Isoflurane
• Ketamine
• Ketazolam
• Ketobemidone
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lithium
• Lofepramine
• Lofexidine
• Lorazepam
• Magnesium Oxybate
• Meclizine
• Melitracen
• Melperone
• Meperidine
• Mephobarbital
• Meprobamate
• Meptazinol
• Mesoridazine
• Metaxalone
• Methacholine
• Methadone
• Methdilazine
• Methocarbamol
• Methohexital
• Methotrimeprazine
• Methylene Blue
• Midazolam
• Molindone
• Moricizine
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Nitrazepam
• Nitrous Oxide
• Nortriptyline
• Olanzapine
• Opipramol
• Opium
• Opium Alkaloids
• Orphenadrine
• Oxazepam
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Pentazocine
• Pentobarbital
• Perampanel
• Perazine
• Periciazine
• Perphenazine
• Phenobarbital
• Pimozide
• Piperacetazine
• Pipotiazine
• Piritramide
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Prochlorperazine
• Promazine
• Promethazine
• Propofol
• Protriptyline
• Quazepam
• Quetiapine
• Ramelteon
• Remifentanil
• Remimazolam
• Remoxipride
• Revefenacin
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Secretin Human
• Sertindole
• Sodium Oxybate
• Sufentanil
• Sulpiride
• Suvorexant
• Tapentadol
• Temazepam
• Thiethylperazine
• Thiopental
• Thiopropazate
• Thioridazine
• Tianeptine
• Tilidine
• Tiotropium
• Tizanidine
• Tolonium Chloride
• Topiramate
• Tramadol
• Trazodone
• Triazolam
• Trifluoperazine
• Trifluperidol
• Triflupromazine
• Trimeprazine
• Trimipramine
• Zaleplon
• Zolpidem
• Zopiclone
• Zotepine
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both medications may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or how often you take one or both of the medicines.

• Betel Nut

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken at the same time as certain foods or types of food to avoid interactions. Drinking alcohol or using tobacco with certain medicines may also cause interactions. The following interactions are significant but may not include all possible interactions.

Other Medical Problems

Having other medical issues may affect how this medicine works for you. Make sure you inform your doctor if you have any other medical problems, especially:

• Blood or bone marrow issues (e.g., leukopenia, neutropenia) or
• Breast cancer, prolactin-dependent or
• Glaucoma or
• Heart or blood vessel disease or
• Hyperprolactinemia (high prolactin levels in the blood) or
• Liver disease or
• Neuroleptic malignant syndrome (NMS), history of or
• Seizures, history of or
• Urinary retention (difficulty passing urine)—Use with caution. This may worsen these conditions.

• Bowel blockage or
• Brain tumor—This medicine may hide symptoms in patients with these conditions.

• Coma or
• Severe depression caused by medicines—This medicine should not be used in patients with these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may happen, if they do occur, they may need medical attention.

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

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

Rare

• 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)
• seizures
• sore throat and fever
• uncontrolled twisting movements of the 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

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
• drowsiness (severe)
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
• pale or blue lips, fingernails, or skin
• troubled breathing (severe)
• unusual tiredness or weakness (severe)

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:

More common

• Blurred vision
• confusion
• dizziness, lightheadedness, or fainting
• drowsiness
• dryness of the mouth

Less common

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

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.

In the U.S.

• Loxitane

Available Dosage Forms:

• Capsule

Therapeutic Class: Antipsychotic

Chemical Class: Dibenzoxazepine

Take this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

To use the oral liquid:

• Measure the medicine only with the measuring dropper provided.
• Mix the medicine with orange juice or grapefruit juice before drinking.

Dosing

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 (Loxitane® capsules and solution): Adults—At first, 10 milligrams (mg) 2 times a day. Some patients may need 50 mg 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.

Missed Dose

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.

Storage

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.

• What drugs cause tardive dyskinesia?