Adasuve inhalation

Name: Adasuve inhalation

For Healthcare Professionals

Applies to loxapine: inhalation powder, intramuscular solution, oral capsule, oral concentrate

General

The most common adverse reactions reported with use of the inhaler were dysgeusia, sedation and throat irritation. Drowsiness, extrapyramidal reactions and akathisia have been reported frequently, especially during the first few days of oral therapy.[Ref]

Gastrointestinal

Very common (10% or more): Dysgeusia (up to 14%)
Common (1% to 10%): Dry mouth, throat irritation
Frequency not reported: Constipation, excessive salivation, paralytic ileus, nausea, tongue protrusion, vomiting[Ref]

Dysgeusia and throat irritation occurred with inhaled formulations.[Ref]

Nervous system

Very common (10% or more): Sedation/somnolence (up to 12%)
Common (1% to 10%): Dizziness
Uncommon (0.1% to 1%): Akathisia/restlessness, dystonia, dyskinesia, neck dystonia, tremor
Frequency not reported: Akinesia, drowsiness, extrapyramidal symptoms, faintness, headache, involuntary muscle contractions, lightheadedness, masked facies, numbness, paresthesia, neuroleptic malignant syndrome, parkinsonian-like symptoms, seizures, shuffling gait, slurred speech, staggering gait, tardive dyskinesia[Ref]

Sedation occurred in up to 12% of patients who used inhaled formulations.

Drowsiness occurred in patients who used oral formulations.

Drowsiness has been frequently reported at the beginning of therapy or when the dosage is increased. It is generally mild and usually subsides with continued therapy. The incidence of sedation has been reported as less than certain aliphatic phenothiazines, and more than the piperazine phenothiazines.[Ref]

Other

Common (1% to 10%): Fatigue, weakness
Frequency not reported: Hyperpyrexia[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension
Frequency not reported: Tachycardia, hypertension, orthostatic hypotension, syncope, ECG changes, flushed facies[Ref]

A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known if these were related to loxapine administration.[Ref]

Psychiatric

Uncommon (0.1% to 1%): Restlessness
Frequency not reported: Agitation, confusional state, insomnia, tension[Ref]

Ocular

Uncommon (0.1% to 1%): Oculogyration
Frequency not reported: Blurred vision, dry eyes, ptosis[Ref]

Respiratory

Uncommon (0.1% to 1%): Bronchospasm/shortness of breath
Frequency not reported: Dyspnea, nasal congestion[Ref]

Bronchospasm occurred with inhaled formulations.

Use of the inhaler was shown to cause bronchospasm in clinical pulmonary safety trials as measured by FEV1 and respiratory signs and symptoms. Additionally, patients with asthma or other pulmonary diseases were shown to be at higher risk and the effect of FEV1 was greater following the second dose (administered 10 hours later).[Ref]

Endocrine

Rare (less than 0.1%): Galactorrhea, amenorrhea, gynecomastia, menstrual irregularity[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia, neutropenia, agranulocytosis[Ref]

Hepatic

Rare (less than 0.1%): Jaundice and/or hepatitis
Frequency not reported: Hepatocellular injury[Ref]

Hepatocellular injury described as AST/ALT elevation has been reported in association with loxapine administration; rarely, jaundice and/or hepatitis has been reported as possibly related to treatment.[Ref]

Dermatologic

Frequency not reported: Dermatitis, facial edema, pruritus, rash, alopecia, seborrhea[Ref]

Metabolic

Frequency not reported: Weight gain, weight loss, polydipsia[Ref]

Musculoskeletal

Frequency not reported: Muscle twitching, rigidity[Ref]

Hypersensitivity

Frequency not reported: Serious skin reactions[Ref]

Genitourinary

Frequency not reported: Urinary retention[Ref]

Some side effects of Adasuve may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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