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loxapine inhaled (Rx)Brand and Other Names:Adasuve

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for oral inhalation

  • 10mg/single-use inhaler
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Schizophrenia & Bipolar I Agitation

Indicated for acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults

10 mg inhaled PO once within a 24-hr period

Must be administered only by a healthcare professional

Dosing Considerations

Because of the risk of bronchospasm, is only available through a restricted program under a risk evaluation and mitigation strategy (REMS) and must be administered only in an enrolled healthcare facility

Prior to administering, screen all patients for a history of asthma, COPD, or other pulmonary disease, and examine patients (including chest auscultation) for respiratory signs (eg, wheezing)

Administration

Step 1. Open pouch and remove inhaler from package (indicator light on inhaler is off)

Step 2. Firmly pull the plastic tab from the rear of the inhaler; check that the green light turns on to indicate that the inhaler is ready for use

Use the inhaler within 15 minutes after removing the tab to prevent automatic deactivation of the inhaler; the green light will turn off, indicating that the inhaler is not usable

Discard the inhaler after one use

Step 3. Explain procedure to patient; inform the patient that the inhaler may produce a flash of light and a clicking sound, and it may become warm during use

Step 4. Instruct the patient to hold the inhalator away from the mouth and breathe out fully to empty the lungs

Step 5. Instruct the patient to put the mouthpiece of the inhaler between the lips, close the lips, and inhale through the mouthpiece with a steady deep breath; check that the green light turns off indicating that the dose has been delivered

Step 6. Instruct the patient to remove the mouthpiece from the mouth and hold the breath for as long as possible, up to 10 seconds

NOTE: If the green light remains on after the patient inhales, the dose has NOT been delivered; instruct the patient to repeat Steps 4-6 up to 2 additional times; if the green light still does not turn off, discard the inhaler and use a new one

Safety and efficacy not established

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Interactions

Interaction Checker

loxapine inhaled and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Respiratory adverse effects in patients with COPD (19%)

            Dysgeusia (14%)

            Sedation (12%)

            1-10%

            Throat irritation (3%)

            <1%

            Bronchospasm (0.8%)

            Akathisia (0.4%)

            Neck dystonia and oculogyration (0.4%)

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            Warnings

            Black Box Warnings

            Bronchospasm

            • Can cause bronchospasm that has the potential to lead to respiratory distress and respiratory arrest
            • Administer only in an enrolled healthcare facility that has immediate access on-site to equipment and personnel trained to manage acute bronchospasm, including advanced airway management (intubation and mechanical ventilation)
            • Prior to administering, screen patients regarding a current diagnosis, history, or symptoms of asthma, COPD and other lung diseases, and examine (including chest auscultation) patients for respiratory signs
            • Monitor for signs and symptoms of bronchospasm following treatment

            Dementia-related psychosis

            • Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death as shown in short-term controlled trials
            • The deaths appeared to be either cardiovascular (eg, heart failure, stroke, sudden death) or infectious (eg, pneumonia) in nature
            • This drug is not approved for the treatment of patients with dementia-related psychosis

            Contraindications

            Current diagnosis or history of asthma, COPD, or other lung disease associated with bronchospasm

            Acute respiratory symptoms or signs (eg, wheezing)

            Current use of medications to treat airways disease, such as asthma or COPD

            History of bronchospasm following treatment

            Known hypersensitivity (including serious skin reactions) to loxapine or amoxapine

            Cautions

            Can cause bronchospasm (see Black Box Warnings)

            Monitor for signs and symptoms of bronchospasm following administration; perform a physical exam, including chest auscultation at least q15min for at least 1 hr after the dose

            Increased mortality in elderly patients with demential-related psychosis (see Black Box Warnings)

            Antipsychotic drugs can cause neuroleptic malignant syndrome; symptoms include hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability; associated findings include increased CPK, rhabdomyolysis, increased urine and serum myoglobin, and renal failure

            May cause hypotension, orthostatic hypotension, and syncope

            Lowers seizure threshold

            May cause cognitive and motor impairment

            May cause sedation and somnolence; caution when coadministered with other drugs known to cause CNS depression

            May cause anticholinergic adverse reactions, including exacerbation of glaucoma and urinary retention; caution when coadministered with other drugs that elicit anticholinergic effects

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            Pregnancy & Lactation

            Pregnancy Category: C

            Neonates exposed to antipsychotic drugs during the 3rd trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery

            These complications vary in severity; in some cases, symptoms have been self-limited, while in other cases neonates have required intensive care unit support and prolonged hospitalization

            Lactation: Unknown whether distributed in breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Typical antipsychotic (dibenzoxazepine subclass of tricyclic antipsychotic agents); mechanism of action is unknown, but is theorized to antagonize central dopamine D2 and serotonin 5-HT2a receptors

            Absorption

            Peak Plasma Time: 2 minutes

            Peak Plasma Concentration: 257 ng/mL

            AUC: 66 ng•h/mL (0-2 hr); 188 ng•h/mL (infinity)

            Distribution

            Protein Bound: 96.6%

            Metabolism

            Metabolized extensively in the liver by hydroxylation; forms 8-OH-loxapine by CYP1A2 and forms 7-OH-loxapine by CYP3A4 and CYP2D6

            Metabolized by N-oxidation to form loxapine N-oxide by flavanoid monoamine oxidases

            Demethylated to form amoxapine Because there are multiple metabolic pathways, the risk of metabolic interactions caused by an effect on an individual isoform is minimal

            Because there are multiple metabolic pathways, the risk of metabolic interactions caused by an effect on an individual isoform is minimal

            Elimination

            Half-life: 7.16 hr (range 6-8 hr)

            Excretion: feces (unconjugated metabolites); urine (conjugated metabolites)

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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