"The U.S. Food and Drug Administration today approved the first generic versions of Abilify (aripiprazole). Generic aripiprazole is an atypical antipsychotic drug approved to treat schizophrenia and bipolar disorder.
“Psychomotor agitation” is defined in DSM-IV as “excessive motor activity associated with a feeling of inner tension.” Patients experiencing agitation often manifest behaviors that interfere with their care (e.g., threatening behaviors, escalating or urgently distressing behavior, self-exhausting behavior), leading clinicians to the use of rapidly absorbed antipsychotic medications to achieve immediate control of the agitation [see Clinical Studies].
Limitations of Use
As part of the ADASUVE REMS Program to mitigate the risk of bronchospasm, ADASUVE must be administered only in an enrolled healthcare facility [see WARNINGS AND PRECAUTIONS].
DOSAGE AND ADMINISTRATION
ADASUVE must be administered only by a healthcare professional. ADASUVE is administered by oral inhalation only. The recommended dose for acute agitation is 10 mg administered by oral inhalation, using a single-use inhaler. Administer only a single dose within a 24-hour period [see WARNINGS AND PRECAUTIONS].
Required Examination Prior to Dosing
Prior to administering ADASUVE, screen all patients for a history of asthma, COPD, or other pulmonary disease, and examine patients (including chest auscultation) for respiratory signs (e.g. wheezing) [see WARNINGS AND PRECAUTIONS].
Important Administration Instructions
Read all of these instructions prior to administering ADASUVE.
Step 1. Open the Pouch
When ready to use, tear open the foil pouch and remove the inhaler from the package (see Figure 1).
Figure 1: Tearing the pouch
When the ADASUVE inhaler is removed from the pouch, the indicator light is off (see Figure 2).
Figure 2: ADASUVE Inhaler with Indicator Light
Step 2. Pull Tab
Firmly pull the plastic tab from the rear of the inhaler (see Figure 3). Check that the green light turns on. This indicates 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 Procedures to the Patient
Explain the administration procedures to the patient prior to use, and advise the patient that it is important to follow the instructions. Inform the patient that the inhaler may produce a flash of light and a clicking sound, and it may become warm during use. These are normal.
Step 4. Instruct the Patient to Exhale
Instruct the patient to hold the inhaler away from the mouth and breathe out fully to empty the lungs (see Figure 4).
Figure 4: Exhale
Step 5. Instruct the Patient to Inhale
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 (see Figure 5). Check that the green light turns off indicating that the dose has been delivered.
Figure 5: Inhale
Step 6. Instruct the Patient to Hold Breath
Instruct the patient to remove the mouthpiece from the mouth and hold the breath for as long as possible, up to 10 seconds (see Figure 6).
Figure 6: Hold Breath
Important: If the green light remains on after the patient inhales, the dose of ADASUVE has NOT been delivered. Instruct the patient to repeat Step 4, Step 5, and Step 6 up to 2 additional times. If the green light still does not turn off, discard the inhaler and use a new one.
Monitoring to Assess Safety
Monitor the patient for signs and symptoms of bronchospasm after ADASUVE administration. Perform a physical examination, including chest auscultation, at least every 15 minutes for at least one hour after ADASUVE administration [see WARNINGS AND PRECAUTIONS].
Dosage Forms And Strengths
ADASUVE is an inhalation powder supplied in a single-use, disposable inhaler containing 10 mg of loxapine base.
ADASUVE™ (loxapine) inhalation powder is supplied as:
ADASUVE 10 mg (NDC 51097-001-01) is a single-use, disposable inhaler containing 10 mg of loxapine, provided in a sealed foil pouch. ADASUVE, 10 mg is supplied in a carton of 5 units per carton.
ADASUVE is only available through a restricted program called the ADASUVE REMS Program [see WARNINGS AND PRECAUTIONS].
Storage and Handling
Store ADASUVE at room temperature, 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
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.
Manufactured by:Alexza Pharmaceuticals, Inc., Mountain View, CA 94043. Issued: 12/2012This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/14/2013
Additional Adasuve Information
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