Loxapine (Inhalation)

Inhaled loxapine is used to treat sudden agitation in adult patients with schizophrenia or bipolar I disorder (a type of depression). It acts in the brain to raise levels of dopamine and serotonin, which are chemicals that help manage agitation, schizophrenia, and depression. Loxapine is an antipsychotic medicine.

This medicine is available only through a special restricted distribution program called the Adasuve® REMS program.

It is very important that your doctor checks your progress after you receive this medicine. This will help your doctor see if the medicine is working properly and decide if you should keep taking it.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects (for example, withdrawal syndrome) in newborn babies if used during the later part of pregnancy.

This medicine may cause bronchospasm (narrowing of the airways) and may lead to breathing problems. Tell your doctor right away if you experience chest tightness, cough, or trouble breathing.

Check with your doctor right away if you have seizures, difficulty breathing, a fast heartbeat, 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.

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, contact your doctor.

This medicine may cause blurred vision, dizziness, drowsiness, difficulty 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 driving, using machines, or doing other tasks that require you to be alert, well-coordinated, or able to think or see clearly.

This medicine may increase the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants include antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, or sleeping medicines, prescription pain medicines or narcotics, medicines for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your doctor before taking any of these after you receive this medicine.

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

In deciding to use a medicine, it is important to consider the risks and benefits together with your doctor. For this medicine, the following points should be noted:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also let your healthcare professional know if you have any other allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies have not been done on how age affects the use of inhaled loxapine in children. Safety and effectiveness have not been established.

Geriatric

Studies have not been done on how age affects the use of inhaled loxapine in older adults. There are no specific problems expected that would limit the use of inhaled loxapine in the elderly. However, this medicine should not be used for behavioral issues in older adults with dementia.

Breast Feeding

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

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In such cases, your doctor may adjust the dose or take other precautions. It is very important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been chosen based on 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.

• 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 frequency of use for 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 may be necessary for your treatment. If both medicines are prescribed together, your doctor may adjust the dose or frequency of use for one or both medicines.

• Betel Nut

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used around the time of eating or with certain foods, as interactions may occur. Using alcohol or tobacco with some medicines may also cause interactions. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Other Medical Problems

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

• History of alcohol or drug abuse or dependence
• History of fainting
• Glaucoma
• Hypotension (low blood pressure)
• History of seizures
• Urinary retention (difficulty passing urine)—Use with caution. May worsen these conditions.

• Dehydration
• History of heart attack
• Heart failure
• Heart or blood vessel disease
• Heart rhythm problems
• Hypertension (high blood pressure)
• Hypovolemia (low blood volume)
• History of stroke—May worsen side effects.

• Lung or breathing problems (e.g., asthma, COPD), or history of—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 occur, if they do, they may need medical attention.

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

Less common

• Blurred vision
• confusion
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• seizures
• sweating
• unusual tiredness or weakness

Rare

• Inability to sit still
• need to keep moving
• restlessness

Incidence not known

• Chest tightness
• cough
• decrease in the frequency of urination
• decrease in urine volume
• decreased vision
• difficulty in passing urine (dribbling)
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• eye pain
• fast, pounding, or irregular heartbeat or pulse
• headache
• high fever
• inability to move the eyes
• increased blinking or spasms of the eyelid
• increased sweating
• loss of balance control
• loss of bladder control
• mask-like face
• nausea or vomiting
• nervousness
• noisy breathing
• painful urination
• pounding in the ears
• severe muscle stiffness
• shuffling walk
• slowed movements
• slurred speech
• sticking out of tongue
• tearing of eyes
• tic-like (jerky) movements of the head, face, mouth, and neck
• tiredness
• trembling and shaking of the fingers and hands
• trouble breathing, speaking, or swallowing
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual facial expressions
• unusually pale skin

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

• Change in taste
• drowsiness
• loss of taste
• sleepiness or unusual drowsiness

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.

• Adasuve

Available Dosage Forms:

• Powder

Therapeutic Class: Antipsychotic

Chemical Class: Dibenzoxazepine

A doctor or other trained health professional will give you this medicine in a hospital. This medicine is breathed in (inhaled) through the mouth and into the lungs.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Your doctor will check you for breathing problems before and after receiving this medicine.

• What drugs cause tardive dyskinesia?