Loxapine

What is Loxapine?

• Loxapine (Adasuve) is a typical antipsychotic used primarily in the treatment of schizophrenia.

Loxapine

Loxapine2D

Loxapine

Loxapine3D

What are the uses of this medicine?

• Adasuve is a prescription medicine that is inhaled through your mouth and is used to treat acute agitation in adults with schizophrenia or bipolar I disorder.

How does this medicine work?

• The mechanism of action of loxapine in the treatment of agitation associated with schizophrenia is unknown.
• However, its efficacy could be mediated through a combination of antagonism of central dopamine D 2 and serotonin 5-HT 2A receptors.
• The mechanism of action of loxapine in the treatment of agitation associated with bipolar I disorder is unknown.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have or have had asthma, chronic obstructive pulmonary disease (COPD), or other airway or lung problems that can cause bronchospasm
• are having problems with wheezing, coughing, chest tightness, or shortness of breath
• are taking medicines to treat asthma or COPD
• have taken Adasuve before and had bronchospasm
• are allergic to loxapine or amoxapine

What drug interactions can this medicine cause?

• The concurrent use of Adasuve with other CNS depressants (e.g., alcohol, opioid analgesics, benzodiazepines, tricyclic antidepressants, general anesthetics, phenothiazines, sedative/hypnotics, muscle relaxants, and/or illicit CNS depressants) can increase the risk of respiratory depression, hypotension, profound sedation, and syncope. Therefore, consider reducing the dose of CNS depressants if used concomitantly with Adasuve.
• The concomitant use of Adasuve and other anticholinergic drugs can increase the risk of anticholinergic adverse reactions including exacerbation of glaucoma and urinary retention.

Is this medicine FDA approved?

• The US Food and Drug Administration (FDA) has approved in the year of 1975 for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.

How should this medicine be used?

• Administer only a single dose within any 24-hour period
• Prior to administering, screen all patients for a history of pulmonary disease, and examine patients (including chest auscultation) for respiratory abnormalities (e.g. wheezing) .

Recommended dosage:

• 10 mg by oral inhalation using an inhaler.
• Administer only a single dose within any 24-hour period.

Administration:

• Your healthcare provider will show you how to take Adasuve right before you take it.
• Take Adasuve exactly as your healthcare provider shows you to take it.
• Adasuve is for oral inhalation only.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Inhalation powder: 10 mg unit in a single-use inhaler
• Loxapine Capsules

This medicine is available in fallowing brand namesː

• Adasuve(inhalation only) LOXAPINE capsule

What side effects can this medication cause?

The most common side effects of this medicine include:

• bad, bitter, or metallic taste in your mouth (dysgeusia)
• sleepiness (especially when used with other drugs that cause sleepiness)
• sore throat

This medicine may cause serious side effects, including:

• Narrowing of the airways (bronchospasm) that can cause you to have problems breathing or to stop breathing
• Increased risk of death in elderly patients with dementia-related psychosis

What special precautions should I follow?

• Do not drive, operate heavy machinery, or do other dangerous activities until you know how Adasuve affects you.
• Do not drink alcohol while taking Adasuve. It can increase your chances of getting serious side effects.
• Neuroleptic Malignant Syndrome may develop in patients treated with antipsychotic drugs. Discontinue treatment.
• Adasuve can cause hypotension, orthostatic hypotension, and syncope. Use with caution in patients with known cardiovascular or cerebrovascular disease.
• Seizures have occurred in patients treated with oral loxapine. Adasuve lowers the seizure threshold. Use with caution in patients with a history of seizures or with conditions that lower the seizure threshold.
• Adasuve can impair judgment, thinking, and motor skills. Use caution when driving or operating machinery
• cerebrovascular adverse reactions (stroke and transient ischemic attacks), including fatalities have occured. Increased incidence of stroke and transient ischemic attack in elderly patients with dementia-related psychosis treated with antipsychotic drugs.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• CNS depression
• unconsciousness
• profound hypotension
• respiratory depression
• extrapyramidal symptoms
• seizure

Management of overdosage:

• Provide supportive care including close medical supervision and monitoring.
• Treatment should consist of general measures employed in the management of overdosage with any drug.
• Consider the possibility of multiple drug overdosage.
• Ensure an adequate airway, oxygenation, and ventilation.
• Monitor cardiac rhythm and vital signs. Use supportive and symptomatic measures.
• Contact a certified poison control center (1-800-222-1222 or www.poison.org).

Can this medicine be used in pregnancy?

• There are no adequate and well-controlled studies of Adasuve use in pregnant women.
• Adasuve should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Can this medicine be used in children?

• The safety and effectiveness of Adasuve in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: loxapine
• Inactive Ingredients: none

Who manufactures and distributes this medicine?

• Manufactured for: Galen US Inc., 25 Fretz Road, Souderton, PA
• Manufactured by: Alexza Pharmaceuticals, Inc., Mountain View, CA

What should I know about storage and disposal of this medication?

• Store Adasuve at room temperature, 15° to 30°C (59° to 86°F) .
• Keep out of reach of children.
• Keep Adasuve in pouch until time of use.
• Adasuve contains a lithium battery. Dispose of Adasuve in accordance with all federal, state and local laws.
• Adasuve is only available through a restricted program called the Adasuve REMS Program.

Antipsychotic agents

First Generation

• Phenothiazines
  • Chlorpromazine, Fluphenazine, Perphenazine, Prochlorperazine, Thioridazine, Trifluoperazine

• Other
  • Haloperidol, Lithium, Loxapine, Molindone, Pimozide

Second Generation (Atypicals)

• Aripiprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Olanzapine, Paliperidone, Pimavanserin, Quetiapine, Risperidone, Ziprasidone

• Dailymed label info on Loxapine
• FDA Loxapine

The following are antidepressant subclasses and drugs

MAO Inhibitors Isocarboxazid, Phenelzine, Tranylcypromine

SNRIs Duloxetine, Levomilnacipran, Venlafaxine

SSRIs Citalopram, Escitalopram, Fluoxetine, Fluvoxamine, Paroxetine, Sertraline, Vilazodone, Vortioxetine

Tricyclics Amitriptyline, Amoxapine, Clomipramine, Desipramine, Doxepin, Imipramine, Nortriptyline, Protriptyline, Trimipramine

Miscellaneous Bupropion, Flibanserin, Mirtazapine, Nefazodone, Trazodone

Pharmacodynamics