Pronunciation:

LOX-a-peen

Brand Names:

• Adasuve

Dosage Forms:

• Powder

Classifications:

Therapeutic—

Antipsychotic

Chemical—

Dibenzoxazepine

Uses of This Medicine:

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

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

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:

Allergies—

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of inhaled loxapine in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies have not been performed on the relationship of age to the effects of inhaled loxapine in the geriatric population, geriatric-specific problems are not expected to limit the usefulness of inhaled loxapine in the elderly. However, this medicine should not be used for behavioral problems in older adults with dementia.

Breast-feeding—

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.

Other medicines—

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 receiving 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.

• Bromopride
• Metoclopramide
• Potassium Citrate

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.

• 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 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

Other interactions—

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:

• Alcohol or drug abuse, or dependence, history of or
• Fainting, history of or
• Glaucoma or
• Hypotension (low blood pressure) or
• Seizures, history of or
• Urinary retention (trouble passing urine)—Use with caution. May make these conditions worse.

• Dehydration or
• Heart attack, history of or
• Heart failure or
• Heart or blood vessel disease or
• Heart rhythm problems or
• Hypertension (high blood pressure) or
• Hypovolemia (low blood volume) or
• Stroke, history of—May cause side effects to become worse.

• Lung or breathing problems (eg, asthma, COPD), or history of—Should not be used in patients with these conditions.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

It is very important that your doctor check your progress after you receive the medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Tell your doctor if you are pregnant or planning to become pregnant. This medicine may cause unwanted effects (eg, withdrawal syndrome) to 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 have a chest tightness, cough, or trouble breathing.

Check with your doctor right away if you are having seizures, difficulty with 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, check with your doctor.

This medicine may cause blurred vision, dizziness, drowsiness, trouble with thinking, trouble with controlling body movements, or trouble with your vision, 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 jobs that require you to be alert, well-coordinated, or able to think or see well.

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

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.

Side Effects of This Medicine:

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 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.