Drugs List

Therapeutic Indications

Uses

Control of mild to moderate agitation in bipolar disorder
Control of mild to moderate agitation in schizophrenia

Contraindications

Children under 18 years
Acute respiratory impairment
Asthma
Chronic obstructive pulmonary disease
Respiratory disease

Precautions and Warnings

Acute alcohol intoxication
Drug intoxication
Family history of long QT syndrome
Patients over 65 years
Predisposition to hypotension
Predisposition to seizures
Breastfeeding
Cardiovascular disorder
Central nervous system depression
Cerebrovascular disorder
Electrolyte imbalance
Glaucoma
History of extrapyramidal disturbance
History of torsade de pointes
Long QT syndrome
Pregnancy
Respiratory depression
Torsade de pointes
Urinary retention

Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Observe patient closely during and immediately after administration
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Consider discontinuation if signs of tardive dyskinesia occur
Drug induced bronchospasm may occur
If hypotension requiring a vasopressor occurs adrenaline should not be used
Discontinue if patient develops neuroleptic malignant syndrome

Short acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side effects.

Mild hypotension has been reported in short-term, placebo-controlled trials in agitated patients taking inhaled loxapine. If vasopresser therapy is required, noradrenaline or phenylephrine is preferred. Avoid adrenaline.

Pregnancy and Lactation

Pregnancy

Use loxapine inhalation powder with caution in pregnancy.

Briggs suggests avoiding routine use of atypical antipsychotics in pregnancy. Schaefer suggests, due to lack of data, loxapine should not be used in pregnancy. However, use is not an indication for termination of pregnancy. The manufacturer suggests loxapine inhalation powder should only be used if the potential benefit justifies the potential risk to the foetus. New-borns repeatedly exposed to antipsychotics during third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms. Monitoring of new-born should be considered.

It is not known if loxapine crosses the human placenta although the molecular weight of the free base (about 328) suggests it will.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use loxapine inhalation powder with caution in breastfeeding.

The Drugs and Lactation Database (LactMed) suggests because no information is available on the use of loxapine in breastfeeding, an alternative may be preferred, especially while nursing a newborn or premature infant. Briggs suggests avoiding routine use. The manufacturer suggests avoiding breastfeeding for a period of 48 hours after receiving loxapine and discarding milk produced in the meantime.

The relatively low molecular weight of loxapine (about 328 for the free base) suggests the drug will be excreted into breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Akathisia
Bronchospasm
Cough
Dizziness
Dry mouth
Dysgeusia
Dyskinesia
Dystonia
Fatigue
Hypotension
Oculogyration
Restlessness
Sedation
Shortness of breath
Somnolence
Throat irritation
Tremor
Wheezing

Presentation

Inhalation powder containing loxapine

Drugs List

Therapeutic Indications

Uses

Control of mild to moderate agitation in bipolar disorder
Control of mild to moderate agitation in schizophrenia

Dosage

Patients should receive regular treatment immediately after control of acute agitation symptoms.

Adults

Elderly

Contraindications

Children under 18 years
Acute respiratory impairment
Asthma
Chronic obstructive pulmonary disease
Respiratory disease

Precautions and Warnings

Acute alcohol intoxication
Drug intoxication
Family history of long QT syndrome
Patients over 65 years
Predisposition to hypotension
Predisposition to seizures
Breastfeeding
Cardiovascular disorder
Central nervous system depression
Cerebrovascular disorder
Electrolyte imbalance
Glaucoma
History of extrapyramidal disturbance
History of torsade de pointes
Long QT syndrome
Pregnancy
Respiratory depression
Torsade de pointes
Urinary retention

Advise ability to drive/operate machinery may be affected by side effects
May reduce seizure threshold
Observe patient closely during and immediately after administration
Consider monitoring ECG in patients at risk of QT prolongation
Monitor serum electrolytes
Consider discontinuation if signs of tardive dyskinesia occur
Drug induced bronchospasm may occur
If hypotension requiring a vasopressor occurs adrenaline should not be used
Discontinue if patient develops neuroleptic malignant syndrome

Short acting beta-agonist bronchodilator treatment should be available for treatment of possible severe respiratory side effects.

Mild hypotension has been reported in short-term, placebo-controlled trials in agitated patients taking inhaled loxapine. If vasopresser therapy is required, noradrenaline or phenylephrine is preferred. Avoid adrenaline.

Pregnancy and Lactation

Pregnancy

Use loxapine inhalation powder with caution in pregnancy.

Briggs suggests avoiding routine use of atypical antipsychotics in pregnancy. Schaefer suggests, due to lack of data, loxapine should not be used in pregnancy. However, use is not an indication for termination of pregnancy. The manufacturer suggests loxapine inhalation powder should only be used if the potential benefit justifies the potential risk to the foetus. New-borns repeatedly exposed to antipsychotics during third trimester are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms. Monitoring of new-born should be considered.

It is not known if loxapine crosses the human placenta although the molecular weight of the free base (about 328) suggests it will.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use loxapine inhalation powder with caution in breastfeeding.

The Drugs and Lactation Database (LactMed) suggests because no information is available on the use of loxapine in breastfeeding, an alternative may be preferred, especially while nursing a newborn or premature infant. Briggs suggests avoiding routine use. The manufacturer suggests avoiding breastfeeding for a period of 48 hours after receiving loxapine and discarding milk produced in the meantime.

The relatively low molecular weight of loxapine (about 328 for the free base) suggests the drug will be excreted into breast milk.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Akathisia
Bronchospasm
Cough
Dizziness
Dry mouth
Dysgeusia
Dyskinesia
Dystonia
Fatigue
Hypotension
Oculogyration
Restlessness
Sedation
Shortness of breath
Somnolence
Throat irritation
Tremor
Wheezing

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: May 2016

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Adasuve 9.1 mg inhalation powder. Galen Ltd. Revised October 2015.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Loxapine. Last revised: 10 March 2015
Last accessed: 18 May 2016