Adasuve inhalation

Name: Adasuve inhalation

What should I discuss with my healthcare provider before receiving loxapine inhalation?

You should not be treated with this medicine if you are allergic to loxapine or amoxapine, or if you have:

  • trouble breathing with cough and wheezing;

  • a history of asthma, chronic obstructive pulmonary disease (COPD), or other lung problems;

  • a breathing disorder you are currently treating with medication; or

  • a history of having bronchospasm after using loxapine inhalation.

Loxapine is not approved for use in psychotic conditions related to dementia. Loxapine may increase the risk of death in older adults with dementia-related conditions.

To make sure loxapine inhalation is safe for you, tell your doctor if you have:

  • epilepsy or other seizure disorder;

  • high or low blood pressure;

  • glaucoma;

  • urination problems;

  • Parkinson's disease;

  • heart disease;

  • a history of heart attack or stroke; or

  • if you drink alcohol or use street drugs.

Tell your doctor if you are pregnant. Using antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles.

It is not known whether loxapine inhalation passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is loxapine inhalation given?

A healthcare provider will give you this medicine in a hospital or clinic setting where you can be quickly treated if any serious side effects occur.

Loxapine inhalation is usually given once every 24 hours as needed.

This medicine comes in a single-use inhaler device. You will be shown how to use this device. Follow all directions carefully.

The inhaler device has a green indicator light on one side and a pull tab at one end. When the pull tab is released the green light will turn on, showing that the device is ready for use.

Once the green light turns on, you must use the inhaler within 15 minutes or the device will deactivate. Do not try to use the inhaler if the green light is off.

While using the loxapine inhaler device, you may hear a clicking sound and the device may feel warm. These are normal functions. After you have inhaled your dose, the green light will turn off to show that the entire dose has been used.

You will be watched closely for at least 1 hour after using loxapine, to make sure you do not have any breathing problems.

Each single-use inhaler device of this medicine is for one use only. Throw the device away after one use.

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Side Effects

Consult your pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

List Adasuve 10 Mg Breath Activated side effects by likelihood and severity.

Loxapine Pregnancy Warnings

In rats, embryofetal toxicity has been demonstrated with doses approximately one-half of the maximum recommended human doses on a mg/m2 basis. Teratogenicity has not been demonstrated in the rat, rabbit, or dog. There are no controlled data in human pregnancy. Neonates exposed during the third trimester are at risk of developing severe and/or prolonged side effects (e.g., agitation, hyper/hypotonia, tremor, somnolence, respiratory distress, feeding disorder). The side effects have varied in severity and duration, with some neonates requiring intensive care support and prolonged hospitalization. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use is not recommended unless the benefit outweighs the risk to the fetus. US FDA pregnancy category: C Comment: Exposed neonates should be monitored for the signs/symptoms of extrapyramidal syndrome and/or withdrawal.

Administrative Information

LactMed Record Number

164

Last Revision Date

20150310

Disclaimer

Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. The U.S. government does not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.

(web3)