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Applies to loxapine: oral capsule
Other dosage forms:
Oral route (Capsule)
Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death compared with placebo. Although the causes of death in clinical trials were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. It is unclear from these studies to what extent the mortality findings may be attributed to the antipsychotic drug as opposed to patient characteristics. Loxapine is not approved for the treatment of patients with dementia-related psychosis.
Along with its needed effects, loxapine 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:
Get emergency help immediately if any of the following symptoms of overdose occur while taking loxapine:
Symptoms of overdose
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:
Applies to loxapine: inhalation powder, intramuscular solution, oral capsule, oral concentrate
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.
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
Dysgeusia and throat irritation occurred with inhaled formulations.
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
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.
Common (1% to 10%): Fatigue, weakness
Frequency not reported: Hyperpyrexia
Uncommon (0.1% to 1%): Hypotension
Frequency not reported: Tachycardia, hypertension, orthostatic hypotension, syncope, ECG changes, flushed facies
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.
Uncommon (0.1% to 1%): Restlessness
Frequency not reported: Agitation, confusional state, insomnia, tension
Uncommon (0.1% to 1%): Oculogyration
Frequency not reported: Blurred vision, dry eyes, ptosis
Uncommon (0.1% to 1%): Bronchospasm/shortness of breath
Frequency not reported: Dyspnea, nasal congestion
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).
Rare (less than 0.1%): Galactorrhea, amenorrhea, gynecomastia, menstrual irregularity
Rare (less than 0.1%): Leukopenia, neutropenia, agranulocytosis
Rare (less than 0.1%): Jaundice and/or hepatitis
Frequency not reported: Hepatocellular injury
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.
Frequency not reported: Dermatitis, facial edema, pruritus, rash, alopecia, seborrhea
Frequency not reported: Weight gain, weight loss, polydipsia
Frequency not reported: Muscle twitching, rigidity
Frequency not reported: Serious skin reactions
Frequency not reported: Urinary retention
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