Adasuve
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Questions & Answers
Side Effects & Adverse Reactions
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
ADASUVE is a typical antipsychotic indicated for the acute treatment of agitation associated with schizophrenia or bipolar I disorder in adults.
"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 (14)].
The efficacy of ADASUVE was established in one study of acute agitation in patients with schizophrenia and one study of acute agitation in patients with bipolar I disorder [see Clinical Studies (14)].
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 (5.2)].
History
There is currently no drug history available for this drug.
Other Information
ADASUVE, a typical antipsychotic, is an inhalation powder of loxapine supplied in a single-use, disposable inhaler containing 10 mg of loxapine base. ADASUVE is a drug-device combination product.
Active Ingredient: Loxapine (base). Loxapine, a dibenzoxazepine compound, represents a subclass of tricyclic antipsychotic agents, chemically distinct from the thioxanthenes, butyrophenones, and phenothiazines. Chemically, it is 2-Chloro-11-(4-methyl-1-piperazinyl) dibenz [b,f] [1,4] oxazepine.
ADASUVE is a single-use, drug-device combination product that provides rapid systemic delivery by inhalation of a thermally-generated aerosol of loxapine. Oral inhalation through the product initiates the controlled rapid heating of a thin film of excipient-free loxapine to form a thermally-generated drug vapor. The vapor condenses into aerosol particles that are dispersed into the airstream created by the patient inhaling through the mouthpiece.
Each product is packaged inside a sealed foil pouch. The product is a white to off-white plastic unit, with a mouthpiece on one end and a pull-tab protruding from the other end.
Removal of a pull-tab from the product renders it ready for use, as indicated by illumination of a green light. After inhalation through the mouthpiece, successful dosing is signaled by the green light turning off.
Under standardized in vitro test conditions, ADASUVE, 10 mg delivers 9.1 mg of loxapine out of the mouthpiece.
Sources
Adasuve Manufacturers
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Teva Select Brands
![Adasuve (Loxapine) Aerosol, Powder [Teva Select Brands]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Adasuve | Teva Select Brands
2.1 Dosing InformationADASUVE 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 (5.1)].
2.2 Required Examination Prior to DosingPrior 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 (5.1)].
2.3 Important Administration InstructionsRead 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.
Figure 3.
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.
2.4 Monitoring to Assess SafetyMonitor 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 (5.1)].
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