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Adasuve Warnings and Precautions

Specific Precautions and Warnings for Adasuve

Some warnings and precautions to be aware of prior to using this drug include the following:
  • Adasuve can cause narrowing of the airways (bronchospasm), which can make it difficult to breathe and could even cause you to stop breathing. People who have asthma, COPD, or other lung problems that cause bronchospasm are more likely to develop bronchospasm from Adasuve. Your healthcare provider will check you for breathing problems before you use Adasuve and every 15 minutes for at least 1 hour after your dose. Let your healthcare provider know right away if you experience any breathing problems, such as:
    • Coughing
    • Wheezing
    • Chest tightness
    • Shortness of breath.
  • Because of the risk for bronchospasm, Adasuve is only available through a special program known as the Adasuve Risk Evaluation and Mitigation Strategy (REMS) program. The healthcare facility that gives you Adasuve must be enrolled in the program and must follow the program requirements. 
  • Antipsychotic medications, such as Adasuve, appear to increase the risk for stroke and death when used to treat behavioral problems and psychosis in people with dementia. Although deaths reported in people with dementia treated with antipsychotics were due to a variety of causes, the majority of deaths were from heart failure and infection. Antipsychotics are not approved to treat the behavioral symptoms associated with dementia.
  • Like other antipsychotic medications, Adasuve may cause a rare but life-threatening problem known as neuroleptic malignant syndrome (NMS). Seek immediate medical attention if you develop signs of NMS, which may include:
    • A high fever
    • Sweating
    • Stiff muscles
    • Confusion
    • A fast or irregular heart rate
    • Irregular blood pressure.
  • This medication can cause extreme drowsiness, which could affect your thinking, judgment, and motor skills. Do not perform any activities that require mental alertness, such as driving, until you know how this medication affects you. Alcohol and other medicines that cause drowsiness can make these effects worse. Do not drink alcohol during Adasuve treatment. 
  • Adasuve can cause low blood pressure (hypotension), which could lead to lightheadedness, dizziness, or fainting. Let your healthcare provider know if you have these symptoms during treatment. This can especially be a problem in people with heart disease or people who are dehydrated.
  • There have been reports of seizures occurring in people taking loxapine (the active ingredient in Adasuve) by mouth. Adasuve should be used cautiously in people with a seizure disorder.
  • This medicine could worsen glaucoma or urinary retention. Make sure your healthcare provider knows if you have these conditions before beginning Adasuve treatment.
  • Adasuve is a pregnancy Category C medication. This means it may not be safe for use during pregnancy. Talk to your healthcare provider about the risks and benefits of using the medicine during pregnancy (see Adasuve and Pregnancy).
  • It is unknown if Adasuve passes through breast milk. Therefore, if you are breastfeeding or plan to start, discuss this with your healthcare provider prior to using the drug (see Adasuve and Breastfeeding).
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Adasuve Drug Information

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