Adasuve inhalation

Loxapine is an antipsychotic medication. It affects the actions of chemicals in your brain.

Loxapine is used to treat agitation related to schizophrenia or bipolar disorder.

Loxapine inhalation is given only in a hospital or clinic setting where any breathing problems can be quickly treated.

Loxapine inhalation may also be used for purposes not listed in this medication guide.

Consult your pharmacist.

How to use Adasuve 10 Mg Breath Activated

Consult your pharmacist.

Consult your pharmacist.

Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Missed Dose

Consult your pharmacist.

Storage

Consult your pharmacist.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.

You should not use Adasuve if you have breathing problems that can cause bronchospasm (such as asthma or COPD), or if you are currently having trouble breathing with cough and wheezing. You should not use this medicine if you have ever had breathing problems after using it in the past.

Adasuve inhalation can cause bronchospasm (wheezing, chest tightness, shortness of breath) that can lead to serious lung problems or make your breathing stop. This medicine must be given in a hospital or clinic setting where your doctor can quickly treat any serious side effects that occur.

Adasuve 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.

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

Using Adasuve with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before taking a sleeping pill, narcotic pain medicine, prescription cough medicine, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all the medicines you have recently used, especially:

• cold or allergy medicine;

• medicine to treat Parkinson's disease;

• medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;

• bladder or urinary medicines; or

• a bronchodilator or other medicines to treat lung problems such as asthma or COPD.

This list is not complete. Other drugs may interact with loxapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Applies to loxapine: oral capsule, oral solution, oral tablet

Other dosage forms:

• inhalation powder

Along with its needed effects, loxapine (the active ingredient contained in Adasuve) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking loxapine:

• Difficulty with speaking or swallowing
• lip smacking or puckering
• loss of balance control
• mask-like face
• puffing of the cheeks
• rapid or fine, worm-like movements of the tongue
• restlessness or desire to keep moving
• shuffling walk
• slowed movements
• stiffness of the arms and legs
• trembling and shaking of the fingers and hands
• uncontrolled chewing movements
• uncontrolled movements of the arms or legs

• Constipation (severe)
• difficult urination
• inability to move the eyes
• muscle spasms, especially of the neck and back
• skin rash
• twisting movements of the body

• Difficult or fast breathing
• fast heartbeat or irregular pulse
• fever (high)
• high or low blood pressure
• increased blinking or spasms of the eyelid
• increased sweating
• loss of bladder control
• muscle stiffness (severe)
• seizures
• sore throat and fever
• uncontrolled twisting movements of the neck, trunk, arms, or legs
• unusual bleeding or bruising
• unusual facial expressions or body positions
• unusual tiredness or weakness
• unusually pale skin
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur while taking loxapine:

• Dizziness, faintness, or lightheadedness when suddenly getting up from a lying or sitting position
• drowsiness (severe)
• irregular, fast or slow, or shallow breathing
• loss of consciousness
• muscle trembling, jerking, stiffness, or uncontrolled movements (severe)
• pale or blue lips, fingernails, or skin
• troubled breathing (severe)
• unusual tiredness or weakness (severe)

Some side effects of loxapine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Blurred vision
• confusion
• dizziness, lightheadedness, or fainting
• drowsiness
• dryness of the mouth

• Constipation (mild)
• decreased sexual ability
• enlargement of the breasts (males and females)
• headache
• increased sensitivity of the skin to sunlight
• missing menstrual periods
• nausea or vomiting
• trouble with sleeping
• unusual secretion of milk
• weight gain

Summary of Use during Lactation

Because no information is available on the use of loxapine during breastfeeding, an alternate drug may be preferred, especially while nursing a newborn or preterm infant.

Drug Levels

Maternal Levels. Relevant published information was not found as of the revision date.

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

Relevant published information was not found as of the revision date.

Effects on Lactation and Breastmilk

Loxapine can elevate serum prolactin.[2] The hyperprolactinemia is caused by the drug's dopamine-blocking action in the tuberoinfundibular pathway.[3]

The prolactin level in a mother with established lactation may not affect her ability to breastfeed.

Alternate Drugs to Consider

Haloperidol, Olanzapine

References

1. Meltzer HY, Fang VS, Goode DJ. Prolactin and neuroleptics: clinical implications for efficacy and toxicity. The effect of neuroleptics and alpha-methyl-para-tyrosine on serum prolactin levels in laboratory animals and man. Psychopharmacol Bull. 1978;14:5-7. PMID: 625539

2. Maguire GA. Prolactin elevation with antipsychotic medications: mechanisms of action and clinical consequences. J Clin Psychiatry. 2002;63(suppl 4):56-62. PMID: 11913677