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CNS Effects: Manifestations of adverse effects on the central nervous system, other than extrapyramidal effects, have been seen infrequently. Drowsiness, usually mild, may occur at the beginning of therapy or when dosage is increased. It usually subsides with continued Loxapine (Loxitane) therapy. The incidence of sedation has been less than that of certain aliphatic phenothiazines and slightly more than the piperazine phenothiazines. Dizziness, staggering gait, faintness, shuffling gait, weakness, muscle twitching, insomnia, tension, agitation, seizures, slurred speech, akinesia, numbness, and confusional states have been reported. Neuroleptic malignant syndrome (NMS) has been reported.

Extrapyramidal Reactions - Neuromuscular (extrapyramidal) reactions during the administration of Loxitane have been reported frequently, open during the first few days of treatment. In most patients, these reactions involved parkinsonian-like symptoms such as tremor, rigidity, excessive salivation, and masked facies. Akathisia (motor restlessness) also has been reported relatively frequently. These symptoms are usually not severe and can be controlled by reduction of Loxitane (Loxapine Succinate) dosage or by administration of antiparkinson drugs in usual dosage. Dystonic and dyskinetic reactions have occurred less frequently, but may be more severe. Dystonias include spasms of muscles of the neck and face, tongue protrusion, and oculogyric movement. Dyskinetic reactions have been described in the form of choreoathetoid movements. These reactions sometimes require reduction or temporary withdrawal of loxapine dosage in addition to appropriate counteractive drugs.

Persistent Tardive Dyskinesia - As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may appear after drug therapy has been discontinued. The risk appears to be greater in elderly patients on high-dose therapy, especially females. The symptoms are persistent and in some patients appear to be irreversible. The syndrome is characterized by rhythmical involuntary movement of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities.

There is no known effective treatment for tardive dyskinesia; antiparkinson agents usually do not alleviate the symptoms of this syndrome. It is suggested that all antipsychotic agents be discontinued if these symptoms appear. Should it be necessary to reinstitute treatment, or increase the dosage of the agent, or switch to a different antipsychotic agent, the syndrome may be masked. It has been suggested that fine vermicular movements of the tongue may be an early sign of the syndrome, and if the medication is stopped at that time the syndrome may not develop.

Cardiovascular Effects: Tachycardia, hypertension, hypotension, orthostatic hypotension, lightheadedness, and syncope have been reported.

A few cases of ECG changes similar to those seen with phenothiazines have been reported. It is not known whether these were related to Loxitane (Loxapine) administration.

Hematologic: Rarely, agranulocytosis, thrombocytopenia, leukopenia.

Skin: Dermatitis, pruritus, edema (puffiness of face), rash, alopecia, and seborrhea have been reported with loxapine.

Anticholinergic Effects: Dry mouth, constipation, nasal congestion, blurred vision, urinary retention, and paralytic ileus have occurred.

Gastrointestinal: Nausea and vomiting have been reported in some patients. Hepatocellular injury (i.e., SGOT/SGPT elevation) has been reported in association with loxapine administration and rarely, jaundice and/or hepatitis questionably related to Loxapine Succinate (Loxitane) treatment.

Other Adverse Reactions: Weight gain, dyspnea, weight loss, ptosis, flushed facies, hyperpyrexia, headache, paresthesia, and polydipsia have been reported in some patients. Rarely, galactorrhea, gynecomastia, amenorrhea, and menstrual irregularity of uncertain etiology have been reported.

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